The Terumo Pall AL6X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 40 microns in size, including gas emboli, fat emboli, and aggregates composed of platelets, red blood cells, and other debris from the arterial line and where the flow rate will not exceed 8 liters per minute.

The device may be used in procedures lasting up to 6 hours in duration.

Device Description

The Terumo Pall AL6X Arterial Filter performs its functions using two basic forms of technology. As a filtration device, particulates in the blood stream are captured and removed from the blood flow as blood passes through a filter mesh material that is contained within the device housing. The filter establishes a physical barrier that entraps particulate matter and prevents it from moving downstream of the arterial filter assembly.

As an air-removal device, the Terumo Pall AL6X Arterial Filter is designed so that air is removed from the blood stream as a result of centripetal force. The blood inlet port of the device is positioned on the upper-side axis of the polycarbonate housing, thereby creating a spiral blood flow pattern as blood enters the device. As the blood flows through the device in a spiral motion, centripetal forces cause the air bubbles to migrate towards the top of the housing assembly where air can subsequently be purged from the circuit.

The materials that are used in the construction of the Terumo Pall AL6X Arterial Filter include polycarbonate, polyester screen, polypropylene, acrylonitrile-butadiene styrene and X-Coating™.

AI/ML Overview

The Terumo Pall AL6X Arterial Filter demonstrates substantial equivalence to the predicate Terumo AL8X Arterial Filter through a series of in-vitro performance evaluations. The study aimed to show functional equivalence in several key areas.

1. Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Filtration Efficiency	Performed; demonstrated functional equivalence to predicate device.
Air Removal Efficiency	Performed; demonstrated functional equivalence to predicate device.
Hemolytic Effect	Performed; demonstrated functional equivalence to predicate device.
Pressure Drop	Performed; demonstrated functional equivalence to predicate device.
Tubing Connection Strength	Performed; demonstrated functional equivalence to predicate device.
Static Priming Volume	Performed; demonstrated functional equivalence to predicate device.
Mechanical Integrity/Leakage	Performed; demonstrated functional equivalence to predicate device.
Sterility Assurance Level (SAL)	Validated to provide SAL of 10⁻⁶ (AAMI guidelines).
Ethylene Oxide Residues	Will not exceed stated or implied maximum limits.
Biocompatibility (X-Coating)	Evaluated in in-vivo animal study; no adverse conditions noted.

2. Sample Size and Data Provenance

The document describes in-vitro performance evaluations. No information is provided regarding specific "test sets" of patient data, as the study involves device performance testing rather than clinical data analysis. The studies were conducted by Terumo Cardiovascular Systems in conjunction with Pall Medical Corporation. No country of origin for data or retrospective/prospective nature is applicable in the context of these in-vitro tests.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The ground truth for these performance evaluations is derived from established engineering test methods and benchmarks against the predicate device, not expert human assessment of medical images or patient outcomes.

4. Adjudication Method

Not applicable. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies, which is not the nature of these in-vitro device performance tests.

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

No. An MRMC study is not relevant for this type of device (an arterial filter) and the in-vitro performance testing conducted. These studies typically compare the diagnostic performance of human readers with and without AI assistance for clinical tasks.

6. Standalone Performance

Yes, the studies described are standalone performance evaluations for the device itself. They assess the inherent functional capabilities of the Terumo Pall AL6X Arterial Filter (e.g., filtration efficiency, air removal efficiency) independent of human interaction during its operation.

7. Type of Ground Truth Used

The ground truth used for these in-vitro performance evaluations is based on:

Engineering specifications and measurements: For metrics like filtration efficiency, pressure drop, static priming volume, and mechanical integrity.
Established industry standards/guidelines: Such as AAMI guidelines for sterility assurance.
Comparative data against a known predicate device: Functional equivalence was demonstrated against the Terumo AL8X Arterial Filter across various performance metrics.
In-vivo animal study results: For biocompatibility of the X-Coating.

8. Sample Size for the Training Set

Not applicable. This document describes the performance evaluation of a physical medical device (an arterial filter), not an AI algorithm requiring a training set of data.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no AI algorithm or training set involved in this submission.

Summary

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TERUMO

K08383Y

Submitter Information: APR 1 7 2009 This submission was prepared in December 2008 by: Eileen Dorsey Regulatory Affairs Specialist Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 Telephone: 1-800-283-7866, Ext. 7406 Fax: 410-398-6079 Alternate Contact (Please contact after January 2009): Garry A. Courtney, MBA, RAC Regulatory Affairs/Quality Systems Mgr. Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 Telephone: 1-800-283-7866, Ext. 7420 Fax: 410-398-6079

This submission was prepared for:

Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 Registration #1124841

Device Names/Classifications:

Proprietary Name Terumo Pall AL6X Arterial Filter

Classification Name Cardiopulmonary Bypass Arterial Line Blood Filter (Code: DTM)

Common Name Arterial Filter

Predicate Device(s):

The device submitted in this 510(k) maintains characteristics that are substantially equivalent to the following devices:

Terumo's Capiox® AL8X Arterial Filter - K032128 .

Intended Use:

The device may be used in procedures lasting up to 6 hours in duration.

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TERUMO

Principles of Operation and Technology:

Design and Materials:

The materials that are used in the construction of the Terumo Pall AL6X Arterial Filter include polycarbonate, polyester screen, polypropylene, acrylonitrile-butadiene styrene and X-Coating™.

Performance Evaluations:

Terumo Cardiovascular Systems, in conjunction with Pall Medical Corporation, conducted the following in-vitro performance evaluations to demonstrate the functional equivalence of the AL6X Arterial Filter to the predicate AL8X Arterial Filter.

The following tests were performed, and are presented on the ensuing pages:

. Filtration Efficiency
Air Removal Efficiency .
Hemolytic Effect Upon Cellular Components of Blood .
Pressure Drop .
. Tubing Connection Strength
Static Priming Volume .
Mechanical Integrity/Leakage Evaluation .

Substantial Equivalence Comparison:

In demonstrating substantial equivalence of the Terumo Pall AL6X Arterial Filter to the predicate AL8X device, a comparative study and/or assessment was performed in each of the following areas:

. Intended use
Duration of use/6-hour use .
. Product labeling
Operation and technology of the devices .
Product design .
Materials used in device construction .
Design performance .

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Substantial Equivalence Statement:

The Terumo Pall AL6X Arterial Filter is substantially equivalent in intended use, duration of use, labeling, operation and technology, design, materials, and performance to the predicate Terumo AL8X Arterial Filter device.

Additional Safety Information:

Sterilization conditions for the Terumo Pall AL6X Arterial Filter will be validated in . accordance with AAMI guidelines to provide a Sterility Assurance Level (SAL) of 10° Terumo further asserts that the ethylene oxide residues will not exceed stated or implied maximum residue limits at the time of product distribution.
The X-Coating material that is applied to the blood-contacting surfaces of the devices was . evaluated in an in-vivo animal study conducted by Terumo Cardiovascular and Sierra Biomedical Laboratories in 1999. No adverse conditions were noted.

Conclusion:

Based upon the comparative studies and analyses, Terumo Cardiovascular Systems concludes that the Terumo Pall AL6X Arterial Filter is substantially equivalent to the predicate Terumo AL8X Arterial Filter device. It is further concluded that any recognized differences noted during the assessments do not raise new issues of patient/user safety or product effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA". Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of thick, black lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 2009

Terumo Cardiovascular Systems Corp. c/o Garry Courtney 125 Blue Ball Rd. Elkton, MD 21921

Re: K083834

Terumo Pall AL6X Arterial Filter Regulation Number: 21 CFR 870.4260 Regulation Name: Arterial Line Blood Filter Regulatory Class: Class II (two) Product Code: DTM Dated: March 24, 2009 Received: March 25, 2009

Dear Mr. Courtney:

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 - Mr. Garry Courtney

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 (OS) 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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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SECTION 4 Indications for Use

510(k) Number (if known): Unknown at time of submission

Device Name: Terumo Pall AL6X Arterial Filter

Indications for Use:

The device may be used in procedures lasting up to 6 hours in duration.

Prescription Use XX (Part 21 CFR 801 Subpart D) OROver-The-Counter Use (Part 21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Regulation Number and Section

§ 870.4260 Cardiopulmonary bypass arterial line blood filter.

(a)
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.(b)
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.”