(59 days)
Not Found
No
The 510(k) summary describes a biointegrative implant made of collagen and poly(D,L-lactide) for tendon repair. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies focus on mechanical and biological properties of the implant.
Yes
The device is indicated for the "management and protection of tendon injuries," which describes a therapeutic purpose.
No
The device description indicates it is an implant designed to manage and protect tendon injuries. It is a therapeutic device, not a diagnostic one used for identifying or characterizing a disease or condition.
No
The device description explicitly states it is an "Implant" composed of physical materials (collagen and poly(D,L-lactide)) and is provided as a sterile, standalone implant, in an insertion sleeve, or on an introducer. This indicates a physical medical device, not a software-only one.
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 description details an implant composed of collagen and poly(D,L-lactide) designed to function as a "protective layer between the tendon and surrounding tissues." This is a physical implant for surgical use.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 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. The implant is provided sterile for single use only. It is supplied as a standalone implant, in an insertion sleeve, or on an introducer assists in delivering the implant to the surgical site during arthroscopic procedures. The device is provided in a dual pouch configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Performance testing submitted to support this change included: introducer functional design verification testing (cannula passage, introducer release, stopper pressure test), simulated-use validation testing in an arthroscopic cadaver model. sterilization validation, and shelf-life testing. A battery of biocompatibility testing was conducted and included the following tests: cytotoxicity, sensitization, system toxicity, and pyrogenicity. Results of the performance testing demonstrated the device functions as intended and appropriate for its intended use and is substantially equivalent to the predicate. The testing in this submission was directly applicable to the new introducer and no additional performance testing was required for the implant based on the modification.
Key Metrics
Not Found
Predicate Device(s)
TAPESTRY® Biointegrative Implant, K212306
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.
0
May 23, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Embody, Inc. Brianna Schehr Director of Quality, Regulatory & Clinical Affairs 4211 Monarch Way, Suite 500 Norfolk, Virginia 23508
Re: K220867
Trade/Device Name: TAPESTRY® Biointegrative Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OWY Dated: April 11, 2022 Received: April 12, 2022
Dear Brianna 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,
Laura C. Rose, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
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)
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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3
Image /page/3/Picture/1 description: The image is completely white and contains no discernible objects, shapes, or patterns. The image appears to be a blank canvas with a uniform white color throughout. There are no variations in shading or texture. It is a simple, unadorned image with no content.
Image /page/3/Picture/2 description: The image shows the word "EMBODY" in a stylized font. The letters are primarily dark blue, except for the "BOD" portion, where the "O" is replaced by an orange square with diagonal lines inside. The font appears modern and bold, with a slight slant to the right, giving the word a dynamic and forward-moving feel.
510(k) Summary
SUBMITTER l.
| Owner/Submitter: | Embody, Inc.
4211 Monarch Way
Suite 500
Norfolk, VA 23508 |
|------------------|--------------------------------------------------------------------------------------|
| Phone: | 236-994-7912 |
| Contact Person: | Brianna Schehr
Director of Quality, Regulatory & Clinical Affairs
Embody, Inc. |
| | Phone: +1 (236) 994-7912
Email: bschehr@embody-inc.com |
| Date Prepared: | May 19, 2022 |
II. DEVICE
| Name of Device: | TAPESTRY® Biointegrative Implant |
|---|---|
| Common or Usual Name: | Tendon Protector |
| Classification Name: | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement of |
| Tendon | |
| Regulation Number: | 21 CFR 878.3300 |
| Regulatory Class: | Class II |
| Product Code: | OWY |
| Medical Specialty: | General & Plastic Surgery |
lll. PREDICATE DEVICE
TAPESTRY® Biointegrative Implant, K212306. This predicate has not been subject to a designrelated recall.
IV. DEVICE DESCRIPTION
The TAPESTRY® Biointegrative Implant 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. The implant is provided sterile for single use only. It is supplied as a standalone implant, in an insertion sleeve, or on an introducer assists in delivering the implant to the surgical site during arthroscopic procedures. The device is provided in a dual pouch configuration.
V. INDICATION 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.
4
Image /page/4/Picture/1 description: The image shows the word "EMBODY" in a stylized font. The letters are primarily dark blue, except for the "O", which is enclosed in an orange square with diagonal lines inside. The word appears to be a logo or brand name, with a modern and clean design.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject device has the same intended use, indication for use, and fundamental scientific technology as the predicate device. The subject device is the same TAPESTRY® Biointegrative Implant as the predicate device, with the exception that an implant introducer will be included with three currently offered (and within the cleared size range) sizes of the predicate device. The introducer assists in delivering the TAPESTRY® Biointegrative Implant to the surgical site during arthroscopic procedures.
VII. PERFORMANCE DATA
A risk analysis was conducted for the design change (i.e., the new introducer instrument) and to identify the verification and validation activities necessary to mitigate any identified risks and establish substantial equivalence. Performance testing submitted to support this change included: introducer functional design verification testing (cannula passage, introducer release, stopper pressure test), simulated-use validation testing in an arthroscopic cadaver model. sterilization validation, and shelf-life testing. A battery of biocompatibility testing was conducted and included the following tests: cytotoxicity, sensitization, system toxicity, and pyrogenicity. Results of the performance testing demonstrated the device functions as intended and appropriate for its intended use and is substantially equivalent to the predicate. The testing in this submission was directly applicable to the new introducer and no additional performance testing was required for the implant based on the modification.
VIII. CONCLUSIONS
The TAPESTRY® Biointeqrative Implant subject device is the same device as its predicate except it is provided on an introducer. The device modification does not raise any different questions of safety or efficacy. The TAPESTRY® Biointegrative Implant subject device is substantially equivalent to the TAPESTRY® Biointegrative Implant predicate device.