VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING

K023381 · Gish Biomedical, Inc. · DTZ · Mar 31, 2003 · Cardiovascular

Device Facts

• Record ID: K023381
• Device Name: VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING
• Applicant: Gish Biomedical, Inc.
• Product Code: DTZ · Cardiovascular
• Decision Date: Mar 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vision Hollow Fiber Oxygenator with Guardian™ Coating is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of one (1.0) to eight (8.0) liters per minute for periods of up to six (6.0) hours. Federal Law (US) restricts this device to sale by or on the order of a physician.

Device Story

Extracorporeal blood oxygenator and heat exchanger; utilizes polypropylene hollow fiber membrane for gas exchange and stainless steel bellows for heat exchange; polycarbonate housing. Used in cardiopulmonary bypass circuits; blood flow driven by external roller or centrifugal pumps. Traps and removes air from blood. Operated by clinical staff in surgical settings. Guardian™ coating applied to surfaces. Benefits patient by providing temporary respiratory support during procedures.

Clinical Evidence

Bench testing only. Extensive safety, performance, and validation testing conducted to ensure compliance with functional requirements and industry safety standards. No clinical trial data presented.

Technological Characteristics

Polypropylene hollow fiber membrane; stainless steel bellows heat exchanger; polycarbonate housing. Biocompatible materials with proprietary Guardian™ coating. Flow rate: 1.0-8.0 L/min. Duration: up to 6 hours. Standalone device for integration into extracorporeal circuits.

Indications for Use

Indicated for patients requiring extracorporeal oxygenation and carbon dioxide removal during procedures; blood flow rates 1.0-8.0 L/min for up to 6 hours. Contraindicated in patients with known or suspected heparin sensitivity due to potential for heparin-induced thrombocytopenia.

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

• Vision Hollow Fiber Oxygenator, Gish Biomedical, Inc. (K961530)

Submission Summary (Full Text)

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# Summary

MAR 3 1 2003

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, | | Delphi Consulting Group |
| Address: | Inc. | | 11874 South Evelyn Circle |
| | 22942 Arroyo Vista | | Houston, TX 77071-3404 |
| | Rancho Santa | | |
| Telephone: | Margarita | | 713-723-4080 voice |
| | CA 92688-2600 | | 775-429-9524 fax |
| Contact: | 949-635-6200 voice | | [e-mail] |
| | 949-635-6299 fax | | J. Harvey Knauss |
| | Edward F. Waddell | | Consultant |
| | Director RA/QA | | |

## 2. Device:

| Proprietary Name: | Vision Hollow Fiber Oxygenator with Guardian™ Coating |
|----------------------|-------------------------------------------------------|
| Common Name: | Blood Oxygenator |
| Classification Name: | Oxygenator, Cardiopulmonary Bypass |

## 3. Predicate Devices:

Vision Hollow Fiber Oxygenator, Gish Biomedical, Inc., K961530.

## 4. Classifications Names & Citations:

21 CFR 870.4350, Oxygenator, Cardiopulmonary Bypass, Class II, DTZ, Cardiovascular.

## 5. Description:

The Gish Vision Hollow Fiber Oxygenator with Guardian™ Coating consists of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The hollow fiber membrane consists of a polypropylene gas permeable mat. The unique mat design increases the interaction between blood and gas, creating a highly efficient blood oxygenator. 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

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exchange while minimizing priming volume. All materials of the heat exchanger are biocompatible and coated with a proprietary coating.

The device allows for trapping and removal of air. Oxygenated blood is delivered to the patient through the tubing and appropriate cannula. Blood flow is driven by a roller pump or centrifugal pump connected through the tubing. The Gish Vision Hollow Fiber Oxygenator with Guardian™ Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.

#### 6. Indications for use:

The Vision Hollow Fiber 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 a blood flow rate of one (1.0) to eight (8.0) liters per minute for periods of up to six (6.0) hours.

## 7. Contra-indications:

For heparin coated oxygenators (HFOE), heparin has been reported, on rare occasions, to induce thrombocytopenia. Since patients undergoing cardiopulmonary bypass are routinely systemically heparinized, and although the amount of heparin contributed by this device is very small in comparison to the typical dose given, caution should be exercised when using this device in patients with known or suspected heparin sensitivity.

## 8. Comparison:

The Vision Hollow Fiber Oxygenator with Guardian ™ Coating has the same device characteristics as the Predicate devices.

## 9. Test Data:

The Vision Hollow Fiber Oxygenator with Guardian™ Coating has been subjected to extensive safety, performance, and validations prior to release. Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the device complies with applicable industry and safety standards.

#### 10. Literature Review:

A review of literature pertaining to the safety and effectiveness has been conducted. Appropriate safequards have been incorporated in the design of the Vision Hollow Fiber Oxygenator with Guardian™ Coating.

#### 11. Conclusions:

The conclusion drawn from these tests is that the Vision Hollow Fiber Oxygenator with Guardian™ Coating is equivalent in safety and efficacy to its predicated devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 2003

Gish Biomedical, Inc. c/o Mr. J. Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle Houston, TX 77071-3404

Re: K023381

Vision Hollow Fiber Oxygenator with Coating Regulation Number: 21 CFR 870.4350 Regulation Name: CPB Oxygenator Regulatory Class: Class II (two) Product Code: DTZ Dated: January 21, 2003 Received: January 23, 2003

Dear Mr. Knauss:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning 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 vours.

Ara Hunkur for
Prem D. Zuckerman, M.D.

ram D. Fuckerman. N Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number K

Device Name: Vision Hollow Fiber Oxygenator with Guardian™ Coating

#### Indications for use:

The Vision Hollow Fiber Oxygenator with Guardian™ Coating is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of one (1.0) to eight (8.0) liters per minute for periods of up to six (6.0) hours.

#### Prescription Device:

Federal Law (US) restricts this device to sale by or on the order of a physician.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|--------------------------------------------------------------------|---------|---------------|
| Prescription Use | OR | Over-The-Cour |
| <img alt="Prescription Use Tick" src="prescription_use_tick.png"/> | | |
| <img alt="Signature" src="signature.png"/> | | |
| (Division Sign-Off) | | |
| Division of Cardiovascular Devices | | |
| 510(k) Number | K023381 | |

(Per 21 CFR 801.109)

Over-The-Counter Use -----------

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