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.

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. The device is fabricated from standard medical and implantable grade materials.

AI/ML Overview

The provided text describes a 510(k) summary for the Coalescent Surgical U-Clip™. However, it does not contain the detailed information required to fill out all sections of your request regarding acceptance criteria and the specific study proving the device meets them. The document states that "in vitro data confirm that functional characteristics are substantially equivalent to the predicate device cited. Testing included in vitro studies. All data fell well within, both, internal specification requirements, as well as external standard requirements and predicate performance expectations." This is a high-level summary and lacks the specifics you're asking for.

Here's an attempt to answer based on the available text, with explicit notes where information is missing:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It generally claims that "All data fell well within, both, internal specification requirements, as well as external standard requirements and predicate performance expectations."

Acceptance Criteria (Not explicitly stated, inferred requirements for equivalence)	Reported Device Performance (Summary statement)
Functional characteristics substantially equivalent to predicate device	Data confirmed substantial equivalence
Met internal specification requirements	All data fell well within
Met external standard requirements	All data fell well within
Met predicate performance expectations	All data fell well within

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions "in vitro studies" but does not specify the sample size for any test set or the data provenance. It only states these were "in vitro test data."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document. The testing described is "in vitro data," implying laboratory or bench testing rather than human subject testing requiring expert ground truth establishment in a clinical context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document. Given the "in vitro" nature, clinical adjudication methods are unlikely to be relevant here.
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:
No MRMC study was mentioned. This device is an implantable surgical clip, not an AI/software diagnostic tool, so such a study would not be applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No standalone algorithm performance study was mentioned. This device is a physical surgical implant, not an algorithm. The "in vitro" testing implies standalone device performance, but not in the context of an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For "in vitro data," the "ground truth" would likely be established engineering specifications, material properties, mechanical test standards, and comparison to the predicate device's known performance characteristics. The document does not explicitly state the type of ground truth beyond fulfilling "internal specification requirements" and "external standard requirements."
The sample size for the training set:
This information is not applicable as the device is a physical medical device, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
This information is not applicable as the device is a physical medical device, not a machine learning algorithm.

Summary

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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.

KO12317 510(k) Number:

Applicant Information:

July 16, 2001 Date Prepared:

Name:	Coalescent Surgical, Inc.
Address:	559 E. Weddell DriveSunnyvale, CA 94089408-743-9794

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 devices:

Coalescent Surgical Sutured-Clip™ 510(k) K994160 .

Device Description:

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510(k) SUMMARY

(Continued)

Intended Use:

Comparison to Predicate Device(s):

The Coalescent Surgical U-Clip™ is substantially equivalent to the Coalescent Surgical Sutured-Clip (K994160). These devices are intended for application of vascular clips to tissue for purposes of performing vascular anastomosis and tissue and graft approximation.

In Vitro Test Data:

Design analysis and in vitro data confirm that functional characteristics are substantially equivalent to the predicate device cited. Testing included in vitro studies. All data fell well within, both, internal specification requirements, as well as external standard requirements and predicate performance expectations.

Summary:

Based upon the product technical information, intended use, performance and biocompatibility information provided in this pre-market notification, the Coalescent Surgical U-Clip™ has been shown to be substantially equivalent to currently marketed predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized representation of three human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 2001

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

Re: K012317

Trade/Device Name: Coalescent Surgical U-Clip™ Regulation Number: 878.4300 Regulatory Class: II Product Code: FZP Dated: July 16, 2001 Received: July 23, 2001

Dear Mr. Daniel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Michael A. Daniel

This letter will allow you to begin marketing your device as described in your 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 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Lise W. L.

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

Coalescent Surgical U-Clip™ Device Name:

Indications For Use:

The Coalescent Surgical U-Clip™ is intended for endoscopic and non-endoscopic use in The Coalescont Burghout o Onpvessels, grafts and other tubular structures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)
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Over-The-Counter Use
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(Optional Format 1-2-96)

(Division Sign-Off)
Division of General, Restorativeand Neurological Devices
510(k) Number	K012517

510(k) Number -

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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.