stainless steel Fixation . A Device preloaded with the Spider Fastener. The Fixation Device is provided with a safety pin that prevents inadvertent deployment of the Spider Fastener.

. Surgical Mesh; Polypropylene monofilament Mesh

· A stainless steel Extraction Device; provided for easy removal of the Spider Fastener when needed under direct vision.

Endogun's EndoFast Reliant System is used to attach or reinforce tissues by fastening them with Spider Fasteners. These Fasteners will attach a suitably designed mesh onto the tissue to ensure fixation between two tissues.

The devices are preloaded for single use.

The EndoFast Reliant System is supplied sterilized and ready for use upon removal from its packaging.

The Fixation Device is provided with a safety pin that prevents inadvertent deployment of the Spider Fastener.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the EndoFast Reliant System:

This document describes a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than establishing acceptance criteria and proving performance against them in the same way a PMA (Premarket Approval) might. Therefore, the "acceptance criteria" here are implicitly linked to demonstrating equivalence through a battery of tests.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated with quantitative targets. Instead, the performance tests were designed to demonstrate that the EndoFast Reliant System is substantially equivalent to the predicate devices. The "acceptance" is implied by the successful completion of these tests.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Fixation Device & Fastener:
Insertion Force	Tested
Fatigue Testing	Tested (for durability and integrity of the Fastener)
Dynamic Grip Strength	Tested
Retraction in response to different tension forces	Tested
Rigidity Tests	Tested
Cyclic Loading	Tested
Anterior Fixation	Tested
Pullout Strength	Tested
Reliability Tests	Tested
Fastener Spread	Tested
Ergonomics	Tested
Sterility	Tested
Extraction Device:
Reliability	Tested
Surgical Mesh:
Anterior Fixation	Tested
Sterility	Tested
Thickness	Tested
Weave Characteristics	Tested
Pore Size	Tested
Mesh Density	Tested
Tensile Strength	Tested
Pullout Strength	Tested
Burst Strength	Tested
Tear Resistance	Tested
Fatigue	Tested
Flexibility	Tested
Overall System (Animal Study):
Safety	Established (histological examination)
Effectiveness	Established
Ease of Introduction	Demonstrated (simple, fast insertion)
Effective Anchoring	Demonstrated

Conclusion from document: "Results of this testing indicate that the EndoFast Reliant System is substantially equivalent to the predicate devices."

Study Information:

The provided text describes a combination of in-vitro/bench testing and an animal study. It does not describe a clinical study involving human subjects or a multi-reader multi-case (MRMC) comparative effectiveness study.

2. Sample Size Used for the Test Set and Data Provenance:

Bench Testing (Fixation Device, Fastener, Extraction Device, Mesh): Specific sample sizes for each test are not provided. The document states that the components "were tested" for various parameters.
Animal Study:
- Sample Size: "Altogether five different experiments were conducted using 4 sheep (2 before sacrifice) and a pig as an animal model."
- Data Provenance: Retrospective, conducted prior to the 510(k) submission. Country of origin not explicitly stated, but the applicant and contact person are associated with Israel.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Bench Testing: Not applicable. These are physical/mechanical tests, not requiring expert ground truth in the same way clinical data would.
Animal Study: "Following animal sacrifice, the pathological effects on tissues were assessed by histological examination." This implies expert assessment (e.g., veterinary pathologists). The number of experts and their specific qualifications are not provided.

4. Adjudication Method for the Test Set:

Bench Testing: Not applicable as it's objective measurement against established test methods.
Animal Study: Not explicitly stated. The histological examination suggests expert assessment, but no details on adjudication (e.g., consensus, single reader) are given.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for a surgical device, not an imaging AI algorithm.

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

Not applicable. This device is a physical surgical fastening system and mesh, not an AI algorithm. Therefore, "standalone" in this context refers to the device's physical performance, which was evaluated through bench and animal testing.

7. The Type of Ground Truth Used:

Bench Testing: Objective physical and mechanical measurements according to established test methodologies (e.g., tensile strength, pullout strength, rigidity, sterility).
Animal Study: Pathological effects on tissues assessed by histological examination. This could be considered a form of "pathology" ground truth, evaluated by experts.

8. The Sample Size for the Training Set:

Not applicable. This document describes a physical medical device. There is no AI component requiring a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. As there is no AI component, there is no "training set" or ground truth for it.

Summary

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K060329 1/3

510(K) SUMMARY PREPARED AUGUST 13, 2006 EndoFast Reliant System

SEP 1 1 2006

Applicant's Name: Endogun Medical Systems 12 Haplada St. South Industrial Park Kiryat Shmona 11013 ISRAEL Tel (972)4-681-8801 Fax (972)4-681-8806
Contact Person: Yoram Levy, Qsite 31 Haavoda St. Binyamina, Israel 30500 Tel (972)4-638-8837; Fax (972)4-638-0510 Yoram@gsitemed.com
Product Name: EndoFast Reliant
Common Name: Minimal invasive fastening device with surgical polymeric Mesh
Classification: KOG and GCI (Endoscope and accessories), FTL (Mesh, Surgical Polymeric) 21 CFR 876.1500, 21 CFR 878.3300 Class: II
Device Description: The EndoFast Reliant System is a sterile, single use system consisting of the following components:

stainless steel Fixation . A Device preloaded with the Spider Fastener. The Fixation Device is provided with a safety pin that prevents inadvertent deployment of the Spider Fastener.

. Surgical Mesh; Polypropylene monofilament Mesh
· A stainless steel Extraction Device; provided for easy removal of the Spider Fastener when needed under direct vision.

Endogun's EndoFast Reliant System is used to attach or reinforce tissues by fastening them with Spider Fasteners. These Fasteners

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	will attach a suitably designed mesh onto the tissue to ensurefixation between two tissues.
	The devices are preloaded for single use.
	The EndoFast Reliant System is supplied sterilized and ready foruse upon removal from its packaging.
	The Fixation Device is provided with asafety pin that prevents inadvertentdeployment of the Spider Fastener.
Intended Use:	The EndoFast Reliant System is indicated for fixation ofsurgical mesh to tissues for tissue reinforcement duringminimally invasive procedures
Predicate Device:	The predicate device for the Fixation Device is: A & A TackerEndoscopic Stapler (K003949).
	The predicate device for the surgical Mesh is AMS Large PorePolypropylene Mesh (K033636).

Performance Data

The Fixation Device and Fastener were tested for Insertion force, Fatigue testing, Dynamic grip strength, Retraction in response to different tension forces, Rigidity tests, Cyclic loading, Fatigue testing for durability and integrity of the Fastener, Anterior Fixation, Pullout strength, Reliability tests, Fastener spread, Ergonomics and Sterility. The Extraction Device was tested for its reliability.

The mesh was tested according to the FDA "Guidance for the Preparation of Premarket Notification Application for a Surgical Mesh". The following performance tests were performed on the mesh: Anterior Fixation, Sterility, Thickness, Weave characteristics, Pore size, Mesh density, Tensile strength, Pullout strength, Burst strength, Tear resistance, Fatigue and Flexibility.

Results of this testing indicate that the EndoFast Reliant System is substantially equivalent to the predicate devices.

Performance Testing - animal

A series of animals were implanted with the EndoFast device in order to evaluate the safety and effectiveness of using the EndoFast Reliant as a tissue reinforcing system. Altogether five different experiments were conducted using 4 sheep (2 before sacrifice) and a pig as an animal model. Two of the sheep studies included two months of followup. Following animal sacrifice, the pathological effects on tissues were assessed by histological examination.

The animal study established the safety and efficacy of using the EndoFast Reliant as a tissue reinforcing system. Specially, this study demonstrated that the EndoFast Reliant device is safe for its intended use, it is easy to introduce, the insertion procedure is simple, fast and the anchoring is effective.

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Comparison with Predicate Devices:

The EndoFast System provides an approximation of soft tissues and fixation of surgical mesh to tissues similar to the cleared A & A Tacker Endoscopic Stapler (K003949) except for some differences in the insertion technique and the structure. The EndoFast's Mesh is substantially equivalent to AMS Large Pore Polypropylene Mesh (K033636). The performance and differences were tested for safety and efficacy.

Ko60329 3/3

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the bird symbol. The text is in all caps and appears to be in a simple, sans-serif font.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 6 2006

Endogun Medical Systems % Yoram Levy 31 Haavoda Street Binyamina, Israel 30500

Re: K060329

Trade/Device Name: EndoFast Reliant System Regulation Number: 21CFR §878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: September 11, 2006 Received: September 11, 2006

Dear Mr. Levy:

This letter corrects our substantially equivalent letter of September 11, 2006. 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 (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.

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); 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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Page 2 - Yoram Levy

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Barbara Friem

Mark N. Melkerson Division of General Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

14060329

Device Name:

EndoFast Reliant

The EndoFast Reliant System is indicated for fixation of Indications for . surgical mesh to tissues for tissue reinforcement during Use: minimally invasive procedures
Prescription Use AND/OR X (Part 21 CFR 801 Subpart D)

Use Over-The-Counter (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-off) Division of Cardiovascular, Respiratory and Neurological Devices 510(k) Number

Pbh
(Dirig

ivision Sign-Off) Division of General, Restorative and Neurological Devices

Number Kdo 0329

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.