(90 days)
Alafair VersaWrap Tendon Protector K200311
No
The summary describes a physical implant for nerve protection and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for the management of peripheral nerve injuries and acts as an interface between an injured nerve and surrounding tissues, which aligns with the definition of a therapeutic device.
No
The device, VersaWrap Nerve Protector, is intended for the management of peripheral nerve injuries by functioning as an interface between an injured nerve and surrounding tissues. It is a protective implant, not a tool used for identifying or determining the nature of a disease or condition.
No
The device description clearly states that VersaWrap Nerve Protector is a "thin, flexible implant" and a "gelatinous interface," indicating it is a physical, absorbable material intended for surgical implantation, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for the management of peripheral nerve injuries by providing a physical interface between the injured nerve and surrounding tissues. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a physical implant designed to encase peripheral nerves. This is a medical device used in vivo (within the body) during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status.
Therefore, VersaWrap Nerve Protector is a medical device used for surgical intervention, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
JXI
Device Description
VersaWrap Nerve Protector (VersaWrap) is designed to function as an interface between an injured nerve and surrounding tissues and is indicated for use in peripheral nerve injuries where there is no significant loss of nerve tissue. VersaWrap Nerve Protector is a thin, flexible implant, designed to be a non-constricting gelatinous interface encasing peripheral nerves and the neural environment; that starts to absorb after implant. VersaWrap Nerve Protector is designed to be flexible and conformable for placement around a peripheral nerve
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional and Safety Testing: Biocompatibility studies demonstrated the Nerve Protector is non-cytotoxic, non-pyrogenic, non-irritating, non-sensitizing, non-toxic, and non-genotoxic. Animal studies demonstrated the device performed as labeled.
Non-Clinical Tests Performed:
- Dimensional and visual inspection: Direct measurement of the mass, lengths, width, thickness with micrometers, calipers, pH meter or balance; and visual inspection. Result: Dimensional analysis was completed to verify the dimensions and visual characteristics and met specifications.
- Pliability/ Tissue conformance and adherence: The device is placed on a simulated model and graded for visual conformance and adherence. Result: Visual inspection was conducted and met specifications.
- Swelling: Direct measurement of the device (with micrometers, calipers) when exposed to fluid. Result: Dimensional analysis was completed and met specifications.
- Strength/Puncture: Direct measurement of the device strength/puncture when measured with a probe. Result: Testing was completed and met specifications.
- Pouch Seal Integrity/Sterile Barrier: The integrity of the pouch was verified with a visual inspection, peel tester, and burst tester. Result: Testing was completed and met specifications.
- Sterilization: The e-beam sterilization process was validated to achieve a sterility assurance level (SAL) of 10-6 per ISO 11137. Result: Testing was completed and met specifications.
- Bacterial endotoxin validation: The bacterial endotoxin validation testing was conducted per USP Bacterial Endotoxins and Ph.Eur. Chpt 2.6.14. Result: Testing was completed and met specification.
- Cytotoxicity: The device was evaluated for potential cytotoxic effects using an in vitro mammalian cell culture test. This study was conducted following the guidelines of ISO 10993-5. Result: The test extract showed no evidence of causing cell lysis or toxicity.
- Sensitization: The device was evaluated for the potential to cause delayed dermal contact sensitization in a guinea pig maximization test. This study was conducted based on the requirements of ISO 10993-10. Result: The test article showed no evidence of causing delayed contact sensitization.
- Irritation: The device was evaluated for the potential to cause irritation following intracutaneous injection. This study was conducted based on ISO 10993-10. Result: There was no evidence of significant irritation from the extracts injected intracutaneously.
- Acute systemic toxicity: The device was evaluated for acute systemic toxicity. This study was conducted based on ISO 10993-11. Result: The sesame oil test article extracts and the sodium chloride test article extracts injected met the passing requirements of the test.
- Pyrogenicity: The device was evaluated for material mediated pyrogenicity in the rabbit. The test was conducted. Result: The total rise of temperatures during the observation period was not found.
- Genotoxicity: The device was evaluated for mutagenic potential, mutagenic changes, and to produce cytogenetic damage. Result: Extract did not cause cytogenetic damage/micronuclei formation. Extracts were well within the limits defined for a negative response and the test article is considered non-mutagenic and considered to be non-mutagenic.
- Subchronic toxicity: The device was surgically implanted in the subcutaneous tissue of the rat to evaluate potential systemic toxicity and local tissue response at the implantation sites. Result: No evidence of systemic toxicity following subcutaneous implantation. Microscopically, the test article was classified as a non-irritant.
- Muscle implantation: The purpose of this study was to assess the local tissue effects and absorption profile following implantation in muscle tissue in at multiple timepoints. Result: At long term timepoints the device was considered to be a non-irritant and a slight irritant at earlier weeks following implantation when compared to the control. At the study mid-point, microscopic evaluation demonstrated the device is bioresorbing as expected. This variable and slight irritation is expected for a device undergoing absorption.
- Neurotoxicity assessment: A risk analysis was conducted. Result: An analysis was conducted to determine any neurotoxicity risk to the patient.
Animal Study: The animal study was conducted on multiple injury types for subject device, predicate control device, and untreated groups. Nerve defects were comparable to the clinical use of the device. Data was collected at an early period, a mid-term period; and a late period. The rat is often used in nerve injury models and is suggested in the ISO standards and Organisation for Economic Co-operation and Development guidelines as an acceptable animal model for evaluating the local tissue response of various articles; and the sample size was selected to be large enough to show consistent results and to be able to compare the test, control, and untreated groups. As recommended by FDA, motor and sensory neurological assessments were conducted prior to surgery, and throughout the study. VersaWrap animals and the predicate control animals demonstrated equivalent safety and equivalent performance results; there were no significant events reported in any group. Histopathological evaluations were performed to assess local and systemic tissue effects specific to the test and predicate control articles. Overall, there was no apparent difference in the character or severity of the reactivity to the test or predicate implant. There were no microscopic changes in the nerve at any interval for either test or Integra implants; the microscopic appearance of the nerve and surrounding tissue for both the control and VersaWrap were similar.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Integra NeuraWrap Nerve Protector K041620
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Alafair VersaWrap Tendon Protector K200311
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5275 Nerve cuff.
(a)
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).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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3
| 510(k) Summary
| VersaWrap Nerve Protector | ||||
|---|---|---|---|---|
| K201631 | ||||
| Submitted by: | Alafair Biosciences, Inc. | |||
| 6101 W Courtyard Drive | ||||
| Ste. 2-225 | ||||
| Austin, TX 78730 | ||||
| 800.206.5586; info@alafairbiosciences.com | ||||
| Date Prepared: | September 8, 2020 | |||
| Contact: | Ben Walthall, Ph.D. | |||
| Chief Regulatory Officer | ||||
| 800.206.5586; info@alafairbiosciences.com | ||||
| 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 | |||
| injured nerve and surrounding tissues and is indicated for use in peripheral nerve injuries | ||||
| where there is no significant loss of nerve tissue. | ||||
| VersaWrap Nerve Protector is a thin, flexible implant, designed to be a non-constricting | ||||
| gelatinous interface encasing peripheral nerves and the neural environment; that starts to | ||||
| absorb after implant. | ||||
| VersaWrap Nerve Protector is designed to be flexible and conformable for placement | ||||
| around a peripheral nerve | ||||
| 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. | ||||
| Functional and Safety | ||||
| Testing: | Biocompatibility studies demonstrated the Nerve Protector is non-cytotoxic, non-pyrogenic, | |||
| non-irritating, non-sensitizing, non-toxic, and non-genotoxic. Animal studies demonstrated | ||||
| the device performed as labeled. | ||||
| Comparative | ||||
| Technology | ||||
| Characteristics: | Parameter | |||
| Device name | Device | |||
| VersaWrap | Predicate Device | |||
| NeuraWrap | Reference Device | |||
| VersaWrap | ||||
| Company | ||||
| Name | Alafair Biosciences | Integra Lifesciences | Alafair Biosciences | |
| 510(k) # | K201631 | K041620 | K200311 | |
| Material | Calcium alginate and | |||
| hyaluronic acid | Type 1 bovine | |||
| collagen and | ||||
| chondroitin-6-sulfate | Calcium alginate and | |||
| hyaluronic acid | ||||
| Intended Use | designed to be an | |||
| interface between the | ||||
| injured area and the | ||||
| surrounding tissue | designed to be an | |||
| interface between the | ||||
| injured area and the | ||||
| surrounding tissue | designed to be an | |||
| interface between the | ||||
| injured area and the | ||||
| surrounding tissue | ||||
| Packaging | Double Pouch | Double Pouch | Double Pouch | |
| Physician | ||||
| Structure | Sheet | Tube | Sheet | |
| Sterilization | ||||
| Method | eBeam | EO | eBeam | |
| Testing was conducted. The specific conclusions drawn from the testing is that the | ||||
| testing demonstrates the proposed device is as safe, as effective, and performs as well | ||||
| as or better than the legally marketed predicate device. | ||||
| Test/Purpose | Test Method Summary | Discussion of results | ||
| Non-Clinical Tests | ||||
| Performed: | Dimensional and | |||
| visual inspection | Direct measurement of the mass, | |||
| lengths, width, thickness with | ||||
| micrometers, calipers, pH meter | ||||
| or balance; and visual inspection. | Dimensional analysis | |||
| was completed to verify | ||||
| the dimensions and | ||||
| visual characteristics and | ||||
| met specifications; | ||||
| Pliability/ Tissue | ||||
| conformance and | ||||
| adherence | The device is placed on a | |||
| simulated model and graded for | ||||
| visual conformance and | ||||
| adherence. | Visual inspection was | |||
| conducted and met | ||||
| specifications. | ||||
| Swelling | Direct measurement of the device | |||
| (with micrometers, calipers) when | ||||
| exposed to fluid. | Dimensional analysis | |||
| was completed and met | ||||
| specifications. | ||||
| Strength/Puncture | Direct measurement of the device | |||
| strength/puncture when measured | ||||
| with a probe. | Testing was completed | |||
| and met specifications. | ||||
| Pouch Seal | ||||
| Integrity/Sterile | ||||
| Barrier | The integrity of the pouch was | |||
| verified with a visual inspection, | ||||
| peel tester, and burst tester. | Testing was completed | |||
| and met specifications. | ||||
| Sterilization | The e-beam sterilization process | |||
| was validated to achieve a sterility | ||||
| assurance level (SAL) of 10-6 per | ||||
| ISO 11137 | Testing was completed | |||
| and met specifications. | ||||
| Bacterial | ||||
| endotoxin | ||||
| validation | The bacterial endotoxin validation | |||
| testing was conducted per USP | ||||
| Bacterial Endotoxins and | ||||
| Ph.Eur. Chpt 2.6.14 | Testing was completed | |||
| and met specification | ||||
| Cytotoxicity | The device was evaluated for | |||
| potential cytotoxic effects using an | ||||
| in vitro mammalian cell culture test. | ||||
| This study was conducted following | ||||
| the guidelines of ISO 10993-5 | The test extract showed no | |||
| evidence of causing cell | ||||
| lysis or toxicity. | ||||
| Sensitization | The device was evaluated for the | |||
| potential to cause delayed dermal | ||||
| contact sensitization in a guinea pig | ||||
| maximization test. This study was | ||||
| conducted based on the | ||||
| requirements of ISO 10993-10 | The test article showed no | |||
| evidence of causing delayed | ||||
| contact sensitization. | ||||
| Irritation | The device was evaluated for the | |||
| potential to cause irritation | ||||
| following intracutaneous injection. | ||||
| This study was conducted based on | ||||
| ISO 10993-10 | There was no evidence of | |||
| significant irritation from | ||||
| the extracts injected | ||||
| intracutaneously. | ||||
| Acute systemic | ||||
| toxicity | The device was evaluated for acute | |||
| systemic toxicity. This study was | ||||
| conducted based on ISO 10993-11. | The sesame oil test article | |||
| extracts and the sodium | ||||
| chloride test article extracts | ||||
| injected met the passing | ||||
| requirements of the test. | ||||
| Pyrogenicity | The device was evaluated for | |||
| material mediated pyrogenicity in | ||||
| the rabbit. The test was conducted | The total rise of | |||
| temperatures during the | ||||
| observation period was |
4
5
6
| Genotoxicity | The device was evaluated for
mutagenic potential, mutagenic
changes, and to produce cytogenetic
damage | Extract did not cause
cytogenetic damage/
micronuclei formation.
Extracts were well within
the limits defined for a
negative response and the
test article is considered
non-mutagenic and
considered to be non-
mutagenic |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subchronic
toxicity | The device was surgically
implanted in the subcutaneous
tissue of the rat to evaluate potential
systemic toxicity and local tissue
response at the implantation sites | No evidence of systemic
toxicity following
subcutaneous implantation.
Microscopically, the test
article was classified as a
non-irritant. |
| Muscle
implantation | The purpose of this study was to
assess the local tissue effects and
absorption profile following
implantation in muscle tissue in at
multiple timepoints. | At long term timepoints the
device was considered to be
a non-irritant and a slight
irritant at earlier weeks
following implantation
when compared to the
control. At the study mid-
point, microscopic
evaluation demonstrated the
device is bioresorbing as
expected. This variable and
slight irritation is expected
for a device undergoing
absorption. |
| Neurotoxicity
assessment | A risk analysis was conducted | An analysis was conducted
to determine any
neurotoxicity risk to the
patient |
7
| Animal Study | The animal study was conducted on multiple injury types for
subject device, predicate control device, and untreated groups.
Nerve defects were comparable to the clinical use of the device.
Data was collected at an early period, a mid-term period; and a
late period.
The rat is often used in nerve injury models and is suggested in
the ISO standards and Organisation for Economic Co-operation
and Development guidelines as an acceptable animal model for
evaluating the local tissue response of various articles; and the
sample size was selected to be large enough to show consistent
results and to be able to compare the test, control, and untreated
groups.
As recommended by FDA, motor and sensory neurological
assessments were conducted prior to surgery, and throughout the
study. VersaWrap animals and the predicate control animals
demonstrated equivalent safety and equivalent performance
results; there were no significant events reported in any group.
Histopathological evaluations were performed to assess local and
systemic tissue effects specific to the test and predicate control
articles. Overall, there was no apparent difference in the character
or severity of the reactivity to the test or predicate implant. There
were no microscopic changes in the nerve at any interval for
either test or Integra implants; the microscopic appearance of the
nerve and surrounding tissue for both the control and VersaWrap
were similar. |
| -------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| 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. |
|---|---|
| ------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |