GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING

K081947 · Gish Biomedical, Inc. · DTN · Feb 4, 2009 · Cardiovascular

Device Facts

• Record ID: K081947
• Device Name: GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING
• Applicant: Gish Biomedical, Inc.
• Product Code: DTN · Cardiovascular
• Decision Date: Feb 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gish CAPVRF44 Hardshell Venous Reservoirs are indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit at flow rates of one (1.0) to eight (8.0) liters per minute for periods up to six hours (6.0) hours. The Gish CAPVRF44 Hardshell Venous Reservoirs are also indicated for the collection and autotransfusion of the same patient's postoperative shed blood with the addition of the Postoperative Conversion Pack with water seal/manometer. Federal Law (US) restricts this device to sale by or on the order of a physician.

Device Story

Sterile, single-use, disposable hardshell venous reservoir; polycarbonate shell; internal defoamer filter cartridge. Venous drainage enters 1/2" inlet, directed to bottom, passes through 160-micron screen filter; intrathoracic suctioned blood enters top, passes through defoamer sponge and 20-micron depth filter. Used in cardiopulmonary bypass surgery; operated by perfusionists/surgeons. Collects/stores venous return; filters/defoams suctioned blood; enables autotransfusion of shed blood. Benefits include blood management and filtration during bypass.

Clinical Evidence

No clinical data. Bench testing only; performance and safety testing conducted to verify functional requirements and compliance with industry standards.

Technological Characteristics

Polycarbonate shell; internal defoamer filter cartridge; 160-micron screen filter; 20-micron depth filter; hyaluronan-based (HA) coating; sterile; non-pyrogenic; single-use; max venous flow 8 L/min; max cardiotomy flow 4 L/min.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring venous return storage and filtration/defoaming of intrathoracic suctioned blood at flow rates of 1.0-8.0 L/min for up to 6 hours; also indicated for autotransfusion of postoperative shed blood when used with a Postoperative Conversion Pack.

Regulatory Classification

Identification

A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.

Special Controls

*Classification.* Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, 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 CAPVRF45 Hardshell Venous Reservoir (K964973)
• Gish CAPVRF44 Hardshell Venous Reservoir with GBS™ Coating (K030726)

Submission Summary (Full Text)

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FEB - 4 2009

510(k) (Traditional) Submission Section 5, 510(k) Summary

# 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, CA 92688-2600 |
| Telephone: | 949-635-6200 voice<br>949-635-6299 fax<br>[e-mail] |
| Contact: | Martin Sellers<br>Sr. Director of Operations and RA |

#### 2. Device:

| Proprietary Name: | Gish CAPVRF44 Hardshell Venous Reservoir with<br>HA Coating |
|----------------------|---------------------------------------------------------------------------------|
| Common Name: | Cardiopulmonary Blood Reservoir |
| Classification Name: | Extracorporeal circuit blood defoamer<br>Cardiopulmonary bypass blood reservoir |

#### 3. Predicate Devices:

Gish CAPVRF45 Hardshell Venous Reservoir, K964973 and Gish CAPVRF44 Hardshell Venous Reservoir with GBS™ Coating, K030726. Both manufactured by Gish Biomedical, Inc.

### 4. Classifications Names & Citations:

21 CFR 870.4230, 21 CFR 870.4400, Extracorporeal circuit blood defoamer, Cardiopulmonary bypass blood reservoir, Cardiopulmonary Bypass, Class II, DTN, Cardiovascular.

#### 5. Description:

The Gish CAPVRF44 Hardshell Venous Reservoirs with hyaluronan based coating (HA Coating) are sterile, non-pyrogenic, single use, disposable, device designed for collection, storage and filtration of blood during cardiopulmonary bypass. The Gish CAPVRF44 has a clear polycarbonate shell and an internal defoamer filter cartridge. Venous drainage enters the ½" venous inlet where it is directed to the bottom of the device and passes through a 160 micron screen filter. Intrathoracic suctioned blood enters the top section of the defoamer/filter cartridge and passes through a defonor

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sponge and 20 micron depth filter. The maximum venous flow rate is 8 lom. The maximum cardiotomy flow rate is 4 lpm.

#### 6. Indications for use:

The Gish CAPVRF44 Hardshell Venous Reservoirs are indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit at flow rates of one (1.0) to eight (8.0) liters per minute for periods up to six hours (6.0) hours. The Gish CAPVRF44 Hardshell Venous Reservoirs are also indicated for the collection and autotransfusion of the same patient's postoperative shed blood with the addition of the Postoperative Conversion Pack with water seal/manometer.

#### 7. Contra-indications:

For HA coated reservoirs, no contra-indications have been noted.

#### 8. Comparison:

The Gish CAPVRF44 Hardshell Venous Reservoirs with HA Coating has the same device characteristics as the predicate devices.

#### 9. Test Data:

The Gish CAPVRF44 Hardshell Venous Reservoir 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. 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 safeguards have been incorporated in the design of Gish CAPVRF44 Hardshell Venous Reservoirs with HA Coating.

#### 11. Conclusions:

Based upon the testing and comparison to the predict device the Gish Biomedical, Inc., CAPVRF44 Hardshell Venous Reservoir with HA Coating has the same intended use, with similar technological characteristics. Gish Biomedical, Inc., therefore posits that its device is equivalent to predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB ~ 4 2009

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

Re: K081947

> Gish CAPVRF44 Hardshell Venous Reservoirs with HA Coating Regulation Number: 21 CFR 870,4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir Regulatory Class: Class II Product Code: DTN 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 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 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 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,

Duna R. Vochner

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 (1947

Device Name: Gish CAPVRF44 Hardshell Venous Reservoirs with HA Coating

#### Indications for use:

The Gish CAPVRF44 Hardshell Venous Reservoirs are indicated for use during cardiopyimonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit at flow rates of one (1.0) to eight (8.0) liters per minute for periods up to six hours (6.0) hours. The Gish CAPVRF44 Hardshell Venous Reservoirs are also indicated for the collection and autotransfusion of the same patients are also including and allood with the addition of the Postoperative Conversion Pack with water seal/manometer.

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)

Munna D. Vachme
(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number k081947

OS Indications for Use do Delphi Consulting Group Houston, TX 7707