The Influence Clip System is indicated for permanent securing of two strands of surgical suture for soft tissue approximation in open or laparoscopic surgical procedures.

Device Description

The Influence Clip System has two components, a suture clip and an applier. To fixate sutures, the stainless steel clip is inserted into the applier. Two strands of suture are threaded through the clip and the applier inserted into the trocar (if a laparoscopic procedure is performed). The applier's handle is then tightly squeezed which causes a rod within the applier's shaft to crimp the clip around the sutures. The sutures' ends are cut close to the clip (alternative version of applier with suture cutter may be used). The system is provided sterile and the applier is disposable, for single patient use.

AI/ML Overview

The provided document is a 510(k) summary for the Influence Clip System, which focuses on the regulatory clearance process for a medical device. It does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity. Instead, the document states that the device's safety and effectiveness were demonstrated through bench testing and that its performance is substantially equivalent to a previously cleared 510(k) device.

Therefore, it is not possible to fill out all the requested information concerning acceptance criteria, study details, ground truth establishment, sample sizes, or expert adjudication for a performance study from this document.

However, based on the information provided, we can infer the primary "acceptance criterion" from a regulatory perspective:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred from regulatory context)	Reported Device Performance
Safety (Biocompatibility, lack of adverse effects)	All materials commonly used or proven biocompatible.
Effectiveness (Ability to permanently secure sutures for soft tissue approximation)	Bench testing demonstrated safety and effectiveness.
Substantial Equivalence to Predicate Devices (Safety and effectiveness profile)	Performance substantially equivalent to a 510(k)-cleared device.

Missing Information (Not available in the provided text):

2. Sample sizes used for the test set and the data provenance: Not mentioned. The testing was "bench testing," meaning lab-based, not clinical data involving patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This refers to expert review of clinical cases, which was not the nature of the testing described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set requiring adjudication by experts is described.
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. This device is a surgical clip, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm. Bench testing would assess the device's physical performance.
7. The type of ground truth used: For a medical device like this, the "ground truth" for bench testing would likely be based on engineering specifications and physical measurements (e.g., tensile strength tests, slip resistance tests for the clip on sutures), rather than expert consensus on clinical findings or pathological diagnoses. The document vaguely states "bench testing has demonstrated that the device is safe and effective."
8. The sample size for the training set: Not applicable, as this is a physical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a regulatory submission focused on substantial equivalence based on bench testing. It does not describe a clinical study with detailed performance metrics, ground truth establishment, or human reader involvement as would be typical for an AI/diagnostic device.

Summary

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JUL 28 1998

K981631.

510(k) Summary of Safety and Effectiveness Influence, Inc.'s Influence Clip System 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 1981631

Submitter's Name:

Peter A. Bick. M.D., President and CEO Influence, Inc. 71 Stevenson Street, Suite 1120 San Francisco, California 94105 Telephone: 415-546-7700 / Fax: 415-546-7744

Device:

Trade name: Influence Clip System Classification Name: Implantable Clip Product Code: 79FZP

Predicate Devices:

United States Surgical Corporation's Auto Suture Suture Closure (K954853), Innovasive Devices, Inc.'s Y-Knot Suture Clip (K973313), and Howmedica, Inc.'s Dall-Miles Cable Grip System (K900926).

Indication for Use:

The Influence Clip System is indicated for permanent securing of two strands of surgical suture for soft tissue approximation in open or laparoscopic surgical procedures.

Device Description:

Technological Characteristics and Performance:

All materials used in the Influence Clip System are either commonly used in medical applications or have been proven to be biocompatible through

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biocompatibility testing. Bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to a 510(k)-cleared device.

510(k) Notification for the Influence Clip System

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Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, bold font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, arranged in a stacked formation. The profiles are connected and form a single, abstract shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the top and left side of the profile design.

JUL 28 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Peter A. Bick. M.D. President and CEO Influence, Inc. 71 Stevenson Street, Suite 1120 San Francisco, California 94105

Re: K981631 Trade Name: Influence Clip System Regulatory Class: II Product Code: FZP Dated: May 4, 1998 Received: May 7, 1998

Dear Dr. Bick:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Dr. Peter Bick

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):	K981631
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Device Name:

Indications for Use:

Influence Clip System, consisting of the Influence Clip System Applier and Influence Clip System Suture Clip

The Influence Clip System is intended for permanent securing of two strands of surgical suture for soft tissue approximation in open or laparoscopic surgical procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-off) Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices 510(k) Number _ . . OR Over the Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use (Per 21 CFR 801.109) 2948167 vik) Number

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Regulation Number and Section

§ 878.4300 Implantable clip.

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