(81 days)
Not Found
No
The document describes a physical implant and solution for tissue management and protection, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used for the management and protection of tendon injuries by providing a non-constricting, protective encasement, but it does not actively treat or heal the injury, nor does it perform a therapeutic function.
No
Explanation: The device description and intended use clearly state that VersaWrap is an absorbable implant designed for the management and protection of tendon and surrounding tissues. It provides a physical encasement and does not gather or interpret data about a patient's health condition, which is the function of a diagnostic device.
No
The device description clearly states that VersaWrap is an "absorbable implant (device)" consisting of a "clear hydrogel (Sheet)" and a "wetting Solution," which are physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- VersaWrap's Intended Use: VersaWrap is intended for the management and protection of tendon injuries and surrounding tissues. It is an implantable device used in vivo (within the body) during surgical procedures.
- Device Description: The description clearly states it's an "absorbable implant" designed to serve as an "interface between the target tissues." This is a physical device used directly on or around tissues within the body.
The information provided describes a surgical implant used for tissue support and protection, not a device used to test samples outside of the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
VersaWrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligaments.
In these procedures, VersaWrap may encounter a variety of implanted structures such as anchors, grafts, staples, and sutures.
Product codes
OWW
Device Description
VersaWrap® is an absorbable implant (device), designed to serve as an interface between the target tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear hydrogel (Sheet) and a wetting Solution. The clear Sheet is a thin membrane of alginate and hyaluronic acid. VersaWrap Sheet is easy to handle, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap may encounter a variety of implanted structures such as anchors, grafts, staples. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet a gelatinous, tissue adherent layer (gel). The Solution, comprised of aqueous citrate, is provided sterile, non-pyrogenic, for single use, in a double peel pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tendon, skeletal muscle, ligaments
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Based on the risk-based assessment no additional testing is required to support the additional determination of substantial equivalence. The prior non-clinical and animal testing for the device were used to support the extended indications.
Based on the risk-based assessment no clinical testing is required to support the additional determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the date June 14, 2024. The month is June, the day is the 14th, and the year is 2024. The text is in a simple, sans-serif font. The date is likely used for a calendar, invitation, or other time-sensitive document.
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized depiction of a human figure. To the right of it is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Alafair Biosciences Inc. Dr. Sarah Mayes Official Correspondent 6101 W Courtvard Dr Ste 1-225 Austin, Texas 78730
Re: K240817
Trade/Device Name: VersaWrap® Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OWW Dated: April 23, 2024 Received: April 24, 2024
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"
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(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).
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 OS 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).
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Sincerely,
Robert M. Stefani -S
Digitally signed by Robert M Stefani -S Date: 2024.06.14 17:19:00 -04'00'
For: Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
VersaWrap®
Indications for Use (Describe)
VersaWrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligaments.
In these procedures, VersaWrap may encounter a variety of implanted structures such as anchors, grafts, staples, and sutures.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| 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: 512-739-9510 | |
| Email: info@alafairbiosciences.com | |
| Device Name | |
| Product Name | VersaWrap® |
| Common Name | Surgical Mesh |
| Classification number | 21 CFR 878.3300 |
| Classification name | Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement of Tendon |
| Product Code | OWW |
| Legally Marketed Predicate Device |
VersaWrap® (K213163)
Device Description Summary
VersaWrap® is an absorbable implant (device), designed to serve as an interface between the target tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear hydrogel (Sheet) and a wetting Solution. The clear Sheet is a thin membrane of alginate and hyaluronic acid. VersaWrap Sheet is easy to handle, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap may encounter a variety of implanted structures such as anchors, grafts, staples. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet a gelatinous, tissue adherent layer (gel). The Solution, comprised of aqueous citrate, is provided sterile, non-pyrogenic, for single use, in a double peel pouch.
Intended Use/Indications for Use
VersaWrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligaments. In these procedures, VersaWrap may encounter a variety of implanted structures such as anchors, grafts, staples,
Indications for Use Comparison
The additional description in the labeling is further identifying the surrounding environment and is not intended therapeutic, diagnostic, prosthetic, or surgical use of the difference does not affect the safety and effectiveness of the device when used as labeled, and describe a new disease, condition, or patient population. The device is not being used differently. The risk-based assessment did not identify any new risks or significantly modified existing risks.
Therefore, the subject device can be considered to be substantially equivalent to the predicate device
Technology Comparison
The subject device has the identical technological characteristics as the predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions
Based on the risk-based assessment no additional testing is required to support the additional determination of substantial equivalence. The prior non-clinical and animal testing for the device were used to support the extended indications.
Based on the risk-based assessment no clinical testing is required to support the additional determination of substantial equivalence.
510(k) Summary
Prepared on: June 10, 2024
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The subject device can be considered to be substantially equivalent to the predicate device.