(449 days)
No
The device description and performance studies focus on the material properties and mechanical performance of a surgical mesh, with no mention of AI or ML capabilities.
No
The device is a surgical mesh for reinforcing soft tissue, not a device used for treatment or diagnosis.
No
The device is a surgical mesh for reinforcing soft tissue, not for diagnosing conditions.
No
The device description clearly states it is a surgical mesh manufactured from physical materials (ovine forestomach matrix and PLGA suture) and is intended for implantation, indicating it is a physical medical device, 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 surgical implant used directly on the patient's body for structural support.
- Device Description: The device is a "surgical mesh manufactured by layering sheets of ovine forestomach matrix... for use in plastic and reconstructive surgery." This further confirms it's a physical implant.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a disease or condition. IVDs are used for diagnostic purposes, not for direct surgical repair or reinforcement.
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) is a surqical mesh manufactured by layering sheets of ovine forestomach matrix to create multi-layer configurations of devices sewn together with resorbable Poly(lactic-co-glycolic Acid) ("PLGA") suture for use in plastic and reconstructive surgery. The 2-8 ply devices are available in surface areas up to 434 cm² in various shapes.
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
Preclinical testing was conducted on OviTex PRS (Long-Term Resorbable) devices to demonstrate substantial equivalence to the predicate device. New bench testing included mechanical strength, suture retention, endotoxin, and compliance testing. Results of the testing confirms that the proposed device meets all product specifications.
Biocompatibility assessment and testing was performed in accordance with ISO 10993-1 on the final, finished device. Additionally, extractable and Leachable (E&L) testing was conducted on the final finished PLGA polymeric suture. A comprehensive assessment of each of the characterized chemicals obtained from this testing was incorporated into a toxicological risk assessment (TRA) regarding the finished subject device in accordance with ISO 10993-18. The results of all performed biocompatibility testing and the accompanying toxicological risk assessment establish the biocompatibility of the OviTex PRS (LTR) device family.
An implantation study was conducted in accordance with ISO 10993-6 for a permanent implant contacting tissue which compared the local tissue response of the subject device to that of the predicate device. The results of this study showed that all devices had advanced to complete resorption by 78 weeks and that the subject device was substantially equivalent to the predicate device, classified as a non-irritant in terms of the local tissue response.
Substantial equivalence was not based on an assessment of clinical performance data.
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 logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 21, 2023
TELA Bio John Urtz Senior Manager, Regulatory and Quality 1 Great Valley Parkway, Suite 24 Malvern, Pennsylvania 19355
Re: K214070
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, FTM, FTL Dated: December 23, 2021 Received: December 27, 2021
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 (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
1
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 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 medical devices and radiation-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,
Deborah A. Fellhauer -S
Deborah Fellhauer RN, BSN 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) K214070
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) |
|---|
| Disposition (Part 1 CFR 301 Subpart A) |
| Sale or Transfer (19 CFR 301 Subpart C) |
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) SUMMARY
| Device trade name: | OviTex PRS (Long-Term Resorbable) |
|---|---|
| Device common name: | Mesh, surgical |
| Regulation number: | §878.3300, Surgical Mesh |
| Product code(s): | FTM / FTL |
| Predicate device: | Endoform Restella (K183398) |
| Reference device: | Endoform Reconstructive Template (Non-Absorbable) |
| (K181935) | |
| Owner / Submitter: | TELA Bio, Inc. |
| 1 Great Valley Parkway | |
| Suite 24 | |
| Malvern, PA 19355 | |
| Contact Person: | John Urtz |
| Sr. Manager, Quality and Regulatory | |
| TELA Bio, Inc. | |
| jurtz@telabio.com | |
| 484-320-2884 | |
| Date prepared: | 16 March 2023 |
Device Description
OviTex PRS (Long-Term Resorbable) is a surqical mesh manufactured by layering sheets of ovine forestomach matrix to create multi-layer configurations of devices sewn together with resorbable Poly(lactic-co-glycolic Acid) ("PLGA") suture for use in plastic and reconstructive surgery. The 2-8 ply devices are available in surface areas up to 434 cm² in various shapes.
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.
Summary/Comparison of Technological Characteristics
OviTex PRS (Long-Term Resorbable) has the same indications for use as the predicate device, Endoform Restella. The principle of operation is also the same.
The subject device, OviTex PRS (Long-Term Resorbable) has similar technological characteristics as the predicate device. Both devices are composed of sheets of ovine forestomach matrix and are sewn together with a polymeric suture. The main differences between the subject and predicate device are the polymeric suture material (PLGA in the subject device vs. Polyglycolic Acid ("PGA") or Polypropylene ("PP") in the predicate device) and the directionality of the ovine tissue fenestrations (bi-directional for the subject device and uni-directional for the predicate device). The subject device is offered in a broader range of shapes, sizes, and thicknesses compared to the predicate, but within the range of
4
sizes/thicknesses of the reference device. OviTex PRS (Long-Term Resorbable) maintains the same fundamental technological characteristics as the predicate device with respect to material types, biocompatibility, device specifications, and sterilization.
| Reference Device | |||
|---|---|---|---|
| Endoform | |||
| Reconstructive | |||
| Subject Device | Predicate Device | Template (Non- | |
| Characteristic | OviTex PRS (LTR) | Endoform Restella | absorbable) |
| 510(k) Number | K214070 | K183398 | K181935 |
| Product Code | FTM / FTL | FTM / FTL | FTL / FTM |
| Regulation | |||
| Number | §878.3300, Surgical | ||
| Mesh | §878.3300, Surgical | ||
| Mesh | §878.3300, Surgical | ||
| Mesh | |||
| Common Name | Mesh, surgical | Mesh, surgical | Mesh, surgical |
| Indications for | |||
| Use | OviTex PRS (Long-Term Resorbable) is intended for use in the reinforcement of 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. | Endoform Restella is intended for use in the reinforcement of 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. | Endoform Reconstructive Template - Non-Absorbable is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome. |
| Animal Derived | |||
| Tissue | Ovine forestomach | ||
| matrix | Ovine forestomach | ||
| matrix | Ovine forestomach | ||
| matrix | |||
| Polymeric Suture | Poly(lactic-co-glycolic Acid) | Polyglycolic Acid OR | |
| Polypropylene | Polypropylene | ||
| Layering | |||
| Configurations | 2-8 layers | 3 layers | 1-10 layers |
| Maximum Device | |||
| Size | 434cm² | 399cm² | 1000cm² |
| Shapes Offered | Rectangle, Contour, | ||
| Oval | Rectangle, Contour | Rectangle | |
| Tissue | |||
| Fenestrations | Bi-directional | Uni-directional | None |
| Biocompatibility | Established | Established | Established |
| Characteristic | Subject Device | ||
| OviTex PRS (LTR) | Predicate Device | ||
| Endoform Restella | Reference Device | ||
| Endoform | |||
| Reconstructive | |||
| Template (Non-absorbable) | |||
| Endotoxin | |||
| Content |