The Terumo® Pall AL20X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 20 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 7 liters per minute. The device may be used in procedures lasting up to 6 hours in duration.

Device Description

The Terumo® Pall AL20X Arterial Filter and the predicate device, Terumo® Pall AL6 Arterial Filter, use the same principles of operation and technology. They perform their functions using two basic forms of technology. As filtration devices, particulates in the blood stream are captured and removed from the blood flow as blood passes through a porous filter 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 air-removal devices, the Terumo® Pall AL20X Arterial Filter and the predicate device, Terumo® Pall AL6X Arterial Filter, are 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.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the Terumo® Pall AL20X Arterial Filter. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for a novel functionality.

Therefore, the requested information regarding "acceptance criteria" for a study that "proves the device meets the acceptance criteria" in the context of AI/ML device assessment (which often involves performance metrics like sensitivity, specificity, AUC) is not directly applicable to this submission. This 510(k) primarily compares the new device to a predicate device based on in-vitro performance evaluations and design characteristics to argue for substantial equivalence.

However, I can extract the closest equivalent information from the provided text, interpreting "acceptance criteria" as the performance measures used to demonstrate equivalence to the predicate device.

Here's the breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical thresholds in the way a modern AI/ML device might. Instead, it demonstrates performance equivalency to a predicate device through a series of in-vitro tests. The implied "acceptance criterion" is that the performance of the Terumo® Pall AL20X Arterial Filter is not significantly worse than the predicate device (Terumo® Pall AL6X Arterial Filter) for key operating parameters, and for some, it is even improved (e.g., smaller pore size).

Table of Performance Evaluations and Implied Comparison to Predicate:

Performance Evaluation	Terumo® Pall AL20X Arterial Filter Performance	Implied "Acceptance Criteria" Relative to Predicate (Terumo® Pall AL6X Arterial Filter)
Filtration Efficiency	Not explicitly detailed, but filter pore size is 20µm	Expected to be at least equivalent, if not superior due to smaller pore size (20µm vs 40µm for predicate)
Air Removal Efficiency	Not explicitly detailed	Expected to be equivalent
Effects on Cellular Components	Not explicitly detailed	Expected to be equivalent (no adverse effects)
Effects on Blood Clotting	Not explicitly detailed	Expected to be equivalent (no adverse effects)
Pressure Drop at Various Flow Rates	Not explicitly detailed	Expected to be within acceptable clinical ranges, comparable to predicate
Static Priming Volume	Not explicitly detailed	Expected to be equivalent
Structural Integrity under Maximum Pressure	Not explicitly detailed	Expected to withstand maximum pressure equivalently to predicate
Structural Integrity under Maximum Flow Rate	Not explicitly detailed	Expected to withstand maximum flow rate (7 L/min) equivalently to predicate
Packaging Integrity	Not explicitly detailed	Expected to be equivalent
Tubing Connection Strength	Not explicitly detailed	Expected to be equivalent
Device Holder Compatibility	Not explicitly detailed	Expected to be compatible

Key Design Differences & Rationale for Equivalence:

Filter Pore Size: AL20X has 20µm, AL6X (predicate) has 40µm. Smaller pore size is an improvement for micro-emboli removal. "Filter pore size of 20 um to 40 um for arterial line filters is standard to the industry."
Maximum Flow Rate: AL20X has 7 L/min, AL6X (predicate) has 8 L/min. This difference is deemed "not clinically relevant" because "A blood flow rate of 7 L/min or less is typically used in Cariopulmonary Bypass procedures and most bypass components are only qualified to a maximum flow rate of 7 L/min."

Other Requested Information (Not directly applicable in the context of this 510(k) for an arterial filter, but addressed based on closest interpretation):

Since this is a submission for a physical medical device (arterial filter) and not an AI/ML diagnostic or prognostic tool, many of the requested fields are designed for AI/ML device evaluation and are not present in this document.

Sample size used for the test set and the data provenance:
- The document mentions "in-vitro performance evaluations," implying lab-based testing. It does not provide specific sample sizes (e.g., number of devices tested for each evaluation).
- Provenance: The tests were conducted by Terumo Cardiovascular Systems ("Terumo Cardiovascular Systems conducted the following in-vitro performance evaluations...").
- Retrospective or Prospective: These would be prospective in-vitro tests performed on manufactured devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is an in-vitro device evaluation; ground truth would relate to physical measurements and engineering specifications, not expert interpretation of outputs.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is an in-vitro device evaluation.
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:
- Not applicable. This is not an AI-assisted device requiring human reader interaction.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a standalone physical medical device. The "performance evaluations" are effectively the standalone performance of the device without human interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For in-vitro tests, the "ground truth" is based on established engineering and scientific principles, measurement standards for parameters like pore size, flow rate, pressure drop, and material compatibility.
The sample size for the training set:
- Not applicable. This device is not an AI/ML model requiring a training set. Its design is based on established engineering principles and prior device iterations (predicate).
How the ground truth for the training set was established:
- Not applicable. No training set for an AI/ML model.

Summary

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510(K) Summary

K121209
pg 1 of 4

Submitter Information:

Primary Contact: This submission was prepared in April 2012 by: Suzanne Grenier Regulatory Affairs Specialist Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 Telephone: 1-800-262-3304, Ext. 7688 Fax: 410-398-6079

Alternate Contact:

Garry A. Courtney, MBA, RAC Regulatory Affairs Manager Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 Telephone: 1-800-262-3304, Ext. 7486 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 AL20X 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® Pall AL6X Arterial Filter (K083834) .

Intended Use:

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Principles of Operation and Technology:

As air-removal devices, the Terumo® Pall AL20X Arterial Filter and the predicate device, Terumo® Pall AL6X Arterial Filter, are 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.

Design and Materials:

The blood-contacting materials that are used in the construction of the Terumo® Pall AL20X Arterial Filter include polycarbonate, polyester, polypropylene, and X-Coating™.

The design differences between the Terumo® Pall AL20X Arterial Filter and the predicate device, Terumo® Pall AL6X Arterial Filter, include filter pore size and maximum flow rate:

Device Characteristics	AL-20X	Predicate:AL-6X
Filter Pore Size	20μm	40μm
Maximum Flow Rate	7 L/min	8 L/min

The Terumo® Pall AL20X Arterial Filter will have a filter pore size of 20 µm while the predicate device, the Terumo® Pall AL6X Arterial Filter, has a filter pore size of 40 um. Filter pore size of 20 um to 40 um for arterial line filters is standard to the industry. 1 The filter pore size dictates the size of micro-emboli such as gas emboli, fat emboli, and aggregates composed of platelets, red blood cells, and other debris that are removed from the fluid flow.

The Terumo® Pall AL20X Arterial Filter will have a maximum flow rate of 7 L/min while the predicate device, the Terumo® Pall AL6X Arterial Filter, has a maximum flow rate of 8 L/min. A blood flow rate of 7 L/min or less is typically used in Cariopulmonary Bypass procedures and most bypass components are only qualified to a maximum flow rate of 7 L/min. 4 For this reason, the difference in flow rates between the modified and current device is not clinically relevant.

Terumo Cardiovascular Systems concludes that the differences between the Terumo® Pall AL20X Arterial Filter and the Terumo® Pall AL6X Arterial Filter do not affect the intended

1 Cardiopulmonary Bypass: Principles and Practices. Ed. Glenn P Gravlee, et al. - 3d ed, p93. (Reference included in Appendix A)

2 Cardiopulmonary Bypass: Principles and Practices. Ed. Glenn P Gravlee, et al. - 3d ed, p35. (Reference included in Appendix A)

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surgical use of the device nor do they affect safety and effectiveness of the device when used as labeled.

Performance Evaluations:

Terumo Cardiovascular Systems conducted the following in-vitro performance evaluations to demonstrate the functional equivalence of the Terumo® Pall AL20X Arterial Filter to the predicate Terumo® Pall AL6X Arterial Filter.

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

Filtration Efficiency
. Air Removal Efficiency
. Effects on Cellular Components
. Effects on Blood Clotting
Pressure Drop at Various Flow Rates .
. Static Priming Volume
Structural Integrity under Maximum Pressure .
. Structural Integrity under Maximum Flow Rate
. Packaging Integrity
Tubing Connection Strength ●
. Device Holder Compatibility

Substantial Equivalence Comparison:

In demonstrating substantial equivalence of the Terumo® Pall AL20X Arterial Filter to the predicate Terumo Pall AL6X Arterial Filter, a comparative study and/or assessment was performed in each of the following areas:

Intended use
Target Population
Duration of use .
Product labeling .
Product design .
Materials used in device construction .
Principles of Operation and Technology .
Device Performance .

Substantial Equivalence Statement:

The Terumo Pall AL20X Arterial Filter is substantially equivalent in intended use, target population, duration of use, labeling, design, materials, principles of operation and technology, and performance to the predicate Terumo® Pall AL6X Arterial Filter device.

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Image /page/3/Picture/0 description: The image shows the logo for Terumo. The logo consists of a circle with the letter T inside, followed by the word "TERUMO" in bold, sans-serif font. There is a small circle above and to the right of the letter O.

Additional Safety Information:

Sterilization conditions for the Terumo® Pall AL20X Arterial Filter will be validated in . accordance with AAMI guidelines to provide a Sterility Assurance Level (SAL) of 10°. Terumo Cardiovascular Systems 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 AL20X Arterial Filter is substantially equivalent to the predicate Terumo® Pall AL6X 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/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY - 8 2012

Terumo Cardiovascular Systems c/o Ms. Suzanne Grenier 125 Blue Ball Road Elkton, MD 21921

Re: K121209

Trade/Device Name: Terumo® Pall AL20X Arterial Filter Regulation Number: 21 CFR 870.4260 Regulation Name: Arterial Line Blood Filter Regulatory Class: Class II Product Code: DTM Dated: April 19, 2012 Received: April 20, 2012

Dear Ms. Grenier:

· 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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Page 2 - Ms. Suzanne Grenier

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/Safety/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

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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T TERUMO

K121209

SECTION 4 Indications for Use

K121209 510(k) Number (if known):

)

Terumo® Pall AL20X Arterial Filter Device Name:

Indications for Use:

Prescription Use XX · (Part 21 CFR 801 Subpart D) OR

Over-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)

(Division Sign-Off) Division of Cardiove 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.”