The Coalescent Surgical U-CLIP™ and accessories is indicated for use in general soft tissue approximation and /or ligation, including use in cardiovascular procedures.

Device Description

The Coalescent Surgical U-CLIP™ device is a single self-closing clip for vascular anastomosis and tissue approximation/attachment applications. The U-CLIP consists of a specially designed vascular clip (optionally containing suture) and connected to needles via flexible members (optionally including various types of suture). 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 removal devices and vessel retention tools.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Coalescent Surgical U-CLIP™ and Accessories:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device(s) (Coalescent Surgical U-CLIP™ K021407, K013664, K012317, K994160, K971588, and Ethicon Stainless Steel, Gut, Poly suture K946173 (GAQ) in terms of materials, use, and application.)	Confirmed to be substantially equivalent.
Functional Characteristics within Internal Specification Requirements	All data fell well within internal specification requirements.
Functional Characteristics within External Standard Requirements	All data fell well within external standard requirements.
Device Performance Expectations for In vitro and In vivo Data	All data fell well within device performance expectations.
USP Suture Testing Requirements	Applicable USP suture testing requirements were met.

Study Details

It's important to note that the provided text is a 510(k) summary for a medical device submitted to the FDA for market clearance, not a detailed scientific study publication. As such, specific methodological details often found in a peer-reviewed research paper are condensed or omitted.

Sample Size used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated in the provided summary. The text mentions "in vitro and in vivo data," implying animal or human testing, but no specific numbers for the test subjects or samples are given.
- Data Provenance: Not explicitly stated. The nature of in vitro and in vivo studies suggests laboratory and potentially animal testing, but the country of origin or whether it was retrospective/prospective is not specified.
Number of Experts used to establish the ground truth for the test set and their qualifications:
- Not applicable/Not mentioned. The "ground truth" here is less about expert consensus on interpretations (as in imaging studies) and more about objective functional performance measurements against established specifications and predicate device performance. The testing would likely be performed by engineers and technicians according to documented protocols.
Adjudication method for the test set:
- Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 typically apply to studies where human interpretation of data (e.g., images) requires consensus. Here, the "ground truth" is based on objective measurements and comparisons.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study assesses human reader performance (e.g., radiologists interpreting images) with and without AI assistance. The U-CLIP is a surgical device, not an AI interpretation tool.
Standalone (Algorithm Only) Performance:
- No, a standalone algorithm-only performance study was not done. The U-CLIP is a physical medical device, not an algorithm. The assessment is of its physical and functional properties.
Type of Ground Truth Used:
- The ground truth for the performance claims appears to be:
  - Objective Functional Measurements: Data derived from in vitro (laboratory) and in vivo (live organism) testing.
  - Comparison to Predicate Device Performance: The functional characteristics and safety profile of the U-CLIP were compared against already legally marketed predicate devices (other U-CLIP models and Ethicon sutures).
  - Compliance with Standards: Adherence to internal specifications, external standards (not explicitly named but implied by "external standard requirements"), and USP suture testing requirements.
Sample Size for the Training Set:
- Not applicable/Not mentioned. The U-CLIP is a manufactured device; there isn't a "training set" in the machine learning sense. Its design involved engineering, material science, and prior iterations (as indicated by the predicate devices).
How the Ground Truth for the Training Set was Established:
- Not applicable/Not mentioned. As there is no "training set" in the AI sense, this question is not relevant. The "ground truth" for its development would be based on design specifications, material properties, biomechanical principles, and the performance characteristics of its predecessors.

Summary

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2.0 510(k) SUMMARY

DEC 1 8 2002

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 18, 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-CLIPTM and Accessories
Common Name:	Implantable Clip / Vascular Clip / Suture
Classification Name:	Surgical Devices: Suture, 79NJU, 21CFR 878.4495Implantable Clip, 79FZP, 21CFR 278.4300

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™ K021407, K013664, K012317, K994160 and . K971588
Ethicon Stainless Steel, Gut, Poly suture K946173 (GAQ) .

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K023125 page 2/2

510(k) SUMMARY

(Continued)

Device Description:

Intended Use:

The Coalescent Surgical U-CLIP™ is indicated for use in general soft tissue approximation and/or ligation, including cardiovascular applications.

Comparison to Predicate Device(s):

The Coalescent Surgical U-CLIP™ and accessories is substantially equivalent to the Coalescent Surgical U-CLIP (K021407) and to Ethicon Stainless Steel, Gut, Poly suture - K946173 (GAO), in terms of materials, use and application.

Test Data:

In vitro and in vivo data confirm 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 this pre-market notification, the Coalescent Surgical U-CLIP™ and accessories has been shown to be substantially equivalent to currently marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K023125

Trade/Device Name: Coalescent Surgical U-CLIPTM and Accessories Regulation Number: 878.4495 Regulation Name: Stainless steel suture Regulatory Class: Class II Product Code: NJU Non-Absorbable nitinal suture Dated: September 16, 2002 Received: September 19, 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 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

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Page 2 - Mr. Michael A. Daniel

the quality systems (OS) 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Proost

Colia 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

K023125

510(k) Number (if known):

Coalescent Surgical U-CLIPTM and Accessories Device Name:

Indications For Use:

The Coalescent Surgical U-CLIP™ and accessories is indicated for use in general soft ti approximation and /or ligation, including use in cardiovascular procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

Ston Sign-O vision of Gold al, Restorative Neurological Devices

K023125

Prescription Use
(Per 21 CFR 801.109) √

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 878.4495 Stainless steel suture.

(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.