81 FR 94251 - Medical Devices; Neurological Devices; Classification of the Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 247 (December 23, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 247 (December 23, 2016)
| Page Range | 94251-94253 | |
| FR Document | 2016-31007 |
[Federal Register Volume 81, Number 247 (Friday, December 23, 2016)] [Rules and Regulations] [Pages 94251-94253] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31007] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 [Docket No. FDA-2016-N-4165] Medical Devices; Neurological Devices; Classification of the Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying the neurovascular mechanical thrombectomy device for acute ischemic stroke treatment 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 neurovascular mechanical thrombectomy device for acute ischemic stroke treatment'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 December 23, 2016. The classification was applicable on September 2, 2016. FOR FURTHER INFORMATION CONTACT: Leigh Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2656, Silver Spring, MD 20993-0002, 301-796-5613, leigh.anderson@fda.hhs.gov. 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 [[Page 94252]] 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 shall classify the device by written order within 120 days. This classification will be the initial classification of the device. On October 26, 2015, Concentric Medical, Inc., submitted a request for classification of the Trevo ProVue and XP ProVue Retrievers (Trevo Retrievers) 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 September 2, 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 882.5600. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a neurovascular mechanical thrombectomy device for acute ischemic stroke treatment will need to comply with the special controls named in this final order. The device is assigned the generic name neurovascular mechanical thrombectomy device for acute ischemic stroke treatment, and it is identified as a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature. FDA has identified the following risks to health associated specifically with this type of device, as well as the measures required to mitigate these risks in table 1. Table 1--Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risk Mitigation measure ------------------------------------------------------------------------ Adverse Tissue Reaction........... Biocompatibility Evaluation. Infection......................... Sterility Testing, Shelf-Life Testing, Labeling. Tissue or Vessel Damage:Dissection........... Non-clinical Performance Testing. Perforation.......... Clinical Performance Testing. Hemorrhage........... Labeling. Stroke Progression................ Non-clinical Performance Testing, Clinical Performance Testing, Labeling. Emboli............................ Non-clinical Performance Testing, Clinical Performance Testing, Labeling. ------------------------------------------------------------------------ FDA believes that the special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness. Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment devices are 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) 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 neurovascular mechanical thrombectomy device for acute ischemic stroke treatment they intend to market. [[Page 94253]] 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. List of Subjects in 21 CFR Part 882 Medical devices, Neurological devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows: PART 882--NEUROLOGICAL DEVICES 0 1. The authority citation for part 882 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 882.5600 to subpart F to read as follows: Sec. 882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment. (a) Identification. A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature. (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) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including: (i) Mechanical testing to demonstrate the device can withstand anticipated tensile, torsional, and compressive forces. (ii) Mechanical testing to evaluate the radial forces exerted by the device. (iii) Non-clinical testing to verify the dimensions of the device. (iv) Non-clinical testing must demonstrate the device can be delivered to the target location in the neurovasculature and retrieve simulated thrombus under simulated use conditions. (v) Non-clinical testing must demonstrate the device is radiopaque and can be visualized. (vi) Non-clinical testing must evaluate the coating integrity and particulates under simulated use conditions. (vii) Animal testing must evaluate the safety of the device, including damage to the vessels or tissue under anticipated use conditions. (3) Performance data must support the sterility and pyrogenicity of the patient contacting components of the device. (4) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf-life. (5) Clinical performance testing of the device must demonstrate the device performs as intended for use in the treatment of acute ischemic stroke and must capture any adverse events associated with the device and procedure. (6) The labeling must include: (i) Information on the specific patient population for which the device is intended for use in the treatment of acute ischemic stroke, including but not limited to, specifying time from symptom onset, vessels or location of the neurovasculature that can be accessed for treatment, and limitations on core infarct size. (ii) Detailed instructions on proper device preparation and use for thrombus retrieval from the neurovasculature. (iii) A summary of the clinical testing results, including a detailed summary of the device- and procedure-related complications and adverse events. (iv) A shelf life. Dated: December 19, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-31007 Filed 12-22-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 247 / Friday, December 23, 2016 / Rules and Regulations 94251
the case of a subcontract for the SECURITES AND EXCHANGE Plan at its open meeting. The expiration
construction of any public facility, or in COMMISSION time of 12:01 a.m. on November 16,
excess of $700,000 in the case of all 2016 for the temporary rule has now
other subcontracts, and which offer 17 CFR Part 242 passed.
further subcontracting possibilities, to [Release No. 34–79237A] Dated: December 19, 2016.
adopt a subcontracting plan of their own Brent J. Fields,
RIN 3235–AL99
consistent with this section, and must Secretary.
ensure at a minimum that all Consolidated Audit Trail [FR Doc. 2016–30883 Filed 12–22–16; 8:45 am]
subcontractors required to maintain BILLING CODE 8011–01–P
subcontracting plans pursuant to this ACTION:Notification regarding expired
paragraph will review and approve temporary rule.
subcontracting plans submitted by their DEPARTMENT OF HEALTH AND
SUMMARY: The Commission is providing
subcontractors; monitor their notice regarding temporary Rule 608T HUMAN SERVICES
subcontractors’ compliance with their under the Securities Exchange Act of
approved subcontracting plans; ensure 1934. The Commission designated 12:01 Food and Drug Administration
that subcontracting reports are a.m. on November 16, 2016, as the
submitted by their subcontractors when expiration time for Rule 608T, because 21 CFR Part 882
required; acknowledge receipt of their after that time the rule would no longer [Docket No. FDA–2016–N–4165]
subcontractors’ reports; compare the be necessary.
performance of their subcontractors to DATES: December 23, 2016. Medical Devices; Neurological
their subcontracting plans and goals; FOR FURTHER INFORMATION CONTACT:
Devices; Classification of the
and discuss performance with their Rebekah Liu, Special Counsel, at (202) Neurovascular Mechanical
subcontractors when necessary to 551–5665; Jennifer Colihan, Special Thrombectomy Device for Acute
ensure their subcontractors make a Counsel, at (202) 551–5642; Leigh Duffy, Ischemic Stroke Treatment
good-faith effort to comply with their Special Counsel, at (202) 551–5928; AGENCY: Food and Drug Administration,
subcontracting plans; and John Lee, Special Counsel, at (202) 551– HHS.
(xi) The prime contractor must 5689; or Ted Uliassi, Special Counsel, at ACTION: Final order.
provide a written statement of the types (202) 551–6905, or Division of Trading
of records it will maintain to and Markets, Securities and Exchange SUMMARY: The Food and Drug
demonstrate procedures which have Commission, 100 F Street NE., Administration (FDA) is classifying the
Washington, DC 20549–7010. neurovascular mechanical
been adopted to ensure subcontractors
SUPPLEMENTARY INFORMATION: On thrombectomy device for acute ischemic
at all tiers comply with the
November 3, 2016, the Securities and stroke treatment into class II (special
requirements and goals set forth in the
Exchange Commission adopted a controls). The special controls that will
subcontracting plan established in apply to the device are identified in this
accordance with paragraph (c)(1)(x) of temporary rule, Rule 608T, under the
Securities Exchange Act of 1934 to order and will be part of the codified
this section, including the establishment language for the neurovascular
extend to November 15, 2016, the date
of source lists of small business mechanical thrombectomy device for
by which the Commission was required
concerns, small business concerns acute ischemic stroke treatment’s
to act on the proposed National Market
owned and controlled by veterans, small classification. The Agency is classifying
System Plan Governing the
business concerns owned and Consolidated Audit Trail (the ‘‘CAT the device into class II (special controls)
controlled by service-disabled veterans, NMS Plan’’). Rule 608T solely governed in order to provide a reasonable
qualified HUBZone small business the timeframe for action on the assurance of safety and effectiveness of
concerns, small business concerns proposed CAT NMS Plan. The the device.
owned and controlled by socially and Commission adopted the temporary rule DATES: This order is effective December
economically disadvantaged as an interim final temporary rule in 23, 2016. The classification was
individuals, and small business light of the impending November 10, applicable on September 2, 2016.
concerns owned and controlled by 2016 date designated by the FOR FURTHER INFORMATION CONTACT:
women; the efforts to identify and Commission under Rule 608 as the date Leigh Anderson, Center for Devices and
award subcontracts to such small by which the Commission would take Radiological Health, Food and Drug
business concerns; and size or action on the proposed CAT NMS Plan. Administration, 10903 New Hampshire
socioeconomic certifications or The Commission designated 12:01 a.m. Ave., Bldg. 66, Rm. 2656, Silver Spring,
representations received in connection on November 16, 2016, as the expiration MD 20993–0002, 301–796–5613,
with each subcontract. time for Rule 608T because after that leigh.anderson@fda.hhs.gov.
* * * * * time the temporary rule would no SUPPLEMENTARY INFORMATION:
longer be necessary.
Dated: December 14, 2016. On November 3, 2016, the I. Background
Maria Contreras-Sweet, Commission published the temporary In accordance with section 513(f)(1) of
Administrator. rule on its Web site. Due to a subsequent the Federal Food, Drug, and Cosmetic
[FR Doc. 2016–30874 Filed 12–22–16; 8:45 am] clerical error, the temporary rule was Act (the FD&C Act) (21 U.S.C.
jstallworth on DSK7TPTVN1PROD with RULES
not published in the Federal Register. 360c(f)(1)), devices that were not in
BILLING CODE 8025–01–P
On November 8, 2016, the Commission commercial distribution before May 28,
provided public notice of its scheduled 1976 (the date of enactment of the
open meeting to consider the CAT NMS Medical Device Amendments of 1976),
Plan, posting the notice on its Web site, generally referred to as postamendments
and on November 15, 2016, the devices, are classified automatically by
Commission approved the CAT NMS statute into class III without any FDA
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![Federal Register / Vol. 81, No. 247 / Friday, December 23, 2016 / Rules and Regulations 94253
II. Analysis of Environmental Impact performs as intended under anticipated DEPARTMENT OF JUSTICE
The Agency has determined under 21 conditions of use, including:
(i) Mechanical testing to demonstrate Bureau of Prisons
CFR 25.34(b) that this action is of a type
that does not individually or the device can withstand anticipated
tensile, torsional, and compressive 28 CFR Parts 500 and 553
cumulatively have a significant effect on
the human environment. Therefore, forces. [Docket No. BOP–1163]
neither an environmental assessment (ii) Mechanical testing to evaluate the
nor an environmental impact statement radial forces exerted by the device. RIN 1120–AB63
is required. (iii) Non-clinical testing to verify the Contraband and Inmate Personal
III. Paperwork Reduction Act of 1995 dimensions of the device. Property: Technical Change
This final order establishes special (iv) Non-clinical testing must
demonstrate the device can be delivered AGENCY: Bureau of Prisons, Justice.
controls that refer to previously
approved collections of information to the target location in the ACTION: Final rule.
found in other FDA regulations. These neurovasculature and retrieve simulated
thrombus under simulated use SUMMARY: In this document, the Bureau
collections of information are subject to of Prisons makes a minor technical
review by the Office of Management and conditions.
change to its regulations on contraband
Budget (OMB) under the Paperwork (v) Non-clinical testing must and inmate personal property to
Reduction Act of 1995 (44 U.S.C. 3501– demonstrate the device is radiopaque maintain consistency in language which
3520). The collections of information in and can be visualized. describes the purpose of the regulations
part 807, subpart E, regarding premarket (vi) Non-clinical testing must evaluate as ensuring the safety, security, or good
notification submissions, have been the coating integrity and particulates order of the facility or protection of the
approved under OMB control number under simulated use conditions. public.
0910–0120, and the collections of (vii) Animal testing must evaluate the DATES: This rule will be effective on
information in 21 CFR part 801, safety of the device, including damage January 23, 2017.
regarding labeling, have been approved to the vessels or tissue under
under OMB control number 0910–0485. FOR FURTHER INFORMATION CONTACT:
anticipated use conditions. Sarah Qureshi, Office of General
List of Subjects in 21 CFR Part 882 (3) Performance data must support the Counsel, Bureau of Prisons, phone (202)
Medical devices, Neurological sterility and pyrogenicity of the patient 307–2105.
devices. contacting components of the device. SUPPLEMENTARY INFORMATION:
Therefore, under the Federal Food, (4) Performance data must support the In this document, the Bureau of
Drug, and Cosmetic Act and under shelf-life of the device by demonstrating Prisons (Bureau) finalizes a minor
authority delegated to the Commissioner continued sterility, package integrity, technical change to its regulations on
of Food and Drugs, 21 CFR part 882 is and device functionality over the contraband and inmate personal
amended as follows: specified shelf-life. property to maintain consistency in
(5) Clinical performance testing of the language which describes the purpose of
PART 882—NEUROLOGICAL DEVICES device must demonstrate the device the regulations as ensuring the ‘‘safety,
performs as intended for use in the security, or good order of the facility or
■ 1. The authority citation for part 882 treatment of acute ischemic stroke and protection of the public.’’
continues to read as follows: must capture any adverse events Variations on this phrase appear
Authority: 21 U.S.C. 351, 360, 360c, 360e, associated with the device and throughout the Bureau’s regulations in
360j, 360l, 371. procedure. 28 CFR Chapter V. See 28 CFR 500.1(h),
■ 2. Add § 882.5600 to subpart F to read (6) The labeling must include: 501.2(b), 501.3(b), 511.10(a), 511.11(a),
as follows: 511.12(a), 511.15(b), 511.17(b),
(i) Information on the specific patient 540.12(a), 540.14(c) and (d), 540.15(d),
§ 882.5600 Neurovascular mechanical population for which the device is 540.40, 540.44(c), 540.51(h), 540.70,
thrombectomy device for acute ischemic intended for use in the treatment of 540.71(b) and (d), 540.100(a),
stroke treatment. acute ischemic stroke, including but not 540.101(a), 541.12, 541.43(b), 541.63(c),
(a) Identification. A neurovascular limited to, specifying time from 543.11(f), 543.14(a) and (c), 543.15(c),
mechanical thrombectomy device for symptom onset, vessels or location of 543.16(b), 544.20, 544.21(b), 548.10,
acute ischemic stroke treatment is a the neurovasculature that can be 548.16–548.18, 549.13(b), 549.50,
prescription device used in the accessed for treatment, and limitations 549.51(b), 551.1, 551.10, 551.12(d),
treatment of acute ischemic stroke to on core infarct size. 551.16(a), 551.31(b), 551.34(b), 551.35,
improve clinical outcomes. The device (ii) Detailed instructions on proper 551.71(d), 551.110(a), 551.112(b),
is delivered into the neurovasculature device preparation and use for thrombus 551.113(a), 551.115(a), 552.13(b),
with an endovascular approach, retrieval from the neurovasculature. 552.20, 552.21(a) and (d), 553.11(h),
mechanically removes thrombus from (iii) A summary of the clinical testing 553.12(b).
the body, and restores blood flow in the results, including a detailed summary of The Bureau has conformed the phrase
neurovasculature. the device- and procedure-related in all revised regulations since
(b) Classification. Class II (special complications and adverse events. approximately 2005. This rule likewise
jstallworth on DSK7TPTVN1PROD with RULES
controls). The special controls for this (iv) A shelf life. conforms this phrase in the Bureau’s
device are: regulations on contraband. An interim
(1) The patient contacting Dated: December 19, 2016. rule on this subject was published on
components of the device must be Leslie Kux, August 3, 2015 (80 FR 45883), and
demonstrated to be biocompatible. Associate Commissioner for Policy. became effective on September 2, 2015,
(2) Non-clinical performance testing [FR Doc. 2016–31007 Filed 12–22–16; 8:45 am] although public comments were
must demonstrate that the device BILLING CODE 4164–01–P accepted until October 2, 2015.
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Document Created: 2016-12-23 12:29:39
Document Modified: 2016-12-23 12:29:39
| 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 December 23, 2016. The classification was applicable on September 2, 2016. | |
| Contact | Leigh Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2656, Silver Spring, MD 20993-0002, 301-796-5613, [email protected] | |
| FR Citation | 81 FR 94251 | |
| CFR Associated | Medical Devices and Neurological Devices |
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