The CAPIOX SX 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 the blood to the patient for blood volume replacement

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

Device Description

CAPIOX® SX hardshell reservoir has a rotatable venous blood inlet port to permit minimizing tubing lengths which could result in lower circuit priming volumes.

The 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 permitting blood to reside in the lower section of the reservoir while not in constant contact with the defoamer. The total capacity of the reservoir is 4,000 mL.

The cardiotomy section of the hardshell reservoir contains a defoamer and a cardiotomy filter to facilitate gas bubble removal of particulates/emboli from suctioned blood entering the reservoir.

AI/ML Overview

The provided text describes the acceptance criteria for the CAPIOX® SX Hardshell Reservoir and states that the device meets these criteria through substantial equivalence to predicate devices, rather than through a direct study.

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

Acceptance Criteria and Device Performance

The acceptance criteria for the CAPIOX® SX Hardshell Reservoir are established by demonstrating substantial equivalence to the Baxter Bentley HSR4000 and Bentley BMR Venous Reservoir. The device's performance aligns with these criteria through direct comparison of specifications and operational principles.

Item	Acceptance Criteria (Predicate Devices: Bentley HSR4000/BMR)	Reported Device Performance (CAPIOX SX Hardshell Reservoir)
Reservoir volume
Maximum	4,500 mL	4,000 mL
Minimum operating volume	300 mL	200 mL
Blood flow rate during CPB
Cardiotomy inlet	1-5 LPM	0.5-5 LPM
Venous flow	1-7 LPM	0.5-7 LPM
Cardiotomy Filtration Efficiency	80% efficiency for particles > 20u	Greater than 90% efficiency for particles ≥20u
Intended Use	Blood storage during extracorporeal circulation, post-operative chest drainage/autotransfusion, vacuum assisted venous return (for BMR)	Blood storage during extracorporeal circulation, post-operative chest drainage/autotransfusion, vacuum assisted venous return
Design	Clear plastic casing, filter and defoamer elements	Clear plastic casing, filter and defoamer elements
Technology/Principles of Operation	Gravity and/or external vacuum for blood collection, air removal via defoamers, particulate removal via filters	Gravity and/or external vacuum for blood collection, air removal via defoamers, particulate removal via filters

Study Details

The provided document does not describe an independent study to prove the device meets acceptance criteria. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices. Therefore, many of the requested study details are not applicable.

Sample size used for the test set and the data provenance: Not applicable, as a direct performance study with a test set is not described. The device's equivalence is based on comparing specifications and design.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set with ground truth established by experts is mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. The device is a medical reservoir, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a medical reservoir, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for substantial equivalence is the established performance and safety profile of the predicate devices, inferred from their regulatory clearance.
The sample size for the training set: Not applicable, as no machine learning model or training set is described.
How the ground truth for the training set was established: Not applicable.

Additional Safety Information (As per the document, not a "study")

The document does include additional safety information, which are compliance statements rather than a performance study:

Pyrogen Testing: Indicated as performed.
Sterilization conditions: Validated to provide a Sterility Assurance Level (SAL) of 10^-6.
Ethylene oxide residuals: Will not exceed maximum residue limits.
Manufacturing control testing: Performed.
Blood contacting materials: Tested in accordance with FDA General Program Memorandum #G95-1 (ISO-10993 for external communicating devices/circulating blood/limited contact duration).

Conclusion: The CAPIOX® SX Hardshell Reservoir was determined to meet acceptance criteria by demonstrating "substantial equivalence" to predicate devices (Baxter Bentley HSR4000 and Bentley BMR Venous Reservoir) based on intended use, design, technology/principles of operation, and specifications. No direct performance study with a test set as typically understood for diagnostic devices was conducted or described in this summary.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

Proprietary Device Name: CAPIOX® SX Hardshell Reservoir

Classification Name: Cardiopulmonary bypass blood reservoir, defoamer, cardiotomy suction line filter

Reason for Submission:

Addition of the use of vacuum assisted venous drainage to the intended use of the hardshell reservoir.

Intended Use:

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

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

Description

CAPIOX® SX hardshell reservoir has a rotatable venous blood inlet port to permit minimizing tubing lengths which could result in lower circuit priming volumes.

The cardiotomy section of the hardshell reservoir contains a defoamer and a cardiotomy filter to facilitate gas bubble removal of particulates/emboli from suctioned blood entering the reservoir.

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II Summary and Certification Summary of Safety and Effectiveness

Substantial Equivalence

The CAPIOX® SX Reservoir is substantially equivalent to the Baxter Bentley HSR4000 (K915573) and Bentley BMR Venous Reservoir (K971455) # as follows:

Intended use: same as described on previous page.

Design

These devices are constructed from a clear plastic casing containing filter and defoamer elements.

Technology and Principles of Operation

Both devices utilize gravity and/or external vacuum (cardiotomy) for blood collection into the reservoir. Air removal is facilitated by defoamers and the tendency of air to rise through liquid. Particulate removal is facilitated by the blood flow pathway through filters contained in the reservoirs. Vacuum can be applied to the reservoirs to increase venous return.

The CAPIOX SX Hardshell Reservoir and the Baxter Bentley HSR4000 and Bentley BMR Venous Reservoir are substantially equivalent in design, technology and principles of operation.

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II - Summary and Certification Summary of Safety and Effectiveness

Specifications

Table 1
Item	CAPIOX SX18/25 Reservoir	Bentley HSR Reservoir
Reservoir volume
Maximum	4,000 mL	4,500 mL
Minimum operating volume	200 mL	300 mL
Blood flow rate during	Cardiotomy inlet: 0.5-5LPM	1-5 LPM
cardiopulmonary bypass	Venous flow: 0.5-7 LPM	1-7 LPM
Cardiotomy Filtration	Greater than 90% efficiency	80% efficiency for particles
Efficiency	for particles ≥20u	> 20u

The specifications of the CAPIOX SX Hardshell Reservoir and the Baxter Bentley HSR4000 and are substantially equivalent.

In summary, the CAPIOX® SX Reservoir and the Baxter Bentley HSR4000 and Bentley BMR Venous Reservoir are substantially equivalent in intended use, design and materials, technology/principles of operation, specifications and performance. Differences as described above do not raise new issues of safety or effectiveness.

Terumo's statement that this device is substantially equivalent to any other device is done solely to comply with the requirements of the Federal Food, Drug and Cosmetic Act and is not intended whatsoever to be the basis for a patent infringement action.

Additional Safety Information

·Pyrogen Testing

·Sterilization conditions have been validated to provide a Sterility Assurance Level (SAL) of 106.

· Ethylene oxide residuals 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).

· Manufacturing control testing

· Blood contacting materials were tested in accordance with 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 contact duration).

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II Summary and Certification Summary of Safety and Effectiveness
Date Prepared June 17, 1998

Prepared by: Sandi Hartka, Manager Regulatory Affairs

for: Terumo Medical Corporation 2101 Cottontail Lane Somerset, NJ 08873

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1998

Ms. Sandi Hartka Manager, Requlatory Affairs Terumo Medical Corporation 125 Blue Ball Road Elkton, MD 21921

Re : K982223 CAPIOX® SX Harshell Reservoir Regulatory Class: II (two) Product Code: DTN Dated: June 22, 1998 - ------Received: June 24, 1998

Dear Ms. Hartka:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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, qood 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 (Premarket Approval) , it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any

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obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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, 2 Misbranding by reference to premarket notification² (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Thomas J. Callahan

Thomas J. Callahar Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 982223 510(k) Number (if known):

CAPIOX® SX Hardshell Reservoir Device Name:

Indications For Use:

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

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

Bee G. Campbell

(Division Sign-Off) Division of Cardiovascular. Respiratory, and Neurological Devices 510(k) Number_K 98222

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

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.