GAS FILTER

K993060 · Olson Medical Sales, Inc. · JOD · Mar 28, 2000 · Cardiovascular

Device Facts

• Record ID: K993060
• Device Name: GAS FILTER
• Applicant: Olson Medical Sales, Inc.
• Product Code: JOD · Cardiovascular
• Decision Date: Mar 28, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4270
• Device Class: Class 2

Indications for Use

The Gas Filter is intended to remove particulate matter from medical gases flowing into the cardiopulmonary bypass circuit for periods up to 6 hours.

Device Story

Gas filter for cardiopulmonary bypass circuits; removes particulate matter from medical gases. Operates via physical barrier; mechanically entraps/separates particles from gas flow to prevent contamination of extracorporeal fluid. Used in clinical settings during extracorporeal circulation; operated by perfusionists or clinical staff. Output is filtered gas flow; ensures gas purity for patient safety during bypass.

Clinical Evidence

No clinical data. Bench testing only; filtration efficiency based on manufacturer certification of 99.98% removal of 0.3 um particles.

Technological Characteristics

Materials: hydrophobic laminated glass media, Versapor (Acrylic), polypropylene. Principle: mechanical filtration/physical barrier. Form factor: gas filter for cardiopulmonary bypass circuit. Sterilization: Ethylene oxide, validated to SAL 10^-6 per AAMI guidelines.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass procedures requiring medical gas filtration to remove particulate matter from gas flow for up to 6 hours.

Regulatory Classification

Identification

A cardiopulmonary bypass cardiotomy suction line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (a blood clot or a piece of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. This device is intended for use in the cardiotomy suction line.

Predicate Devices

• Gish Biomedical Gas Filter (K832935)

Submission Summary (Full Text)

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K993060

## Gas Filter

| 510(k) Submission: | Component 0008-00313 |
|--------------------|--------------------------------------|
| Predicate Device: | Gish Biomedical Gas Filter (K832935) |

### Intended Use:

The proposed gas filter and the Gish filter are intended to remove particulate matter from the gases flowing into the cardiopulmonary bypass circuit.

### Principle of Operation/Technology:

During extracorporeal circulation, it is necessary to adequately provide for blood gas maintenance. Typically, the circuitry that enables gas to be introduced to the blood flow contains a gas filtration device. The proposed gas filter and the Gish filter each utilize a physical barrier that mechanically entraps and separates particulate matter from the flow of gas, thereby preventing such matter from entering into, and contaminating the extracorporeal fluid.

## Design/Materials:

The proposed device and the Gish filter are each made of materials that are commonly used in cardiopulmonary bypass devices and circuits. The Gish filter is made of ABS, and Versapor (Acrylic); the proposed devices are made of hydrophobic laminated glass media, Versapor (Acrylic) and polypropylene. The differences in these materials raise no new issues of safety or effectiveness.

### Performance:

Evaluations of the gas filter demonstrated an acceptable level of performance.

Filtration efficiency not tested due to certification from original Note: manufacturer of 99.98% efficiency of 0.3 um particle removal.

# Conclusion:

In summary, the gas filter submitted in this 510(k) is substantially equivalent in intended use, design, technology/principles of operation, and performance to the cleared Gish filter (K832935).

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# Additional Safety Information

Sterilization conditions have been validated in accordance with AAMI guidelines to provide a Sterility Assurance Level (SAL) of 10 to the negative sixth.

Ethylene oxide residuals will not exceed the maximum residue limits imposed for Part 821 of Title 21 in the Federal Register of June 23, 1978 (or as finalized or amended).

The expiration dating of the submitted components is controlled by the component with the shortest expiry that is included in a kit, or two years; whichever is the shortest duration.

#### Conclusion

The gas filter submitted in this 510(k) is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared device indicated within. Differences between the submitted gas filter and the corresponding cleared device do not raise any new issues of safety or effectiveness.

Olson Medical Sales' statement that this device is substantially equivalent to any other device is done solely to comply with the requirements of the Federal Food, Drug and Cosmetic Act and is not intended to be the basis for a patent infringement action.

This Summary of Safety and Effectiveness was prepared on September 9, 1999.

| This Summary was prepared by: | | | |
|-------------------------------|--|--|--|
|-------------------------------|--|--|--|

Garry A. Courtney Regulatory Affairs Specialist

This Summary was prepared for:

OLSON MEDICAL SALES 28 Howe Street Ashland, MA 01721 Phone: [phone] Fax: [phone]

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2000

Olson Medical Sales, Inc. C/O Mr. Gary A. Courtney Regulatory Affairs Associate Terumo Medical Corporation 125 Blue Ball Road 21921 Elkton, MD

K993060 Re: Gas Filter 0008-00313 Requlatory Class: II (two) Product Code: JOD Date: January 7, 2000 Received: January 10, 2000

Dear Mr. Courtney:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Gary A. Courtney

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Sox Lare & Lamperlee
James E. Dillard III

James E. Dillard III Director Division of Cardiovascular, Respiratory, And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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K993060 510(k) Number:

Components For Cardiovascular Procedure Kit - Gas Filter Device Name:

Indications For Use:

The Gas Filter is intended to remove particulate matter from medical gases flowing into the cardiopulmonary bypass circuit for periods up to 6 hours.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Ketle G. Capers, M.D.
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________ વવાયું