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

Device Description

The Coalescent Surgical U-CLIP™ is a single self-closing clip for vascular anastomosis and tissue approximation applications. The U-CLIP consists of a specially designed vascular clip with a needle connected to one end via a flexible member. This design allows precise placement of clips prior to closure and facilitation of an interrupted technique. The device is fabricated from standard medical and implantable grade materials.

AI/ML Overview

I am sorry, but the provided text does not contain the specific information required to complete the table and answer the questions asked about acceptance criteria and study details. The document is a 510(k) summary for a medical device (Coalescent Surgical U-CLIP™), which primarily focuses on establishing substantial equivalence to predicate devices, rather than detailing specific performance acceptance criteria and study results in the manner requested.

The document mentions "Clinical data confirm that functional characteristics are substantially equivalent to the predicate, and fall within, both, internal specification requirements, as well as device performance expectations," but it does not provide:

A table of specific acceptance criteria.
Reported device performance against those criteria.
Sample sizes for test or training sets.
Data provenance.
Details about expert involvement, adjudication, or ground truth establishment.
Information on MRMC studies or standalone algorithmic performance.

Therefore, I cannot fulfill your request based on the provided text.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 8 2003

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

Re: K013664

Trade/Device Name: Coalescent Surgical U-CLIPTM Regulation Number: 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NCA Dated: October 31, 2001 Received: November 6, 2001

Dear Mr. Daniel:

This letter corrects our substantially equivalent letter of January 24, 2002 regarding the Coalescent Surgical U-CLIP™. We are changing the product code from FZP to NCA.

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 (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 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.

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

Page 2 - Mr. Michael A. Daniel

This letter will allow you to continue 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 and additionally Part 809.10 for in vitro diagnostic devices), 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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Miriam C. Provost

(ar 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

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

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

Coalescent Surgical U-CLIPTM 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)

Prescription Use > (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

for Mark H. Mulhearn
(Division Sign-Off)
Division of General, Restorative

Neurological Devices

510(k) Number

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

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

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: _______________________________________________________________________________________________________________________________________________________________

JAN 2 4 2002

Applicant Information:

October 31, 2001 Date Prepared:
Coalescent Surgical, Inc. Name: 559 E. Weddell Drive Address: Sunnyvale, CA 94089 408-743-9794

Contact Person:	Michael A. Daniel
Phone Number:	(415) 407-0223
Facsimile Number:	(925) 932-5706

Device Information:

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

Predicate Devices:

The Coalescent Surgical U-CLIP™ is substantially equivalent in intended use and method of operation to the following predicate device:

Coalescent Surgical U-CLIP™ 510(k) K012317 ●
Predicate devices intended for tissue approximation and the creation of anastomosis that have been cleared for cardiovascular indications include:
St. Jude Medical, Symmetry Aortic Clip System 510(k) K003446 .
Ethicon, Polypropylene, PRONOVA Nonabsorbable Suture 510(k) K001625 .

Device Description:

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

510(k) SUMMARY

(Continued)

Intended Use:

The Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic use in tissues are a The Coalescont Burgiour o CE = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = and prosuletic matchar approximation and coronary artery bypass grafting procedures.

Comparison to Predicate Device(s):

The Coalescent Surgical U-CLIP™ is substantially equivalent to the Coalescent Surgical U-CLIP The Coalescon Burgiour O ODI - - secular clips to tissue for purposes of (KVI2317). These dovises and tissue and graft approximation. The specific performing vasoular unacionsbirantially equivalent to both the St. Jude Symmetry Clip, Cardrovasound the Ethicon PRONOVA Nonabsorbable Suture, K001625.

Test Data:

Clinical data confirm that functional characteristics are substantially equivalent to the predicate Chilical data commini that fallowithin, both, internal specification requirements, as well as device offed. The data it ments and device performance expectations.

Summary:

Based upon the product technical information, intended use and clinical performance information Based upon the product technical monitial.com the Coalescent Surgical U-CLIP™ has been shown to be substantially equivalent to currently marketed predicate devices.

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.