(102 days)
Not Found
No
The device description and performance studies focus on the material composition and physical properties of the implant, with no mention of AI or ML.
Yes
The device is indicated for the management and protection of tendon injuries, functioning as a protective layer and facilitating tissue ingrowth, which aligns with the definition of a therapeutic device designed to treat or manage a medical condition.
No
Explanation: The device is described as an implant used for the management and protection of tendon injuries, functioning as a non-constricting, protective layer. Its use involves placement and fixation, rather than diagnosing a condition.
No
The device description clearly describes a physical implant made of collagen and poly(D,Llactide), provided in various sizes and potentially with an insertion sleeve. This is a hardware device, not software.
Based on the provided information, the TAPESTRY® Biointegrative Implant is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- TAPESTRY's Intended Use: The intended use of TAPESTRY is for the "management and protection of tendon injuries." This is a therapeutic and protective function performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details a physical implant made of collagen and poly(D,Llactide) designed to be placed between tissues. This is consistent with a surgical implant, not a diagnostic device.
- Anatomical Site: The anatomical site is the "tendon," which is a part of the body where the implant is placed.
- Intended User: The intended user is a "surgeon," which aligns with the use of a surgical implant.
The information provided clearly describes a device intended for surgical implantation to support tendon healing, not a test performed on a sample outside the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
TAPESTRY® Biointegrative Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
Product codes (comma separated list FDA assigned to the subject device)
OWY
Device Description
The TAPESTRY® Biointegrative Implant (TAPESTRY) is composed of collagen and poly(D,Llactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. TAPESTRY is conformable and designed for easy placement between the tendon and surrounding tissue and may be secured in place using standard fixation techniques. TAPESTRY is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, ranging from 20mm x 25mm to 70mm x 50mm. TAPESTRY is available with or without a co-packaged polyethylene Insertion Sleeve, which is used to maintain the implant's orientation and to facilitate easy application onto the tendon. The Insertion Sleeve is discarded after use and not implanted. TAPESTRY is designed for stand-alone use. At the discretion of the surgeon. TAPESTRY may be hydrated with sterile isotonic solution.
Preclinical studies of TAPESTRY showed dense collagenous fibrous connective tissue ingrowth into and around the scaffolding.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tendon
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)
TAPESTRY is the same device as its predicate, TAPESTRY (K201572), in regard to all aspects of the device. Only the collagen stability validation method changed between the current device and the predicate device. Past performance testing (safety, biocompatibility, bench) of the predicate device is directly applicable to the subject device. Additional tests to confirm the collagen stability of the device were performed. Hydroxyproline analysis was conducted to confirm the collagen quantity and Fourier Transform Infrared (FTIR) analysis was conducted to confirm collagen quality. Together with the product stability testing of the predicate device, the collagen stability testing will be used to support expansion of the shelf life of the subject device. No new performance testing was required to support the additional product sizes, as the sizes are within the cleared size range and the cleared labeling allows for trimming of the device. The performance testing demonstrates that TAPESTRY is substantially equivalent to the predicate device.
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.
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.
Not Found
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
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
November 2, 2021
Embody, Inc. Brianna Schehr Director of Regulatory Affairs 4211 Monarch Way, Suite 500 Norfolk, Virginia 23508
Re: K212306
Trade/Device Name: Tapestry Biointegrative Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OWY Dated: September 29, 2021 Received: September 30, 2021
Dear Ms. Schehr:
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 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
1
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 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,
for Deborah Fellhauer, RN, BSN Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212306
Device Name TAPESTRY® Biointegrative Implant
Indications for Use (Describe)
TAPESTRY® Biointegrative Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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
| Device Trade Name: | TAPESTRY® Biointegrative Implant |
|---|---|
| Device Common Name: | Tendon Protector |
| Device Class: | II |
| Classification Name: | Mesh, Surgical |
| Regulation No.: | 878.3300 |
| Product Code: | OWY |
| Predicate Device: | TAPESTRY® Biointegrative Implant, K201572 |
| Owner/Submitter: | Embody, Inc. |
| 4211 Monarch Way, Suite 500 | |
| Norfolk, VA 23508 | |
| (757) 777-5674 | |
| Regulatory Contact: | Brianna Schehr |
| Director of Regulatory Affairs | |
| Email: bschehr@embody-inc.com | |
| Telephone: (236) 994-7912 | |
| Date Prepared: | September 29, 2021 |
DEVICE DESCRIPTION
The TAPESTRY® Biointegrative Implant (TAPESTRY) is composed of collagen and poly(D,Llactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. TAPESTRY is conformable and designed for easy placement between the tendon and surrounding tissue and may be secured in place using standard fixation techniques. TAPESTRY is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, ranging from 20mm x 25mm to 70mm x 50mm. TAPESTRY is available with or without a co-packaged polyethylene Insertion Sleeve, which is used to maintain the implant's orientation and to facilitate easy application onto the tendon. The Insertion Sleeve is discarded after use and not implanted. TAPESTRY is designed for stand-alone use. At the discretion of the surgeon. TAPESTRY may be hydrated with sterile isotonic solution.
Preclinical studies of TAPESTRY showed dense collagenous fibrous connective tissue ingrowth into and around the scaffolding.
INTENDED USE/INDICATIONS FOR USE
TAPESTRY is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
4
SUBSTANTIAL EQUIVALENCE SUMMARY
TAPESTRY is the same device as its TAPESTRY predicate, with the same indications for use, design, materials, and technological characteristics and, therefore is substantially equivalent. Validation methods for establishing collagen stability throughout TAPESTRY's shelf life has been added to support expansion of the shelf life of the subject device. Two new product size/shape offerings, within the originally cleared size range, have been added based on user feedback.
SUMMARY OF PERFORMANCE TESTING
TAPESTRY is the same device as its predicate, TAPESTRY (K201572), in regard to all aspects of the device. Only the collagen stability validation method changed between the current device and the predicate device. Past performance testing (safety, biocompatibility, bench) of the predicate device is directly applicable to the subject device. Additional tests to confirm the collagen stability of the device were performed. Hydroxyproline analysis was conducted to confirm the collagen quantity and Fourier Transform Infrared (FTIR) analysis was conducted to confirm collagen quality. Together with the product stability testing of the predicate device, the collagen stability testing will be used to support expansion of the shelf life of the subject device. No new performance testing was required to support the additional product sizes, as the sizes are within the cleared size range and the cleared labeling allows for trimming of the device. The performance testing demonstrates that TAPESTRY is substantially equivalent to the predicate device.
CONCLUSION
The purpose of this 510(k) application was to notify the Food and Drug Administration of the new validation methods for establishing collagen stability throughout TAPESTRY's shelf life. TAPESTRY is the same device as the TAPESTRY device cleared under K201572 with the same intended use, design, and technological characteristics. The new collagen stability validation methods do not raise any different questions of safety or efficacy. Therefore, the TAPESTRY subject device is substantially equivalent to the TAPESTRY predicate device.