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.

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.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for the OviTex PRS (Long-Term Resorbable) surgical mesh. While it discusses the device's characteristics and its comparison to a predicate device, it does not contain information about the acceptance criteria and study that proves the device meets specific performance criteria in the way typically expected for an AI/ML medical device.

The document indicates that substantial equivalence was not based on an assessment of clinical performance data. Instead, it relies on preclinical, mechanical, and biocompatibility testing to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested points cannot be answered from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document states: "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." However, it does not provide the specific acceptance criteria (e.g., tensile strength > X N, suture retention > Y N) or the quantitative reported device performance for these tests.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Bench Testing (Mechanical, Suture Retention, Endotoxin, Compliance): The sample sizes for these tests are not provided. Data provenance is not specified beyond "Preclinical testing."
Biocompatibility Assessment: Not specified.
Implantation Study: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the type of studies described (mechanical, biocompatibility, implantation) for a surgical mesh. These studies do not typically involve experts establishing ground truth in the way an AI/ML diagnostic device would for image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for the types of studies described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC study was not done. This device is a surgical mesh, not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Bench Testing: Engineering specifications and standardized test methods.
Biocompatibility: ISO 10993 standards and toxicological risk assessment.
Implantation Study: Histopathological evaluation of tissue response compared to the predicate, as per ISO 10993-6. This could be considered a form of "pathology" ground truth. The study concluded that the subject device was "classified as a non-irritant" and had "advanced to complete resorption by 78 weeks."

8. The sample size for the training set

Not applicable. This device does not use an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary Table (Limited Information Available from Document):

Criterion	Information from Document
Acceptance Criteria & Device Performance	Acceptance Criteria: "product specifications" (details not provided). Reported Performance: "Results of the testing confirms that the proposed device meets all product specifications." (Quantitative results not provided.)
Study Type to Prove Acceptance	Preclinical bench testing (mechanical strength, suture retention, endotoxin, compliance), biocompatibility assessment (ISO 10993-1, E&L, TRA in accordance with ISO 10993-18), and an implantation study (ISO 10993-6). Substantial equivalence was not based on clinical data.
Test Set Sample Size	Not specified for any of the studies.
Data Provenance (Test Set)	Not detailed beyond "Preclinical testing."
Number of Experts (Ground Truth)	Not applicable for mechanical, biocompatibility, or implantation studies in the context of "ground truth" for a diagnostic device.
Qualifications of Experts	Not applicable.
Adjudication Method (Test Set)	Not applicable.
MRMC Comparative Effectiveness Study	No.
AI vs. Without AI Assistance Effect Size	Not applicable.
Standalone Performance (Algorithm Only)	Not applicable.
Type of Ground Truth Used	Engineering specifications, standardized test methods, ISO 10993 standards (biocompatibility, toxicological risk assessment), and histopathological evaluation (implantation study).
Training Set Sample Size	Not applicable.
How Ground Truth for Training Set Established	Not applicable.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K214070

Device Name OviTex PRS (Long-Term Resorbable)

Indications for Use (Describe)

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)

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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 ParkwaySuite 24Malvern, PA 19355
Contact Person:	John UrtzSr. Manager, Quality and RegulatoryTELA Bio, Inc.jurtz@telabio.com484-320-2884
Date prepared:	16 March 2023

Device Description

Intended Use / Indications for 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

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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
RegulationNumber	§878.3300, SurgicalMesh	§878.3300, SurgicalMesh	§878.3300, SurgicalMesh
Common Name	Mesh, surgical	Mesh, surgical	Mesh, surgical
Indications forUse	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 DerivedTissue	Ovine forestomachmatrix	Ovine forestomachmatrix	Ovine forestomachmatrix
Polymeric Suture	Poly(lactic-co-glycolic Acid)	Polyglycolic Acid ORPolypropylene	Polypropylene
LayeringConfigurations	2-8 layers	3 layers	1-10 layers
Maximum DeviceSize	434cm²	399cm²	1000cm²
Shapes Offered	Rectangle, Contour,Oval	Rectangle, Contour	Rectangle
TissueFenestrations	Bi-directional	Uni-directional	None
Biocompatibility	Established	Established	Established
Characteristic	Subject DeviceOviTex PRS (LTR)	Predicate DeviceEndoform Restella	Reference DeviceEndoformReconstructiveTemplate (Non-absorbable)
EndotoxinContent	< 20 EU/device	< 20 EU/device	< 20 EU/device
SterilizationMethod andSterilityAssurance Level(SAL)	Ethylene Oxide, 10-6	Ethylene Oxide, 10-6	Ethylene Oxide, 10-6
Usage	Single use only	Single use only	Single use only

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Non-clinical Performance Data

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.

Clinical Performance Data

Substantial equivalence was not based on an assessment of clinical performance data.

Conclusion

The results of preclinical, mechanical, and biocompatibility testing demonstrate that OviTex PRS (Long-Term Resorbable) is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.