GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING

K081838 · Gish Biomedical, Inc. · DTR · Jan 26, 2009 · Cardiovascular

Device Facts

• Record ID: K081838
• Device Name: GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING
• Applicant: Gish Biomedical, Inc.
• Product Code: DTR · Cardiovascular
• Decision Date: Jan 26, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4240
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vision Biood Cardioplegia System with HA 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 system for blood/cardioplegia temperature control. Input: blood flow driven by external roller pump. Operation: blood passes through polycarbonate housing over stainless steel bellows to effect heat exchange. Includes integral bubble trap, 105-micron gross particulate filter, and pressure relief valve (600 mmHg). Output: temperature-regulated blood delivered to patient via extension line and cannula. Used in clinical settings (e.g., cardiopulmonary bypass) by medical professionals. Benefits: provides thermal regulation and air/particulate removal during extracorporeal circulation.

Clinical Evidence

No clinical data. Safety and effectiveness supported by bench testing, performance validation, and literature review.

Technological Characteristics

Stainless steel bellows heat exchanger; polycarbonate housing; hyaluronan (HA) based coating; integral bubble trap; 105-micron gross particulate filter; pressure relief valve (600 mmHg). Biocompatible materials. Flow rate: 100-600 mL/min. Duration: up to 6 hours.

Indications for Use

Indicated for patients requiring extracorporeal fluid temperature control (blood or cardioplegia) during procedures; supports normothermic or hypothermic applications at flow rates of 100-600 mL/min for up to 6 hours. No contraindications noted.

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

• Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger (K020106)
• Vision Blood Cardiopleara System and Extracorporeal Heat Exchanger with GBS 110 Coating (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 § 807 92

#### 1 Company making the submission

JAN 2 6 2009

| Name | Gish Biomedical, Inc |
|-----------|--------------------------------|
| Address | 22942 Arroyo Vista |
| | Rancho Santa Margarita, CA |
| | 92688-2600 |
| Telephone | 949-635-6200 voice |
| | 949-635-6291 fax |
| | martıns@gıshbıomedical com |
| Contact | Martın Sellers |
| | Director of Regulatory Affairs |

#### Device 2

| Proprietary Name | Vision Blood Cardioplegia System and<br>Extracorporeal Heat Exchanger with HA Coating |
|---------------------|---------------------------------------------------------------------------------------|
| Common Name | Cardioplegia Heat Exchanger |
| Classification Name | Cardiopulmonary Bypass Heat Exchanger |

# 3. Predicate Devices

Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger, K020106 and Vision Blood Cardiopleara System and Extracorporeal Heat Exchanger with GBS 110 Coating, K020106 Both manufactured by Gısh Bıomedical, Inc

#### ব Classifications Names & Citations

21 CFR 870 4240, Cardiovascular bypass heat exchanger, Class II, DTR, Cardiovascular

#### ਦ Description

The Gish Vision Blood Cardioplegia System with hyaluronan based coating (HA 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 brocompatible

The device allows for the monitoring of pressure and allows for trapping and removal of air Additionally, the device includes an integral bubble trap, gross particulate filter

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(105 u) and pressure relief device designed to open in the event of excessive fluid pressure (600 mmHq) 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

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

All blood contact materials of the Vision Blood Cardioplegia System with HA coatung are biocompatible and coated with a proprietary coating

#### 6 Indications for use

The Gish Vision Blood Cardioplegia System with HA 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 sıx hundred (600) milliliters per mınute for periods up to sıx (6 0) hours

#### 7 Contra-Indications

For HA coated blood cardioplegia systems, no contra-indications have been noted

#### 8 Comparıson

The Gish Vision Blood Cardioplegia System with HA Coating has the same device characteristics as the predicate devices

#### ਹੈ Test Data

The Gish Vision Blood Cardioplegia System with HA 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 Vision Blood Cardioplegia System with HA Coating

# 11 Conclusions

Based upon the testing and comparison to the predict device the Gish Biomedical, Inc , Vision Blood Cardioplegia System with HA Coating has the same intended use, with similar technological characteristics Gish Biomedical, Inc , therefore posits that its device is equivalent in safety and effectiveness to predicate devices

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 6 2009

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

Re K081838

> Vision Blood Cardioplegia and Extracorporeal Heat Exchanger with HA Coating Regulation Number 21 CFR 870 4240 Regulation Name Cardiopulmonary Bypass Heat Exchanger Regulatory Class Class II Product Code DTR 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 pror 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 - 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 requrements, 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 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.

R. lo. Lunes

Image /page/3/Picture/5 description: The image contains a handwritten symbol or character. It appears to be a cursive letter or a stylized mark, possibly part of a signature or a unique identifier. The symbol is drawn with a thick line, and it has a loop or curve at the top and a diagonal stroke at the bottom.

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_081838

Device Name Gish Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger with HA Coating

### Indications for use

The Vision Biood Cardioplegia System with HA 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

# 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)

Duna R. Vahner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Ko81838