GISH RELIANCE OXYGENATOR (MODEL HFO)

K961530 · Gish Biomedical, Inc. · DTZ · Dec 5, 1996 · Cardiovascular

Device Facts

• Record ID: K961530
• Device Name: GISH RELIANCE OXYGENATOR (MODEL HFO)
• Applicant: Gish Biomedical, Inc.
• Product Code: DTZ · Cardiovascular
• Decision Date: Dec 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gish Reliance™ Oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of, and carbon dioxide removal from, human blood. It is designed to operate at blood flow rates of one half (0.5) to eight (8.0) liters per minute for periods of up to six (6.0) hours.

Device Story

Gish Reliance™ Oxygenator is a sterile, single-use, disposable extracorporeal device for cardiopulmonary bypass. It features a microporous hollow fiber bundle for gas exchange and an integral stainless steel bellows heat exchanger for blood temperature control. Blood enters the bottom, flows upward through the heat exchanger and around the hollow fibers, then exits via a top manifold. Gas flows downward through the hollow fibers in a countercurrent direction to blood flow, facilitating diffusion. Used in clinical settings by perfusionists/surgeons to support lung function during surgery. Benefits include controlled gas exchange and temperature regulation during bypass.

Clinical Evidence

Bench testing only. Includes biocompatibility testing on sterilized product and in-vitro bench testing on sterilized and aged product to verify safety and performance characteristics.

Technological Characteristics

Sterile, single-use, disposable extracorporeal oxygenator. Features microporous hollow fiber membrane for gas exchange and stainless steel bellows heat exchanger. Bottom-up blood flow design. Supports 0.5 to 8.0 L/min blood flow. No software or electronic components.

Indications for Use

Indicated for patients undergoing procedures requiring extracorporeal oxygenation and carbon dioxide removal during cardiopulmonary bypass surgery, supporting blood flow rates of 0.5 to 8.0 L/min for up to 6 hours.

Regulatory Classification

Identification

A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”

Predicate Devices

• COBE Optima Oxygenator (K923272)
• Sorin MONOLYTH Oxygenator (K922933)

Submission Summary (Full Text)

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K961530

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## COMPANY NAME AND CONTACT PERSON

Gish Biomedical. Inc.
2681 Kelvin Avenue
Irvine, CA 92714-5821
714.756.5485 (Phone)
714.553.7390 (FAX)

Jack W. Brown
President

DEC - 5 1996

## DEVICE NAME
Gish Reliance™ Oxygenator

## MODEL NUMBER
HFO

## NAME OF PREDICATE OR LEGALLY MARKETED DEVICE
COBE Optima Oxygenator (K923272) and Sorin MONOLYTH Oxygenator (K922933).

## DESCRIPTION OF DEVICE

The Gish Reliance™ Oxygenator is designed to control blood gases in the extracorporeal circuit during cardiopulmonary bypass surgery.

The Gish Reliance™ Oxygenator is a sterile, non-pyrogenic, single use, disposable extracorporeal device. It is intended for the supply of oxygen to, and the removal of carbon dioxide from, the blood of humans. An integral heat exchanger is included which is intended to control the temperature of the blood. The Gish Reliance™ Oxygenator has one (1) blood inlet located at the bottom of the assembly, an integral heat exchanger intended to control the temperature of blood, a bundle of microporous hollow fibers for the exchange of gases, two (2) blood outlet ports, one (1) gas inlet port, one (1) gas outlet port and three (3) gas vents to prevent over pressurization.

The design of the oxygenator allows for a bottom-up flow of blood through the heat exchanger and around and between the hollow fibers of the gas exchange bundle. The bottom-up flow aids in priming and air removal from the unit. Once the blood reaches the top of the unit, it flows into a manifold which directs the blood downward and out the main blood outlet. The other blood outlet port is located at the top of the unit and may be used for air removal or recirculation.

Gas enters the oxygenator through a gas inlet located at the top of the unit and then flows downward (countercurrent to the blood flow) through the inside of the hollow fibers. Gas exchange occurs with the blood through diffusion across the hollow fiber membrane. Gas leaves the oxygenator through gas outlets or vents. One (1) gas outlet port is provided to scavenge gas leaving the oxygenator.

510(k) NOTIFICATION
GISH BIOMEDICAL, INC.

APRIL 18, 1996

CONFIDENTIAL
PAGE 350 of 460

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The integral heat exchanger controls the temperature of blood. Blood flows on the outside of the heat exchanger while heated or cooled water flows on the inside. Heat is transferred between the blood and water by the stainless steel bellows.

## STATEMENT OF INTENDED USE

The Gish Reliance™ Oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of, and carbon dioxide removal from, human blood. It is designed to operate at blood flow rates of one half (0.5) to eight (8.0) liters per minute for periods of up to six (6.0) hours.

## STATEMENT OF INTENDED USE OF PREDICATE/MARKETED DEVICES

The COBE Optima Open System is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to six hours.

The Sorin MONOLYTH has been designed to substitute lung function in an extracorporeal bypass circuit by providing oxygenation and removal of carbon dioxide from venous blood. The MONOLYTH integrates a high efficiency heat exchanger and a hardshell venous reservoir. The MONOLYTH is indicated for use with blood flows of 1 to 8 liters per minute (“LPM”). The MONOLYTH has been tested for 6 hours of continuous use. Use of this device for more than 6 hours is not advised.

## STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON

The Gish Reliance™ Oxygenator has technological characteristic which are substantially equivalent to the COBE Optima Oxygenators (K923272) and the Sorin MONOLYTH Oxygenators (K922933). The design, construction, materials and nominal specifications of the Gish Reliance™ Oxygenator are either identical or substantially equivalent to COBE Optima Oxygenators or Sorin MONOLYTH Oxygenators.

A Device Comparison Chart comparing the technological characteristics of the Gish Reliance™ Oxygenator with two substantially equivalent devices, the COBE Optima Oxygenators and the Sorin MONOLYTH Oxygenators is provided in Appendix III.

## DETERMINATION OF SUBSTANTIAL EQUIVALENCE

This premarket notification submission provides substantial equivalence information and rationale which addresses the introduction to commercial distribution of the Gish Reliance™ Oxygenator. The Gish Reliance™ Oxygenator is substantially equivalent to other oxygenators which are in commercial distribution. These predicate/marketed devices include the COBE Optima Oxygenators (K923272) and the Sorin MONOLYTH Oxygenators (K922933).

The Gish Reliance™ Oxygenator has an intended use which is substantially equivalent to other oxygenators which are in commercial distribution, such as the COBE Optima Oxygenators or Sorin MONOLYTH Oxygenators.

The Gish Reliance™ Oxygenator has technological characteristic which are substantially equivalent to

510(k) NOTIFICATION
GISH BIOMEDICAL, INC.
APRIL 18, 1996
CONFIDENTIAL
PAGE 351 of 460

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the COBE Optima Oxygenators and the Sorin MONOLYTH Oxygenators. The design, construction, materials and nominal specifications of the Gish Reliance™ Oxygenator are either identical or substantially equivalent to COBE Optima Oxygenators or Sorin MONOLYTH Oxygenators.

A Device Comparison Chart comparing the technological characteristics of the Gish Reliance™ Oxygenator with two substantially equivalent devices, the COBE Optima Oxygenators and the Sorin MONOLYTH Oxygenators is provided in Appendix III.

In addition to the above assessment of intended use and technological characteristics, Gish Biomedical, Inc. has provided additional information to support substantial equivalence of the Gish Reliance™ Oxygenator. This includes biocompatibility testing on sterilized product and various in-vitro bench testing on sterilized and aged product. These data support that the Gish Reliance™ oxygenator does not significantly affect safety and effectiveness and is substantially equivalent to other marketed oxygenators.

510(k) NOTIFICATION
GISH BIOMEDICAL, INC.
APRIL 18, 1996
CONFIDENTIAL
PAGE 352 of 460