VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)

K251505 · Alafair Biosciences · JXI · Jul 22, 2025 · Neurology

Device Facts

• Record ID: K251505
• Device Name: VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)
• Applicant: Alafair Biosciences
• Product Code: JXI · Neurology
• Decision Date: Jul 22, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

VersaCoat Nerve Protector is an absorbable implant functioning as a gelatinous interface between injured nerves and surrounding tissues. It consists of a hollow, cylindrical hydrogel pellet (alginate and hyaluronic acid) and an aqueous citrate wetting solution. The clinician hydrates the pellet with the solution using a provided dual-syringe system to create a viscous, flowable, tissue-adherent gel. The gel is applied to the nerve site to provide a non-constricting, protective encasement. By acting as a physical barrier, it keeps damaged tissues separated during healing and provides a gliding surface, facilitating normal axonal survival and growth. It is intended for single use in a clinical setting.

Clinical Evidence

No human clinical data. Evidence includes bench performance testing (visual, dimensional, weight, gel integrity, handling, migration, coverage, cadaveric evaluation), biocompatibility testing (ISO 10993 series), and an animal study in rats. The animal study evaluated neurological, macroscopic, and histological outcomes, demonstrating the device safely provides an interface for injured nerves, permitting axonal survival and growth comparable to the predicate.

Technological Characteristics

Materials: Alginate and hyaluronic acid hydrogel; aqueous citrate wetting solution. Form: Hollow cylindrical pellet. Energy: None (passive implant). Sterilization: Radiation (SAL 10^-6). Biocompatibility: Tested per ISO 10993-3, 5, 6, 10, and 11. Endotoxin: < 20 EU/device.

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

• VersaWrap Nerve Protector (K232029)

Submission Summary (Full Text)

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FDA U.S. FOOD &amp; DRUG ADMINISTRATION

July 22, 2025

Alafair Biosciences
Sarah Mayes, Ph.D.
Chief Scientific Officer
6101 W Courtyard Drive, Suite 1-225
Austin, Texas 78730

Re: K251505
Trade/Device Name: VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)
Regulation Number: 21 CFR 882.5275
Regulation Name: Nerve Cuff
Regulatory Class: Class II
Product Code: JXI
Dated: May 15, 2025
Received: May 16, 2025

Dear Dr. Mayes:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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K251505 - Sarah Mayes, Ph.D.
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

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K251505 - Sarah Mayes, Ph.D.
Page 3

Sincerely,

Adam D. Pierce -S
Digitally signed by
Adam D. Pierce -S
Date: 2025.07.22
15:01:56 -04'00'

Adam D. Pierce, Ph.D.
Assistant Director
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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VersaCoat Nerve Protector
Page 8 of 35

| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K251505 | ? |
| Please provide the device trade name(s). | | ? |
| VersaCoat Nerve Protector (VTP-44G2);
VersaCoat Nerve Protector (VTP-12G1) | | |
| Please provide your Indications for Use below. | | ? |
| VersaCoat Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |

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K251505 Page 1 of 3

# 510(k) Summary

Prepared on: July 17, 2025

| Contact Details | |
| --- | --- |
| Submitted by: | Alafair Biosciences, Inc.
6101 W Courtyard Drive Ste. 1-225
Austin, TX 78730 |
| Contact: | Dr. Sarah Mayes
Alafair Biosciences Inc.
6101 W Courtyard Dr Ste 1-225
Austin TX 78730 United States
Phone: [phone]
Email: [e-mail] |
| Device Name | |
| Product Name | VersaCoat Nerve Protector |
| Common Name | Cuff, Nerve |
| Classification number | 21 CFR 882.5275 |
| Product Code | JXI |
| Legally Marketed Predicate Device | |
| VersaWrap Nerve Protector (K232029) | |
| Device Description Summary | |
| VersaCoat Nerve Protector is an absorbable implant (device) designed to function as a gelatinous interface between an injured nerve and surrounding tissues, providing a non-constricting, protective encasement for injured nerves. VersaCoat Nerve Protector consists of a Hydrogel Pellet and Wetting Solution. The Pellet is a hollow, cylindrical hydrogel of alginate and hyaluronic acid. The Pellet is easy to handle and is designed for quick hydration with the Wetting Solution. The Pellet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The Wetting Solution hydrates the Pellet, rendering a viscous, flowable, tissue-adherent gel. The Wetting Solution is aqueous citrate and is provided in a dropper packaged in a double peel pouch. The Wetting Solution is sterile, non-pyrogenic, and is intended for single use only. A sterile container (dual syringe system) is provided and may be used to facilitate hydration of the Pellet with Wetting Solution. | |
| Indications for Use | |
| VersaCoat Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue. | |
| Principle of Operation | |
| The mechanism of action of VersaCoat Nerve Protector is to manage nerve injuries by providing a gliding surface and by keeping damaged tissues physically separated during healing | |
| Comparative Technology Characteristics | |
| A comparison of the subject device and the predicate device demonstrates equivalent technological characteristics. Equivalence is based upon intended use, indications for use, materials of construction, operating principle, fundamental scientific technology, and performance. When implanted, the subject and predicate device are identical. Minor technological characteristic differences do not raise new questions of safety and effectiveness. Minor differences include the geometry, or the form of hydrogel from a flat sheet to a hollow, cylindrical pellet. This change is to allow end users an easier ability to apply the device as a gel. This change is not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device because the difference | |

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K251505 Page 2 of 3

does not affect the safety and effectiveness of the device when used as labeled, and does not describe a new disease, condition, or patient population. The risk-based assessment did not identify any new risks or significantly modified existing risks. Therefore, the subject device is substantially equivalent to the predicate device.

| Functional and Safety Testing |
| --- |
| To verify that device design met functional and performance requirements, representative samples of the device underwent nonclinical testing. These data demonstrate substantially equivalent safety and effectiveness to the predicate. |

# Non-Clinical Tests Summary &amp; Conclusions

The following tests were performed to support substantial equivalence.

Performance Testing, including:

- Visual inspection
- Dimensional and weight measurements
- Gel integrity (including homogeneity, cohesivity, and viscosity)
- Handling
- Migration testing
- Coverage testing
- Cadaveric evaluation

Animal Testing, including:

- In the animal study conducted, rats underwent various peripheral nerve injuries that received either the subject or predicate device. There were no procedure related complications or device related premature deaths in this study, at all follow-up timepoints. The safety and efficacy of the subject device were evaluated by neurological assessment, and macroscopic and histological evaluation. These studies demonstrate that the subject device can safely provide an interface between injured nerve and surrounding tissues, permitting normal axonal survival and growth in a variety of clinically relevant nerve injury models, performing similar to the predicate device.

Biocompatibility Testing, including:

- Cytotoxicity (ISO 10993-5)
- Sensitization (ISO 10993-10)
- Irritation - Intracutaneous Reactivity (ISO10993-10)
- Acute Systemic Toxicity (ISO10993-11)
- Pyrogenicity (ISO 10993-11)
- Genotoxicity (ISO 10993-3)
- Subchronic toxicity (13 weeks, ISO 10993-11 and ISO 10993-6)
- Muscle implantation toxicity/irritation (ISO 10993-6)

Sterilization:

Sterilization of the VersaCoat Nerve Protector was completed using radiation. Sterilization validation was conducted to verify the subject device meets SAL of 10-6.

Pyrogenicity (endotoxin):

Bacterial endotoxin testing was conducted to verify the subject device meets the requirement of $&lt; 20$ EU/device.

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K251505 Page 3 of 3

| Shelf life / packaging: Packaging integrity and stability were tested to verify the packaging meets product requirements and maintains its integrity during conditions normally encountered during sterilization, shipping, and storage over the proposed shelf-life. |
| --- |
| Conclusion |
| No new questions of safety or effectiveness were identified during device testing; therefore, the VersaCoat Nerve Protector device is considered substantially equivalent to the predicate device(s) in terms of safety and effectiveness. |