The FasTouch Fixation System is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repairs.

Device Description

The FasTouch Fixation System is a manual laparoscopic surgical instrument which is intended to facilitate fixation of prosthetic material to soft tissue in laparoscopic or open surgical procedures such as ventral hernia repair. The FasTouch Fixation System is disposable, single-use system.

The Via Surgical's FasTouch Fixation System is designed to be inserted through a laparoscopic port sleeve but may be used during open surgical procedures as well. The FasTouch Fixation System is packaged in its unloaded state and contains a handle and a cartridge.

The FasTouch Handle is a multi-fire, sterile, single-use handle that is compatible to work with Via Surgical's FasTouch cartridges (25PS cartridge).

AI/ML Overview

The provided document describes the Via Surgical FasTouch Fixation System and its premarket notification (510(k)) submission to the FDA (K132698). However, it does not contain the level of detail requested in the prompt regarding specific acceptance criteria, reported performance values, or detailed study methodologies that would typically be found in a clinical trial report or a comprehensive validation study.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on:

Identical intended use.
Similar fixation technology and fastener design/material.
Similar technological characteristics (trigger handle, penetration depth, spring load firing mechanism, shaft length).
Same principle of operation and similar materials.

The document states that minor technological differences were tested and do not raise new questions of safety and effectiveness.

Here's an attempt to extract and describe the information based on the provided text, while acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria or provide a table of performance metrics. The performance is summarized as "safe and effective" and "substantially equivalent" to predicate devices. The listed tests are qualitative or comparative:

Acceptance Criteria Category	Reported Device Performance
Functionality
Cartridge loading and replacement (BT-011)	Demonstrated (implied successful operation)
Performance Evaluation (BT-014)	Demonstrated (implied successful operation)
Fixation Strength
Fixation strength evaluation (BT-012)	Demonstrated (implied sufficient strength, potentially comparable to predicates)
Mesh Compatibility
Mesh compatibility and Integrity following fixation (BT-013)	Demonstrated (implied compatible with various market-cleared meshes and maintains integrity)
Deployment/Clinical Use
Animal study for deployment and fixation with surgeons feedback	Positive feedback, demonstrated safe and effective deployment and fixation
Clinical usability test	Device found safe and effective for its intended use
Overall Comparison
Substantial Equivalence	Concluded to be substantially equivalent to predicate devices

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

The document does not specify sample sizes for "test sets" in the context of statistical validation for AI/algorithm performance. The studies mentioned are:

Bench Testing (BT-011, BT-012, BT-013, BT-014): No sample sizes are provided.
Animal Study: No sample size is provided. Data provenance is not explicitly stated (e.g., country), but it would likely be a controlled laboratory environment. Retrospective/prospective is not specified, but animal studies are typically prospective.
Clinical Usability Test: No sample size is provided. Data provenance is not explicitly stated. Retrospective/prospective is not specified; usability tests are typically prospective.

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

This information is not provided for any of the studies mentioned. The animal study involved "surgeons' feedback," but their number and specific qualifications are not detailed. Clinical usability also implies expert opinion but no specifics are given.

4. Adjudication Method

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study is mentioned. The device described is a surgical fixation system, not an AI or imaging diagnostic tool that would typically involve a multi-reader study. The comparison is against predicate devices, not human readers.

6. Standalone Performance Study (Algorithm Only)

Not applicable. The FasTouch Fixation System is a physical surgical device, not an algorithm.

7. Type of Ground Truth Used

For the physical device, "ground truth" would relate to its mechanical and functional performance, as well as its biological interaction.

Mechanical/Functional Bench Tests: Ground truth would be defined by engineering standards, measurement results (e.g., force, integrity), and successful operation as per design specifications.
Animal Study: Ground truth would be based on successful deployment, effective fixation in living tissue, and potentially histological assessment of tissue response. "Surgeons feedback" serves as expert assessment of performance.
Clinical Usability Test: Ground truth would be the assessment of usability, safety, and effectiveness by medical professionals (surgeons or similar) during simulated or actual use cases, validating the device's practical application.

8. Sample Size for the Training Set

Not applicable. As a physical device, there isn't a "training set" in the context of machine learning algorithms. The development and refinement of the device would involve engineering design, prototyping, and iterative testing, but not a "training set" in the computational sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable (see point 8). Development and testing would rely on engineering principles, material science, and pre-clinical evaluations to guide design improvements.

Summary

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Pre Market Notification Submission - 510(k)

510(K) SUMMARY FasTouch Fixation System 510(k) Number K_132698

5.1 Company Name

Via Surgical Ltd. Mitzpe Kineret Street 22/1 Moshav Amirim, Amirim 20115, Israel Tel: +972-52-639-5765 Fax: +972-153-77-500-8214

5.2 Contact Person

Leo Basta NorthStar Biomedical Associates for Via Surgical Ltd. 93 Benefit Street Providence, RI 02904 617.834.9866 (phone) 401.454.1733 lbasta@northstarbiomedical.com

And/or

Orly Maor 25 A Sirkin Street Kfar-Saba 4442156, Israel Tel: 972-7453607 Fax: 972-153-9-7453607 oram.ma@gmail.com

5.3 Trade/Proprietary Name

FasTouch Fixation System

5.4 Classification Name Staple Implantable
Via Surgical 510(k) Rev. A

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5.5 Product Code/Regulation No.

Implantable staple, product code: GDW, Regulation No. 878.4750.

ર્ટ.6 Device Classification Class II
5.7 Panel

General & Plastic Surgery

રું. ક Predicate Devices

Ethicon LLC SECURFSTRAP 5mm Absorbable Strap Fixation Device, l . cleared under K093845, (product code GDW, Regulation No. 878.475).
Davol Inc. Bard PermaFix Fixation System, K092483 (product code 2. GDW, Regulation No. 878.475).

5.9 Intended Use

The FasTouch Fixation System is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repairs.

5.10 Device Description

The FasTouch Handle is a multi-fire, sterile, single-use handle that is compatible to work with Via Surgical's FasTouch cartridges (25PS cartridge).

5.11 Performance Standards

No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act.

Via Surgical 510(k) Rev. A

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5.12 Substantial Equivalence

Via Surgical Ltd. believes that the FasTouch Fixation System is substantially equivalent to the legally marketed predicate devices due to the following reasons:

A ) The same intended use and indications for use as the predicate devices.

B) All devices use a similar fixation technology to deliver the fasteners by compressing a trigger.

C) Similar fastener strap design to the fasteners used with the SecureStrap predicate and similar non-absorbable polymer material as used in the PermaFix predicate.

D) Similar technological characteristics to the predicate devices such as: trigger handle, penetration depth, spring load firing mechanism and shaft length.

E) Same principle of operation.

F) Similar materials.

As demonstrated in the completed battery of preclinical tests that were conducted by the company minor technological differences between the FasTouch Fixation System and the predicate devices do not raise new questions of safety and effectiveness. Any minor differences in technological characteristics have been tested and reported on in this notification and demonstrate that any differences do not adversely affect the safety, effectiveness, or intended performance of the device. Therefore, the FasTouch Fixation System is substantially equivalent to the legally marketed predicate devices. Testing included laboratory bench testing, biocompatibility testing, animal testing, and clinical usability testing.

5.13 Performance Characteristics of the FasTouch Fixation System

The FasTouch Fixation System underwent a full battery of bench testing, animal testing, and biocompatibility testing to demonstrate its safe and effective performance in fixation of prosthetic material (e.g., hernia mesh) to soft tissues. In addition, clinical usability testing was conducted. It was concluded that the device is safe and effective for its intended use. Tests were performed with variety of market-cleared mesh types and sizes using the FasTouch Fixation System. In addition, tests were done in comparison to the predicate devices. Specifically, testing included:

Via Surgical 510(k) Rev. A

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Device Cartridge loading and replacement (BT-011) .
Fixation strength evaluation (BT-012) .
Mesh compatibility and Integrity following fixation with the FasTouch . Device (BT-013)
Performance Evaluation (BT-014) .
Animal study for deployment and fixation including surgeons feedback ●
. Clinical usability test

All testing performed demonstrated that the FasTouch Fixation System is a safe and effective device for facilitating the fixation of soft tissue prosthetics during the laparoscopic repair of hernia and is considered substantially equivalent to its predicate devices.

5.14 Conclusion

Via Surgical Ltd. believes that, based on the descriptive and test information provided in this submission, the FasTouch Fixation System is substantially equivalent to its predicate devices.

Via Surgical 510(k) Rev. A

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 14, 2014

Via Surgical Ltd. % Mr. Leo Basta Northstar Biomedical Associates 93 Benefit Street Providence, Rhode Island 02904

Re: K132698

Trade/Device Name: Fastouch Fixation system Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: February 10, 2014 Received: February 11, 2014

Dear Mr. Basta:

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 cither 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Leo Basta

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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

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

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K132698

Device Name: FasTouch Fixation System

Indications for Use:

The FasTouch Fixation System is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repairs.

Prescription Use _ ✔ (Part 2) C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter L. Hudson -S 2014.03.14 09:43:16 -04'00'

Via Surgical 510(k) Rev. A

Regulation Number and Section

§ 878.4750 Implantable staple.

(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.