81 FR 40181 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Gynecologic Laparoscopic Power Morcellation Containment System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 119 (June 21, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 119 (June 21, 2016)
| Page Range | 40181-40183 | |
| FR Document | 2016-14627 |
[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)] [Rules and Regulations] [Pages 40181-40183] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-14627] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 884 [Docket No. FDA-2016-N-1318] Medical Devices; Obstetrical and Gynecological Devices; Classification of the Gynecologic Laparoscopic Power Morcellation Containment System AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying the gynecologic laparoscopic power morcellation containment system 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 gynecologic laparoscopic power morcellation containment system's 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 June 21, 2016. The classification was applicable on April 7, 2016. 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, [email protected]. 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, 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 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 will classify the device by written order within 120 days. This classification will be the initial classification of the device. On June 19, 2015, Advanced Surgical Concepts submitted a request for classification of the PneumoLiner device under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1). 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 [[Page 40182]] 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 April 7, 2016, 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 884.4050. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a gynecologic laparoscopic power morcellation containment system will need to comply with the special controls named in this final order. The device is assigned the generic name gynecologic laparoscopic power morcellation containment system and is identified as a prescription device consisting of an instrument port and tissue containment method that creates a working space allowing for direct visualization during a power morcellation procedure following a laparoscopic procedure for the excision of benign gynecologic tissue that is not suspected to contain malignancy. FDA has identified the following risks to health associated with this type of device and the measures required to mitigate these risks, in Table 1. Table 1--Gynecologic Laparoscopic Power Morcellation Containment System Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risk Mitigation measure ------------------------------------------------------------------------ Adverse tissue reaction................ Biocompatibility. Infection.............................. Sterilization validation, shelf life validation, and labeling. Intraperitoneal tissue dissemination Non-clinical performance (benign or malignant): testing (bench and animal),Material permeability; shelf life validation, labeling, and training. Improper function of containment device; Inadequate material strength; Physical trauma to liner caused by contact with morcellator or grasper/tenaculum; Damage to liner (intentional or accidental) from instrument inserted through secondary port; Tearing during removal with loss of contents into abdominal cavity; and Use error. Traumatic injury to non-target tissue/ Non-clinical performance organ: testing (bench and animal), Active end of morcellator or labeling, and training. grasper/tenaculum breaches liner; Loss of insufflation; Inadequate space to perform morcellation; Inadequate visualization of the laparoscopic instruments and tissue specimen relative to the external viscera; and Use error. Hernia through abdominal wall incision. Labeling and training. Prolongation of procedure and exposure Labeling and training. to anesthesia. ------------------------------------------------------------------------ FDA believes that the special controls, in addition to the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. A gynecologic laparoscopic power morcellation containment system is not safe for use except under the supervision of a practitioner licensed by law to direct the 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) of the FD&C Act if 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, prior to marketing the device, which contains information about the gynecologic laparoscopic power morcellation containment system they intend to market. II. Analysis of Environmental Impact The Agency has 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 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485. IV. Reference The following reference is on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also [[Page 40183]] available electronically at http://www.regulations.gov. 1. DEN150028: De novo request from Advanced Surgical Concepts, dated June 19, 2015. 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 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 0 2. Add Sec. 884.4050 to subpart E to read as follows: Sec. 884.4050 Gynecologic laparoscopic power morcellation containment system. (a) Identification. A gynecologic laparoscopic power morcellation containment system is a prescription device consisting of an instrument port and tissue containment method that creates a working space allowing for direct visualization during a power morcellation procedure following a laparoscopic procedure for the excision of benign gynecologic tissue that is not suspected to contain malignancy. (b) Classification. Class II (special controls). The special controls for this device are: (1) The patient-contacting components of the device must be demonstrated to be biocompatible; (2) Device components that are labeled sterile must be validated to a sterility assurance level of 10-\6\; (3) Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components, package integrity, and device functionality over the intended shelf life; (4) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested: (i) Demonstration of the device impermeability to tissue, cells, and fluids; (ii) Demonstration that the device allows for the insertion and withdrawal of laparoscopic instruments while maintaining pneumoperitoneum; (iii) Demonstration that the containment system provides adequate space to perform morcellation and adequate visualization of the laparoscopic instruments and tissue specimen relative to the external viscera; (iv) Demonstration that intended laparoscopic instruments and morcellators do not compromise the integrity of the containment system; and (v) Demonstration that intended users can adequately deploy the device, morcellate a specimen without compromising the integrity of the device, and remove the device without spillage of contents; (5) Training must be developed and validated to ensure users can follow the instructions for use; and (6) Labeling must include the following: (i) A contraindication for use in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy; (ii) Unless clinical performance data demonstrates that it can be removed or modified, a contraindication for removal of uterine tissue containing suspected fibroids in patients who are: Peri- or postmenopausal, or candidates for en bloc tissue removal, for example, through the vagina or via a mini-laparotomy incision; (iii) The following boxed warning: ``Warning: Information regarding the potential risks of a procedure with this device should be shared with patients. Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer. The use of this containment system has not been clinically demonstrated to reduce this risk.'' (iv) A statement limiting use of device to physicians who have completed the training program; and (v) An expiration date or shelf life. Dated: June 15, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-14627 Filed 6-20-16; 8:45 am] BILLING CODE 4164-01-P
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SUPPLEMENT NO. 4 TO PART 744—ENTITY LIST—Continued
Country Entity License requirement License review policy Federal Register citation
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Road, Deirah, Dubai, United Arab of the EAR).
Emirates; and P.O. Box 39948,
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* * * * * *
Mehrdad Moeinansari, a.k.a., the fol- For all items subject to Presumption of denial ...... 81 FR [INSERT FR PAGE
lowing one alias: the EAR. (See § 744.11 NUMBER] 6/21/16.
—Mehrdad Ansari. No 7101, Index of the EAR).
Tower DIFC, Dubai, U.A.E.; and
No 508, Sheikha Maryam Bldg.,
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* * * * * * *
Dated: June 9, 2016. Radiological Health, Food and Drug within 30 days of receiving an order
Kevin J. Wolf, Administration, 10903 New Hampshire classifying the device into class III
Assistant Secretary for Export Ave., Bldg. 66, Rm. G116, Silver Spring, under section 513(f)(1) of the FD&C Act,
Administration. MD 20993–0002, 301–796–6538, the person requests a classification
[FR Doc. 2016–14515 Filed 6–20–16; 8:45 am] veronica.price@fda.hhs.gov. under section 513(f)(2). Under the
BILLING CODE 3510–33–P SUPPLEMENTARY INFORMATION: second procedure, rather than first
submitting a premarket notification
I. Background under section 510(k) of the FD&C Act
DEPARTMENT OF HEALTH AND In accordance with section 513(f)(1) of and then a request for classification
HUMAN SERVICES the Federal Food, Drug, and Cosmetic under the first procedure, the person
Act (the FD&C Act) (21 U.S.C. determines that there is no legally
Food and Drug Administration 360c(f)(1)), devices that were not in marketed device upon which to base a
commercial distribution before May 28, determination of substantial
21 CFR Part 884 1976 (the date of enactment of the equivalence and requests a classification
Medical Device Amendments of 1976), under section 513(f)(2) of the FD&C Act.
[Docket No. FDA–2016–N–1318]
generally referred to as postamendments If the person submits a request to
Medical Devices; Obstetrical and devices, are classified automatically by classify the device under this second
Gynecological Devices; Classification statute into class III without any FDA procedure, FDA may decline to
of the Gynecologic Laparoscopic rulemaking process. These devices undertake the classification request if
Power Morcellation Containment remain in class III and require FDA identifies a legally marketed device
System premarket approval, unless and until that could provide a reasonable basis for
the device is classified or reclassified review of substantial equivalence with
AGENCY: Food and Drug Administration, into class I or II, or FDA issues an order the device or if FDA determines that the
HHS. finding the device to be substantially device submitted is not of ‘‘low-
ACTION: Final order. equivalent, in accordance with section moderate risk’’ or that general controls
513(i) of the FD&C Act, to a predicate would be inadequate to control the risks
SUMMARY: The Food and Drug device that does not require premarket
Administration (FDA) is classifying the and special controls to mitigate the risks
approval. The Agency determines cannot be developed.
gynecologic laparoscopic power whether new devices are substantially In response to a request to classify a
morcellation containment system into equivalent to predicate devices by device under either procedure provided
class II (special controls). The special means of premarket notification by section 513(f)(2) of the FD&C Act,
controls that will apply to the device are procedures in section 510(k) of the FDA will classify the device by written
identified in this order and will be part FD&C Act (21 U.S.C. 360(k)) and part order within 120 days. This
of the codified language for the 807 (21 CFR part 807) of the regulations. classification will be the initial
gynecologic laparoscopic power Section 513(f)(2) of the FD&C Act, as classification of the device.
morcellation containment system’s amended by section 607 of the Food and On June 19, 2015, Advanced Surgical
classification. The Agency is classifying Drug Administration Safety and Concepts submitted a request for
the device into class II (special controls) Innovation Act (Pub. L. 112–144), classification of the PneumoLiner
in order to provide a reasonable provides two procedures by which a device under section 513(f)(2) of the
assurance of safety and effectiveness of
rmajette on DSK2TPTVN1PROD with RULES
person may request FDA to classify a FD&C Act. The manufacturer
the device. device under the criteria set forth in recommended that the device be
DATES: This order is effective June 21, section 513(a)(1). Under the first classified into class II (Ref. 1).
2016. The classification was applicable procedure, the person submits a In accordance with section 513(f)(2) of
on April 7, 2016. premarket notification under section the FD&C Act, FDA reviewed the
FOR FURTHER INFORMATION CONTACT: 510(k) of the FD&C Act for a device that request in order to classify the device
Veronica Price, Center for Devices and has not previously been classified and, under the criteria for classification set
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![Federal Register / Vol. 81, No. 119 / Tuesday, June 21, 2016 / Rules and Regulations 40183
available electronically at http:// adequate visualization of the DEPARTMENT OF THE TREASURY
www.regulations.gov. laparoscopic instruments and tissue
1. DEN150028: De novo request from specimen relative to the external Alcohol and Tobacco Tax and Trade
Advanced Surgical Concepts, dated June 19, viscera; Bureau
2015. (iv) Demonstration that intended
27 CFR Parts 40, 41, and 44
laparoscopic instruments and
List of Subjects in 21 CFR Part 884
morcellators do not compromise the
Medical devices. [Docket No. TTB–2013–0006; T.D. TTB–137;
integrity of the containment system; and
Re: T.D. TTB–115; Notice No. 137; T.D. ATF–
Therefore, under the Federal Food, (v) Demonstration that intended users 421; T.D. ATF–422; ATF Notice Nos. 887
Drug, and Cosmetic Act and under can adequately deploy the device, and 888]
authority delegated to the Commissioner morcellate a specimen without
of Food and Drugs, 21 CFR part 884 is
compromising the integrity of the RIN 1513–AB37
amended as follows:
device, and remove the device without
PART 884—OBSTETRICAL AND spillage of contents; Importer Permit Requirements for
GYNECOLOGICAL DEVICES Tobacco Products and Processed
(5) Training must be developed and
Tobacco, and Other Requirements for
validated to ensure users can follow the Tobacco Products, Processed
■ 1. The authority citation for part 884 instructions for use; and
continues to read as follows: Tobacco and Cigarette Papers and
(6) Labeling must include the Tubes
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
following:
AGENCY: Alcohol and Tobacco Tax and
(i) A contraindication for use in Trade Bureau, Treasury.
■ 2. Add § 884.4050 to subpart E to read gynecologic surgery in which the tissue
as follows: ACTION: Final rule; Treasury decision.
to be morcellated is known or suspected
§ 884.4050 Gynecologic laparoscopic to contain malignancy; SUMMARY: The Alcohol and Tobacco Tax
power morcellation containment system. (ii) Unless clinical performance data and Trade Bureau is adopting as a final
(a) Identification. A gynecologic demonstrates that it can be removed or rule, without change, a temporary rule
laparoscopic power morcellation modified, a contraindication for removal concerning permit and other
containment system is a prescription of uterine tissue containing suspected requirements related to importers and
device consisting of an instrument port fibroids in patients who are: Peri- or manufacturers of tobacco products and
and tissue containment method that postmenopausal, or candidates for en processed tobacco published in the
creates a working space allowing for bloc tissue removal, for example, Federal Register on June 27, 2013. The
direct visualization during a power through the vagina or via a mini- regulatory amendments adopted in this
morcellation procedure following a laparotomy incision; final rule include an extension in the
laparoscopic procedure for the excision duration of new permits for importers of
of benign gynecologic tissue that is not (iii) The following boxed warning: tobacco products and processed tobacco
suspected to contain malignancy. ‘‘Warning: Information regarding the from three years to five years, a
(b) Classification. Class II (special potential risks of a procedure with this technical correction amending the
controls). The special controls for this device should be shared with patients. definition of ‘‘Manufacturer of tobacco
device are: Uterine tissue may contain unsuspected products’’ to reflect a statutory change,
(1) The patient-contacting cancer. The use of laparoscopic power and a technical correction related to
components of the device must be morcellators during fibroid surgery may references to the sale price of large
demonstrated to be biocompatible; spread cancer. The use of this cigars. This final rule also permanently
(2) Device components that are containment system has not been incorporates and reissues other TTB
labeled sterile must be validated to a clinically demonstrated to reduce this regulations pertaining to importer
sterility assurance level of 10¥6; risk.’’ permit requirements for tobacco
(3) Performance data must support products as well as minimum
shelf life by demonstrating continued (iv) A statement limiting use of device
manufacturing and marking
sterility of the device or the sterile to physicians who have completed the
requirements for tobacco products and
components, package integrity, and training program; and
cigarette papers and tubes that also were
device functionality over the intended (v) An expiration date or shelf life. incorporated in the June 27, 2013,
shelf life; Dated: June 15, 2016. temporary rule.
(4) Non-clinical performance data DATES: Effective July 21, 2016, the
must demonstrate that the device meets Leslie Kux,
Associate Commissioner for Policy. temporary regulations published in the
all design specifications and Federal Register as T.D. TTB–115 at 78
performance requirements. The [FR Doc. 2016–14627 Filed 6–20–16; 8:45 am]
FR 38555 on June 27, 2013, are adopted
following performance characteristics BILLING CODE 4164–01–P
as final, and those temporary
must be tested: regulations will no longer have a sunset
(i) Demonstration of the device
date of August 26, 2016.
impermeability to tissue, cells, and
fluids; FOR FURTHER INFORMATION CONTACT:
Jessie Longbrake, Regulations and
rmajette on DSK2TPTVN1PROD with RULES
(ii) Demonstration that the device
allows for the insertion and withdrawal Rulings Division, Alcohol and Tobacco
of laparoscopic instruments while Tax and Trade Bureau, 1310 G Street,
maintaining pneumoperitoneum; Box 12, Washington, DC 20005;
(iii) Demonstration that the telephone 202–453–2265; email
containment system provides adequate TobaccoRegs@ttb.gov.
space to perform morcellation and SUPPLEMENTARY INFORMATION:
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Document Created: 2016-06-21 01:30:42
Document Modified: 2016-06-21 01:30:42
| 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 June 21, 2016. The classification was applicable on April 7, 2016. | |
| 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, [email protected] | |
| FR Citation | 81 FR 40181 |
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