The Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.

Device Description

The Coalescent Surgical U-CLIP™ device is a self-closing clip for vascular anastomosis and tissue approximation/attachment applications. The U-CLIP consists of specially designed vascular clips optionally connected to needles via flexible members. These clips may not include coils surrounding a Nitinol wire core. This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique through elimination of knot tying. The device is fabricated from standard medical and implantable grade materials. Accessories include Clip delivery and removal devices as well as vessel retention tools.

AI/ML Overview

Due to the nature of the provided text, which is an FDA 510(k) summary for a medical device and not a study report, it does not contain the specific acceptance criteria or the detailed results of a study as typically presented for AI/ML device evaluations. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against quantified acceptance criteria for a novel AI/ML application.

Therefore, many of the requested items (e.g., sample sizes for test/training, number of experts, adjudication methods, MRMC study results, ground truth types for AI/ML) are not applicable or extractable from this document.

However, I can extract information related to the device characteristics and the claim of equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't define explicit numerical acceptance criteria for AI/ML performance metrics. Instead, it states:

Criterion	Reported Device Performance
Functional Characteristics	"In vitro and in vivo data have confirmed that functional characteristics are substantially equivalent to the predicate device cited as well as applicable USP suture testing requirements. All data fell well within, both, internal specification requirements, as well as external standard requirements and device performance expectations."

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

Not Applicable. This document describes a medical device, not an AI/ML algorithm. The "test set" would refer to the in vitro and in vivo studies performed, but specific sample sizes are not provided in this summary.
Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective.

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

Not Applicable. As this is not an AI/ML study, there is no mention of experts establishing a "ground truth" in the context of an algorithmic evaluation. The evaluation is based on standard biomedical testing.

4. Adjudication Method for the Test Set:

Not Applicable. No information on adjudication methods for an AI/ML test set is present.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

Not Applicable. This is not an AI/ML device, so an MRMC comparative effectiveness study in the context of human readers analyzing AI output is not relevant nor mentioned.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance relies on established in vitro and in vivo biological and mechanical testing methods, and adherence to applicable USP suture testing requirements and internal/external standard requirements. It's not a "ground truth" in the sense of expert-annotated data for an AI/ML system.

8. The Sample Size for the Training Set:

Not Applicable. This document does not describe the development or training of an AI/ML algorithm; therefore, a "training set" in that context is not relevant.

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

Not Applicable. See point 8.

Summary

{0}------------------------------------------------

JAN 17 2003

K024366 Page 11

2.0 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number:

Applicant Information:

Date Prepared:	December 30, 2002
Name:	Coalescent Surgical, Inc.
Address:	559 E. Weddell DriveSunnyvale, CA 94089408-743-9780
Contact Person:	Michael A. Daniel
Phone Number:	(415) 407-0223
Facsimile Number:	(925) 254-5187

Device Information:

Classification:	Class II Implantable Clips / Class II Suture
Trade Name:	Coalescent Surgical U-CLIP™ and Accessories
Common Name:	Implantable Clip / Vascular Clip / Suture
Classification Name:	Surgical Devices: Implantable Clip, 79FZP, 21CFR 878.4300Suture, 79NJU, 21CFR 878.4495

Predicate Devices:

The Coalescent Surgical U-CLIP™ and accessories is substantially equivalent in intended use, fabrication and design to the following predicate device:

Coalescent Surgical U-CLIP™ K023125, K021407, K013664, K012317, K994160, and . K971588

Device Description:

{1}------------------------------------------------

(Continued)

K024366
page 2/2

Intended Use:

Comparison to Predicate Device(s):

The Coalescent Surgical U-CLIP™ and accessories is substantially equivalent to the Coalescent Surgical U-CLIP K023125, K021407, K013664, K012317, K994160 and K971588 in terms of materials, use and application.

Test Data:

In vitro and in vivo data have confirmed that functional characteristics are substantially equivalent to the predicate device cited as well as applicable USP suture testing requirements. All data fell well within, both, internal specification requirements, as well as external standard requirements and device performance expectations.

Summarv:

Based upon the product technical information, intended use, in vivo and clinical performance information provided in previous pre-market notifications, the Coalescent Surgical U-CLIP™ and accessories has been shown to be substantially equivalent to currently marketed predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract, curved lines that resemble a human profile, possibly representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2003

Coalescent Surgical, Inc. Michael A. Daniel Regulatory and Clinical Affairs 559 East Weddell Drive Sunnyvale, California 94089

Re: K024366

Trade/Device Name: Coalescent Surgical U-CLIP™ and Accessories Regulation Number: 878.4300; 878.4495 Regulation Name: Implantable clip; Nitinol suture Regulatory Class: Class II Product Code: FZP; NJU Dated: December 30, 2002 Received: December 31, 2002

Dear Mr. Daniel:

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

{3}------------------------------------------------

Page 2 – Mr. Michael A. Daniel

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.

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 (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

{4}------------------------------------------------

4.0 INDICATIONS FOR USE FORM

K024366

510(k) Number (if known):

Coalescent Surgical U-CLIPTM and Accessories Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

Division of General, Restorative and Neurological Devices

(k) Number K024366

Prescription Use ﺎ (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.