GISH ARTERIAL FILTER WITH HA COATING

K081054 · Gish Biomedical, Inc. · DTM · Jan 15, 2009 · Cardiovascular

Device Facts

• Record ID: K081054
• Device Name: GISH ARTERIAL FILTER WITH HA COATING
• Applicant: Gish Biomedical, Inc.
• Product Code: DTM · Cardiovascular
• Decision Date: Jan 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arterial Filter with HA Coating is indicated for use for up to 6 hours in the extracorporeal bypass circuit for the removal of microemboli. Prescription Device: Federal Law (US) restricts this device to sale by or on the order of a physician.

Device Story

Arterial filter designed for final filtration in extracorporeal bypass circuits; removes microemboli from blood flow. Features vent port for priming/air removal; optional filter bypass line for high-pressure scenarios; includes four-way stopcock. Components are sterile, nonpyogenic, and biocompatible with proprietary HA coating. Used in clinical settings (e.g., OR) by perfusionists or surgeons during cardiopulmonary bypass. Device may be standalone or pre-connected to circuit tubing. Provides mechanical filtration to reduce embolic load, potentially improving patient outcomes during bypass.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, performance validation, and literature review confirming safety and effectiveness.

Technological Characteristics

Arterial line blood filter for cardiopulmonary bypass. Features proprietary HA (hyaluronic acid) coating on biocompatible materials. Includes vent port and optional bypass line. Mechanical filtration principle. Class II device (21 CFR 870.4260).

Indications for Use

Indicated for use in extracorporeal bypass circuits for up to 6 hours for the removal of microemboli in patients undergoing procedures requiring cardiopulmonary bypass.

Regulatory Classification

Identification

A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”

Predicate Devices

• Gish Arterial Filter (K914791)
• Gish Arterial Filter with GBS™ Coating (K023833)

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 1 5 2009

| | Company | or | Correspondent (contract): |
|------------|------------------------|----|-----------------------------|
| Name: | Gish Biomedical, Inc. | | Delphi Consulting Group |
| Address: | 22942 Arroyo Vista | | 11874 South Evelyn Circle |
| | Rancho Santa Margarita | | Houston, TX 77071-3404 |
| | CA 92688-2600 | | |
| Telephone: | 949-635-6240 voice | | 713-723-4080 voice |
| | 949-635-6294 fax | | 832-615-3550 fax |
| Contact: | Edward F. Waddell | | J. Harvey Knauss |
| | Director RA/QA | | Consultant |
| | [e-mail] | | [e-mail] |

### 2. Device:

| Proprietary Name: | Gish Arterial Filter with HA Coating |
|----------------------|----------------------------------------------------|
| Common Name: | Arterial Filter |
| Classification Name: | Arterial Line Blood Filter, Cardiopulmonary Bypass |

#### Predicate Devices: ဒ်

Gish Arterial Filter, Gish Biomedical, Inc., K914791 and Gish Arterial Filter with GBS™ Coating, K023833. Both manufactured by Gish Biomedical, Inc.

### Classifications Names & Citations: 4.

・ 21 CFR 870.4260, Arterial Line Blood Filter, Cardiopulmonary Bypass, Class II, DTM, Cardiovascular.

### 5. Description:

The Gish Arterial Filter with HA Coating is designed for use as the final filtration product in the arterial line of the extracorporeal bypass circuit. The top of the filter housing contains a vent port to assist in the priming and removal of air from the arterial filter.

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

A filter bypass line may be used to enable blood to bypass the arterial filter should higher than normal pressures be observed on the inlet side of the arterial filter.

A four way stopcock is also provided for placement on the vent port of the arterial filter.

All materials of the arterial filter are biocompatible and coated with a proprietary coating.

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

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#### Indications for use: 6.

The Arterial Filter with HA Coating is indicated for use for up to 6 hours in the extracorporeal bypass circuit for the removal of microemboli.

### 7. Contraindications:

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

#### 8. Comparison:

The Gish Arterial Filter with HA Coating has the same device characteristics as the predicate devices.

### 9. Test Data:

The Gish Arterial Filter 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 Arterial Filter with HA Coating.

### 11. Conclusions:

The conclusion drawn from these tests is that Gish Arterial Filter with HA Coating is equivalent in safety and efficacy to its predicate device.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle, with its wings spread and its head turned to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .

Gish Biomedical, Inc. c/o Ms. Janet Peets Regulatory & Clinical Affairs Specialist 22942 Arroyo Vista Rancho Santa Margarita, CA 92688-2600

JAN 1 5 2009

Re: K081054

> Gish Arterial Filter with HA Coating Regulation Number: 21 CFR 870.4260 Regulation Name: Arterial Line Blood Filter, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DTM 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 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 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,

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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## Inductions for Use Statement (Per 21 CFR 801.109)

510(k) Number K 08 105 4

Device Name: Arterial Filter with HA Coating

Indications for use:

ﺔ ﺍﻟﻤﺘﺤﺪﺓ

The Arterial Filter with HA Coating is indicated for use for up to 6 hours in the extracorporeal bypass circuit for the removal of microemboli.

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)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K081054

406 Arterial Indications for Use_tab 4_updated.doc