The Terumo Pall AL3X Pediatric 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 3 liters per minute. The device may be used in procedures lasting up to 6 hours in duration.

Device Description

The Terumo Pall AL3X Pediatric 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 AL3X Pediatric 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. Because 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 be manually purged from the circuit.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Terumo Pall AL3X Pediatric Arterial Filter, asserting its substantial equivalence to predicate devices. The information provided is primarily focused on demonstrating this substantial equivalence through performance evaluations and comparisons.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" with numerical thresholds for each test. Instead, it lists performance evaluations and implies that meeting the performance of the predicate device (Terumo Capiox® AF02X Arterial Filter) is the acceptance criterion for substantial equivalence. The reported device performance is presented as being "functional equivalence" to the predicate.

Performance Evaluation Category	Acceptance Criteria (Implied)	Reported Device Performance
Filtration Efficiency	Functionally equivalent to Terumo Capiox® AF02X Arterial Filter	Demonstrated functional equivalence
Air Removal Efficiency	Functionally equivalent to Terumo Capiox® AF02X Arterial Filter	Demonstrated functional equivalence
Hemolytic Effect	Functionally equivalent to Terumo Capiox® AF02X Arterial Filter	Demonstrated functional equivalence
Pressure Drop	Functionally equivalent to Terumo Capiox® AF02X Arterial Filter	Demonstrated functional equivalence
Tubing Connection Strength	Functionally equivalent to Terumo Capiox® AF02X Arterial Filter	Demonstrated functional equivalence
Static Priming Volume	Functionally equivalent to Terumo Capiox® AF02X Arterial Filter	Demonstrated functional equivalence
Mechanical Integrity/Leakage	Functionally equivalent to Terumo Capiox® AF02X Arterial Filter	Demonstrated functional equivalence
Sterility Assurance Level	10⁻⁶ (Validated in accordance with AAMI guidelines)	Will be validated to provide SAL of 10⁻⁶
Ethylene Oxide Residues	Not to exceed stated/implied maximum residue limits	Will not exceed stated/implied maximum residue limits
Biocompatibility	Equivalent to predicate (Terumo Pall AL8X)	Demonstrated equivalence (referenced Terumo Pall AL8X)

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

The document does not explicitly specify the sample sizes (e.g., number of devices tested) for the in-vitro performance evaluations. It simply states that "the following in-vitro performance evaluations" were conducted.

The data provenance is described as:

Country of Origin: Not explicitly stated, but the submission is from Terumo Cardiovascular Systems Corporation in Elkton, MD, USA. It's likely the tests were conducted in the US, but this is not confirmed.
Retrospective or Prospective: The performance evaluations were conducted to demonstrate functional equivalence, suggesting they were specifically performed for this 510(k) submission, making them prospective with respect to the submission.

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

This information is not provided in the text. The evaluations are described as "in-vitro performance evaluations" conducted by "Terumo Cardiovascular Systems, in conjunction with Pall Medical Corporation," implying laboratory testing rather than expert-derived ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable as the evaluations are in-vitro performance tests, not subjective assessments requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. The device is an arterial filter, not an AI-powered diagnostic tool, and therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable. The device is an arterial filter (a mechanical device), not an algorithm or AI system. Its performance is evaluated in-vitro as a standalone device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the in-vitro performance evaluations, the "ground truth" implicitly refers to the established functional performance of the predicate device (Terumo Capiox® AF02X Arterial Filter). The new device's performance is compared against the predicate's known performance characteristics.
For the in-vivo animal study mentioned for the X-Coating™ material, "No adverse conditions were noted" serves as the outcome, but the specific ground truth methodology (e.g., histological analysis, clinical observation) is not detailed.

8. The sample size for the training set:

This information is not applicable. The device is a physical medical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established:

This information is not applicable for the same reasons as above.

Summary

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TERUMO

(08374)

AUG 2009

Submitter Information:

This submission was prepared in November 2008 by: 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 AL3X Pediatric 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® AF02X Arterial Filter K011804 .
Terumo Pall AL8X Arterial Filter $(032128 .

Intended Use:

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

Principles of Operation and Technology:

As an air-removal device, the Terumo Pall AL3X Pediatric 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. Because the blood flows through the device in a

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spiral motion, centripetal forces cause the air bubbles to migrate towards the top of the housing assembly where air can be manually purged from the circuit.

Design and Materials:

The materials that are used in the construction of the Terumo Pall AL3X Pediatric 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 AL3X Arterial Filter to the predicate AF02X 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 AL3X Arterial Filter to the predicate AF02X device, a comparative study and/or assessment was performed in each of the following areas;

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

The Terumo Pall AL8X device is referenced as a predicate device with respect to packaging equivalence and biocompatibility equivalence.

Substantial Equivalence Statement:

The Terumo Pall AL3X Pediatric Arterial Filter is substantially equivalent in intended use, duration of use, labeling, operation and technology, design, materials, and performance to the predicate Terumo AF02X Arterial Filter device. Additionally, the AL3X device and predicate AL8X device utilize equivalent packaging schemes.

Additional Safety Information:

Sterilization conditions for the Terumo Pall AL3X Pediatric Arterial Filter will be validated t in accordance with AAMI guidelines to provide a Sterility Assurance Level (SAL) of 10°.

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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 AL3X Pediatric Arterial Filter is substantially equivalent to the predicate Terumo AF02X Arterial Filter device with respect to safety and effectiveness - and the AL8X device with respect to packaging. 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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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

AUG 2 0 2009

Terumo Cardiovascular Systems Corp. c/o Mr. Garry Courtney Regulatory Affairs/Quality Systems Manager 125 Blue Ball Rd. Elkton, MD 21921

Re: K083747

Terumo Pall AL3X Pediatric Arterial Filter Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary bypass arterial line blood filter Regulatory Class: Class II (two) Product Code: DTM Dated: July 10, 2009 Received: July 15, 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 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. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510/k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

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Page 2 - Mr. Garry Courtney

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/SafetyReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

ina R. Vahner

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

Unknown at time of submissions K 08374 7 510(k) Number (if known):

Device Name: Terumo Pall AL3X Pediatric 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)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

hune R.v.hunes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_

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.”