The CAPIOX® SX10 Hardshell Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line during cardiopulmonary bypass procedures lasting up to 6 hours. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal. The Hardshell Reservoir is also used in the vacuum-assisted venous return technique during cardiopulmonary bypass procedures lasting up to 6 hours.

Device Description

CAPIOX® SX10 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 contact with the defoamer. The total capacity of the reservoir is 3000 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

There is no study described that proves the device meets specific acceptance criteria in the provided document. The document is primarily a 510(k) submission for substantial equivalence. It compares a new device (CAPIOX® SX10 Hardshell Reservoir) to a predicate device (CAPIOX® SX Hardshell Reservoir), asserting substantial equivalence rather than presenting an effectiveness study with acceptance criteria.

The document lists "Specifications" for both devices, which could be interpreted as performance criteria for the device itself rather than acceptance criteria for a study.

Here's the information as requested, based on the provided text, with many fields noted as "Not Applicable" or "Not Provided" because the document is a 510(k) submission for substantial equivalence, not a clinical or performance study report.

Acceptance Criteria and Device Performance (from Specifications Table)

Item	Acceptance Criteria (from Predicate Device)	Reported Device Performance (CAPIOX® SX10)
Reservoir Volume
Maximum Volume	3000 mL	Not explicitly stated (implied 3000 mL based on predicate)
Minimum Volume	100 mL	Not explicitly stated (implied 100 mL based on predicate)
Blood Flow Rate During Cardiopulmonary Bypass
Cardiotomy Inlet Maximum	0.5-5 L/min	4.0 L/min Max.
Venous Flow Minimum	0.5 L/min	0.5 L/min Min.
Venous Flow Maximum	7.0 L/min	4.0 L/min Max.
Cardiotomy Filtration Efficiency	Greater than 90% efficiency for particles ≥ 20u	Greater than 90% efficiency for particles ≥ 20u

Study Details

Sample size used for the test set and the data provenance: Not applicable. The document does not describe a performance or clinical study with a test set. It's a submission for substantial equivalence based on design, technology, and specifications comparison to a predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth establishment by experts is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set is described.
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 document pertains to a medical device (hardshell reservoir) and does not involve AI, human readers, or image interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document pertains to a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth is established as there is no performance study or data acquisition described. The "ground truth" for the submission is the existence and established safety/effectiveness of the predicate device.
The sample size for the training set: Not applicable. No training set is described as this is not a machine learning or data-driven study.
How the ground truth for the training set was established: Not applicable. No training set or ground truth for it is described.

Summary of the document's approach to "proof":

The document argues for substantial equivalence by demonstrating that the CAPIOX® SX10 Hardshell Reservoir has:

The same intended use.
Similar design and materials.
Equivalent technology and principles of operation.
Specifications that are either identical or whose differences "do not raise new issues of safety and effectiveness" (e.g., maximum flow rates, which are within acceptable ranges).

Safety information provided (pyrogen testing, sterilization, EO residuals, manufacturing control, biocompatibility testing via ISO-10993) addresses general device safety rather than specific performance as measured in a comparative study.

Therefore, the "proof" that the device meets "acceptance criteria" is primarily an assertion of substantial equivalence to a legally marketed predicate device, rather than data from a direct performance study establishing novel acceptance criteria. The acceptance criteria used are implicitly the performance characteristics and safety profile of the predicate device.

Summary

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SECTION II: SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

Proprietary Device Name: CAPIOX® SX10 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 Hardshell Reservoir is also used in the vacuum-assisted venous return technique during cardiopulmonary bypass procedures lasting up to 6 hours.

Description:

CAPIOX® SX10 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 contact with the defoamer. The total capacity of the reservoir is 3000 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.

Substantial Equivalence:

The CAPIOX® SX10 Hardshell Reservoir is substantially equivalent to the CAPIOX® SX Hardshell Reservoir (K982223) as follows:

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Substantially Equivalent in 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® SX10 Hardshell Reservoir and the CAPIOX® SX Hardshell Reservoir are substantially equivalent in design, technology and principles of operation.

Specifications:

Table 1

Item	CAPIOX® SX10 HardshellReservoir	CAPIOX® SX HARDSHELLRESERVOIR
Reservoir Volume
	Maximum	3000 mL
	Minimum	100 mL
Blood Flow Rate DuringCardiopulmonary Bypass	Cardiotomy Inlet: 4.0 L/min Max.	Cardiotomy Inlet: 0.5-5 L/min
	Venous Flow: Min: 0.5 L/min	Venous Flow: Min: 0.5 L/min
	Max: 4.0 L/min	Max: 7.0 L/min
Cardiotomy FiltrationEfficiency	Greater than 90% efficiency for	Greater than 90% efficiency for
	particles ≥ 20u	particles ≥ 20u

The difference in specifications between the CAPIOX® SX10 Hardshell Reservoir and the CAPIOX® SX Hardshell Reservoir do not raise new issues of safety and effectiveness.

In summary, the CAPIOX® SX10 Hardshell Reservoir and the CAPIOX® SX Hardshell 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.

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Additional Safety Information:

Pyrogen Testing ●
Sterilization conditions have been validated to provide a Sterility Assurance Level . (SAL) of 10 to the negative sixth.
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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Section II. Summary of Safety and Effectiveness Information

The Summary of Safety and Effectiveness Information Pertaining to Substantial Equivalence was prepared on May 13, 1999.

Prepared by: Garry A. Courtney Regulatory Affairs Specialist
Prepared for: Terumo Medical Corporation 2101 Cottontail Lane Somerset, NJ 08873

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing protection and care.

SEP | 3 1999

Mr. Gary A. Courtney Regulatory Affairs Associate Terumo Medical Corporation Requlatory Affairs Department 125 Blue Ball Road Elkton, MD 21921

Re : K991973 CAPIOX® SX10 HARDSHELL RESERVOIR Requlatory Class: III (Three) Product Code: 74 DPN, 74 DTN Dated: June 6, 1999 Received: June 11, 1999

Dear Mr. Courtney:

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, 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 Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 Please note: this response to your premarket Federal Register. 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.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Page 2 - Mr. Gary A. Courtney

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, "Misbranding by reference to premarket notification" (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. Callehan

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

Enclosure

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510(k) Number (if known):

K.991913

Device Name: CAPIOX® SX10 Hardshell Reservoir

Indications For Use:

The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass procedures lasting up to 6 hours

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Buce L. Rempe le

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K991973

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

(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.