VersaWrap Nerve Protector

K201631 · Alafair Biosciences, Inc. · JXI · Sep 14, 2020 · Neurology

Device Facts

• Record ID: K201631
• Device Name: VersaWrap Nerve Protector
• Applicant: Alafair Biosciences, Inc.
• Product Code: JXI · Neurology
• Decision Date: Sep 14, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5275
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

VersaWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

Device Story

VersaWrap Nerve Protector is a thin, flexible, bioresorbable implant; functions as a non-constricting gelatinous interface between injured peripheral nerves and surrounding tissues. Designed to encase the neural environment; prevents adhesions; absorbs over time. Used in surgical settings; placed by surgeons around peripheral nerves. Provides physical barrier; reduces potential for nerve entrapment; benefits patient by supporting nerve healing environment. Material composition: calcium alginate and hyaluronic acid.

Clinical Evidence

No human clinical data. Evidence based on non-clinical bench testing (dimensional, swelling, strength, sterilization, biocompatibility per ISO 10993) and an animal study (rat model). Animal study compared VersaWrap, predicate, and untreated groups across early, mid, and late timepoints. Endpoints included motor/sensory neurological assessments and histopathological evaluation of local/systemic tissue response. Results showed equivalent safety and performance to predicate with no significant adverse events.

Technological Characteristics

Materials: calcium alginate and hyaluronic acid. Form factor: flexible sheet. Sterilization: eBeam (SAL 10^-6 per ISO 11137). Biocompatibility: ISO 10993 compliant (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity).

Indications for Use

Indicated for management of peripheral nerve injuries without substantial loss of nerve tissue.

Regulatory Classification

Identification

A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).

Predicate Devices

• Integra NeuraWrap Nerve Protector (K041620)

Reference Devices

• Alafair VersaWrap Tendon Protector (K200311)

Submission Summary (Full Text)

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September 14, 2020

Alafair Biosciences, Inc. % Angela Mallery Regulatory Consultant NAMSA 400 Highway 169 South, Suite 500 Minneapolis, Minnesota 55426

Re: K201631

Trade/Device Name: VersaWrap Nerve Protector Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve Cuff Regulatory Class: Class II Product Code: JXI Dated: June 12, 2020 Received: June 16, 2020

Dear Angela Mallery:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Adam Pierce, Ph.D. Assistant Director (Acting) DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K201631

Device Name VersaWrap Nerve Protector

## Indications for Use (Describe)

VersaWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial;"> <svg height="15" width="15"> <rect fill="none" height="15" stroke="black" width="15" x="0" y="0"></rect> <path d="M2 2 L13 13 M2 13 L13 2" stroke="black"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-family: Arial;"> <svg height="15" width="15"> <rect fill="none" height="15" stroke="black" width="15" x="0" y="0"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
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| 510(k) Summary<br>VersaWrap Nerve Protector | | | | |
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| K201631 | | | | |
| Submitted by: | Alafair Biosciences, Inc.<br>6101 W Courtyard Drive<br>Ste. 2-225<br>Austin, TX 78730<br>800.206.5586; [e-mail] | | | |
| Date Prepared: | September 8, 2020 | | | |
| Contact: | Ben Walthall, Ph.D.<br>Chief Regulatory Officer<br>800.206.5586; [e-mail] | | | |
| Product Name | VersaWrap Nerve Protector | | | |
| Common Name | Cuff, Nerve | | | |
| Classification number | 21 CFR 882.5275 | | | |
| Product Code | JXI | | | |
| Primary Predicate: | Integra NeuraWrap Nerve Protector K041620 | | | |
| Reference Device: | Alafair VersaWrap Tendon Protector K200311 | | | |
| Device Description: | VersaWrap Nerve Protector (VersaWrap) is designed to function as an interface between an<br>injured nerve and surrounding tissues and is indicated for use in peripheral nerve injuries<br>where there is no significant loss of nerve tissue.<br>VersaWrap Nerve Protector is a thin, flexible implant, designed to be a non-constricting<br>gelatinous interface encasing peripheral nerves and the neural environment; that starts to<br>absorb after implant.<br>VersaWrap Nerve Protector is designed to be flexible and conformable for placement<br>around a peripheral nerve | | | |
| Indications for Use: | VersaWrap Nerve Protector is indicated for the management of peripheral nerve injuries in<br>which there has been no substantial loss of nerve tissue. | | | |
| Functional and Safety<br>Testing: | Biocompatibility studies demonstrated the Nerve Protector is non-cytotoxic, non-pyrogenic,<br>non-irritating, non-sensitizing, non-toxic, and non-genotoxic. Animal studies demonstrated<br>the device performed as labeled. | | | |
| Comparative<br>Technology<br>Characteristics: | Parameter<br>Device name | Device<br>VersaWrap | Predicate Device<br>NeuraWrap | Reference Device<br>VersaWrap |
| | Company<br>Name | Alafair Biosciences | Integra Lifesciences | Alafair Biosciences |
| | 510(k) # | K201631 | K041620 | K200311 |
| | Material | Calcium alginate and<br>hyaluronic acid | Type 1 bovine<br>collagen and<br>chondroitin-6-sulfate | Calcium alginate and<br>hyaluronic acid |
| | Intended Use | designed to be an<br>interface between the<br>injured area and the<br>surrounding tissue | designed to be an<br>interface between the<br>injured area and the<br>surrounding tissue | designed to be an<br>interface between the<br>injured area and the<br>surrounding tissue |
| | Packaging | Double Pouch | Double Pouch | Double Pouch |
| | Physician<br>Structure | Sheet | Tube | Sheet |
| | Sterilization<br>Method | eBeam | EO | eBeam |
| | Testing was conducted. The specific conclusions drawn from the testing is that the<br>testing demonstrates the proposed device is as safe, as effective, and performs as well<br>as or better than the legally marketed predicate device. | | | |
| | Test/Purpose | Test Method Summary | Discussion of results | |
| Non-Clinical Tests<br>Performed: | Dimensional and<br>visual inspection | Direct measurement of the mass,<br>lengths, width, thickness with<br>micrometers, calipers, pH meter<br>or balance; and visual inspection. | Dimensional analysis<br>was completed to verify<br>the dimensions and<br>visual characteristics and<br>met specifications; | |
| | Pliability/ Tissue<br>conformance and<br>adherence | The device is placed on a<br>simulated model and graded for<br>visual conformance and<br>adherence. | Visual inspection was<br>conducted and met<br>specifications. | |
| | Swelling | Direct measurement of the device<br>(with micrometers, calipers) when<br>exposed to fluid. | Dimensional analysis<br>was completed and met<br>specifications. | |
| | Strength/Puncture | Direct measurement of the device<br>strength/puncture when measured<br>with a probe. | Testing was completed<br>and met specifications. | |
| | Pouch Seal<br>Integrity/Sterile<br>Barrier | The integrity of the pouch was<br>verified with a visual inspection,<br>peel tester, and burst tester. | Testing was completed<br>and met specifications. | |
| | Sterilization | The e-beam sterilization process<br>was validated to achieve a sterility<br>assurance level (SAL) of 10-6 per<br>ISO 11137 | Testing was completed<br>and met specifications. | |
| | Bacterial<br>endotoxin<br>validation | The bacterial endotoxin validation<br>testing was conducted per USP<br><85> Bacterial Endotoxins and<br>Ph.Eur. Chpt 2.6.14 | Testing was completed<br>and met specification | |
| | Cytotoxicity | The device was evaluated for<br>potential cytotoxic effects using an<br>in vitro mammalian cell culture test.<br>This study was conducted following<br>the guidelines of ISO 10993-5 | The test extract showed no<br>evidence of causing cell<br>lysis or toxicity. | |
| | Sensitization | The device was evaluated for the<br>potential to cause delayed dermal<br>contact sensitization in a guinea pig<br>maximization test. This study was<br>conducted based on the<br>requirements of ISO 10993-10 | The test article showed no<br>evidence of causing delayed<br>contact sensitization. | |
| | Irritation | The device was evaluated for the<br>potential to cause irritation<br>following intracutaneous injection.<br>This study was conducted based on<br>ISO 10993-10 | There was no evidence of<br>significant irritation from<br>the extracts injected<br>intracutaneously. | |
| | Acute systemic<br>toxicity | The device was evaluated for acute<br>systemic toxicity. This study was<br>conducted based on ISO 10993-11. | The sesame oil test article<br>extracts and the sodium<br>chloride test article extracts<br>injected met the passing<br>requirements of the test. | |
| | Pyrogenicity | The device was evaluated for<br>material mediated pyrogenicity in<br>the rabbit. The test was conducted | The total rise of<br>temperatures during the<br>observation period was | |

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| Genotoxicity | The device was evaluated for<br>mutagenic potential, mutagenic<br>changes, and to produce cytogenetic<br>damage | Extract did not cause<br>cytogenetic damage/<br>micronuclei formation.<br>Extracts were well within<br>the limits defined for a<br>negative response and the<br>test article is considered<br>non-mutagenic and<br>considered to be non-<br>mutagenic |
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| Subchronic<br>toxicity | The device was surgically<br>implanted in the subcutaneous<br>tissue of the rat to evaluate potential<br>systemic toxicity and local tissue<br>response at the implantation sites | No evidence of systemic<br>toxicity following<br>subcutaneous implantation.<br>Microscopically, the test<br>article was classified as a<br>non-irritant. |
| Muscle<br>implantation | The purpose of this study was to<br>assess the local tissue effects and<br>absorption profile following<br>implantation in muscle tissue in at<br>multiple timepoints. | At long term timepoints the<br>device was considered to be<br>a non-irritant and a slight<br>irritant at earlier weeks<br>following implantation<br>when compared to the<br>control. At the study mid-<br>point, microscopic<br>evaluation demonstrated the<br>device is bioresorbing as<br>expected. This variable and<br>slight irritation is expected<br>for a device undergoing<br>absorption. |
| Neurotoxicity<br>assessment | A risk analysis was conducted | An analysis was conducted<br>to determine any<br>neurotoxicity risk to the<br>patient |

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| Animal Study | The animal study was conducted on multiple injury types for<br>subject device, predicate control device, and untreated groups.<br>Nerve defects were comparable to the clinical use of the device.<br>Data was collected at an early period, a mid-term period; and a<br>late period.<br>The rat is often used in nerve injury models and is suggested in<br>the ISO standards and Organisation for Economic Co-operation<br>and Development guidelines as an acceptable animal model for<br>evaluating the local tissue response of various articles; and the<br>sample size was selected to be large enough to show consistent<br>results and to be able to compare the test, control, and untreated<br>groups.<br>As recommended by FDA, motor and sensory neurological<br>assessments were conducted prior to surgery, and throughout the<br>study. VersaWrap animals and the predicate control animals<br>demonstrated equivalent safety and equivalent performance<br>results; there were no significant events reported in any group.<br>Histopathological evaluations were performed to assess local and<br>systemic tissue effects specific to the test and predicate control<br>articles. Overall, there was no apparent difference in the character<br>or severity of the reactivity to the test or predicate implant. There<br>were no microscopic changes in the nerve at any interval for<br>either test or Integra implants; the microscopic appearance of the<br>nerve and surrounding tissue for both the control and VersaWrap<br>were similar. |
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| Conclusion | Based on the results of animal studies, prior in vitro product characterization studies, in vitro and in vivo biocompatibility and performance studies, we conclude the device is as safe as, and substantially equivalent to its predicate devices. |
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