The CAPIOX Cardioplegia is cardiopulmonary bypass heat exchanger consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device for periods up to 6 hours.

Device Description

CAPIOX® Cardioplegia consists of heat exchanger pipes, filter screen, casing, ports, screw ring, O-ring and potting material. A thermistor probe is located on the blood outlet port which can be connected to temperature monitoring equipment. The water ports can be connected to 1/2" inner diameter water tube or coupler (e.g. Hansen-quick connect). This device provides high heat exchanger performance and air trapping function. Blood (or perfusion fluid) flows through the heat exchanger pipes and water flows outside the pipes. Blood (or perfusion fluid) flow is counter-current to the water flow.

AI/ML Overview

The provided text describes a medical device, the CAPIOX® Cardioplegia, and its substantial equivalence to predicate devices, but does not contain information about a study proving the device meets acceptance criteria in the way typically required for AI/software-based medical devices. The document is a 510(k) submission for a hardware medical device (a heat exchanger) and focuses on comparing its specifications and performance to legally marketed predicate devices to demonstrate substantial equivalence, rather than establishing acceptance criteria and proving performance through a clinical or technical study against those criteria for a novel AI algorithm.

Therefore, many of the requested sections (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details) are not applicable to this type of device submission.

However, I can extract information related to "acceptance criteria" through the lens of device specifications and performance comparison, which served as the basis for its substantial equivalence determination.

Acceptance Criteria and Device Performance (Interpreted from Substantial Equivalence Information)

For this device, "acceptance criteria" are implicitly defined by the specifications and performance of the predicate devices (Sorin BCD Vanguard and Sarns Conducer). The CAPIOX® Cardioplegia is considered acceptable if its performance and specifications are found to be substantially equivalent and do not raise new safety or effectiveness concerns compared to these predicates.

Table 1: Key Specifications and Performance (CAPIOX® Cardioplegia vs. Predicate Devices)

Characteristic	Acceptance Criterion (Predicate Range/Value)	Reported CAPIOX® Cardioplegia Performance
Intended Use	Used to cool or warm oxygenated blood, cardioplegic solution, or their mixture (Both Predicates)	Used to cool or warm oxygenated blood, cardioplegic solution, or their mixture
Priming volume (mL)	15 - 335 (Sarns: 15, Sorin: 335)	$52 \pm 5$
Maximum blood flow rate (mL/min)	500 (Sorin Adult: 500)	500
Maximum operating pressure (mmHg)	500 (Sorin: 500, Sarns: 600)	500
Filter material	Polyester (Sorin)	Polyester
Filter area (cm²)	3.81 (Sorin)	$9.8 \pm 1.0$
Pore size (um)	105 (Sorin)	$96 \pm 10$
Heat Exchanger Type	Pleated plate (Sorin), Bellows (Sarns)	Straight pipe
Heat Exchanger Material	Epoxy-coated Stainless steel (Sorin)	Stainless steel (SUS-304, 304L, 316, 316L)
Surface area (cm²)	500 (Sorin)	$640 \pm 60$
Blood inlet port	1/4 inch (Both Predicates)	1/4 inch
Blood outlet port	3/16 inch (Sorin), 1/4 inch (Sarns)	3/16 inch
Heat exchanger performance factor	Tbo-Tbi / Twi-Tbi (General formula applies to all)	Compared against Sorin BCD Vanguard
Water compartment pressure drop	Compared against Sarns Conducer	Compared against Sarns Conducer

Conclusion of Study/Comparison: "In summary, some differences in performance were observed between the CAPIOX Cardioplegia and the Sorin BCD Vanguard, however, these differences are not clinically significant nor do they raise new issues of safety or effectiveness."

Information Not Applicable/Available for this Device Submission:

Sample size used for the test set and the data provenance: Not applicable. This is a hardware medical device submission focused on substantial equivalence to predicate devices, not an AI/software device undergoing performance testing on a discrete test set with patient data. Performance was likely evaluated through bench testing and engineering comparisons rather than clinical trials with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method 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. This is a hardware device, not an AI/software diagnostic or assistive tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For this device, the "ground truth" for comparison effectively relied on the established performance and safety profiles of the legally marketed predicate devices. Performance tests (e.g., heat exchange efficiency, pressure drop) were conducted against physical measurements and engineering specifications, not expert-derived labels on clinical data.
The sample size for the training set: Not applicable. There is no AI/machine learning component to this device that would require a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

Proprietary Device Name: CAPIOX® Cardioplegia

Classification Name: Cardiovascular heat exchanger

Reason for Submission:

New device.

Intended Use:

Description

The water ports can be connected to 1/2" inner diameter water tube or coupler (e.g. Hansen-quick connect).

This device provides high heat exchanger performance and air trapping function.

Blood (or perfusion fluid) flows through the heat exchanger pipes and water flows outside the pipes. Blood (or perfusion fluid) flow is counter-current to the water flow.

Substantial Equivalence

The CAPIOX® Cardioplegia is substantially equivalent to Sorin BCD Vanguard and the Sarns Conducer. The discussion and table below compare the CAPIOX® Cardioplegia with the Sorin BCD Vanguard cleared under K934847 and the Sarns Conducer (K923311).

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Intended Use

All the devices are cardiopulmonary bypass heat exchangers consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.

Design and Materials

All three devices are designed for blood/fluid flow into the lower portion of the device and exit at the top. The water flow enters the top and exits the bottom. The blood flow is counter current to the water flow.

The Sarns Conducer shares some generic blood contact materials with the CAPIOX Cardioplegia. The materials that are different are commonly present in devices used in the cardiopulmonary bypass circuit. (No information was available for the Sorin Vanguard materials).

The CAPIOX Cardioplegia is designed with straight stainless steel pipe blood conduits. The Sorin Vanguard uses pleated plate epoxy-coated stainless steel and the Sarns Conducer uses bellows.

Technology and Principles of Operation

All three devices receive blood/fluid which is pumped through tubing into the device. The water flow in counter current to the blood flow in all three devices. The water temperature is controlled separately from the cardioplegia device. The water either heats or cools the blood/fluid based upon the water temperature entering the device and the blood/fluid entering the device as shown in the following formula:

Heat exchanger performance factor: Tbo-Tbi

Twi-Tbi

Twi : Water temperature (40°C) Tbi: Inlet test solution temperature Tbo: Outlet test solution temperature

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II - Summary and Certification Summary of Safety and Effectiveness

Specifications

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Table 1

	CAPIOXCardioplegia	SorinBCD Vanguard	SarnsConducer
Intended Use	Used to cool or warmoxygenated blood,cardioplegic solution,or their mixture	Used to cool or warmoxygenated blood,cardioplegic solution,or their mixture	Used to cool or warmoxygenated blood,cardioplegic solution,or their mixture
Priming volume(mL)	$52\pm5$	335	15
Maximum bloodflow rate (mL/min)	500	Adult: 500Pediatric: 250	***
Maximum operatingpressure (mmHg)	500	500**	600
Filter
Filter material	Polyester	Polyester	Not available
Filter area (cm²)	$9.8\pm1.0$	3.81
Pore size (um)	$96\pm10$	105
Heat Exchanger
Type	Straight pipe	Pleated plate	Bellows
Material	Stainless steel*	Epoxy-coatedStainless steel	***
Surface area (cm²)	$640\pm60$	500	***
Blood inlet port	1/4 inch	1/4 inch	1/4 inch
Blood outlet port	3/16 inch	3/16 inch	1/4 inch

*Stainless steel: SUS-304, 304L, 316, 316L specified in JIS G4305

**Maximum pressure is not defined, but labeled as 'Pressure relief valve opens at 500 mmHg or above."

***Unknown

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p.age 495

II - Summary and Certification Summary of Safety and Effectiveness

Performance

Comparison of the CAPIOX® Cardioplegia and Sorin BCD Vanguard performance was conducted. A comparison of the Sarns Conducer was compared with the CAPIOX Cardioplegis for the water compartment pressure drop.

In summary, some differences in performance were observed between the CAPIOX Cardioplegia and the Sorin BCD Vanguard, however, these differences are not clinically significant nor do they raise new issues of safety or effectiveness.

Conclusion:

In summary, the CAPIOX Cardioplegia and the Sorin BCD Vanguard 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 July 6, 1998

. "

Prepared by: Sandi Hartka, Manager Regulatory Affairs

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/5/Picture/2 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

JUN 2 3 1999

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

Re : K982467 CAPIOX® Cardioplegia Regulatory Class: II (Two) Product Code: DTR March 24, 1999 Dated: Received: March 26, 1999

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, 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, 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 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 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 - 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 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. Callahon

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):

CAPIOX® Cardioplegia Device Name:

Indications For Use:

Bere L. Campbell

Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_1 982467

(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

§ 870.4240 Cardiopulmonary bypass heat exchanger.

(a)
Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.(b)
Classification. Class II (performance standards).