(29 days)
Not Found
No
The description focuses on the material composition and physical properties of a surgical mesh, with no mention of AI or ML capabilities.
No
The device is described as an implantable matrix for reinforcing soft tissue, not as a device that delivers therapeutic energy or substances for treatment.
No
The device is described as an implant used to reinforce soft tissue, not to diagnose a condition.
No
The device description clearly states it is a "reinforced tissue matrix composed of biological tissue (ovine extracellular matrix) and Poly(lactic co-glycolic acid)," indicating it 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 "implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery." This describes a device used in vivo (within the body) for structural support and repair.
- Device Description: The description details a "sterile reinforced tissue matrix composed of biological tissue (ovine extracellular matrix) and Poly(lactic co-glycolic acid)." This is a material intended for surgical implantation.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such testing on specimens.
Therefore, OviTex PRS (Long-Term Resorbable) is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
OviTex PRS (Long-Term Resorbable) is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
Product codes
FTM, FTL
Device Description
OviTex PRS Long-Term Resorbable (OviTex PRS LTR) is a sterile reinforced tissue matrix composed of biological tissue (ovine extracellular matrix) and Poly(lactic co-glycolic acid). The device contains bidirectional fenestrations to allow for multidirectional stetch. The polymer imparts additional structure to the ECM and maintains device integrity through the initial phases of healing. OviTex PRS is provided in various shapes and sizes to suit surgeon preference and nature of the soft tissue repair in plastic and reconstructive surgery. The device may be trimmed to a desired shape to further accommodate an individual patient's requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
Real-time shelf life testing was utilized to confirm that OviTex PRS LTR meets specification through 18 months of storage.
The additional device offerings underwent non-clinical testing including endotoxin and ethylene oxide sterilization residuals (ISO 10993-7:2008) quantification. The results of testing showed that these devices met the predefined acceptance criteria.
Overall, the results of non-clinical testing support a determination of substantial equivalence between and the predicate device.
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.
0
Image /page/0/Picture/0 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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
December 19, 2024
TELA Bio, Inc. John Urtz Associate Director - Regulatory and Quality 1 Great Valley Parkway Suite 24 Malvern, Pennsylvania 19355
Re: K243595
Trade/Device Name: OviTex PRS (Long-Term Resorbable) Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM, FTL Dated: November 20, 2024 Received: November 20, 2024
Dear John Urtz:
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.
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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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
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assistance/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,
Irada S.
Isayeva -S
Digitally signed by
Irada S. Isayeva -S
Date: 2024.12.19
17:39:25-05'00'
for Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive 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
Submission Number (if known)
Device Name
OviTex PRS (Long-Term Resorbable)
Indications for Use (Describe)
OviTex PRS (Long-Term Resorbable) is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
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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| K243595 | Page 1 of 2 | |
|---|---|---|
| 510(k) #: | 510(k) Summary | Prepared on: 2024-12-10 |
| Contact Details | 21 CFR 807.92(a)(1) | |
| Applicant Name | TELA Bio, Inc. | |
| Applicant Address | 1 Great Valley Parkway Suite 24 Malvern PA 19355 United States | |
| Applicant Contact Telephone | 4843202884 | |
| Applicant Contact | Mr. John Urtz | |
| Applicant Contact Email | jurtz@telabio.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | OviTex PRS (Long-Term Resorbable) | |
| Common Name | Surgical mesh | |
| Classification Name | Mesh, Surgical | |
| Regulation Number | 878.3300 | |
| Product Code(s) | FTM, FTL | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K214070 | OviTex PRS (Long-Term Resorbable) | FTM |
| Device Description Summary | 21 CFR 807.92(a)(4) | |
| OviTex PRS Long-Term Resorbable (OviTex PRS LTR) is a sterile reinforced tissue matrix composed of biological tissue (ovine extracellular matrix) and Poly(lactic co-glycolic acid). The device contains bidirectional fenestrations to allow for multidirectional stetch. The polymer imparts additional structure to the ECM and maintains device integrity through the initial phases of healing. OviTex PRS is provided in various shapes and sizes to suit surgeon preference and nature of the soft tissue repair in plastic and reconstructive surgery. The device may be trimmed to a desired shape to further accommodate an individual patient's requirements. | ||
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) | |
| OviTex PRS (Long-Term Resorbable) is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use. | ||
| Indications for Use Comparison | 21 CFR 807.92(a)(5) | |
| The indications for use are the same for the subject device as the predicate device. | ||
| Technological Comparison | 21 CFR 807.92(a)(6) | |
| The subject device has the same technological characteristics as the predicate device including materials of construction and principle of operation. There are two changes between the subject and the predicate device. | ||
| First, all OviTex PRS Long-Term Resorbable devices have been modified to remove a layer of foil packaging. The sterile barrier is |
5
unchanged.
Second, two additional device configurations are being introduced - a 25cm diameter circle and a 25x30cm oval. Both devices contain three layers of decellularized extracellular matrix and are embroidered together with Poly(lactic co-glycolic Acid) suture.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Real-time shelf life testing was utilized to confirm that OviTex PRS LTR meets specification through 18 months of storage.
The additional device offerings underwent non-clinical testing including endotoxin and ethylene oxide sterilization residuals (ISO 10993-7:2008) quantification. The results of testing showed that these devices met the predefined acceptance criteria.
Overall, the results of non-clinical testing support a determination of substantial equivalence between and the predicate device.