CTS MIDCAB STITCHER

K963965 · Cardiothoracic Systems, Inc. · GEI · Mar 17, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K963965
• Device Name: CTS MIDCAB STITCHER
• Applicant: Cardiothoracic Systems, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Vascular Stitcher is a stainless steel surgical instrument designed for needle holding and suturing. Operates in semi-automatic or manual modes. Used in general surgery and endoscopic procedures, with or without trocar sleeves. Compatible with CTS-specific needles and sutures. Facilitates vascular tissue approximation. Operated by surgeons in clinical or OR settings to improve suturing efficiency and access in minimally invasive environments.

Clinical Evidence

No clinical data provided. Substantial equivalence established through descriptive comparison of design, materials, and intended use.

Technological Characteristics

Stainless steel construction. Manual or semi-automatic mechanical operation. Designed for use with compatible needles and sutures. Form factor optimized for endoscopic and general surgical access.

Indications for Use

Indicated for patients requiring vascular suturing during general surgery, including endoscopic procedures.

Regulatory Classification

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.

Predicate Devices

• Young Boomerang Needle Holder
• Harris Boomerang Needle Holder
• Millin Boomerang Needle Holder
• U.S. Surgical EndoStitch Suturing Instrument
• U.S. Surgical Endoscopic Needle Driver

Submission Summary (Full Text)

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501(k) Premarket Notification
Vascular Stitcher
MAR 17 1998
K963965

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

## GENERAL INFORMATION

**Manufacturer:** CardioThoracic Systems, Inc.
10600 North Tantau Avenue
Cupertino, California
[phone]
[phone] 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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ID

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501(k) Premarket Notification
Vascular Stitcher

## PRODUCT DESCRIPTION

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.

## SUBSTANTIAL EQUIVALENCE

The Vascular Stitcher is substantially equivalent to other predicate devices currently being marketed. The marketed predicate devices are identified above. The Vascular Stitcher 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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

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

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 (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.

MAR 17 1998

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

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 ☑
(Per 21 CFR 801.109)


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