The CAPIOX® RX Hardshell Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal.

The Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return blood to the patient for blood volume replacement.

The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass.

The Hardshell Reservoir contains X-Coating, which is intended to reduce platelet adhesion on the surfaces of the device.

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

Device Description

The design of the CAPIOX® RX Reservoir consist of a hard casing reservoir. It has a rotatable venous blood inlet port that permits minimizing tubing lengths, which could result in lower circuit priming volumes. The total capacity of the reservoir is 4000 mL.

The CAPIOX® RX Hardshell Reservoir contains a defoamer and a screen filter in the venous blood inlet section. The defoamer resides in the upper part of the reservoir, thus permitting blood to reside in the lower section of the reservoir.

The cardiotomy section of the RX 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® RX Hardshell Reservoir are polycarbonate, polypropylene, PET, polyvinyl chloride, polyurethane, nylon, stainless steel and ceramic. The device also contains Terumo's X-Coating polymer solution.

AI/ML Overview

This device is a CAPIOX® RX Hardshell Reservoir, classified as a Class II device (Blood Reservoir). The provided text describes a 510(k) premarket notification for demonstrating substantial equivalence to a predicate device, the CAPIOX® SX Hardshell Reservoir (K002238).

The acceptance criteria provided are not quantitative performance metrics for a diagnostic or AI device, but rather a set of functional and safety demonstrations for a medical device. The "study that proves the device meets the acceptance criteria" refers to the performance evaluations conducted to demonstrate substantial equivalence to the predicate device.

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

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Performance Evaluation Conducted)	Reported Device Performance
Filter Defoaming - Venous Section	Demonstrated equivalence to predicate device.
Filter Defoaming - Cardiotomy Section	Demonstrated equivalence to predicate device.
Pressure Drop/Flow Rate Testing - Venous Section	Demonstrated equivalence to predicate device.
Pressure Drop - Cardiotomy Section	Demonstrated equivalence to predicate device.
Filtration Efficiency - Cardiotomy Section	Demonstrated equivalence to predicate device.
Effects Upon Cellular Blood Components	Demonstrated equivalence to predicate device.
Pressure Integrity Testing	Demonstrated equivalence to predicate device.
Tubing Connection Strength	Demonstrated equivalence to predicate device.
Sterilization (SAL of 10-6)	Validated in accordance with AAMI guidelines.
Ethylene Oxide Residues	Will not exceed maximum residue limits.
Biocompatibility (ISO 10993)	Blood contacting materials found to be biocompatible.
Polymer Coating (in-vivo animal study)	No adverse conditions noted.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the performance tests. The data provenance is not mentioned, and it is likely from internal laboratory testing rather than clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The "ground truth" for this type of device (a blood reservoir) is based on engineering and material performance standards and physical measurements, not expert diagnostic assessments.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a diagnostic device involving expert adjudication of findings.
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 or diagnostic imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI or algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device's performance evaluations would be derived from:
- Engineering specifications and regulatory standards: For tests like pressure integrity, tubing connection strength, and acceptable pressure drop/flow rates.
- Material science standards: Biocompatibility following ISO 10993.
- Validated testing protocols: For defoaming efficiency and filtration efficiency.
- Chemical analysis standards: For ethylene oxide residues.
- Biological/physiological measurements: For effects on cellular blood components (e.g., hemolysis, platelet activation) and in-vivo animal study (for coating).
The sample size for the training set
Not applicable. This is not a machine learning or AI device. The term "training set" is not relevant here.
How the ground truth for the training set was established
Not applicable. As above, there is no "training set" for this type of medical device's performance evaluation.

Summary

{0}------------------------------------------------

CAPIOX® RX Hardshell Reservoir

K013526

Submitter Information:

This premarket notification is submitted by:

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

Date of Preparation: October 12, 2001

Device Names:

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

Predicate Device:

The CAPIOX® RX Hardshell Reservoir is substantially equivalent in intended use, materials, design, technology and principles of operation, and performance to the CAPIOX® SX Hardshell Reservoir (K002238).

Intended Use:

The Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return blood to the patient for blood volume replacement.

The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass.

The Hardshell Reservoir contains X-Coating, which is intended to reduce platelet adhesion on the surfaces of the device.

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

Principles of Operation and Technology:

The CAPIOX® RX Hardshell Reservoir is used as a blood storage device during and after cardiopulmonary bypass procedures. Venous blood enters the reservoir via gravity, or by way of external vacuum that may be applied to the reservoir.

{1}------------------------------------------------

Venous blood that is drawn from the patient enters the device through the venous blood inlet port. The blood passes through a defoamer to remove air from the blood and through a filter for removal of particulates.

Blood may also be suctioned into the reservoir from the cardiotomy field. This blood enters the device through the cardiotomy blood suction ports. As with the venous blood, the blood passes through a defoamer to remove air and through a filter for removal of particulates.

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

Design and Materials:

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

Performance Evaluations:

The performance of the CAPIOX® RX Hardshell Reservoir is substantially equivalent to the performance of the predicate devices. The following tests were conducted to demonstrate equivalence in performance:

Filter Defoaming Venous Section ●
Filter Defoaming - Cardiotomy Section
Pressure Drop/Flow Rate Testing Venous Section .
Pressure Drop Cardiotomy Section .
Filtration Efficiency Cardiotomy Section .
Effects Upon Cellular Blood Components .
Pressure Integrity Testing ●
Tubing Connection Strength ●

{2}------------------------------------------------

Substantial Equivalence Comparison:

The CAPIOX® RX Hardshell Reservoir is substantially equivalent to the predicate SX Hardshell Reservoir device as follows:

The RX Reservoir and the predicate SX Reservoirs share the same Intended Use: intended uses. Each is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoirs contain filters to remove particulate matter and defoamers to facilitate air bubble removal.

The Hardshell Reservoirs are also used for post-operative chest drainage and autotransfusion procedures to aseptically return blood to the patient for blood volume replacement.

The Hardshell Reservoirs are also used with the vacuum-assisted venous return technique during cardiopulmonary bypass.

The Hardshell Reservoir each contain X-Coating, which is intended to reduce platelet adhesion on the surfaces of the device.

The CAPIOX RX® Hardshell Reservoir and the predicate SX Reservoir may be used in procedures lasting up to 6 hours.

Principles of Operation and Technology: The RX Reservoir and the predicate SX Reservoirs each utilize gravity and/or vacuum to draw blood into the device, and each has filters and defoamers that facilitate the removal of particulate and air, respectively.

Design and Materials: The design and the materials of the RX Reservoir and the SX Reservoir is essentially the same. The generic materials used in the two devices are comparable.

Performance: Comparisons of the performance of the RX Reservoir and the predicate SX Reservoirs were conducted. The comparisons demonstrated that there were no clinically significant performance differences between the devices.

Substantial Equivalence Summary:

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

{3}------------------------------------------------

Additional Safety Information:

Sterilization conditions have been validated in accordance with AAMI guidelines to . provide a Sterility Assurance Level (SAL) of 10-6.
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 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.
The polymer coating material that is applied to the blood-contacting surfaces of the . device was also evaluated in an in-vivo animal study. No adverse conditions were noted.

Conclusion:

In summary, the CAPIOX® RX Hardshell Reservoir is substantially equivalent in intended use, principles of operation and technology, design and materials, and performance to the predicate SX Hardshell Reservoir (K002238).

{4}------------------------------------------------

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 features a stylized eagle with three lines forming its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 5 2001

Mr. Garry A. Courtney Regulatory Affairs Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921

Re: K013526

Trade Name: CAPIOX® RX Hardshell Reservior Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary bypass blood reservoir Regulatory Class: Class II (two) Product Code: DTN Dated: October 22, 2001 Received: October 23, 2001

Dear Mr. Courtney:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your Section 310(t) premaint in substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the clerosule) to regarly manage and commerce prior to May 26, 1976, the enaounters with the provisions of the Federal Food, Drug, devices that have been recassined in accessor wl of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applic and Cosmetic Ac. (Act) that do not request of the general controls provisions of the Act. The You may, ulerclore, market the devices, becjocher to the more
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the Fiel 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 If your device is classified (500 a0070) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may oc subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found interests concerning your device in the Federal Register.

{5}------------------------------------------------

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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

James E/ Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

NOV 1 5 2001

510(k) Number (if known):

K013526

CAPIOX® RX Hardshell Reservoir Device Name:

Indications For Use:

Reservoir is also used for post-operative chest drainage and The Hardshell autotransfusion procedures to aseptically return blood to the patient for blood volume replacement.

The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass.

The Hardshell Reservoir contains X-Coating, which is intended to reduce platelet adhesion on the surfaces of the device.

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

Harry A. Courtney 10/19/01
Garry A. Courtney

Regulatory Affairs Terumo Cardiovascular Systems

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number: K013526

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

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.