SUTURE CLINCH by APPLIED MEDICAL RESOURCES

The Suture Clinch fastens sterile non-absorbable sutures in sizes 0 to 4-0 USP by crimping the suture ends during soft tissue approximation. The Suture Clinch is manufactured from implant grade titanium. Its unique shape provides an optimum means of capturing and securing the suture. The unique shape of the Suture Clinch also allows the applicator (clip applier) to close the Suture Clinch completely around the suture. The Surure Clinch is available preloaded in a cartridge. The Suture Clinch Cartridge is designed to easily snap fit into the barrel of the applicator for application and quickly detach from the barrel after the clinch is applied to the suture. The single use Suture Clinch Cartridge is supplied sterile, packaged individually in a tyvek pouch.

AI/ML Overview

The provided document is a 510(k) summary for the Suture Clinch device, which is a regulatory submission to the FDA. It does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device, as required for certain medical devices. This typically involves comparing specifications, materials, and intended use, rather than presenting a performance study with detailed acceptance criteria and results as would be found in a clinical or performance validation report.

Therefore, I cannot provide the requested information from the given text.

To explicitly address your request based on the provided input, I must state:

A table of acceptance criteria and the reported device performance: Not found in the document.
Sample sized used for the test set and the data provenance: Not found in the document, as no specific performance study is detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not found, as no ground truth establishment for a test set is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not found.
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. The device (Suture Clinch) is a physical implantable clip, not an AI software/diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical implantable clip.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not found.
The sample size for the training set: Not applicable/Not found, as no machine learning model or training set is mentioned.
How the ground truth for the training set was established: Not applicable/Not found.

Summary

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949-582-6243

P.03/03 F-650 T-735

KS92852

NOV 2,2 1999

510(k) SUMMARY

PENDING

510(k) NUMBER:

SUBMITTED BY:

Applied Medical Resources Corporation 26051 Merit Circle, Unit # 103 Laguna Hills, California 92653 (949) 582-6120

CONTACT PERSON: Anil Bhalani Director of Regulatory Affairs and Clinical Programs DATE OF PREPARATION: November 19, 1999 NAME OF DEVICE: Suture Clinch

CLASSIFICATION NAME: Implantable Clip (21 CFR 878.4300)

TRADE NAME: Not Determined

SUMMARY STATEMENT:

The Applied Medical Suture Clinch is substantially equivalent to predicate devices and introduces no new safety and effectiveness issues when used as instructed.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 22 1999

Mr. Anil Bhalani Director of Regulatory Affairs and Clinical Programs Applied Medical Resources 26051 Merit Circle, #104 Laguna Hills, California 92653

Re: K992852 Trade Name: Suture Clinch Regulatory Class: II Product Code: GCJ Dated: August 20, 1999 Received: August 24, 1999

Dear Mr. Bhalani:

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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.

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Page 2 – Mr. Anil Bhalani

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.

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 vours,

Neil R.P. Ogden for

James E. Dillard Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K992852

INDICATIONS FOR USE

44 JUL 4640

Applied Medical Resources is providing this separate cover page for the Suture Clinch "Indications for Use" as required.

K992852 510(k) Number:

Device Name: Suture Clinch

( 1/4/1 ( 1 ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( )

Indications for Use: The Suture Clinch fastens sterile non-absorbable sutures in sizes 0 to 4-0 USP by crimping the suture ends during soft tissue approximation.

Signature:

Title: Director RA/Clinical Programs Date: 11-19-99

DRO for
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992852

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR Over-The -(Counter Use _______________

(Optional Format 1-2-96)

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.