The proposed gas filter 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.

AI/ML Overview

Here's an analysis of the provided 510(k) submission for the Gas Filter, focusing on acceptance criteria and supporting studies:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Filtration efficiency (0.3 µm particles)	99.98% efficiency (certified by original manufacturer)
Sterility Assurance Level (SAL)	10⁻⁶ (validated per AAMI guidelines)
Ethylene Oxide Residuals	Will not exceed maximum residue limits (21 CFR Part 821)
Expiration Dating	Controlled by shortest expiry component or 2 years

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a distinct "test set" in the context of typical AI/ML device testing. Instead, it relies on:

Manufacturer Certification for Filtration Efficiency: The 99.98% efficiency for 0.3 µm particles is stated to be a "certification from original manufacturer." This implies no new testing was performed for this 510(k) submission. Therefore, details on sample size, "test set," or data provenance (country of origin, retrospective/prospective) are not applicable or provided in this document directly related to the filtration efficiency claim. It's likely based on the predicate device's performance data.
Validation for Sterility and EO Residuals: These are standard regulatory tests. While they involve samples, the specific 'test set' sample sizes and data provenance are not detailed in this summary. These would typically be part of a separate validation report.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This document does not describe the use of experts to establish a "ground truth" for a test set, as this is a mechanical filtration device, not an AI/ML diagnostic system. The performance claims are based on direct physical measurements or established manufacturing certifications.

4. Adjudication Method for the Test Set

Not applicable, as there's no "ground truth" established by experts in this context.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or described. This type of study is typically relevant for interpretative AI/ML devices where human reader performance is a key metric. This device is a passive mechanical filter.

6. Standalone (Algorithm Only) Performance Study

No standalone algorithmic performance study was conducted. This device is not an algorithm, but a physical component. The "performance" refers to its mechanical capabilities.

7. Type of Ground Truth Used

The 'ground truth' for the performance metrics is:

Filtration Efficiency: Manufacturer certification, which would have been based on established standardized test methods using calibrated particle counters and known particle sizes (e.g., using a test aerosol).
Sterility: Achieved through validated sterilization cycles (e.g., bioburden testing, sterility testing after terminal sterilization), adhering to AAMI guidelines.
Ethylene Oxide Residuals: Measured through analytical chemistry methods to ensure levels are below regulatory limits.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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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: 508-881-2250 Fax: 508-881-4858

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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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

Regulation Number and Section

§ 870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter.

(a)
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.(b)
Classification. Class II (performance standards).