The CAPIOX® Cardiotomy Reservoir is designed to facilitate the removal of particulate matter and micro air bubbles from blood that is aspirated from the thoracic cavity and/or the left ventricle, and store it during extra corporeal circulation. The device may be used for procedures lasting up to 6 hours.

Device Description

The design of the CAPIOX® Cardiotomy Reservoir is comprised of a hardshell casing that serves as a blood containment system within the bypass circuit. The upper portion of the reservoir consists of a hardshell lid assembly that contains the necessary inlet ports and vent ports. The total capacity of the reservoir is 4000 mL. The cardiotomy section of the CAPIOX® Cardiotomy Reservoir contains a defoamer and a filter to facilitate air removal and the removal of particulates from suctioned blood entering the reservoir.

AI/ML Overview

The provided text describes a medical device (CAPIOX® Cardiotomy Reservoir) and its premarket notification, largely focusing on demonstrating substantial equivalence to a predicate device. This type of submission does not typically include a study with explicit acceptance criteria for device performance based on a statistical analysis of a test set, particularly in the way that an AI/ML algorithm or diagnostic device approval would.

Instead, the "acceptance criteria" here are implied by the demonstration of "substantial equivalence" through various performance tests conducted on the device. The study is a series of engineering and performance tests designed to show that the new device performs equivalently to the predicate device.

Here's how to interpret the request within the context of the provided document:

Acceptance Criteria and Performance Study for CAPIOX® Cardiotomy Reservoir

Since this is a submission for a physical medical device demonstrating substantial equivalence to a predicate, the "acceptance criteria" are not quantitative thresholds for metrics like sensitivity, specificity, or AUC, but rather the demonstrated equivalence in specified functional performance areas. The "study" refers to the performance evaluations conducted.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Implied)	Specific Performance Test	Actual Device Performance (Reported)
Equivalence to Predicate Device's Cardiotomy Section	Filter Defoaming Cardiotomy Section	Functionally equivalent to predicate.
	Pressure Drop Cardiotomy Section	Functionally equivalent to predicate.
	Filtration Efficiency Cardiotomy Section	Functionally equivalent to predicate.
	Effects Upon Cellular Blood Components	Functionally equivalent to predicate.
Mechanical Integrity & Safety	Pressure Integrity Testing	Performance deemed acceptable.
	Tubing Connection Strength	Performance deemed acceptable.
	Filter Breakthrough Time	Performance deemed acceptable.
Biocompatibility & Sterilization	Sterilization conditions	Validated to SAL of 10^-6 (AAMI guidelines).
	Ethylene Oxide residues	Will not exceed maximum residue limits.
	Biocompatibility	Found to be biocompatible (based on predicate device materials and design).

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated. The tests are likely performed on a representative number of manufactured units, rather than a "test set" of data in the AI/ML sense.
Data Provenance: Not specified, but generally, these are laboratory tests conducted on manufactured device samples. The data would be prospective, as the tests are performed specifically to evaluate the new device. Country of origin for testing is not mentioned but would typically be at the manufacturer's R&D or testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This concept doesn't directly apply here. For a physical device like this, "ground truth" is established by direct measurement of physical or chemical parameters (e.g., pressure, filtration efficiency, residual chemicals, sterility) using established engineering and scientific methods, rather than expert consensus on a diagnostic outcome. The "experts" would be the engineers and scientists conducting and validating the tests, adhering to industry standards.

4. Adjudication method for the test set

Not applicable. Performance is determined by objective measurements against engineering specifications or comparative data from the predicate, not by expert 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

Not applicable. This is a physical blood reservoir, not an AI/ML diagnostic aid.

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

Not applicable for a physical medical device. The device operates standalone as a component in a cardiopulmonary bypass circuit.

7. The type of ground truth used

The "ground truth" for these tests is based on objective physical and chemical measurements against established engineering specifications, safety standards (e.g., AAMI for sterility), and direct comparison to the well-characterized performance of the predicate device's cardiotomy section.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set." The design and manufacturing process are informed by general engineering principles and experience with similar devices, not machine learning training.

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

Not applicable.

Summary

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MAY 1 4 2003

CAPIOX® Cardiotomy Reservoir

Submitter Information:

This premarket notification is submitted by:

Garry A. Courtney, MBA, RAC Sr. Regulatory Affairs Specialist Terumo Cardiovascular Systems Telephone: 1-800-283-7866, Ext. 7420

Date of Preparation: February 13, 2003

Device Names:

Proprietary Name:	CAPIOX® Cardiotomy Reservoir
Common Name:	Blood Reservoir
Classification:	CPB Reservoirs are classified as Class II devices

Predicate Device:

The CAPIOX® Cardiotomy Reservoir is substantially equivalent in intended use, materials, design, technology and principles of operation, and performance to the CAPIOX® RX Hardshell Reservoir (K013526).

Intended Use:

Principles of Operation/Technology:

The CAPIOX® Cardiotomy Reservoir is used as a blood storage device during and after cardiopulmonary bypass procedures. The patient's blood enters the reservoir from the thoracic cavity and/or the left ventricle. Typically, the blood is pulled into the reservoir via suction.

The blood that is drawn from the patient enters the device via the blood inlet ports and suction ports that are positioned above the cardiotomy filter that is contained within the reservoir. The blood passes through a defoamer (to remove air from the blood) and through a filter (for mechanical entrapment/removal) of particulate matter from the blood.

Blood exits the device via gravity through the blood outlet port and is subsequently pumped through the remainder of the cardiopulmonary bypass circuit.

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Design and Materials:

The cardiotomy section of the CAPIOX® Cardiotomy Reservoir contains a defoamer and a filter to facilitate air removal and the removal of particulates from suctioned blood entering the reservoir.

The generic materials used in the CAPIOX® Cardiotomy Reservoir are polycarbonate, polypropylene, PET, polyvinyl chloride, polyurethane, nylon, stainless steel, ceramic and Terumo's X-Coating polymer solution.

Performance Evaluations:

The performance of the CAPIOX® Cardiotomy Reservoir is substantially equivalent to the performance of the cardiotomy section of the predicate device. The following tests were conducted to demonstrate equivalence in performance:

Filter Defoaming Cardiotomy Section .
Pressure Drop Cardiotomy Section ●
Filtration Efficiency Cardiotomy Section .
. Effects Upon Cellular Blood Components
Pressure Integrity Testing
Tubing Connection Strength .
Filter Breakthrough Time

Substantial Equivalence Comparison:

The CAPIOX® Cardiotomy Reservoir is substantially equivalent to cardiotomy section of the predicate CAPIOX® RX Hardshell Reservoir device as follows:

Intended Use: The CAPIOX® Cardiotomy Reservoir and the predicate RX Hardshell Reservoir share the same intended uses. Each is used to facilitate the removal of particulate matter and micro air bubbles from blood that is aspirated from the thoracic cavity and/or the left ventricle, and store it during extra corporeal circulation. Each device may be used for procedures lasting up to 6 hours.

Principles of Operation/Technology: The CAPIOX® Cardiotomy Reservoir and the predicate RX Hardshell Reservoir utilize the same technology in their respective operations. With each device, the patient's blood enters the reservoir from the thoracic cavity and/or the left ventricle. Typically, the blood is pulled into the reservoir via suction.

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The blood that is drawn from the patient enters the devices via the blood inlet ports and suction ports that are positioned above the cardiotomy filter that is contained within the reservoirs. The blood passes through a defoamer (to remove air from the blood) and through a filter (for mechanical entrapment/removal) of particulate matter from the blood.

Blood exits the devices via gravity through the blood outlet port and is subsequently pumped through the remainder of the cardiopulmonary bypass circuit.

Design and Materials: The design of the CAPIOX® Cardiotomy Reservoir is identical to the predicate RX Hardshell Reservoir except that it does not contain a venous filter. As such, the materials are also identical for the two devices, excepting that a venous filter is not present in the CAPIOX® Cardiotomy Reservoir. There are no new and/or additional materials utilized in the CAPIOX® Cardiotomy Reservoir that are not also utilized in the predicate RX Hardshell Reservoir.

Performance: The cardiotomy section of the CAPIOX® Cardiotomy Reservoir is exactly the same as the cardiotomy section of the predicate RX Hardshell Reservoir. As such, there are no performance differences between the cardiotomy sections of the two devices. The removal of the venous filter does not alter the performance of the cardiotomy filter. as the two filters operate and perform independently of each other.

Substantial Equivalence Summary:

In summary, the CAPIOX® Cardiotomy Reservoir and the predicate RX Hardshell Reservoir are substantially equivalent in intended use, principles of operation/technology, design and materials, and performance. Any noted differences between the devices do not raise new issues of safety and effectiveness.

Additional Safety Information:

Sterilization conditions have been validated in accordance with AAMI guidelines to . provide a Sterility Assurance Level (SAL) of 106.
Ethylene Oxide residues will not exceed the maximum residue limits proposed for . Part 821 of Title 21 in the Federal Register of June 23, 1978 (or as finalized or amended).
. Biocompatibility studies were conducted on the predicate device as recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing." [External Communicating Devices, Circulating Blood, Limited Exposure (≤ 24 hours) Contact Duration]. The blood contacting materials were found to be biocompatible. It is not necessary to conduct these studies on the new CAPIOX® Cardiotomy Reservoir since the materials and design are exactly the same

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as those of the predicate device (except that a venous filter is not included in the subject device).

Conclusion:

In summary, the CAPIOX® Cardiotomy Reservoir is substantially equivalent in intended use, principles of operation/technology, design and materials, and performance to the cardiotomy section of the predicate RX Hardshell Reservoir (K013526).

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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 its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 2003

Terumo Cardiovascular Systems Corporation c/o Mr. Garry A. Courtney 125 Blue Ball Road Elkton, MD 21921

Re: K030505

CAPIOX® Cardiotomy Reservoir Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir Regulatory Class: Class II (two) Product Code: DPW Dated: February 13, 2003 Received: February 19, 2003

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 (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 (301) 594-4646. Also, please note the regulation enitled, "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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

KakaTM

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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KO30505 510(k) Number (if known):

CAPIOX® Cardiotomy Reservoir Device Name:

Indications For Use:

Larry J. Courtney, Feb 13, 2003
Garry A. Courtney, MBA, RAC

Sr. Regulatory Affairs Specialist Terumo Cardiovascular Systems

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Deleth

510(k) N

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

Regulation Number and Section

§ 870.2100 Cardiovascular blood flowmeter.

(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).