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 1000 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

Here's a breakdown of the acceptance criteria and the study information for the CAPIOX® Cardiotomy Reservoir, based on the provided text:

Summary of Acceptance Criteria and Device Performance

The device's acceptance criteria are implicitly tied to demonstrating "substantial equivalence" to predicate devices. This means that its performance must be comparable to, and not raise new questions of safety or effectiveness compared to, established devices already on the market. The study aims to prove this equivalence.

Acceptance Criteria Category	Reported Device Performance
Intended Use Equivalence	The CAPIOX® Cardiotomy Reservoir and the predicate CAPIOX® RX05 Hardshell Reservoir share the same intended uses: facilitating removal of particulate matter and micro air bubbles from aspirated blood, and storing it during extracorporeal circulation for procedures up to 6 hours.
Principles of Operation/Technology Equivalence	Both the CAPIOX® Cardiotomy Reservoir and the predicate CAPIOX® RX05 Hardshell Reservoir utilize the exact same technology: blood enters via inlet/suction ports, passes through a defoamer and filter, and exits via gravity.
Design and Materials Equivalence	The CAPIOX® Cardiotomy Reservoir's design and materials are identical to the predicate CAPIOX® RX05 Hardshell Reservoir, with the only difference being the absence of a venous filter in the proposed device. No new materials are used.
Performance Equivalence	The cardiotomy section of the CAPIOX® Cardiotomy Reservoir is exactly the same as the cardiotomy section of the predicate CAPIOX® RX05 Hardshell Reservoir. Therefore, there are no performance differences between their cardiotomy sections. Comparative studies with the Medtronic Minimax Reservoir further demonstrated substantial equivalence for select performance evaluations.
Sterilization Assurance Level (SAL)	Sterilization conditions validated in accordance with AAMI guidelines to provide an SAL of 10^-6.
Biocompatibility	Biocompatibility studies conducted on the CAPIOX® RX25 Hardshell Reservoir (constructed of the same materials) were referenced. Blood-contacting materials satisfied all biocompatibility test specifications as per ISO 10993 for External Communicating Devices, Circulating Blood, Limited Exposure (≤ 24 hours).
Specific Performance Tests	- 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: (Detailed results for these specific tests are not provided in the text, only that the tests were conducted.)

Study Details:

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document refers to "comparative studies" and "tests were conducted" without providing specific numbers of devices or test runs. Given the nature of medical device testing (e.g., sterilization, biocompatibility, mechanical performance), it would involve a sufficient number of units to ensure statistical validity and representativeness, but the exact count is not given.
- Data Provenance: Not explicitly stated. However, given that Terumo Cardiovascular Systems (a US-based company) is submitting a 510(k) to the FDA, it is highly likely the testing was conducted in the US or in facilities compliant with US regulatory standards. The testing appears to be prospective in nature, as it was conducted specifically to demonstrate equivalence for this new device submission.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This type of device (a cardiotomy reservoir) does not typically involve expert consensus for "ground truth" in the way a diagnostic AI algorithm might. The "ground truth" for its performance is established through objective engineering and biological tests (e.g., measuring filtration efficiency, pressure drop, cellular damage, sterility, biocompatibility) against predetermined specifications or established predicate device performance.
- Therefore, no information on the number or qualifications of experts establishing "ground truth" in this context is provided or relevant. The "ground truth" comes from the physical and chemical properties of the device and its interaction with blood.
Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations (e.g., image reading by radiologists) used to establish ground truth for AI algorithms. For medical devices like this, the performance is measured objectively through assays and tests, not subjective expert judgment.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The CAPIOX® Cardiotomy Reservoir is mechanical blood processing device, and its evaluation does not involve human "readers" or diagnostic tasks that would benefit from such a study.
Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
- Not applicable. This device is not an algorithm or AI system. Its performance is inherently standalone in the sense that it functions physically and biologically without human "input" for its core operation (processing blood). The "standalone performance" is what the various engineering and biological tests were designed to assess.
Type of Ground Truth Used:
- The "ground truth" is based on objective measurements, laboratory test results, and established standards. This includes:
  - Biocompatibility test results: Against ISO 10993 standards.
  - Sterilization validation: Against AAMI guidelines for SAL.
  - Physical performance measurements: Such as filtration efficiency, pressure drop, pressure integrity, tubing connection strength, and filter breakthrough time, benchmarked against predicate devices.
  - Cellular effects: Assessment of impact on blood components.
Sample Size for the Training Set:
- Not applicable. This device is not an AI or machine learning model, so there is no concept of a "training set." The device itself is manufactured, and its performance is evaluated, not "trained."
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for a mechanical medical device like this.

Summary

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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: November 3, 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 following devices:

CAPIOX® RX05 Hardshell Reservoir (Cardiotomy Section) K022115. t
Medtronic Minimax Hardshell Reservoir (Cardiotomy Section) K933586. .

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 facilitate the removal of air from the blood) and through a filter for mechanical entrapment/removal of particulate matter from the blood.

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

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, polyurethane, silicone rubber, PMMA-PHEMA 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 sections of the aforementioned predicate devices. 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 devices as indicated below:

Intended Use: The CAPIOX® Cardiotomy Reservoir and the predicate CAPIOX® RX05 Hardshell Reservoir share the same intended uses. The cardiotomy section of each device 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. The respective cardiotomy sections of these two devices are identical. Their intended uses are identical.

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Principles of Operation/Technology: The CAPIOX® Cardiotomy Reservoir and the predicate CAPIOX® RX05 Hardshell Reservoir utilize the exact 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.

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.

The principals of operation and employed technology of the two devices are identical.

Design and Materials: The design of the CAPIOX® Cardiotomy Reservoir is identical to the predicate CAPIOX® RX05 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 CAPIOX® RX05 Hardshell Reservoir.

Performance: The cardiotomy section of the CAPIOX® Cardiotomy Reservoir is exactly the same as the cardiotomy section of the predicate CAPIOX® RX05 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. Additionally, comparative studies between the CAPIOX® Cardiotomy Reservoir and the predicate Medtronic Minimax Reservoir further demonstrate the substantial equivalence of the proposed device to another legally marketed device.

Substantial Equivalence Summary:

. *

In summary, the CAPIOX® Cardiotomy Reservoir and the predicate CAPIOX® RX05 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. Additionally, equivalence is also demonstrated between the CAPIOX® Cardiotomy Reservoir and the Medtronic device (with respect to select performance evaluations).

Additional Safety Information:

Sterilization conditions have been validated in accordance with AAMI guidelines to . provide a Sterility Assurance Level (SAL) of 10-6.

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Biocompatibility studies were conducted on the CAPIOX® RX25 Hardshcll . Reservoir - which is constructed of the same materials as the CAPIOX® Cardiotomy Reservoir. As such. Terumo makes reference to the RX25 biocompatibilty studies to support the requirements for this submission.
The biocompatibility studies were conducted on the CAPIOX® RX25 Hardshell Reservoir 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 satisfy all biocompatibility test specifications.

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 CAPIOX® RX05 Hardshell Reservoir (K022115) and to the Medtronic Minimax Reservoir (Cardiotomy Section) - K933586.

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Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized symbol that resembles a human figure.

FEB 1 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Terumo Cardiovascular Systems Corporation c/o Garry A. Courtney MBA, RAC Sr. Regulatory Affairs Specialist 125 Blue Ball Road Elkton, MD 21921

Re: K033800 CAPIOX® Cardiotomy Reservoir Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiotomy Reservoir Regulatory Class: Class II (two) Product Code: DTN Dated: December 3, 2003 Received: December 5, 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 cnactment 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 -- Garry A. Courtney MBA, RAC

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substances with other requirements of the Act
that FDA has made a determination that your device with other requirements of the Act that FDA has made a determination in a your correct complex Federal agencies. You must
or any Federal statutes and regulations administered by registration and listin or any Federal statutes and regulations and limited to: registration and listing (21)
comply with all the Act's requirements, including, but not limited to set comply with all the Act's requirements, including, bactice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Patl on ); good manatesan; gro-if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat 820); and if applicable, forth in the quality systems (QS) regulation (2 r CF (2 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 53 (542 of the Action Section S product radiation control provisions (Scetions 3-1-2 42 - 2-2 - 2-2 - 2-1)
This letter will allow you to begin marketing your device of your device to a legal This letter will allow you to begin marketing your advice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of yo premarket notification. The FDA finding of substantial equice 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
r the If you desire specific advice for your device at (301) 594-4646. Additionally, for questions on the contact the Utfice of Compilance at (501) 591-1010 act the Office of Compliance at
promotion and advertising of your device, please contine and advanced promotion and advertising of your devices, areas and the design one of information (301) 594-4639. Also, please note the regulation on and obtain. Other general information on your
premarket notification" (21CFR Part 807.97) you may obtain of Small Manufac premarket notification" (21CFN Patt 607.77 July 10 Since of Small Manufacturers,
responsibilities under the Act may be obtained from the Division of Small of (301) 44 responsibilities under the Act may be ood its toll-free number (800) 638-2041 or (301) 443-6597
International and Consumer Assistance at its toll-free mumber (800) 638-2041 o International and Consumer Tissis.com/cdrh/dsma/dsmamain.html

Sincerely yours,

uma R. Kirchner

] 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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510(k) Number (if known): K033800

CAPIOX® Cardiotomy Reservoir Device Name:

Indications For Use:

Garry A. Courtney, MBA, RAC
Terumo Cardiovascular Systems

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

..............................................................................................................................................................................

Prescription Use X

Over-The-Counter Use

(Per 21 CFR 801.109)

Duna R. V. Jones

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K 033800

Regulation Number and Section

§ 870.4400 Cardiopulmonary bypass blood reservoir.

(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.