82 FR 35071 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Closed Loop Hysteroscopic Insufflator With Cutter-Coagulator
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 144 (July 28, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 144 (July 28, 2017)
| Page Range | 35071-35073 | |
| FR Document | 2017-15892 |
[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)] [Rules and Regulations] [Pages 35071-35073] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-15892] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 884 [Docket No. FDA-2017-N-1914] Medical Devices; Obstetrical and Gynecological Devices; Classification of the Closed Loop Hysteroscopic Insufflator With Cutter-Coagulator AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is classifying the closed loop hysteroscopic insufflator with cutter- coagulator into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the closed loop hysteroscopic insufflator with cutter-coagulator classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. DATES: This order is effective July 28, 2017. The classification was applicable on March 28, 2014. FOR FURTHER INFORMATION CONTACT: Veronica Price, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G116, Silver Spring, MD 20993-0002, 301-796-6538. SUPPLEMENTARY INFORMATION: I. Background In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations. Section 513(f)(2) of the FD&C Act, also known as De Novo classification, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification [[Page 35072]] under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of ``low-moderate risk'' or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed. In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA shall classify the device by written order within 120 days. This classification will be the initial classification of the device. On September 5, 2013, IOGYN, Inc., submitted a request for classification of the IOGYN System, Models FG-0200, FG-0201, and FG- 0202 under section 513(f)(2) of the FD&C Act. In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on March 28, 2014, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 884.1710. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a closed loop hysteroscopic insufflator with cutter-coagulator will need to comply with the special controls named in the final order. A De Novo classification decreases regulatory burdens. When FDA classifies a device type as class I or II via the De Novo pathway, other manufacturers do not have to submit a De Novo request or premarket approval application in order to market the same type of device, unless the device has a new intended use or technological characteristics that raise different questions of safety or effectiveness. Instead, manufacturers can use the less burdensome pathway of 510(k), when necessary, to market their device, and the device that was the subject of the original De Novo classification can serve as a predicate device for additional 510(k)s from other manufacturers. The device is assigned the generic name closed loop hysteroscopic insufflator with cutter-coagulator, and it is identified as a prescription device configured for hysteroscopic insufflation, resection, and coagulation. It is used to perform diagnostic and surgical procedures (i.e., resection and coagulation). This device type contains a closed loop recirculating fluid management system for the controlled delivery of filtered distension fluid. This device type also contains a bipolar radiofrequency device used in conjunction with a hysteroscope for resection and coagulation of intrauterine tissues. FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in Table 1: Table 1--Closed Loop Hysteroscopic Insufflator With Cutter-Coagulator Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risks Mitigation measures ------------------------------------------------------------------------ Adverse tissue reaction................ Biocompatibility. Labeling. Equipment malfunction leading to injury Non-clinical Performance Testing. Software Verification, Validation, and Hazards Analysis. Labeling. Training. Recirculated fluid causes adverse Biocompatibility. tissue reaction. Non-clinical Performance Testing. Fluid overload, embolism, perforation Non-clinical Performance or other adverse events. Testing. Software Verification, Validation, and Hazards Analysis. Labeling. Training. Infection.............................. Sterility. Shelf Life Testing. Non-clinical Performance Testing. Electromagnetic interference/electrical Electromagnetic Compatibility safety issues. Testing. Electrical Safety Testing. Labeling. Operator error leading to patient Labeling. injury. Training. ------------------------------------------------------------------------ FDA believes that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. Closed loop hysteroscopic insufflators with cutter-coagulator are not safe for use except under the supervision of a practitioner licensed by law to direct use of the device. As such, the device is a prescription device and must satisfy prescription labeling requirements (see 21 CFR 801.109 Prescription devices). Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k), if [[Page 35073]] FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification (510(k)), prior to marketing the device, which contains information on the closed loop hysteroscopic insufflator with cutter-coagulator they intend to market. II. Analysis of Environmental Impact We have determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. III. Paperwork Reduction Act of 1995 This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in part 801 regarding labeling have been approved under OMB control number 0910-0485. List of Subjects in 21 CFR Part 884 Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 884 is amended as follows: PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES 0 1. The authority citation for part 884 is revised to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 884.1710 to subpart B to read as follows: Sec. 884.1710 Closed loop hysteroscopic insufflator with cutter- coagulator. (a) Identification. A closed loop hysteroscopic insufflator with cutter-coagulator is a prescription device configured for hysteroscopic insufflation, resection, and coagulation. It is used to perform diagnostic and surgical procedures (i.e., resection and coagulation). This device type contains a closed-loop recirculating fluid management system for the controlled delivery of filtered distension fluid. This device type also contains a bipolar radiofrequency device used in conjunction with a hysteroscope for resection and coagulation of intrauterine tissues. (b) Classification. Class II (special controls). The special control(s) for this device are: (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Software validation, verification, and hazard analysis must be provided. (3) Electrical equipment safety, including appropriate thermal and mechanical safety and electromagnetic compatibility (EMC) testing must be performed. (4) Device components that are labeled sterile must be validated to a sterility assurance level of 10-\6\. (5) Shelf-life testing that demonstrates the device packaging maintains sterility and the functionality of the device is maintained following simulated shipping and handling must be provided to support the proposed shelf life. (6) Non-clinical testing data must demonstrate the performance characteristics of the device. Detailed protocols and the test reports must be provided for each test. (i) The following tests must be performed for the resection portion of the device: (A) Mechanical testing to assess critical joint strength. (B) Device electrode temperature testing. (C) Coagulation depth testing. (D) Simulated use testing. (E) Device durability testing. (ii) The following tests must be performed for the fluid management portion of the device: (A) Mechanical testing to assess tensile strength of connections. (B) Pressure testing that demonstrates the following parameters, including accuracy of the pressure displayed; appropriate detection and response to overpressure conditions; activation of a secondary overpressure relief valve at the maximum safe level; and all accessories within the fluid path meet the pressure requirements. (C) Fluid delivery volume testing that demonstrates that the maximum fluid volume delivered is below a predefined level. (D) Flow rate testing. (E) Simulated use testing. (F) Filtration testing. (G) Blood filtration capacity testing. (H) Tissue collection capacity testing. (I) Filtrate characterization and testing that demonstrates that the continuous reintroduction of filtrate into the uterus does not pose a safety risk. (7) Clinician labeling must include: (i) Specific instructions and the clinical training needed for the safe use of the device. (ii) Appropriate warnings, precautions, and information related to overpressurization. (iii) Appropriate EMC information. (iv) An expiration date/shelf life. Dated: July 24, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-15892 Filed 7-27-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 144 / Friday, July 28, 2017 / Rules and Regulations 35071
effectiveness of the device. For this type (b) Classification. Class II (special classifying the closed loop
of device, FDA believes premarket controls). The special controls for this hysteroscopic insufflator with cutter-
notification is not necessary to provide device are: coagulator into class II (special
reasonable assurance of the safety and (1) The technical parameters of the controls). The special controls that will
effectiveness of the device type and, device, hardware and software, must be apply to the device are identified in this
therefore, is planning to exempt the fully characterized and include the order, and will be part of the codified
device from the premarket notification following information: language for the closed loop
requirements under section 510(m) of (i) Hardware specifications must be hysteroscopic insufflator with cutter-
the FD&C Act. Once finalized, persons provided. Additionally, verification and coagulator classification. The Agency is
who intend to market this device type validation testing as well as a hazard classifying the device into class II
need not submit a 510(k) premarket analysis must be performed. (special controls) in order to provide a
notification containing information on (ii) Software must be described in reasonable assurance of safety and
the cranial motion measurement device detail in the Software Requirements effectiveness of the device.
prior to marketing. Specification (SRS) and Software Design DATES: This order is effective July 28,
Specification (SDS). Additionally, 2017. The classification was applicable
II. Analysis of Environmental Impact software verification and validation on March 28, 2014.
The Agency has determined under 21 testing as well as a hazard analysis must
FOR FURTHER INFORMATION CONTACT:
CFR 25.34(b) that this action is of a type be performed.
(2) The device parts that contact the Veronica Price, Center for Devices and
that does not individually or Radiological Health, Food and Drug
cumulatively have a significant effect on patient must be demonstrated to be
biocompatible. Administration, 10903 New Hampshire
the human environment. Therefore, Ave., Bldg. 66, Rm. G116, Silver Spring,
neither an environmental assessment (3) The device must be designed and
tested for electrical, thermal, and MD 20993–0002, 301–796–6538.
nor an environmental impact statement
mechanical safety, and electromagnetic SUPPLEMENTARY INFORMATION:
is required.
compatibility (EMC). I. Background
III. Paperwork Reduction Act of 1995 (4) Clinical performance testing must
This final order establishes special demonstrate the accuracy, precision, In accordance with section 513(f)(1) of
controls that refer to previously stability, and repeatability of measuring the Federal Food, Drug, and Cosmetic
approved collections of information cranial motion per the intended use in Act (the FD&C Act) (21 U.S.C.
found in other FDA regulations. These the intended use environment. 360c(f)(1)), devices that were not in
collections of information are subject to (5) The labeling must include: commercial distribution before May 28,
review by the Office of Management and (i) The intended use population and 1976 (the date of enactment of the
Budget (OMB) under the Paperwork the intended use environment. Medical Device Amendments of 1976),
Reduction Act of 1995 (44 U.S.C. 3501– (ii) Instructions for technicians to generally referred to as postamendments
3520). The collections of information in convey to patients regarding the devices, are classified automatically by
part 807, subpart E, regarding premarket collection of cranial acceleration data to statute into class III without any FDA
notification submissions have been ensure device measurement accuracy, rulemaking process. These devices
approved under OMB control number precision, stability, and repeatability. remain in class III and require
0910–0120, and the collections of (iii) Information allowing clinicians to premarket approval, unless and until
information in 21 CFR part 801 understand potential sources of the device is classified or reclassified
regarding labeling have been approved variability in the measurement to help into class I or II, or FDA issues an order
under OMB control number 0910–0485. recognize and identify changes in the finding the device to be substantially
measurement. equivalent, in accordance with section
List of Subjects in 21 CFR Part 882 Dated: July 24, 2017. 513(i) of the FD&C Act, to a predicate
Medical devices; Neurological Leslie Kux,
device that does not require premarket
devices. approval. The Agency determines
Associate Commissioner for Policy.
Therefore, under the Federal Food, whether new devices are substantially
[FR Doc. 2017–15895 Filed 7–27–17; 8:45 am]
Drug, and Cosmetic Act and under equivalent to predicate devices by
BILLING CODE 4164–01–P means of premarket notification
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 882 is procedures in section 510(k) of the
amended as follows: FD&C Act (21 U.S.C. 360(k)) and part
DEPARTMENT OF HEALTH AND 807 (21 CFR part 807) of the regulations.
HUMAN SERVICES Section 513(f)(2) of the FD&C Act,
PART 882—NEUROLOGICAL DEVICES
Food and Drug Administration also known as De Novo classification, as
■ 1. The authority citation for part 882 amended by section 607 of the Food and
continues to read as follows: 21 CFR Part 884 Drug Administration Safety and
Authority: 21 U.S.C. 351, 360, 360c, 360e, Innovation Act (Pub. L. 112–144),
360j, 360l, 371. [Docket No. FDA–2017–N–1914] provides two procedures by which a
■ 2. Add § 882.1630 to subpart B to read person may request FDA to classify a
Medical Devices; Obstetrical and device under the criteria set forth in
as follows: Gynecological Devices; Classification section 513(a)(1). Under the first
asabaliauskas on DSKBBXCHB2PROD with RULES
§ 882.1630 Cranial motion measurement of the Closed Loop Hysteroscopic procedure, the person submits a
device. Insufflator With Cutter-Coagulator premarket notification under section
(a) Identification. A cranial motion AGENCY: Food and Drug Administration, 510(k) of the FD&C Act for a device that
measurement device is a prescription HHS. has not previously been classified and,
device that utilizes accelerometers to ACTION: Final order. within 30 days of receiving an order
measure the motion or acceleration of classifying the device into class III
the skull. These measurements are not SUMMARY: The Food and Drug under section 513(f)(1) of the FD&C Act,
to be used for diagnostic purposes. Administration (FDA, Agency, or we) is the person requests a classification
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![Federal Register / Vol. 82, No. 144 / Friday, July 28, 2017 / Rules and Regulations 35073
FDA determines that premarket coagulator is a prescription device (D) Flow rate testing.
notification is not necessary to provide configured for hysteroscopic (E) Simulated use testing.
reasonable assurance of the safety and insufflation, resection, and coagulation. (F) Filtration testing.
effectiveness of the device. For this type It is used to perform diagnostic and (G) Blood filtration capacity testing.
of device, FDA has determined that surgical procedures (i.e., resection and (H) Tissue collection capacity testing.
premarket notification is necessary to coagulation). This device type contains (I) Filtrate characterization and testing
provide reasonable assurance of the a closed-loop recirculating fluid that demonstrates that the continuous
safety and effectiveness of the device. management system for the controlled reintroduction of filtrate into the uterus
Therefore, this device type is not delivery of filtered distension fluid. does not pose a safety risk.
exempt from premarket notification This device type also contains a bipolar (7) Clinician labeling must include:
requirements. Persons who intend to radiofrequency device used in (i) Specific instructions and the
market this type of device must submit conjunction with a hysteroscope for clinical training needed for the safe use
to FDA a premarket notification resection and coagulation of intrauterine of the device.
(510(k)), prior to marketing the device, tissues. (ii) Appropriate warnings,
which contains information on the (b) Classification. Class II (special precautions, and information related to
closed loop hysteroscopic insufflator controls). The special control(s) for this overpressurization.
with cutter-coagulator they intend to device are: (iii) Appropriate EMC information.
market. (1) The patient-contacting (iv) An expiration date/shelf life.
components of the device must be
II. Analysis of Environmental Impact Dated: July 24, 2017.
demonstrated to be biocompatible.
(2) Software validation, verification, Leslie Kux,
We have determined under 21 CFR
and hazard analysis must be provided. Associate Commissioner for Policy.
25.34(b) that this action is of a type that
does not individually or cumulatively (3) Electrical equipment safety, [FR Doc. 2017–15892 Filed 7–27–17; 8:45 am]
have a significant effect on the human including appropriate thermal and BILLING CODE 4164–01–P
environment. Therefore, neither an mechanical safety and electromagnetic
environmental assessment nor an compatibility (EMC) testing must be
environmental impact statement is performed. DEPARTMENT OF HOMELAND
required. (4) Device components that are SECURITY
labeled sterile must be validated to a
III. Paperwork Reduction Act of 1995 sterility assurance level of 10¥6. Coast Guard
This final order establishes special (5) Shelf-life testing that demonstrates
controls that refer to previously the device packaging maintains sterility 33 CFR Parts 3, 20, 64, 67, 80, 82, 83,
approved collections of information and the functionality of the device is 84, 104, 105, 109, 110, 115, 117, 120,
found in other FDA regulations. These maintained following simulated 133, 135, 136, 137, 138, 151, 155, 157,
collections of information are subject to shipping and handling must be 159, 161, 162, 164, 165, 174, and 181
review by the Office of Management and provided to support the proposed shelf
Budget (OMB) under the Paperwork life. 46 CFR Parts 4, 28, 31, 39, 44, 50, 58,
(6) Non-clinical testing data must 63, 69, 71, 107, 110, 111, 116, 120, 127,
Reduction Act of 1995 (44 U.S.C. 3501–
demonstrate the performance 153, 154, 161, 162, 170, 177, 182, and
3520). The collections of information in
characteristics of the device. Detailed 189
part 807, subpart E, regarding premarket
protocols and the test reports must be
notification submissions have been [Docket No. USCG–2016–0498]
provided for each test.
approved under OMB control number (i) The following tests must be
0910–0120, and the collections of performed for the resection portion of Navigation and Navigable Waters, and
information in part 801 regarding the device: Shipping; Technical, Organizational,
labeling have been approved under (A) Mechanical testing to assess and Conforming Amendments
OMB control number 0910–0485. critical joint strength. AGENCY: Coast Guard, DHS.
List of Subjects in 21 CFR Part 884 (B) Device electrode temperature
testing. ACTION: Final rule.
Medical devices. (C) Coagulation depth testing.
Therefore, under the Federal Food, (D) Simulated use testing. SUMMARY: This final rule makes non-
Drug, and Cosmetic Act and under (E) Device durability testing. substantive technical, organizational,
authority delegated to the Commissioner (ii) The following tests must be and conforming amendments to existing
of Food and Drugs, 21 CFR part 884 is performed for the fluid management Coast Guard regulations. This rule will
amended as follows: portion of the device: have no substantive effect on the
(A) Mechanical testing to assess regulated public.
PART 884—OBSTETRICAL AND tensile strength of connections. DATES: This final rule is effective July
GYNECOLOGICAL DEVICES (B) Pressure testing that demonstrates 28, 2017.
the following parameters, including ADDRESSES: Documents mentioned in
■ 1. The authority citation for part 884 accuracy of the pressure displayed;
is revised to read as follows: this preamble as being available in the
appropriate detection and response to docket are part of docket USCG–2016–
Authority: 21 U.S.C. 351, 360, 360c, 360e, overpressure conditions; activation of a 0498, which is available at https://
asabaliauskas on DSKBBXCHB2PROD with RULES
360j, 360l, 371. secondary overpressure relief valve at regulations.gov.
■ 2. Add § 884.1710 to subpart B to read the maximum safe level; and all
accessories within the fluid path meet FOR FURTHER INFORMATION CONTACT: If
as follows: you have questions on this final rule,
the pressure requirements.
§ 884.1710 Closed loop hysteroscopic (C) Fluid delivery volume testing that call or email LCDR Felicia Raybon,
insufflator with cutter-coagulator. demonstrates that the maximum fluid Coast Guard; telephone 202–372–1499,
(a) Identification. A closed loop volume delivered is below a predefined email Felicia.K.Raybon@uscg.mil.
hysteroscopic insufflator with cutter- level. SUPPLEMENTARY INFORMATION:
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Document Created: 2017-07-28 03:10:13
Document Modified: 2017-07-28 03:10:13
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final order. | |
| Dates | This order is effective July 28, 2017. The classification was applicable on March 28, 2014. | |
| Contact | Veronica Price, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G116, Silver Spring, MD 20993-0002, 301-796-6538. | |
| FR Citation | 82 FR 35071 |
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