The Vascular Stitcher is a stainless steel surgical product designed for use with CTS compatible needle and suture in a semi-automatic or manually operated mode. The Vascular Stitcher is designed for use with or without trocar sleeves depending on the endoscopic technique or whether during minimally invasive surgical procedures.

AI/ML Overview

This 510(k) Premarket Notification for the Vascular Stitcher does not contain the information you requested regarding acceptance criteria and a study to prove the device meets those criteria, as it is related to AI/ML software.

The document describes a medical device, the Vascular Stitcher, which is a physical surgical instrument (a needle holder/driver). The submission focuses on demonstrating substantial equivalence to predicate physical devices already on the market, rather than performance against specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: This document does not describe acceptance criteria or performance metrics for a software device. It states the Vascular Stitcher is a "stainless steel surgical product."
Sample size used for the test set and the data provenance: Not applicable to a physical surgical instrument submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
If a standalone (algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The 510(k) for the Vascular Stitcher primarily relies on demonstrating:

Intended Use Equivalence: "The Vascular Stitcher is intended to be used in performing vascular suturing in general surgery, including endoscopic procedures," which is equivalent to predicate devices.
Technological Characteristics Equivalence: Stating it has "similar functions and is composed of similar materials as the predicate devices."
Product Description: A stainless steel surgical product for use with compatible needles and sutures in a semi-automatic or manually operated mode.

The FDA's letter (K963965) confirms "substantial equivalence" to devices marketed prior to May 28, 1976, or reclassified devices. This is the primary method of approval for such a device, rather than a performance study against AI/ML-specific acceptance criteria.

Summary

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501(k) Premarket Notification Vascular Stitcher

MAR 17 1998 长963965

CardioThoracic Systems, Inc. 510(k) Summary Vascular Stitcher 510(k) Notification K963965

GENERAL INFORMATION

Manufacturer:	CardioThoracic Systems, Inc.
	10600 North Tantau Avenue
	Cupertino, California
	(408) 342-1700
	(408) 342-1717 FAX
	Est. Reg. No. (awaiting issuance)
Contact Person:	Michael J. Billig
	Vice President, Regulatory, Quality, and Clinical Research
Date Prepared:	September 28, 1996

DEVICE DESCRIPTION

Classification: Class I

Trade Name: Vascular Stitcher

Generic/Common Name: Needle Holder/Needle Driver

PREDICATE DEVICES

(1) Young Boomerang Needle Holder
(2) Harris Boomerang Needle Holder
(3) Millin Boomerang Needle Holder
(4) U.S. Surgical EndoStitch Suturing Instrument
(5) U.S. Surgical Endoscopic Needle Driver

INTENDED USE

The Vascular Stitcher is intended to be used in performing vascular suturing in general surgery, including endoscopic procedures.

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501(k) Premarket Notification Vascular Stitcher

PRODUCT DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The Vascular Stitcher is substantially equivalent to other predicate devices currently being marketed. The marketed predicate devices are identified above. The Vascular Sticher is substantially equivalent to the predicate devices with regard to intended use, function, physical characteristics, and materials.

SUMMARY

As contained in this 510(k) summary, the Vascular Stitcher is substantially equivalent to the predicate devices identified, in that, the stitcher has similar functions and is composed of similar materials as the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes extending upwards and to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael J. Billig Vice President, Regulatory, Quality, and Clinical Research 10600 N. Tantau Avenue Cupertino, California 95014-0739

K963965 Re: Trade Name: Vascular Stitcher Regulatory Class: II Product Code: GEI Dated: December 22, 1997 Received: December 24, 1997

MAR 1 7 1998

Dear Mr. Billig:

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 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 (OS) 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. Billig

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) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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501(k) Premarket Notification Vascular Stitcher

Vascular Stitcher 510(k) Premarket Notification

STATEMENT OF INDICATIONS OF USE

The Vascular Stitcher is intended to be used in performing vascular suturing in general surgery, including endoscopic procedures.

Prescription Use	X
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of General Restorative Devices	C463965
510(k) Number

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.