(130 days)
No
The device description and performance studies focus on the material composition and biological integration of the implant, with no mention of AI or ML capabilities.
No
The device is described as a non-constricting, protective layer for tendon injuries, which is a supportive rather than directly therapeutic function.
No
The device is described as an "implant" that functions as a "non-constricting, protective layer between the tendon and surrounding tissues" for the "management and protection of tendon injuries". It is a physical device used for treatment, not for diagnosing conditions.
No
The device description clearly states it is composed of collagen and poly(D,L-lactide) and is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "management and protection of tendon injuries." This describes a therapeutic or protective function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is an implant composed of collagen and poly(D,L-lactide) designed to be placed between the tendon and surrounding tissues. This is a physical implant, not a reagent, instrument, or system used to examine specimens.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The TAPESTRY® Biointegrative Implant is used in vivo (within the body) for a therapeutic/protective purpose.
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
OWY
Device Description
The TAPESTRY® Biointegrative Implant device is composed of collagen and poly(D,L-lactide). 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
Preclinical studies of TAPESTRY® showed dense collagenous fibrous connective tissue ingrowth into and around the scaffolding.
Biocompatibility Testing for TAPESTRY® including, cytotoxicity, sensitization, intracutaneous irritation, systemic toxicity, pyrogenicity, and genotoxicity satisfied the requirements outlined in ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process, and helped demonstrate that the device is substantially equivalent to its predicate and is biocompatible in accordance to ISO 10993-1.
The in vivo animal study evaluated local tissue response, systemic toxicity, and the device resorption profile in a clinically relevant tendon model. TAPESTRY® was found to be completely resorbed between the 52 to 72-week time points with a complete quiescence of the associated inflammatory response. The device was shown to yield favorable results in the calcaneal tendon incision model and supports a determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 16, 2021
Embody, Inc. % Scott Bruder CEO, Bruder Consulting and Venture Group Bruder Consulting and Venture Group 4211 Monarch Way, Ste. 500 Norfolk, Virginia 23508
Re: K201572
Trade/Device Name: TAPESTRY Biointegrative Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OWY
Dear Mr. Bruder:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 19, 2020. Specifically, FDA is updating this SE Letter as an administrative correction to the product codes removing FTM as a secondary product code.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Deborah Fellhauer, OHT4: Office of Surgical and Infection Control Devices, Deborah.Fellhauer@fda.hhs.gov.
Sincerely,
Min Zhang-S
for Deborah Fellhauer 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
1
Image /page/1/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services USA logo, which features a stylized eagle. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 19, 2020
Embody, Inc. % Scott Bruder CEO, Bruder Consulting and Venture Group Bruder Consulting and Venture Group 4211 Monarch Way, Ste. 500 Norfolk, Virginia 23508
Re: K201572
Trade/Device Name: TAPESTRY Biointegrative Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OWY, FTM Dated: June 10, 2020 Received: June 11, 2020
Dear Dr. Bruder:
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
2
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 (OS) 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,
Cindy Chowdhury -S
Cindy Chowdhury, Ph.D., M.B.A. 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
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Indications for Use
510(k) Number (if known) K201572
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: | Rotation Medical Inc. Collagen Tendon Sheet, K112423 | |
| Reference Device: | Surgi Wrap MAST Tendon Sheet, K063648 | |
| Owner/Submitter: | Embody, Inc. | |
| 4211 Monarch Way, Suite 500 | ||
| Norfolk, VA 23508 | ||
| (757) 777-5674 | ||
| Regulatory Contact: | Scott Bruder, MD, PhD | |
| Founder and CEO, Bruder Consulting & Venture Group | ||
| scott@bruderconsulting.com | ||
| Tele: 201.874.9701 | ||
| Date Prepared: | October 13, 2020 |
DEVICE DESCRIPTION
The TAPESTRY® Biointegrative Implant device is composed of collagen and poly(D,L-lactide). 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.
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SUMMARY/COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
TAPESTRY® and its predicate have the same intended use/indications for use, and basic similarities in design, materials, and technological characteristics and are substantially equivalent. A comparison of the subject and predicate device are provided in the table below.
| haracteristic | Subject Device
Embody
TAPESTRY® | Predicate Device
Rotation Medical Collagen Tendon
Sheet |
|-----------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Material
Composition | Highly aligned composite implant
(70% PDLLA, 30% type I bovine
collagen) non crosslinked | Highly oriented implant, (100% type I
bovine collagen), crosslinked |
| Form | Resorbable flat sheet | Resorbable flat sheet |
| Color/
Appearance | White to off white with blue
orientation lines on unaligned side | White to off white with a blue perimeter |
| Size | Multiple sizes from 2.0cm x 2.5cm to
7.0cm x 5.0cm | 1.5x2cm, 2x2.5cm,2.5x3cm |
| Density | Low (85% porosity | 85-90% porosity |
| Intraoperative
Characteristics | Open and laparoscopic/endoscopic and
arthroscopic procedures.
Can be sutured | Open and laparoscopic/endoscopic and
arthroscopic procedures.
Can be sutured |
| Pyrogenicity | Non-pyrogenic
(