(118 days)
Not Found
No
The summary describes a physical implant for nerve protection and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for the management of peripheral nerve injuries, which constitutes a therapeutic use.
No
Explanation: The device is described as a "Nerve Protector" indicated for the management of peripheral nerve injuries. Its function is to act as an interface between an injured nerve and surrounding tissues. There is no mention of it being used to detect, identify, or determine a disease or condition.
No
The device description explicitly states it is a "thin, flexible implant" and a "gelatinous interface encasing peripheral nerves," indicating it is a physical, absorbable material, not software.
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, which is a therapeutic intervention performed in vivo (within the body). IVDs are used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as an implant designed to function as an interface between an injured nerve and surrounding tissues. This is a physical barrier or protective device, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory testing.
Therefore, VersaWrap Nerve Protector is a medical device used for surgical intervention and protection of nerves, 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 nerve
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
No additional functional or safety testing was required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VersaWrap Nerve Protector K201631
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
November 2, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Alafair Biosciences Inc Angela Mallery Regulatory 6101 West Courtyard Drive, Suite 2-225 Austin, Texas 78730
Re: K232029
Trade/Device Name: VersaWrap Nerve Protector Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve Cuff Regulatory Class: Class II Product Code: JXI Dated: October 5, 2023 Received: October 5, 2023
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 (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).
1
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 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-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 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.
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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
Image /page/1/Picture/6 description: The image shows a digital signature. The name "Adam D. Pierce -S" is written in a large font on the left side of the image. On the right side of the image, the text "Digitally signed by Adam D. Pierce -S Date: 2023.11.02 16:14:48 -04'00'" is written in a smaller font.
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232029
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
| 510(k) Summary
VersaWrap Nerve Protector
| K232029 | |||
|---|---|---|---|
| Submitted by: | Alafair Biosciences, Inc. | ||
| 6101 W Courtyard Drive | |||
| Ste. 1-225 | |||
| Austin, TX 78730 | |||
| 800.206.5586; info@alafairbiosciences.com | |||
| Date Prepared: | October 26, 2023 | ||
| 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 | ||
| Predicate Device: | VersaWrap Nerve Protector K201631 | ||
| 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: | No additional functional or safety testing was required. | ||
| Comparative | |||
| Technological | |||
| Characteristics | Device Name | VersaWrap | VersaWrap |
| 510(k) # | K232029 | K201631 | |
| Material | Calcium alginate and hyaluronic acid | Calcium alginate and hyaluronic acid | |
| Intended Use | Designed to be an interface between an | ||
| injured area and surrounding tissue | Designed to be an interface between an | ||
| injured area and surrounding tissue | |||
| Physical Structure | Sheet | Sheet | |
| Precautions | Do not resterilize. Discard all opened | ||
| and unused portions of VersaWrap | |||
| Nerve Protector. | |||
| Based on in vivo animal studies in a rat | |||
| sciatic nerve injury model, the | |||
| VersaWrap Nerve Protector can | |||
| displace or move after placement on the | |||
| nerve. Patient mobility should be | |||
| considered to mitigate the risk of device | |||
| movement post-implant. | Do not resterilize. Discard all opened | ||
| and unused portions of VersaWrap | |||
| Nerve Protector. | |||
| Intended population. Safety and | |||
| effectiveness has not been established in | |||
| pediatric patients. | |||
| Based on in vivo animal studies in a rat | |||
| sciatic nerve injury model, the | |||
| VersaWrap Nerve Protector can | |||
| displace or move after placement on the | |||
| nerve. Patient mobility should be | |||
| considered to mitigate the risk of device | |||
| movement post-implant. | |||
| Conclusion | Based on an assessment of the risks associated with use in a pediatric population and prior animal, in vitro | ||
| product characterization, in vitro and in vivo biocompatibility, and performance studies, we conclude the | |||
| device is as safe as, and substantially equivalent to, its predicate device. |