CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR

K970463 · Terumo Medical Corp. · DTZ · May 6, 1997 · Cardiovascular

Device Facts

• Record ID: K970463
• Device Name: CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR
• Applicant: Terumo Medical Corp.
• Product Code: DTZ · Cardiovascular
• Decision Date: May 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Device is a hollow fiber membrane oxygenator with integrated heat exchanger and arterial reservoir; used during cardiopulmonary bypass surgery. Input: venous blood flow (gravity-fed). Operation: blood flows external to microporous polypropylene hollow fibers while gas flows inside; heat exchanger uses stainless steel tubes with blood flowing outside and water inside. Output: oxygenated, temperature-regulated blood returned to arterial circulation. Operated by perfusionists/clinicians in OR. Benefits: provides gas exchange and temperature control during extracorporeal circulation. Includes thermistor probe for temperature monitoring and polyurethane foam defoamer for air removal.

Clinical Evidence

Bench testing only. Performance comparison conducted between CAPIOX E and CAPIOX SX18. Biocompatibility testing performed per ISO-10993. Sterilization validated to SAL 10^-6. Manufacturing controls include 100% performance and leak testing.

Technological Characteristics

Materials: Polypropylene hollow fibers, stainless steel heat exchanger tubes, clear polycarbonate housing, polyurethane foam defoamer. Principle: Membrane gas exchange; heat exchange via conductive tubes. Connectivity: Thermistor probe for external monitoring. Sterilization: Ethylene oxide. Flow rate: 0.5-6.5 LPM. Gas flow: Max 20 LPM.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring extracorporeal circulation for up to 6 hours.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• CAPIOX SX18 Hollow Fiber Oxygenator (K961000)

Submission Summary (Full Text)

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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:

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.

## 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.

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## 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 CX*E and the SX18 oxygenators both have integrated heat exchangers. Both heat exchangers use straight stainless steel tubes. In the CX*E 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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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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Table 1
Specifications

| Appendix | 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 |

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Table 1 (continued)

| | 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 from venous return during cardiopulmonary bypass for up to 6 hours | 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 |
| Ports
Venous blood inlet
Suction
Blood outlet
Vertical port to filter
Quick prime & vent port
Female luer
Auxiliary | ---
3/8"
---
1/4"
2 to inside filter
--- | 1/2" rotatable
1/4" X 6
3/8"
3/8"
1/4"
4 to inside filter
1 to outside filter
2 on venous blood inlet
3/8" |
| Reservoir volume
Maximum
Minimum | 3,500 mL
300 mL | 4,000 mL
200 mL |
| Maximum blood flow rate | 6.5 LPM | Cardiotomy inlet: 5 LPM
Venous flow: 7 LPM
Combined: 7 LPM |
| Antifoam component | Polyurethane foam defoamer | Polyurethane foam defoamer |
| Thermistor probe | Luer thermistor on venous blood inlet and arterial blood outlet | Luer thermistor on venous blood inlet |

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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 10⁻⁶.
- 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 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

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