GISH TUBING AND CONNECTORS WITH HA COATING

K081881 · Gish Biomedical, Inc. · DWF · Jan 23, 2009 · Cardiovascular

Device Facts

• Record ID: K081881
• Device Name: GISH TUBING AND CONNECTORS WITH HA COATING
• Applicant: Gish Biomedical, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Jan 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2

Intended Use

The Gish Tubing and Connectors with HA 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) 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 (straight, Y, Luer, reducer) coated with proprietary HA (hyaluronic acid) coating. Used in surgical settings by medical professionals to create extracorporeal bypass circuits by interconnecting oxygenators, reservoirs, filters, and heat exchangers. Provides sterile, non-pyrogenic conduit for blood flow. HA coating intended to improve biocompatibility. Device may be used as individual components or pre-connected circuits. Benefits include safe, reliable blood transport during cardiopulmonary bypass procedures.

Clinical Evidence

Bench testing only. Performance testing conducted to ensure functional requirements and specifications were met. Literature review performed to support safety and effectiveness.

Technological Characteristics

Materials: Polyvinyl chloride (PVC) tubing, polycarbonate connectors. Surface: Proprietary HA (hyaluronic acid) coating. Biocompatible, sterile, non-pyrogenic. Flow capacity: 1.0 to 6.0 L/min. Duration: up to 6 hours.

Indications for Use

Indicated for patients undergoing surgical procedures requiring extracorporeal blood flow via a bypass circuit. Designed for flow rates of 1.0 to 6.0 liters per minute for durations up to 6 hours. No contraindications noted.

Regulatory Classification

Identification

A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

Predicate Devices

• Gish Tubing and Connectors (manufactured by Gish Biomedical, Inc)

Submission Summary (Full Text)

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Kort/881

510(k) (Tradıtıonal) Submıssıon Section 5, 510(k) Summary

# JAN 2 3 2009

# Summary

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807 92

#### 1 Company making the submission

| Name | Gish BioMedical, Inc |
|-----------|------------------------------------------------------------------|
| Address | 22942 Arroyo Vista<br>Rancho Santa Margarita,<br>CA 92688-2600 |
| Telephone | 949-635-6200 voice<br>949-635-6299 fax<br>[e-mail] |
| Contact | Edward F Waddell<br>Director RA/QA |

#### 2 Device

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

#### 3 Predicate Devices

Gısh Tubıng and Connectors Both manufactured by Gısh Bıomedical, Inc

#### র্ব Classifications Names & Citations

21 CFR 870 4210, Catheter, Cannula or Tubıng, Vascular Cardiopulmonary Bypass, Class II, DWF, Cardiovascular

21 CFR 870 4290, Adaptor, Stopcock, Manifold, or Fitting, Cardiopulmonary Bypass, Class II, DTL, Cardiovascular

#### 5 Description

1

The Gish Tubing and Connectors with HA Coating are used in surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass cırcuit - 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", Luer and reducer types

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The components of this system which have contact with the fluid path are sterle and nonpyroqenic

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

The Gish Tubing and Connectors with HA Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit

#### 6 Indications for use

The Gish Tubing and Connectors with HA Coating are indicated for use in surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass cırcuit it is designed to operate at flow rates of one (1 0) to six (6) liters per minute for periods up to six (6) hours

#### 7 Contra-Indications '

For HA coated tubing and connectors, no contra-indications have been noted

#### 8 Comparıson

The Gish Tubing and Connectors with HA Coating have the same device characteristics as the predicate devices

#### 9 Test Data

The Gish Tubing and Connectors with HA Coating has been subjected to extensive safety, performance, and validations prior to release Final testing for the systems ıncludes vanous 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 HA Coating

### 11 Conclusions

The conclusion drawn from these tests is that Gish Tubing and Connectors with HA 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

JAN 2 9 2009

Gish Biomedical, Inc c/o Ms Janet Peets Regulatory & Clinical Affairs Specialist 22942 Arroyo Vista Rancho Santa Margarita, CA 92688

Re K081881

> Gish Tubing and Connectors with HA Coating Regulation Number 21 CFR 870 4210 Regulation Name Cardiopulmonary Bypass Cannula or Tubing Regulatory Class Class II Product Code DWF Dated January 8, 2009 Received January 12, 2009

### Dear Ms Peets

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 regure 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 etther 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 - Ms Janet Peets

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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone] Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 You may obtain other general information on your responsibilities under the Act 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/industry/support/index html

Sincerely yours.

onna 2. Volmer

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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510(k) Number K_08) 88 |

Device Name Gish Tubing and Connectors with HA Coating

### Indications for use.

The Gish Tubing and Connectors with HA 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) 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

| Prescription Use | Yes |
|----------------------|-----|
| | OR |
| Over-The-Counter Use | No |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

uma R. Jones
(Driver Sig. OR)

(Division Simn-Off) Division of Cardiovascular Devices

510(k) Number_k08)&&

Indications forUse_K081881 doo Gish Blomadles Rancho Santa Marganta CA 92688