The Capiox® Bubble Trap with X-coating " is a device intended to facilitate air bubble removal from the blood flowing through a cardiopulmonary bypass circuit for up to 6 hours.

Device Description

The Capiox® Bubble Trap with X-coating is comprised of a single outer housing with no inner housing. This outer housing is cylindrical in shape and has a slight conical-shaped lid assembly affixed to the upper area of the cylinder. The lid assembly has an air vent (purge) port on the top outer surface to facilitate air removal during use. The blood inlet port is positioned along the upper-side_axis_of_the_cylinder_housing_and_allows_for the entry of blood ... The base_of_the housing contains the blood outlet port. The cylinder housing contains a screen filter assembly through which blood will pass through for filtration of air bubbles. After the blood has been filtered, it then exits the assembly via the blood outlet port.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets those criteria:

Acceptance Criteria and Device Performance Study for Capiox® Bubble Trap with X-coating™

The provided document describes the Terumo Capiox® Bubble Trap with X-coating™ and its performance evaluation for substantial equivalence to a predicate device. The core of the performance evaluation is a comparison study.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical targets. Instead, it demonstrates "functional equivalence" and "substantial equivalence" to a predicate device, the non-coated BT15 Bubble Trap. Therefore, the "acceptance criteria" are implicitly that the new device performs comparably to the predicate device in the listed performance evaluations. The "reported device performance" refers to the demonstration of this equivalence.

Acceptance Criterion (Implicitly: performance comparable to predicate)	Reported Device Performance
Air Removal Efficiency	Demonstrated functional equivalence to predicate Capiox® Bubble Trap.
Hemolytic Effect Upon Cellular Components of Blood	Demonstrated functional equivalence to predicate Capiox® Bubble Trap.
Pressure Drop	Demonstrated functional equivalence to predicate Capiox® Bubble Trap.
Mechanical Integrity/Leakage Evaluation	Demonstrated functional equivalence to predicate Capiox® Bubble Trap.
Prime Volume	Demonstrated functional equivalence to predicate Capiox® Bubble Trap.
Substantial Equivalence in Intended Use	Confirmed by comparative study/assessment.
Substantial Equivalence in Duration of Use/6-hour use	Confirmed by comparative study/assessment.
Substantial Equivalence in Product Labeling	Confirmed by comparative study/assessment.
Substantial Equivalence in Operation and Technology	Confirmed by comparative study/assessment.
Substantial Equivalence in Product Design	Confirmed by comparative study/assessment.
Substantial Equivalence in Materials Used in Device Construction	Confirmed by comparative study/assessment.
Substantial Equivalence in Design Performance	Confirmed by comparative study/assessment.

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

The document does not explicitly state the numerical sample sizes for each in-vitro performance evaluation. It only mentions that "the following tests were performed."

Sample Size: Not explicitly stated for the in-vitro tests.
Data Provenance: The in-vitro performance evaluations were conducted by "Terumo Corporation, in conjunction with Terumo Cardiovascular Systems Corporation," implying an internal, retrospective (for the purpose of this submission, though the tests themselves would have been prospective investigations) study. No country of origin for the direct test data is specified beyond the Terumo entities.

An in-vivo animal study was conducted by Terumo Cardiovascular Systems and Sierra Biomedical Laboratories in 1999 to evaluate the X-Coating material itself. This study would be considered retrospective for the current submission.

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

This type of information is not provided in the document. The studies described are primarily in-vitro lab tests and material evaluations, not clinical studies requiring expert ground truth for interpretation of patient data.

4. Adjudication Method (for the test set)

This information is not applicable or not provided. The studies are in-vitro performance evaluations demonstrating equivalence to a predicate, not clinical studies requiring adjudication of medical diagnoses.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not mentioned. The studies described are in-vitro performance evaluations and an in-vivo animal study for material safety, not studies involving human readers or comparative effectiveness in a clinical setting.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical medical device (bubble trap), not an algorithm or software. The "standalone" performance in this context would be the in-vitro functional performance tests, which were indeed conducted without human intervention in the function of the device itself during the test.

7. The Type of Ground Truth Used

For the in-vitro performance evaluations (Air Removal Efficiency, Hemolytic Effect, Pressure Drop, Mechanical Integrity/Leakage, Prime Volume), the "ground truth" is defined by objective, measurable physical and chemical properties and engineering specifications. The performance of the new device is compared directly against the established performance of the predicate device.

For the X-Coating material's safety, the "ground truth" was established by in-vivo animal study outcomes, specifically looking for "adverse conditions."

8. The Sample Size for the Training Set

This information is not applicable or not provided. The Capiox® Bubble Trap with X-coating™ is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" for such a device would be its design, manufacturing processes, and material selection based on established engineering principles and prior device knowledge.

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

This information is not applicable as there is no "training set" in the context of AI/ML for this physical device. The "ground truth" for its development and design would have been established through a combination of engineering principles, material science knowledge, regulatory standards, and performance data from previous device generations (like the predicate device).

Summary

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TERUMO

Submitter Information:

This submission was prepared in March 2009 by:

Garry A. Courtney, MBA, RAC Manager, Regulatory Affairs 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:

Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho, Fujinomiya City Shizuoka Prefecture 418-0015 Japan Facility Registration No. 9681834

Device Names/Classifications:

Proprietary Name Capiox® Bubble Trap with X-coating

Classification Name Detector, Bubble, Cardiopulmonary Bypass (KRL) Common Name Bubble Trap

Predicate Device(s):

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

Capiox® Bubble Trap (K911632). .

Intended Use:

The Capiox® Bubble Trap with X-coating is a device intended to facilitate air bubble removal from the blood flowing through a cardiopulmonary bypass circuit for up to 6 hours.

Principles of Operation and Technology:

The cylinder housing contains a screen filter assembly through which blood will pass through for filtration of air bubbles. After the blood has been filtered, it then exits the assembly via the blood outlet port.

Design and Materials:

The materials that are used in the construction of the Capiox® Bubble Trap with X-coating include polycarbonate, polyester screen, polyurethane, polyethylene and X-CoatingTM.

JUN - 8 2009

11 09060

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Performance Evaluations:

Terumo Corporation, in conjunction with Terumo Cardiovascular Systems Corporation, conducted the following in-vitro performance evaluations to demonstrate the functional equivalence of the Capiox® Bubble Trap with X-coating™ to the predicate (non-coated) BT15 Bubble Trap.

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

Air Removal Efficiency .
Hemolytic Effect Upon Cellular Components of Blood
Pressure Drop .
Mechanical Integrity/Leakage Evaluation
Prime Volume ●

Substantial Equivalence Comparison:

In demonstrating substantial equivalence of the Capiox® Bubble Trap with X-coating" to the predicate (non-coated) BT15 Bubble Trap, 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

Substantial Equivalence Statement:

The Capiox® Bubble Trap with X-coating is substantially equivalent in intended use, duration of use, labeling, operation and technology, design, materials, and performance to the predicate (non-coated) Capiox® Bubble Trap device.

Additional Safety Information:

Sterilization conditions for the Capiox® Bubble Trap with X-coating " are validated in . accordance with applicable standards 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 Systems and Sierra Biomedical Laboratories in 1999. No adverse conditions were identified.

Conclusion:

Based upon the comparative studies and analyses, Terumo Corporation concludes that the Capiox® Bubble Trap with X-coating" is substantially equivalent to the predicate (non-coated) Capiox® Bubble Trap 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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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font. The words are arranged on a single line. There is a logo to the left of the text.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN = 8 2009

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

Re: K090698

Capiox Bubble Trap with X-coating Regulation Number: 21 CFR 870.4205 Regulation Name: Detector, Bubble, Cardiopulmonary Bypass Regulatory Class: Class II Product Code: KRL Dated: May 7, 2009 Received: May 13, 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 A. 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 (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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivatence 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

. Vochner

\ Bram D. Zuckerman, M.D. Division Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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TTERUMO

SECTION 4 Indications for Use

Unknown at time of submission Ko 906 18 510(k) Number (if known):

Capiox® Bubble Trap with X-coating™ Device Name:

Indications for Use:

The Capiox® Bubble Trap with X-coating " is a device intended to facilitate air bubble removal from the blood flowing through a cardiopulmonary bypass circuit for up to 6 hours.

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)

una D. V. M.

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Ko 90678

Regulation Number and Section

§ 870.4205 Cardiopulmonary bypass bubble detector.

(a)
Identification. A cardiopulmonary bypass bubble detector is a device used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit.(b)
Classification. Class II (performance standards).