Endoform Restella 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

Endoform Restella is a surgical mesh manufactured by layering sheets of ovine forestomach matrix to create multi-layer configurations of devices laminated with absorbable polyglycolic acid (PGA) and non-absorbable polypropylene (PP) suture material for use in plastic and reconstructive surgery. The 3-ply devices are available in sizes up to 400 cm² in arced rectangle, contour, and oval shapes.

AI/ML Overview

The provided text is a 510(k) summary for the medical device "Endoform Restella." This document describes the device, its intended use, and how it demonstrates substantial equivalence to a predicate device for FDA clearance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (Summary)
Material Composition	Equivalent to predicate device.
Biocompatibility	Equivalent to predicate device.
Sterilization	Equivalent to predicate device.
Packaging Materials	Equivalent to predicate device.
Packaging Processes	Equivalent to predicate device.
Mechanical Strength	Meets product specifications.
Endotoxin	Meets product specifications.
Dimensional Verification	Meets product specifications.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes (e.g., number of devices, number of tests performed) for the bench testing.
The data provenance is from non-clinical bench testing. The text does not provide country of origin or whether it's retrospective or prospective, though bench testing is inherently prospective in nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. Bench testing typically relies on predefined engineering specifications rather than expert consensus on a 'ground truth' in the same way clinical data would.

4. Adjudication method for the test set

This information is not applicable/not provided. Adjudication methods are typically relevant for human-interpreted data (e.g., imaging studies, clinical endpoints), not for objective bench test results like mechanical strength or endotoxin levels.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical mesh; the concept of "human readers" and "AI assistance" is not relevant to its type of evaluation.

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

This question is not applicable to this medical device. The "Endoform Restella" is a physical surgical mesh, not an algorithm or AI performing a task. Its performance is evaluated through physical and material properties, not by an algorithm's output.

7. The type of ground truth used

The ground truth used for the non-clinical performance evaluation was based on product specifications and the characteristics of the predicate device. The device was deemed acceptable if it met these predefined specifications and demonstrated equivalence in key properties to the legally marketed predicate.

8. The sample size for the training set

This information is not applicable/not provided. The "Endoform Restella" is a physical device, not a machine learning algorithm that requires a "training set."

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

This question is not applicable to this medical device.

Summary

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April 11, 2019

Aroa Biosurgery Ltd. Tina O'brien Director, Regulatory Affairs 2 Kingsford Smith Place Airport Oaks, 2022 Nz

Re: K183398

Trade/Device Name: Endoform Restella Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM, FTL Dated: December 6, 2018 Received: December 7, 2018

Dear Tina O'brien:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5. 510(k) Summary

Contact person/submitter	Tina O'Brien
	Director of Regulatory Affairs
	Aroa Biosurgery Ltd.
Date prepared	6 December 2018
Contact details	2 Kingsford Smith PlaceAirport Oaks, Auckland 2022, New Zealand+64 9 369 3035, ext. 214
Trade name	Endoform® Restella - Absorbable and Non-Absorbable
Common name	Surgical mesh
Classification name	Mesh, Surgical; Mesh, Surgical Polymeric
Predicate device	Endoform® Plastics & Reconstruction Matrix (K162461)

Device Description 5.1

5.2 Intended Use and Indications for Use

5.2.1 Intended 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 plastics and reconstructive surgery.

5.2.2 Indications for Use

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Endoform Restella - Traditional 510(k)_- K183398

5.3 Technological Characteristics Comparison

Endoform Restella devices are a line extension to Endoform Reconstructive Template devices embroidered with either absorbable polyglycolic acid (K130547) or non-absorbable polypropylene suture (K153632) to introduce new configurations for use in plastic and reconstructive surgery.

Endoform Restella maintains the same fundamental technological characteristics as the predicate device, Endoform® Plastics & Reconstruction Matrix (K162461) with respect to material composition, biocompatibility, sterilization, and packaging materials and processes. The primary difference is the lamination method in that the subject device is embroidered with either polyglycolic acid and polypropylene suture material, while the predicate contains no suture material and is laminated using a proprietary lugging method.

Performance and validation testing executed based on risk analysis of the design changes supports substantial equivalence of the subject device. The primary characteristic specifications for the ovine forestomach matrix have not changed as a result of the modification. However, the Restella device may not have sufficient strength to support stresses encountered in some ventral hernias or large-area, body-wall repairs

5.4 Non-Clinical Performance Data

The bench testing and validation conducted on Restella devices demonstrates substantial equivalence to the predicate device. Bench testing included mechanical strength, endotoxin, and dimensional verification testing. Results of the testing confirms that the proposed device meets all product specifications for the intended use.

Previous biocompatibility testing performed for the product presented in K153632 remains applicable to Restella based on the equivalence of the material composition of the proposed device to the predicate.

5.5 Clinical Performance Data

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

5.6 Conclusions

The technological characteristics and materials of the subject device are equivalent to the predicate. Based on the results of verification and validation testing it can be concluded that the proposed device is substantially equivalent to the predicate device and does not raise new questions of safety or effectiveness

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Indications for Use

510(k) Number (if known)

K183398

Device Name

Endoform Restella

Indications for Use (Describe)

Endoform Restella is for implantation to reinforce soft tissue where weakness exists in patients repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.

	X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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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.