GISH TUBING AND CONNECTORS WITH GBS COATING

K030077 · Gish Biomedical, Inc. · DTL · Mar 14, 2003 · Cardiovascular

Device Facts

• Record ID: K030077
• Device Name: GISH TUBING AND CONNECTORS WITH GBS COATING
• Applicant: Gish Biomedical, Inc.
• Product Code: DTL · Cardiovascular
• Decision Date: Mar 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4290
• Device Class: Class 2

Intended Use

The Gish Tubing and Connectors with GBS™ Coating are indicated for use in Surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass circuit. It is designed to operate at flow rates of one (1.0) to six (6.0) liters per minute for periods up to six (6) hours. Federal Law (US) restricts this device to sale by or on the order of a physician.

Device Story

Device consists of PVC tubing and polycarbonate connectors used as conduits in extracorporeal bypass circuits; connects oxygenators, reservoirs, filters, and heat exchangers. Features proprietary GBS™ coating. Used in surgical settings by clinical staff. Operates at flow rates of 1.0 to 6.0 L/min for up to 6 hours. Provides sterile, nonpyrogenic fluid path for blood circulation during bypass. Benefits patient by facilitating extracorporeal circulation during surgery.

Clinical Evidence

Bench testing only. No clinical data provided. Performance validated through safety and functional testing to ensure compliance with specifications for cardiopulmonary bypass applications.

Technological Characteristics

Materials: PVC (tubing), polycarbonate (connectors). Proprietary GBS™ coating applied to fluid path. Dimensions: various configurations (straight, Y, Luer, reducer). Connectivity: physical interconnection of bypass circuit components. Sterilization: sterile and nonpyrogenic. Energy source: none (passive conduit).

Indications for Use

Indicated for patients undergoing surgical procedures requiring extracorporeal blood flow via cardiopulmonary bypass circuit. Contraindicated in patients with known or suspected heparin sensitivity due to potential for heparin-induced thrombocytopenia.

Regulatory Classification

Identification

A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Gish Tubing and Connectors, Gish Biomedical, Inc.

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.

- Company making the submission: 1.
## MAR 1 4 2003

| | Company | or | Correspondent (contract): |
|------------|-----------------------------------------|----|---------------------------------------------------------------|
| Name: | Gish BioMedical, Inc. | | Delphi Consulting Group |
| Address: | 22942 Arroyo Vista | | 11874 South Evelyn Circle |
| | Rancho Santa Margarita<br>CA 92688-2600 | | Houston, TX 77071-3404 |
| Telephone: | 949-635-6240 voice<br>949-635-6294 fax | | 713-723-4080 voice<br>775-429-9524 fax |
| Contact: | Edward F. Waddell<br>Director RA/QA | | [e-mail]<br>J. Harvey Knauss<br>Consultant |

#### 2. Device:

| Proprietary Name: | Gish Tubing and Connectors with GBS™ Coating |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Cardiopulmonary Bypass Tubing and Connectors |
| Classification Name: | Catheter, Cannula or Tubing, Vascular Cardiopulmonary<br>Bypass<br>Adaptor, Stopcock, Manifold, or Fitting, Cardiopulmonary<br>Bypass |

- Predicate Devices: 3.
Gish Tubing and Connectors, Gish Biomedical, Inc.

- Classifications Names & Citations: ধ:
21 CFR 870.4210, Catheter, Cannula or Tubing, Vascular Cardiopulmonary Bypass, Class II, DWF, Cardiovascular.

21 CFR 870.4290, Adaptor, Stopcock, Manifold, or Fitting, Cardiopulmonary Bypass, Class II, DTL, Cardiovascular.

- 5. Description:
The Gish Tubing and Connectors with GBS™ Coating are used in surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass circuit. Specifically they are used in connecting oxygenators, reservoirs, filters, heat exchangers and other devices used in surgical procedures. The tubing is polyvinyl chloride (PVC). The connectors are polycarbonate of various configurations such as straight, "Y", Leur and reducer types.

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

All materials of the Gish Tubing and Connectors are biocompatible and coated with a proprietary coating.

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The Gish Tubing and Connectors with GBS™ Coating may be purchased separately or preconnected with tubing and other components of an extracorporeal circuit

- 6. Indications for use:
The Gish Tubing and Connectors with GBS™ Coating are indicated for use in surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass circuit. It is designed to operate at flow rates of one (1.0) to six (6.0) liters per minute for periods up to six (6) hours.

- 7. Contraindications:
For heparin coated devices, 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 Gish Tubing and Connectors with GBS™ Coating have the same device characteristics as the predicate devices.

- ഗ് Test Data:
The Gish Tubing and Connectors with GBS™ 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.

- 10. Literature Review:
A review of literature pertaining to the safety and effectiveness has been conducted. Appropriate safeguards have been incorporated in the design of Gish Tubing and Connectors with GBS™ Coating.

- 11. Conclusions:
The conclusion drawn from these tests is that Gish Tubing and Connectors with GBS™ Coating is equivalent in safety and efficacy to its predicated devices.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three curved lines above them, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2003

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

Re: K030077

Tubing and Connectors with GBS Coating. Regulation Number: 21 CFR 870.4290, 870.4210 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting Cardiopulmonary Bypass Vascular Catheter, Cannula and Tubing Regulatory Class: Class II (two) Product Code: DTL, DWF Dated: January 6, 2003 Received: January 8, 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/cdrb/dsma/dsmamain.html

Sincerely yours,

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

Enclosure

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510(k) Number K030077

#### Device Name: Gish Tubing and Connectors with GBS™ Coating.

#### Indications for use:

The Gish Tubing and Connectors with GBS™ Coating are indicated for use in Surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass circuit. It is designed to operate at flow rates of one (1.0) to six (6.0) liters per minute for periods up to six (6) 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-Counter Use

(Division Sign-Off
Division or Caldruve

510(k) Number. K030072

(Per 21 CFR 801.109)

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