VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING

K040355 · Gish Biomedical, Inc. · DTR · Mar 15, 2004 · Cardiovascular

Device Facts

• Record ID: K040355
• Device Name: VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING
• Applicant: Gish Biomedical, Inc.
• Product Code: DTR · Cardiovascular
• Decision Date: Mar 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4240
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gish Vision Blood Cardioplegia System with GBS™ coating is indicated for use in applications that require control of fluid temperature, such as blood or cardioplegia, typically in an extracorporeal circuit. The device may be used for normothermic or hypothermic applications. It is designed to operate at flow rates of one hundred (100) to six hundred (600) milliliters per minute for periods up to six (6.0) hours.

Device Story

Extracorporeal heat exchanger and fluid administration set used during cardiopulmonary bypass; manages fluid temperature (normothermic/hypothermic) for blood or cardioplegia solutions. Device consists of stainless steel bellows encased in polycarbonate housing; includes integral bubble trap and 105-micron gross particulate filter. Operated by perfusionists/clinicians in clinical settings; blood flow driven by external roller pump. Features pressure monitoring and safety relief valve (600 mmHg). GBS™ coating applied to blood-contact surfaces. Provides temperature control to protect myocardium during surgery; output monitored by clinician via circuit instrumentation.

Clinical Evidence

Bench testing only. No clinical data provided. Performance validated through extensive safety, performance, and validation testing to ensure functional requirements and specifications were met.

Technological Characteristics

Stainless steel bellows heat exchanger; polycarbonate housing. Biocompatible materials with proprietary GBS™ coating. Flow rate: 100-600 mL/min. Includes integral bubble trap and 105-micron particulate filter. Pressure relief valve set at 600 mmHg. Sterile, nonpyrogenic. Standalone extracorporeal circuit component.

Indications for Use

Indicated for patients requiring extracorporeal circulation for temperature control of blood or cardioplegia solutions. Used for normothermic or hypothermic applications at flow rates of 100-600 mL/min for up to 6 hours. Contraindicated in patients with heparin-induced thrombocytopenia.

Regulatory Classification

Identification

A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.

Predicate Devices

• Gish Vision Blood Cardioplegia System and Extracorporal Heat Exchanger (K020106)

Submission Summary (Full Text)

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## Summary

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR part 807.92.

- 1. Company making the submission:

| | Company | or | Correspondent (contract): |
|------------|---------------------------------------------------------------|----|---------------------------------------------------------------|
| Name: | Gish BioMedical, Inc. | | Delphi Consulting Group |
| Address: | 22942 Arroyo Vista<br>Rancho Santa Margarita<br>CA 92688-2600 | | 11874 South Evelyn Circle<br>Houston, TX 77071-3404 |
| Telephone: | 949-635-6240 voice<br>949-635-6294 fax | | 832-285-9423 voice<br>832-615-3550 fax |
| Contact: | Edward F. Waddell<br>Director RA/QA<br>[e-mail] | | J. Harvey Knauss<br>Consultant<br>[e-mail] |

- 2. Device:

| Proprietary Name: | Vision Blood Cardioplegia Sytem and Extracorporal Heat<br>Exchanger with GBS™ Coating |
|----------------------|---------------------------------------------------------------------------------------|
| Common Name: | Cardioplegia Heat Exchanger |
| Classification Name: | Cardiopulmonary Bypass heat exchanger |

- 3. Predicate Devices:
Gish Vision Blood Cardioplegia System and Extracorporal Heat Exchanger, Gish Biomedical, Inc., K020106.

- 4. Classifications Names & Citations:
21 CFR 870.4240, Cardiovascular bypass heat exchanger, Class II, DTR, Cardiovascular.

- 5. Description:
The Gish Vision Blood Cardioplegia System with GBS™ coating consists of an extracorporeal heat exchanger and fluid administration set. The heat exchanger consists of a one piece, stainless steel bellows, configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood through the outside convolutions of the stainless steel bellows, and therefore effects heat exchange while minimizing priming volume. All materials of the heat exchanger are biocompatible.

The device allows for the monitoring of pressure and allows for trapping and removal of air. I he us not allow to the cludes an integral bubble trap, gross particulate filter (105 u) and Aaalonarely and evere designed to open in the event of excessive fluid pressure (600 mmHg) during use. Solutions are delivered to the patient through the extension line and appropriate cannula. Blood flow is driven by a roller pump connected through an extension line.

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The components of this system which have contact with the fluid path are sterile and nonpyrogenic.

All blood contact materials of the Vision Blood Cardioplegia System with GBS™ coating are All Blood comatible and coated with a proprietary coating.

- 6. Indications for use:
The Gish Vision Blood Cardioplegia System with GBS™ coating is indicated for use in The Gist Vision Diood Oardloplegia Oyeem Prature, such as blood or cardioplegia, typically in
applications that require control of fluid temperature, such as breathermin applications that require control of liaid tomporation of hypothermic or hypothermic an extracorpored circuit. The device maff on the hundred (100) to six hundred (600) applications: minute for periods up to six (6.0) hours.

- 7. Contraindications:
For heparin coated devices, heparin has been reported, on rare occasions, to induce For hepann coatied devices, hepant has boon reported, would be the buttingly thromocytopenia. Since patients undergoing caralopains.contributed by this device is systemically nepamized, and although the arream caution should be exercised when using very small in companson to the typroal dose as a sub-

- Comparison: 8.
The Gish Vision Blood Cardioplegia System with GBS™ coating has the same device characteristics as the predicate devices.

- 9. Test Data:
The Gish Vision Blood Cardioplegia System with GBS™ Coating has been subjected to The Gisli Vision Blood Oardloplogia Cystem Wall Books . Final testing for the systems
extensive safety, performance, and validations prior to release. Final testing for the extensive salery, performance, and validation photographed that the device meets all of its functional requirements and performance specifications.

- 10. Special Controls Section 514 of the ACT
This submission complies with "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) This submission complics with "Guidanto for Caracepain" and other Guidance and Standards listed in Tab 17.

- 11. Literature Review:
A review of literature pertaining to the safety and effectiveness has been conducted. A review of literature portaining to the can incorporated in the design of Gish Vision Blood Cardioplegia System with GBS™ Coating.

- 12. Conclusions:
The conclusion drawn from these tests is that Gish Vision Blood Cardioplegia System with The conclusion drawn from those fety and efficacy to its predicate device.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2004

Gish Biomedical, Inc. c/o Mr. J. Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle Houston, TX 77071

Re: K040355

K040355
Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with GBS™ Coating Regulation Number: 21 CFR 870.4240 Regulation Name: Cardiopulmonary Bypass Heat Exchanger (Cardioplegia) Regulatory Class: Class II (two) Product Code: DTR Dated: February 10, 2004 Received: February 18, 2004

Dear Mr. Knauss:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained is substantially equivalent (for the indications
referenced above and have cletermined the device anarketed in interstate referenced and nave clecemined the arrest predicate devices marketed in interstate for use stated in the enclosure) to legally manced profits in enimal perior Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drug commerce prior to May 28, 1970, the charger with the provisions of the Federal Food, Drug, devices that have been reciassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The You may, merelore, market the device, subject to the gaments for annual registration, listing of
general controls provisions of the Act include requirements michreading and general controls provisions of the rice mericas requirems against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can in may be subject to such additional connois. Existing major regals In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition be found in the Code of Poseral Regaring your device in the Federal Register.

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Page 2 – Mr. J. Harvey Knauss

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Duna R. lohner

> ( Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

K040355 510(k) Number: Vision Blood and Extracorporal Heat Exchanger With GBS™ Device Name: Coating. The Vision Blood Cardioplegia System with GBS™ coating is Indications For Use: indicated for use in applications that require control of fluid temperature, such as blood or cardioplegia, typically in an extracorporeal circuit. The device may be used for normothermic or hypothermic applications. It is designed to operate at flow rates of one hundred (100) to six hundred (600) milliliters per minute for periods up to six (6.0) hours.

Prescription Use Yes (Part 21 CFR 801 Subplart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dune R. Lochner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K0403555

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