VACUUM ASSIST STABILIZER

K992833 · Cardio Thoracic Systems · MWS · Nov 10, 1999 · Cardiovascular

Device Facts

• Record ID: K992833
• Device Name: VACUUM ASSIST STABILIZER
• Applicant: Cardio Thoracic Systems
• Product Code: MWS · Cardiovascular
• Decision Date: Nov 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4500
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The CTS Vacuum Assist Stabilizer is intended for use during the performance of minimally invasive cardiac surgery. Used in conjunction with the CTS Ultima OPCAB System, the stabilizer isolates and provides local immobilization of the target vessel on the beating heart.

Device Story

CTS Vacuum Assist Stabilizer is a surgical instrument used during minimally invasive cardiac surgery. Device consists of a curved shaft with an articulating foot at the distal end and a mount for connection to the CTS AccessRail Platform. Operates via vacuum-assisted suction to isolate and provide local immobilization of an anastomotic site on the beating heart. Used by surgeons in the operating room to stabilize target vessels, facilitating surgical procedures. Device provides mechanical stabilization to assist in vessel grafting; benefits include improved surgical access and precision on a moving target.

Clinical Evidence

No clinical data provided. Evidence consists of functional bench testing, animal testing, and histology testing to verify performance and suitability for intended use.

Technological Characteristics

Mechanical surgical instrument; curved shaft with articulating foot; vacuum-based stabilization mechanism; connects to CTS AccessRail Platform. No software or electronic components.

Indications for Use

Indicated for patients undergoing minimally invasive cardiac surgery requiring local immobilization of a target vessel on the beating heart.

Regulatory Classification

Identification

Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

Predicate Devices

• Octopus2 Tissue Stabilization System (K964445)

Submission Summary (Full Text)

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# 510(k) Summary CardioThoracic Systems, Inc. Vacuum Assist Stabilizer 510(k) Notification K_________________________________________________________________________________________________________________________________________________________

# GENERAL INFORMATION

| Manufacturer: | CardioThoracic Systems, Inc.<br>10600 North Tantau Avenue<br>Cupertino, California<br>[phone]<br>[phone] FAX<br>Est. Reg. No. 9027735 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael J. Billig<br>Vice President, Regulatory, Quality, and Clinical Research |
| Date Prepared: | August 1999 |

#### DEVICE DESCRIPTION

| Classification: | Cardiovascular Surgical Instruments (21 CFR section<br>870.4500) |
|----------------------|------------------------------------------------------------------|
| Trade Name: | CTS Vacuum Assist Stabilizer |
| Generic/Common Name: | Cardiovascular Surgical Instrument |

### PREDICATE DEVICES

Octopus2 Tissue Stabilization System manufactured by Medtronic (K964445)

#### INTENDED USE

The CTS Vacuum Assist Stabilizer is intended for use during the performance of minimally invasive cardiac surgery. Used in conjunction with the CTS Ultima OPCAB System, the stabilizer isolates and provides local immobilization of the target vessel on the beating heart.

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# PRODUCT DESCRIPTION

The CTS Vacuum Assist Stabilizer consists of a curved shaft with an articulating foot at the distal end and a mount that connects to the CTS AccessRail™ Platform. The stabilizer provides local immobilization of an anastomotic site.

# SUBSTANTIAL EQUIVALENCE

The safety and effectiveness of the Vacuum Assist Stabilizer is substantially equivalent to the predicate device (Medtronic's Octopus2 Tissue Stabilization System; K964445) in regards to intended use, technology, functionality, applicable patient population and performance. Any differences between the CTS Vacuum Assist Stabilizer and its predicate device does not raise any new issues of safety and effectiveness.

Functional bench, animal and histology testing has been conducted and the results of the testing verified that the Vacuum Assist Stabilizer performs as designed and is suitable for its intended use.

## SUMMARY

As contained in this 510(k) summary, the CTS Vacuum Assist Stabilizer is substantially equivalent to the predicate device identified in that the Vacuum Assist Stabilizer has a similar intended use, technology, functionality, patient population and performance as the predicate device.

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Public Health Service

NOV 1 0 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael J. Billig Vice President, Regulatory, Quality and Clinical Research CardioThoracic Systems, Inc. 10600 North Tantau Avenue Cupertino, CA 95014-0739

Re: K992833 CTS Vacuum Assist Stabilizer Trade Name: Regulatory Class: I Product Code: MWS Dated: August 20, 1999 August 23, 1999 Received:

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 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 In addition, FDA may publish further announcements concerning action. your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation

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Page 2 - Mr. Michael J. Billig

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.

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 requlation (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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Nancy C brogdon for

Celia M Witter Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CardioThoracic Systems, Inc. CTS Vacuum Assist Stabilizer 510(k) Premarket Notification

# STATEMENT OF INDICATIONS FOR USE

The CTS Vacuum Assist Stabilizer is intended for use during the performance of minimally invasive cardiac surgery. Used in conjunction with the CTS Ultima™ OPCAB™ System, the stabilizer isolates and provides local immobilization of the target vessel on the beating heart.

A. Cattay for C. Sloan

(Division Sign-Off) Division of Cardiovascular, Respiratory and Neurological Devices 510(k) Number