The CAPIOX® E Hollow Fiber Oxygenator is used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery. The integral heat exchanger is used to warm or cool the blood or perfusion fluid flowing through the device. The reservoir is used to store blood and the defoamer facilitates air removal. The device is intended for use during extracorporeal circulation for up to 6 hours.

Device Description

CAPIOX® E Hollow Fiber Oxygenator contains an integrated heat exchanger. The CAPIOX E oxygenator is a membrane oxygenator consisting of microporous polypropylene hollow fibers. Blood flows external to the hollow fibers while gases flow inside the fibers. The heat exchanger consists of stainless steel pipes with blood flowing outside the pipes and water flowing inside the pipes. A thermistor probe is located near the blood ports of the oxygenator which can be connected to accessory temperature monitoring equipment if desired. The device also contains an arterial reservoir with a defoamer which facilitates removal of air.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CAPIOX® E Hollow Fiber Oxygenator based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document establishes substantial equivalence by comparing the CAPIOX® E (the new device) to the CAPIOX® SX18 (the predicate device). The "acceptance criteria" are implicitly the specifications and performance characteristics of the predicate device, which the new device must meet or be sufficiently similar to, without raising new issues of safety or effectiveness.

Specifications / Performance Metric	Acceptance Criteria (CAPIOX® SX18)	Reported Device Performance (CAPIOX® E)
Intended Use (Oxygenator)	Used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of patients during open heart surgery for up to 6 hours	Used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of patients during open heart surgery for up to 6 hours
Membrane technology	Hollow Fiber	Hollow Fiber
Membrane material	Polypropylene	Polypropylene
Blood flow relative to fiber	Outside	Outside
Effective surface area of oxygenator	1.8 m2	3.0 m2
Heat exchanger	Integrated	Integrated
Heat Exch. Material	Stainless steel tubes	Stainless steel tubes
Heat Exch. Max. water Pressure	42 PSI	42 PSI
Blood Flow relative to Heat Exchanger Pipes	Inside	Outside
Blood Flow Path	Reservoir-> Pump-> HE -> Oxygenator-> Patient	HE-> Oxygenator-> Reservoir-> Pump -> Patient
Blood Flow Rate (Oxygenator)	0.5-7 LPM	0.5-6.5 LPM
Static Priming Volume (Oxygenator and heat exchanger)	270 mL (oxygenator and heat exchanger)	800 mL (with 300 mL of priming solution in arterial reservoir)
Hardshell Reservoir	Detachable	Integrated
Maximum Gas Flow	20 LPM	20 LPM
Blood Port	Blood Inlet port: 3/8", Blood Outlet port: 3/8"	Blood Inlet/Outlet port: 1/2"
Female Luer Port	1 port (air purge port)	(Not specified for oxygenator, but 2 to inside filter for reservoir)
Gas Port	Gas inlet and outlet ports: 1/4"	Gas inlet and outlet ports: 1/4"
Water Port	Water inlet and outlet ports: 1/2" (Hansen quick connect fittings)	Water inlet and outlet ports: 1/2" (Hansen quick connect fittings)
Cardiotomy Port	---	3/8"
Intended Use (Reservoir)	To temporarily store blood, facilitate filtration of particulates and air removal from venous return and suctioned blood during cardiopulmonary bypass for up to 6 hours	To temporarily store blood, facilitate air removal from venous return during cardiopulmonary bypass for up to 6 hours
Venous blood inlet (Reservoir)	1/2" rotatable	---
Suction (Reservoir)	1/4" X 6	---
Blood Outlet (Reservoir)	3/8"	3/8"
Vertical port to filter (Reservoir)	3/8"	---
Quick prime & vent port (Reservoir)	1/4"	1/4"
Female Luer (Reservoir)	4 to inside filter, 1 to outside filter, 2 on venous blood inlet	2 to inside filter
Auxiliary (Reservoir)	3/8"	---
Maximum Reservoir Volume	4,000 mL	3,500 mL
Minimum Reservoir Volume	200 mL	300 mL
Maximum blood flow rate (Reservoir)	Cardiotomy inlet: 5 LPM, Venous flow: 7 LPM, Combined: 7 LPM	6.5 LPM
Antifoam component	Polyurethane foam defoamer	Polyurethane foam defoamer
Thermistor probe	Luer thermistor on venous blood inlet	Luer thermistor on venous blood inlet and arterial blood outlet
Overall Performance	Adequate gas exchange for clinical use (implicit via predicate)	"The test results indicated the CAPIOX E performs in a substantially equivalent manner to the CAPIOX SX18." and "both provide adequate gas exchange for clinical use."

2. Sample size used for the test set and the data provenance:

The document states "Comparison of the CAPIOX E oxygenator with integrated heat exchanger and the CAPIOX SX18 oxygenator with integrated heat exchanger performance was conducted." However, it does not specify the sample size for this performance testing.
Data provenance is not explicitly mentioned. The testing appears to be internal device performance testing, rather than human clinical trial data from a specific country or in a retrospective/prospective manner. It is laboratory or bench testing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to this type of device submission. The "ground truth" for oxygenator performance is established by direct measurement of physical and chemical parameters (e.g., gas exchange rates, pressure drops, heat exchange efficiency) in a laboratory setting, not by expert consensus or interpretation of images/data by human experts.

4. Adjudication method for the test set:

Not applicable. As the "ground truth" is derived from direct measurements, there's no need for human adjudication of results.

5. 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:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic/interpretive devices where human performance is being evaluated. This submission is for a physical medical device (an oxygenator) and does not involve AI or human "readers."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device does not have an "algorithm only" component. It is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance evaluation of the CAPIOX E, as inferred from the context of oxygenator testing, is based on direct physical and chemical measurements obtained under controlled laboratory conditions, simulating physiological parameters. These measurements likely included parameters such as oxygen transfer rate, carbon dioxide removal rate, pressure drop, blood flow rates, heat exchange efficiency, and priming volume.

8. The sample size for the training set:

Not applicable. This submission is for a physical medical device and does not involve machine learning algorithms that require a "training set."

9. How the ground truth for the training set was established:

Not applicable. As there is no training set for an algorithm, this question is irrelevant.

Summary

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K970463 MAY - 6 1997

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

Proprietary Device Name: CAPIOX® E Hollow Fiber Oxygenator with integral heat exchanger and arterial reservoir.

Classification Name: Cardiopulmonary bypass oxygenator, heat exchanger, reservoir.

Reason for Submission:

Modification to existing device.

Intended Use:

Description

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II - Summary and Certification Summary of Safety and Effectiveness

Substantial Equivalence

The CAPIOX® E with integrated heat exchanger and arterial reservoir is substantially equivalent to the CAPIOX SX18 Hollow Fiber Oxygenator with integrated heat exchanger and venous reservoir (K961000) as follows:

Intended use: same

Design and Materials:

Gas exchange is accomplished through hollow polypropylene fibers in both devices. In both devices blood flows outside the fibers while gas flows on the inside of the fibers.

The CXE and the SX18 oxygenators both have integrated heat exchangers. Both heat exchangers use straight stainless steel tubes. In the CXE blood flows outside the tubes and water flows inside the tubes, and in the SX18 blood flows inside the tubes while water flows outside the tubes.

Both oxygenators housings are made of clear polycarbonate and the fibers of both oxygenators are the same polypropylene.

The reservoir of the CAPIOX E is positioned to receive the oxygenated blood from the oxygenator and the blood is then pumped to the arterial circulation. The reservoir of the CAPIOX SX18 is positioned to receive the blood from the venous circulation and from the cardiotomy field; this blood is pumped into the oxygenator and then into the arterial circulation. In both cases the reservoirs are employed to hold a reservoir of blood and to facilitate air removal with defoamers.

There are no significant differences in design and materials of these devices.

Technology and Principles of Operation

Both the CX*E and the SX18 devices use membrane hollow fiber technology. The CAPIOX E receives blood from the venous circulation by gravity; blood flows into the heat exchanger/oxygenator and into the arterial reservoir from which it is pumped into the arterial circulation. Blood flows into the SX18 reservoir by gravity (or by suction from the cardiotomy field). From the reservoir, some form of pumping mechanism is

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II Summary and Certification Summary of Safety and Effectiveness
utilized to transfer blood to the heat exchanger and from there to the oxygenator compartment and into the arterial circulation.

The technology and principles of operation for the CAPIOX E and the SX18 are substantially equivalent.

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II - Summary and Certification
Summary of Safety and Effectiveness

Table 1

Specifications

Specifications	CAPIOX E	CAPIOX SX18
Intended Use(Oxygenator)	Used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of patients during open heart surgery for up to 6 hours	Used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of patients during open heart surgery for up to 6 hours
Membrane technology	Hollow Fiber	Hollow Fiber
Membrane material	Polypropylene	Polypropylene
Blood flow relative to fiber	Outside	Outside
Effective surface area of oxygenator	3.0 m2	1.8 m2
Heat exchanger	Integrated	Integrated
Heat Exch. Material	Stainless steel tubes	Stainless steel tubes
Heat Exch. Max. water Pressure	42 PSI	42 PSI
Blood Flow relative to Heat Exchanger Pipes	Outside	Inside
Blood Flow	HE-> Oxygenator->Reservoir-> Pump- > Patient	Reservoir-> Pump-> HE- > Oxygenator-> Patient
Blood Flow Rate	0.5-6.5 LPM	0.5-7 LPM
Static Priming Volume(Oxygenator and heat exchanger)	800 mL (with 300 mL of priming solution in arterial reservoir)	270 mL (oxygenator and heat exchanger)
Hardshell Reservoir	Integrated	Detachable
Maximum Gas Flow	20 LPM	20 LPM
	CAPIOX® E	CAPIOX® SX18
Ports
-Blood port	Blood Inlet/Outlet port: 1/2"	Blood Inlet port: 3/8"Blood Outlet port: 3/8"
-Female luer port		1 port (air purge port)
-Gas port	Gas inlet and outlet ports: 1/4"	Gas inlet and outlet ports: 1/4"
-Water port	Water inlet and outlet ports:1/2"(Hansen quick connect fittings)	Water inlet and outlet ports:1/2"(Hansen quick connect fittings)
Cardiotomy port	3/8"	---
Reservoir
Intended Use	To temporarily store blood,facilitate air removal fromvenous return duringcardiopulmonary bypass for upto 6 hours	To temporarily store blood,facilitate filtration ofparticulates and air removalfrom venous return andsuctioned blood duringcardiopulmonary bypass for upto 6 hours
Ports
Venous blood inlet	---	1/2" rotatable
Suction	---	1/4" X 6
Blood outlet	3/8"	3/8"
Vertical port to filter	---	3/8"
Quick prime & vent port	1/4"	1/4"
Female luer	2 to inside filter	4 to inside filter1 to outside filter2 on venous blood inlet
Auxiliary	---	3/8"
Reservoir volume
Maximum	3,500 mL	4,000 mL
Minimum	300 mL	200 mL
Maximum blood flow rate	6.5 LPM	Cardiotomy inlet: 5 LPMVenous flow: 7 LPMCombined: 7 LPM
Antifoam component	Polyurethane foam defoamer	Polyurethane foam defoamer
Thermistor probe	Luer thermistor on venousblood inlet and arterial bloodoutlet	Luer thermistor on venousblood inlet

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Table 1 (continued)

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II - Summary and Certification Summary of Safety and Effectiveness

These differences do not affect the substantial equivalence of the devices since both provide adequate gas exchange for clinical use.

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Performance

Comparison of the CAPIOX E oxygenator with integrated heat exchanger and the CAPIOX SX18 oxygenator with integrated heat exchanger performance was conducted.

The test results indicated the CAPIOX E performs in a substantially equivalent manner to the CAPIOX SX18.

The CAPIOX E oxygenator with integrated heat exchanger and the CAPIOX SX18 oxygenator with integrated heat exchanger 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.

Additional Safety Information

·Pyrogen Testing
·Sterilization conditions have been validated to provide a Sterility Assurance Level (SAL) of 10%.
· 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 tests include 100% performance and leak 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).

Date Prepared January 24, 1997

Prepared by: Sandi Hartka, M.A.S., R.A.C. Manager Regulatory Affairs
- for: Terumo Medical Corporation 2100 Cottontail Lane Somerset, NJ 08873

Regulation Number and Section

§ 870.4350 Cardiopulmonary bypass oxygenator.

(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”