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.

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 and the removal of particulates/emboli from suctioned blood entering the reservoir.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the CAPIOX® SX Hardshell Reservoir, asserting its substantial equivalence to the predicate device, Maxima Forte (Medtronic, K961836). The acceptance criteria and "study" proving its compliance are based on a comparison to this predicate device rather than a standalone clinical study with detailed performance metrics against predefined criteria.

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

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are implicitly defined by the specifications and performance of the Maxima Forte predicate device. The "reported device performance" is the CAPIOX® SX Hardshell Reservoir's specifications, demonstrating substantial equivalence.

Item	Acceptance Criteria (Predicate: Maxima Forte)	Reported Device Performance (CAPIOX® SX Reservoir)
Reservoir maximum volume	4,000 mL	4,000 mL
Minimum operating volume	500 mL	200 mL
Cardiotomy inlet flow rate	1-5 LPM	0.5-5 LPM
Venous flow rate	1-7 LPM	0.5-7 LPM
Cardiotomy Filtration Efficiency	95% efficient for particles ≥20u	Greater than 90% efficiency for particles ≥20u
Sterility Assurance Level	Not explicitly stated but implied to be validated for marketed device	10^-6
Biocompatibility (Blood Contacting Materials)	Not explicitly stated but implied to be compliant for marketed device	Tested in accordance with FDA GPM #G95-1 / ISO-10993

Note: The document explicitly states, "The specifications of the CAPIOX SX Hardshell Reservoir and the Maxima Forte are substantially equivalent." Also, for the filtration efficiency, it states, "This difference in filter material does not have a significant clinical impact."

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

No information is provided regarding a "test set" in the context of clinical or performance data for comparing the CAPIOX® SX Hardshell Reservoir directly against the predicate. The "study" is a comparison of specifications and design features for substantial equivalence. Therefore, there is no mention of sample size or data provenance (country of origin, retrospective/prospective). The assessment is based on product specifications and engineering design.

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

Not applicable. This is not a study involving expert consensus or image interpretation. The ground truth for this submission is the established performance and specifications of the legally marketed predicate device (Maxima Forte) and the design/material specifications of the new device.

4. Adjudication Method for the Test Set

Not applicable. There was no test set requiring expert adjudication. The comparison is based on documented specifications and design.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. This document does not describe an MRMC comparative effectiveness study. The submission relies on establishing substantial equivalence to a predicate device based on design, materials, technology, and performance specifications, not on clinical effectiveness studies or human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device (a hardshell reservoir) is not an algorithm or an AI device.

7. The Type of Ground Truth Used

The "ground truth" for the substantial equivalence determination is the established specifications and performance of the predicate device (Maxima Forte) and the verified design, material, and manufacturing standards of the CAPIOX® SX Hardshell Reservoir. This includes:

Engineering specifications (e.g., volume, flow rates, filtration efficiency).
Material composition and biocompatibility testing (in accordance with GPM #G95-1 / ISO-10993).
Sterility validation.
Pyrogenicity testing.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that would have a "training set."

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

Not applicable, as explained in point 8.

Summary

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MAY | 4 1998

K980935

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 postoperative chest drainage and autotransfusion 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 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.

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.

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II - Summary and Certification Summary of Safety and Effectiveness

Substantial Equivalence

The CAPIOX® SX Reservoir is substantially equivalent to the Maxima Forte (Medtronic, K961836) as follows:

Intended use: same as described on previous page.

Design and Materials

· Design: Both devices are constructed from a clear plastic casing. Both contain filter and defoamer elements. Venous and cardiotomy blood flow through the same filter and defoamer in the Maxima Forte. In the CAPIOX SX reservoir the venous blood flows through a separate channel containing a separate defoamer element from the cardiotomy section.

·Materials:

Component	CAPIOX SX Reservoir	MAXIMA Forte
Housing	Polycarbonate	Polycarbonate
Defoamer	Polyurethane	Polyurethane
Filter	Polyethylene terephthalatenonwoven fabric	Polyester felt filter 20 um

This difference in filter material does not have a significant clinical impact.

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.

The CAPIOX SX Hardshell Reservoir and the Maxima Forte are substantially equivalent in technology and principles of operation.

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II - Summary and Certification Summary of Safety and Effectiveness

Specifications

Table 2
Item	CAPIOX SX18/25 Reservoir	Maxima Forte
Reservoir volume
Maximum	4,000 mL	4,000 mL
Minimum operating volume	200 mL	500 mL
Blood flow rate during	Cardiotomy inlet: 0.5-5LPM	Cardiotomy inlet: 1-5LPM
cardiopulmonary bypass	Venous flow: 0.5-7 LPM	Venous flow: 1-7 LPM
Cardiotomy Filtration	Greater than 90% efficiency	95% efficient for particles
Efficiency	for particles ≥20u	≥20u

The specifications of the CAPIOX SX Hardshell Reservoir and the Maxima Forte are substantially equivalent.

In summary, the CAPIOX® SX Reservoir and the Maxima Forte 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 10-6.

· 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 February 23, 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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

MAY 1 4 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re : K980935 CAPIOX® SX Hardshell Reservoir Regulatory Class: II (Two) Product Code: DTN Dated: April 28, 1998 Received: May 4, 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, Druq, 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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations 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 reguirements, as set forth in the Quality System Requlation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any 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 .

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Page 2 - Ms. Sandi Hartka

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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. Callahon

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

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510(k) Number (if known): 980935 ﻠ

Device Name: CAPIOX® SX Hardshell Reservoir

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.

Bete L. Semperle
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________ K 980934

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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.