HEPATOSTAT SET, MODEL 760X by VYGON CORP.

Hepatostat Set is a compression system acting as a tourniquet on the hepatic tissue. It is intended to reduce the risk of bleeding and to achieve hemostasis in hepatic resections (from large to small superficial hepatectomy). It can also be used for traumatic liver injuries.

Device Description

The Hepatostat Set is an absorbable compression device which was developed for the purpose of hepatic resection, large or small, without any significant bleeding. It consists of four pre-perforated absorbable strips which are sutured together with Safil polyfilament ligatures introduced through the liver with a tubular needle.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Hepatostat Set," an absorbable compression device intended for hepatic resection and traumatic liver injuries to reduce bleeding and achieve hemostasis. The submission references Biocompatibility and implant testing, performance testing, and risk assessment as the studies demonstrating safety and effectiveness.

However, the provided text does not contain the detailed acceptance criteria or numerical performance data typically found in a clinical study report for AI/ML devices. It focuses on the regulatory submission process for a physical medical device. Therefore, I will create a table outlining the stated acceptance criteria (which are more general compliance requirements for this type of device) and the reported device performance based on the information provided.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a traditional medical device (not an AI/ML device), the "acceptance criteria" are framed as regulatory and performance standards, and "device performance" refers to its ability to meet those standards as demonstrated by various tests.

Acceptance Criteria (Stated Requirements)	Reported Device Performance (as per submission)
Biocompatibility: Device materials must be safe for implantation and not cause adverse biological reactions. (ISO 10993-1)	Demonstrated: Biocompatibility testing of the material in accordance with ISO 10993-1, including implantation testing at 3, 6, 12, and 15 months, demonstrates performance and biocompatibility of the device.
Device Performance (Mechanical/Functional): The device must function as intended (e.g., provide compression, degrade appropriately).	Demonstrated: In vitro testing demonstrates that the device performance. The absorbable strips and Safile sutures are broken down by hydrolysis, degrading into glycolic and lactic acid, which are subsequently metabolized and absorbed by the body. Complete absorption of sutures occurs between 60 and 90 days. Liver hemostasis is fairly rapid (approximately 15 days) and not impeded by reabsorption of components.
Sterility: The device must be sterile to a specified assurance level.	Ensured: Sterility testing ensures a sterility assurance level of 10^-6.
Risk Assessment: Potential risks associated with the device must be identified and mitigated.	Addressed: Risk assessment was performed.
Safety and Effectiveness: The device must be safe and effective for its intended use.	Concluded: Biocompatibility and implant testing, performance testing, and risk assessment demonstrate that the Hepatostat Set is safe and effective to use when used in accordance with the supplied instructions for use.
Substantial Equivalence: The device must be substantially equivalent to a legally marketed predicate device.	Achieved: FDA reviewed the 510(k), found it substantially equivalent to predicate devices (Mar-Med Liver Strap K924223, Vicryl Synthetic Absorbable Surgical Suture K033746, Safil Synthetic Absorbable Surgical Suture K031286, MonoSyn Synthetic Absorbable Surgical Suture K011375), and issued K061796.

Since the provided document is a 510(k) summary for a physical medical device and NOT an AI/ML device, the following points address what would typically be included for an AI/ML device but are not applicable or present in this specific document.

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

Not applicable for this device. This information is typically for AI/ML performance evaluation using real-world data. For this physical device, "test set" would refer to samples used in laboratory and animal in vivo studies, but specific numbers and provenance of "data" in the context of AI are not present.

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

Not applicable for this device. Ground truth for AI/ML models is often established by human experts labeling data. For this physical device, "ground truth" would relate to biological outcomes (e.g., hemostasis, tissue reaction) observed in pre-clinical studies, assessed by pathologists or researchers, not a consensus of experts on a dataset.

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

Not applicable for this device. This term refers to how disagreements among annotators are resolved in AI/ML dataset creation.

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:

Not applicable for this device. MRMC studies are specific to evaluating AI/ML systems that assist human operators in tasks like image interpretation.

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

Not applicable for this device. This refers to the performance of an AI/ML algorithm independently.

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

For the biological studies mentioned (biocompatibility, implantation, hemostasis, absorption), the ground truth would be established through:
- Histopathology: for tissue reactions, inflammation, and degradation in implantation studies.
- Chemical analysis: for degradation products and absorption rates.
- Direct observation/measurement: of hemostasis efficacy in in vivo models.
The document doesn't explicitly detail the methodology of "ground truth" for these pre-clinical studies but implies standard methods for material and medical device testing.

8. The sample size for the training set:

Not applicable for this device. This information is for AI/ML model development.

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

Not applicable for this device. This information is for AI/ML model development.

Summary

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Kα61796

page i/2

VYGON CORPORATION

2495 General Armistead Avenue Norristown, PA 19403-3685

(800) 544-4907 (610) 630-3350 Fax (610) 630-3835

510K Premarket Notification Submission Summary of Safety and Efficacy

Date of Preparation: September 22, 2006

NOV - 2 2006

Applicant:

Vygon Corporation 2495 General Armistead Ave. Norristown, PA 19403

878.4493 + 878. 4800

Mar-Med Liver Strap (K924223)

through the liver with a tubular needle.

Contact Individual:

Courtney Smith, Regulatory Affairs Manager 610-539-9300 Ext. 110

Trade Name:

Common Name:

Product Code:

Classification Name:

Classification: Class II

Predicate Device Name:

Device Description:

Vicryl Synthetic Absorbable Surgical Suture (K033746) The Hepatostat Set is an absorbable compression device which was developed for the purpose of hepatic resection, large or small, without any significant bleeding. It consists of four pre-perforated absorbable strips which are sutured together with Safil polyfilament ligatures introduced

Synthetic Absorbable Surgical Suture & Surgical Clamp

Safil Synthetic Absorbable Surgical Suture (K031286) MonoSyn Synthetic Absorbable Surgical Suture (K011375)

Intended Use:

Vicon

Hepatostat Set

AbSorbable

GAM

Liver Clamp

Name:

Name:

Regulation Number:

Product Code:

Classification Name

Predicate Device Names

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K061796 Page 42

Technology Characteristics: The Absorbable strips and Safile sutures are broken down by bydrolysis, both copolymers degrade into glycolic and lactic acid which are subsequently metabolized and absorbed by the body. Liver hemostasis is fairly rapid (approximately 15 days) and is not impeded by the reabsorption of the strips and sutures. Complete absorption of the sutures occurs between 60 and 60 days.

Summary of Design Control Activities:

Biocompatibility testing of the material in accordance with ISO 10993-1, including implantation testing at 3, 6, 12 and 15 months demonstrates performance and biocompatibility of the device. In vitro testing demonstrates that the device performance. Sterility testing ensures a sterility assurance level of 10-6.

Conclusion:

Biocompatibility and implant testing, performance testing and risk assessment demonstrate that the Hepatostat Set is safe and effective to use, when used in accordance with the supplied instructions for use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vygon Corporation % Regulatory Affairs Associates, LLC Mr. Stephen Goldner 30833 Northwestern Highway Suite 121 Farmington Hills, Michigan 48334

NOV - 2 2006

Re: K061796

Trade/Device Name: Hepatostat Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM, GDJ Dated: September 30, 2006 Received: October 3, 2006

Dear Mr. Goldner:

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,

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 – Mr. Stephen Goldner

This letter will allow you to begin 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/industry/support/index.html.

Sincerely yours,

for
Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K061796

Device Name: Hepatostat

Indications For Use:

Prescription Use X X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Rmz

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Division of General Restorative. and Neurological Devices

510(k) Number L061796

Regulation Number and Section

§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.

(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.