HEART-LIFT BALLOON POSITIONER

K982419 · Cardiothoracic Systems, Inc. · MWS · Jan 13, 1999 · Cardiovascular

Device Facts

• Record ID: K982419
• Device Name: HEART-LIFT BALLOON POSITIONER
• Applicant: Cardiothoracic Systems, Inc.
• Product Code: MWS · Cardiovascular
• Decision Date: Jan 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4500
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

The CTS Heart-LIFT Balloon Positioner is a surgical instrument intended to lift and position the heart during cardiac surgery.

Device Story

CTS Heart-LIFT Balloon Positioner is a manual surgical instrument used during cardiac surgery to lift and position the heart. Device consists of a malleable shaft attached to a latex-free balloon; balloon is inflated via a hand pump connected by a flexible air tube. Includes a pressure release valve for deflation and a pressure relief valve to prevent over-inflation. Operated by surgeons in an operating room environment. By providing stable heart positioning, the device facilitates surgical access to cardiac structures, potentially improving procedural outcomes.

Clinical Evidence

Functional bench testing and animal testing were conducted to verify performance and suitability for the intended use. No human clinical trial data provided.

Technological Characteristics

Manual surgical instrument; latex-free balloon; malleable shaft; hand pump inflation system; pressure release and pressure relief valves. Non-powered, mechanical device.

Indications for Use

Indicated for patients undergoing cardiac surgery requiring heart lifting and positioning. Prescription use only.

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

• Janke-Barron Heart Support (Baxter)

Submission Summary (Full Text)

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## 510(k) Summary CardioThoracic Systems, Inc. Heart-LIFT Balloon Positioner 510(k) Notification K982419

# GENERAL INFORMATION

| Manufacturer: | CardioThoracicSystems, Inc. |
|---------------|-----------------------------|
| | 10600 North Tantau Avenue |
| | Cupertino, California |
| | [phone] |
| | [phone] FAX |
| | Est. Reg. No. 9027735 |

| Contact Person: | Michael J. Billig |
|-----------------|---------------------------------------------------|
| | Vice President, Regulatory, Quality, and Clinical |
| | Research |

July 08, 1998 Date Prepared:

#### DEVICE DESCRIPTION

| Classification: | Cardiovascular Surgical Instruments 21 CFR<br>870.4500 (510(k) exempt) | | | | |
|----------------------|------------------------------------------------------------------------|--|--|--|--|
| Trade Name: | CTS Heart-LIFT™ Balloon Positioner | | | | |
| Generic/Common Name: | Heart Positioner; Cardiovascular Surgical Instrument | | | | |

## PREDICATE DEVICES

Janke-BarronHeart Support manufactured by Baxter

#### INTENDED USE

The CTS Heart-LIFT Balloon Positioner is a surgical instrument intended to lift and position the heart during cardiac surgery.

## PRODUCT DESCRIPTION

The CTS Heart-LIFT Balloon Positioner consists of a manually inflatable, latex-free balloon attached to a malleable shaft. The balloon is inflated using a hand pump,

Response to Questions K982419 CTS Heart-LIFT Balloon Positioner

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which is attached via a flexible air tube to the proximal end of the malleable shaft. A pressure release valve allows deflation of the balloon. There also is a pressure relief valve to prevent over-inflation.

## SUBSTANTIAL EQUIV ALENCE

The CTS Heart-LIFT Balloon Positioner is a surgical instrument intended to lift and position the heart during cardiac surgery. The Heart-LIFT Balloon Positioner is substantially equivalent to the Baxter Janke-Barron Heart Support in regards to intended use, patient population and anatomical site. The predicate device is a Class I pre-amendment device.

Functional bench testing and animal testing has been conducted and the results of the testing verified that the Heart-LIFT Balloon Positioner performs as designed and is suitable for its intended use.

#### SUMMARY

As contained in this 510(k) summary, the CTS Heart-LIFT Balloon Positioner is substantially equivalent to the predicate device identified in that the Heart-LIFT Balloon Positioner has a similar intended use, patient population and anatomical site as the predicate device.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 1999

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

Re: K982419 Heart-Lift Balloon Positioner Requlatory Class: I Product Code: 74 MWS Dated: October 20, 1998 Received: October 21, 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 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to

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Page 2 - Mr. Michael J. Billig

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 requlations.

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" (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,

Thomas J. Callahon

Thomas J. Callaha n, Ph.D. 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 Heart-LIFT Balloon Positioner 510(k) Premarket Notification

# STATEMENT OF INDICATIONS FOR USE

The CTS Heart-LIFT Balloon Positioner is a surgical instrument intended to lift and position the heart during cardiac surgery.

Naitlynn Starr for TJC

Division Sig Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

- For PRESCRIPTION USE ONLY

Image /page/4/Picture/7 description: The image shows a handwritten note with the text "P.S. This is a prescription device.". The handwriting is in black ink on a white background. The note appears to be a quick message or reminder, possibly attached to a document or item related to a medical prescription.