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 cutting and retention tools.

AI/ML Overview

The provided document, K031623, is a 510(k) summary for the Coalescent Surgical U-CLIP™ and Accessories. It outlines the device's intended use and claims substantial equivalence to previously cleared predicate devices. However, this document does not contain specific acceptance criteria or an analytical study proving the device meets those criteria in the way you've outlined for AI/ML devices.

The information provided about testing is very high-level and focused on demonstrating substantial equivalence to predicate devices and adherence to USP standards, not on detailed performance metrics as would be expected for a diagnostic or AI-driven system.

Therefore, I cannot fully complete your request based on the provided text. Here's what I can extract and what is missing:

Acceptance Criteria and Device Performance

Acceptance Criteria (Expected Performance)	Reported Device Performance
Not explicitly stated in the document	"All data fell well within, both, internal specification requirements, as well as external standard requirements and device performance expectations."
Substantial equivalence to predicate devices (K024366, K023125, K021407, K013664, K012317, . K994160, and K971588) in terms of materials, use, and application.	Confirmed through in vitro and in vivo data.
Compliance with applicable USP suture testing requirements.	Confirmed.

Missing Information as per Request:

The provided document does not include the following information, as it describes a surgical device and not an AI/ML-driven diagnostic or analytical tool. The questions below are tailored for AI/ML performance studies and are not applicable to this 510(k) submission for a surgical clip.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is not an AI/ML diagnostic device with a "test set" of data in the typical sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a surgical device would be its mechanical and biological performance in a physiological environment, not discrete data labels.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of what the document provides regarding testing:

The document briefly states: "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."

This indicates that a series of tests (both laboratory/benchtop and animal/human studies, usually) were conducted to ensure the U-CLIP performs similarly to existing, legally marketed surgical clips and meets recognized performance standards for surgical materials. However, it does not provide the granular detail about specific performance metrics, sample sizes, or ground truth establishment that would be present in a submission for an AI/ML device.

Summary

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K031623
Page 1/2

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: TBD

Applicant Information:

May 21, 2003 Date Prepared:
Facsimile Number:

Name:	Coalescent Surgical, Inc
Address:	559 E. Weddell DriveSunnyvale, CA 94089408-743-9780
Contact Person:	Michael A. Daniel
Phone Number:	(415) 407-0223

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 878.4300 Suture, 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™ K024366, K023125, K021407, K013664, K012317, . K994160, and K971588

Device Description:

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510(k) SUMMARY

(Continued)

K031623
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 K024366, 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.

Summary:

Based upon the product technical information, intended use, in vitro, 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.

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Image /page/2/Picture/12 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporatie Boulevard Rockville MD 20850

JUL 3 2003

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

Re: K031623

Trade/Device Name: Coalescent Surgical U-CLIP™ and Accessories Regulation Number: 21 CFR 878.4300, 21 CFR 878.4495 Regulation Name: Implantable clip, Stainless steel suture Regulatory Class: II Product Code: FZP, NCA, NJU Dated: May 22, 2003 Received: June 4, 2003

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 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. Michael A. Daniel

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) you may obtain. 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,

Sincerely yours,
Mark A. Mellman

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

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4.0 INDICATIONS FOR USE FORM

KO31623 TBD 510(k) Number (if known):

Coalescent Surgical U-CLIP™ 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)

for Mark n Mlbun
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K031623

Prescription Use
(Per 21 CFR 801.109)
OR
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.