Kerecis SecureMesh is intended for use as a prosthesis when staple line reinforcement is needed in surgical repair of soft tissue deficiencies using surgical staplers.

Kerecis SecureMesh can be used for reinforcement of staple lines during:

Bariatric surgical procedures
Colorectal and Colon surgical procedures
Gastric, small bowels and mesentery procedures
Lung and bronchus resections

Device Description

Subject Device is formed of intact acellular fish skin and is intended to be used as a staple line buttress with surgical staplers. The buttress material is supplied in a double pouch sterile packaging (EtO), where a pair of buttresses is provided on a pair of carriers to be used by a healthcare professional, to transfer the buttresses to the opposed jaws of a surgical stapler in the operating theatre prior to a stapling procedure. One pair of carrier and a buttress is used for each stapler firing.

AI/ML Overview

The provided text is a 510(k) summary for the Kerecis SecureMesh, a surgical mesh. This document describes the device, its intended use, comparison with predicate devices, and performance testing to demonstrate substantial equivalence for regulatory clearance.

However, the questions you've asked are typically relevant to the development and validation of an AI/Machine Learning medical device, particularly concerning diagnostic or interpretative capabilities. The Kerecis SecureMesh is a physical surgical implant, not a software or AI-driven diagnostic tool. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, training/test sets) do not apply to this medical device.

The document describes performance testing for a surgical mesh, which includes:

Bench Testing:
- Biocompatibility (by leveraging prior testing on a similar product).
- Viral-inactivation evaluation (also leveraged from similar product).
- Tensile strength comparison with predicate.
- Usability (loading time, transfer to stapler, ease of use, force to fire, slippage).
- Performance (leak at staple line, leak pressure, seal burst).
Animal Studies:
- An acute porcine ex-vivo study comparing the Subject Device to a predicate device and un-buttressed stapling (negative control). The conclusion was "no significant difference."
Clinical Studies:
- "No clinical testing was included in this submission." This means no human clinical trials were performed for the 510(k) clearance based on substantial equivalence to predicate devices and the non-clinical testing.

Given the nature of the device and the provided text, I cannot answer the questions about AI/ML device validation. The "acceptance criteria" for this device would be established engineering and performance specifications, and the "proof" is the bench and animal testing demonstrating equivalence to a legally marketed predicate device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 19, 2016

Kerecis Limited Gudmundur Sigurjonsson CEO Eyrargata 2 Isafjordur, 400 Iceland

Re: K153364

Trade/Device Name: Kerecis SecureMesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OXE Dated: July 15, 2016 Received: July 21, 2016

Dear Gudmundur Sigurjonsson:

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

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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Indications for Use

510(k) Number (if known) K153364

Device Name

Kerecis SecureMesh

Indications for Use (Describe)

Kerecis SecureMesh is intended for use as a prosthesis when staple line reinforcement is needed in surgical repair of soft tissue deficiencies using surgical staplers.

Kerecis SecureMesh can be used for reinforcement of staple lines during:

Bariatric surgical procedures
Colorectal and Colon surgical procedures
Gastric, small bowels and mesentery procedures
Lung and bronchus resections

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)

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510k Summary

SUBMITTER/510K HOLDER 1

Address:	Kerecis LimitedEyrargata 2400 IsafjordurIceland
Contact Person:	Gudmundur Fertram SigurjonssonExecutive Chairman
Telephone:	011 354 562 2601
Date Prepared:	November 9th, 2015

2 DEVICE NAME

Proprietary Name:	Kerecis SecureMes
Common/Usual Name:	Surgical Mesh
Classification Name:	Mesh, Surgical
Classification Product Code:	OXE
Regulatory Number:	878.3300

3 PREDICATE DEVICES

Veritas Dry Collagen Matrix (K041669)- PrimaryPredicate
. MariGen Wound (K132343) - Supporting Predicate

DEVICE DESCRIPTION বা

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INTENDED USE ഗ

Subject Device is intended for use as a prosthesis when staple line reinforcement is needed in surgical repair of soft tissue deficiencies using surgical staplers.

Subject Device can be used for reinforcement of staple lines during:

. Bariatric surgical procedures
. Colo-rectal and colon surgical procedures
. Gastric, small bowels and mesentery procedures
Lung, and bronchus resections

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 6 PREDICATE DEVICES

Subject Device is substantially equivalent to the Primary Predicate, where the intended use and indication list of the Subject Device falls within the intended use and indication list of the Primary Predicate.

The Subject Device, and the Supporting Predicate, both are fish skin sheets that have been decellularized and lyophilized. Both devices consist of a terminally sterilized sheet of the provided in prescribed size configuration and thicknesses. Both are packaged in a pouch configuration.

510(k)	Subject Device K153364	Primary Predicate(K041669)
Device name	Kerecis SecureMesh	Veritas Dry Collagen Matrix
Product Codes	OXE	FTM
Intended use	Intended to be used as a stapleline buttress	Intended to be used as a stapleline buttress
Indications	Reinforcement of staple linesduring	Reinforcement of staple linesduring
1	Bariatric surgical procedures	Bariatric surgical procedures

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2	Gastric, small bowels andmesentery procedures	Gastric, small bowel, mesentery
3	Colorectal and colon procedures	Colon and colorectal procedures
4	Lung, and bronchus resections	Lung and bronchus resections
5	Not claimed	Occlusion of the left atrialappendage during open chestprocedures during cardiac
Animal Origin	Atlantic Cod Fish	Bovine
Tissue type	Skin	Pericardium
Presentation	A delivery system with anabsorbable buttress(dehydrated, non-cross- linked	A delivery system with abuttress (comprised ofdehydrated, non-cross- linked

Table 1 Comparing the predicate device and subject device Intended Use and Indication for Use. The the underlying functional design and principles of operation

PERFORMANCE 7

7.1 BENCH TESTING

The Supporting Predicate, MariGen Wound (K132343) has undergone appropriate biocompatibility testing and viral-inactivation evaluation. The information provided demonstrate that the device is biocompatible and that viral risks are not present. The Subject Device, (K153364) and the Supporting Predicate, MariGen Wound (K132343) utilize the same raw materials (fish skin), processing components/solutions and manufacturing processes, and are identical. Therefore, no further biocompatibility testing or anti-viral considerations were made.

The Subject Device is substantially equivalent to the Primary Predicate in terms of physical characteristics and tests results. The following tests have been performed to substantiate the equivalence.

510(k)	Subject Device K153364
Device name	Kerecis SecureMesh
Tensile strength	A Uniaxial strength test was performed to compare the tensile strength of theproduct and the predicate

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Usability	Loading time, Transfer of buttress to stapler, Ease of Use, Force to fire andSlippage
Performance	Leak at Staple line, Leak Pressure and Seal burst

Table 2 - Subject Device Bench testing

7.2 ANIMAL STUDIES

An acute porcine ex-vivo study was performed on the Subject Device and Peri-Strips Dry Staple Line Reinforcement (K040415) to support substantial equivalence. Peri-Strips Dry Staple Line Reinforcement (K040415) is the Predicate Device for the Veritas Dry Collagen Matrix (K041669) and the two materials are identical, from the material source, with the same treatment indications as well as mechanical and clinical properties. Comparison with un-buttressed stapling was also undertaken (negative control).

There was no significant difference between the Subject Device and the Primary Predicate. The Subject Device technological and physical characteristics are equivalent to the Predicate Device.

7.3 CLINICAL STUDIES

No clinical testing was included in this submission

CONCLUSION 8

The subject device, Kereis SecureMesh, meets the requirements to perform its intended use as a staple line sealer and is substantially equivalent to the legally marketed predicate device, Veritas Dry Collagen Matrix (K041669).

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.