The Coalescent Surgical PG-CLIP™ and accessories are intended for endoscopic and non-endoscopic peripheral vascular and general surgical soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in peripheral vascular blood vessels, grafts and other tubular structures. The PG-CLIP is not intended for use in cardiac and/or thoracic procedures; including, but not limited to intra-cardiac and coronary artery bypass grafting (CABG) procedures.

Device Description

The Coalescent Surgical PG-CLIP™ device is a self-closing clip for peripheral vascular anastomosis and tissue approximation/attachment applications. The PG-CLIP consists of specially designed vascular clips optionally connected to needles via flexible members. These clips may or 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 text is a 510(k) summary for the Coalescent Surgical PG-CLIP™ device. It's a premarket notification to demonstrate that the device is substantially equivalent to legally marketed predicate devices. This type of submission focuses on comparing a new device to an existing one, rather than proving the new device's performance against specific acceptance criteria through extensive new studies.

Therefore, the document does not contain the kind of information requested regarding acceptance criteria, a study proving the device meets those criteria, or specific performance metrics in the way a clinical trial or algorithm validation study would.

Here's why the requested information cannot be extracted and what the document does state:

No new performance data was acquired for this specific submission. The crucial sentence is: "No test data has been acquired related to this restricted indication for use." This means the submission relies on the existing performance data and substantial equivalence demonstrated for the predicate devices.
The submission is based on "substantial equivalence." This regulatory pathway avoids the need for a full clinical trial to establish new safety and effectiveness criteria if the device is sufficiently similar to an already cleared device.

Given this, I cannot fill out the requested table and answer the specific questions about performance studies. However, I can explain why based on the provided text.

Reason For Inability to Fulfill Request:

The provided 510(k) summary explicitly states: "No test data has been acquired related to this restricted indication for use." (Section: Test Data). This means that for this particular submission (K040821), no new studies, performance data, or acceptance criteria beyond those established for the predicate devices were used or provided to the FDA. The submission relies on establishing "substantial equivalence" to previously cleared devices (Coalescent Surgical U-CLIP™ K031623, K024366, K023125, K021407, K013664, K012317, K994160, and K971588).

Therefore, specific information regarding:

A table of acceptance criteria and reported device performance
Sample sizes used for the test set and data provenance
Number and qualifications of experts for ground truth
Adjudication method
MRMC comparative effectiveness study results
Standalone performance
Type of ground truth used
Sample size for the training set
How training set ground truth was established

is not available within this document because such studies were not conducted or reported for this specific 510(k) submission. The FDA clearance for K040821 was based on the substantial equivalence to predicate devices, leveraging their existing pre-market notification data.

Summary

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APR 2 3 2004

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.

TBD 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Applicant Information:

March 29, 2004 Date Prepared: Coalescent Surgical, Inc. Name: 559 E. Weddell Drive Address: Sunnyvale, CA 94089 408-743-9780

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 878.4300 Suture, 79NJU, 21CFR 878.4495

Predicate Devices:

The Coalescent Surgical PG-CLIP™ and accessories is substantially equivalent in intended use (although restricted in this submission), fabrication and design to the following predicate device:

Coalescent Surgical U-CLIP™ K031623, K024366, K023125, K021407, K013664, . K012317, K994160, and K971588

Device Description:

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K040821 Page 2/2

510(k) SUMMARY

(Continued)

Intended Use:

The Coalescent Surgical PG-CLIP™ and accessories are intended for endoscopic and nonendoscopic peripheral vascular and general surgical soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in peripheral vascular blood vessels, grafts and other tubular structures. The PG-CLIP is not intended for use in cardiac and/or thoracic procedures; including, but not limited to intra-cardiac and coronary artery bypass grafting (CABG) procedures.

Comparison to Predicate Device(s):

The Coalescent Surgical PG-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 (with the exclusion of cardiovascular indications).

Test Data:

No test data has been acquired related to this restricted indication for use.

Summary:

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human form or a caduceus, with three curved lines representing the body and a wavy line at the bottom.

Public Health Service

APR 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K040821

Trade/Device Name: PG-CLIPTM Regulation Number: 21 CFR 878.4300, 878.4495 Regulation Name: Implantable clip, Stainless stecl suture Regulatory Class: II Product Code: FZP, NJU Dated: March 29, 2004 Received: March 30, 2004

Dear Mr. Daniel:

We have reviewed your Section 510(k) promarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de necs that have been reciasined require approval of a premarket approval application (PMA). and Costicule real (71ct) that the novice, subject to the general controls provisions of the Act. The I ou may, therefore, manel are act include requirements for annual registration, listing of general controll pro resuring practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your device is classified (600 abb rotrols. Existing major regulations affecting your device can may be subject to back additions, Title 21, Parts 800 to 898. In addition, FDA may or route in the Ooscements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dri 3 ibeautes er our device complies with other requirements of the Act that I DA has Inade a determination an administered by other Federal agencies. You must of any I cocal slatates and regirements, including, but not limited to: registration and listing (21 Compry with an the 70€ 5 requirements) 11); good manufacturing practice requirements as set Crici at 607), adverlig (Dr OFRegulation (21 CFR Part 820); and if applicable, the clectronic forth in the quality bysteins (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) I ms letter will anow you to ogli mailing 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 If you desire specific as not any 101) 594-4659. Also, please note the regulation entitled, Continet the Office of Court Court (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other geleral information of your corpumer 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

Sinccrely yours,

Miriaml 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

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Indications for Use

510(k) Number (if known): _K040821

Device Name:_PG-CLIP™

Indications For Use:

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Musiam C. Parrost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K040821 and Page 1 of 1

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.