(89 days)
Not Found
No
The description focuses on the physical components and function of a blood oxygenator and heat exchanger, with no mention of AI/ML capabilities or data processing beyond basic temperature monitoring.
Yes
The device is described as "exchanging gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery," which is a therapeutic function.
No
The device is an oxygenator used to exchange gases in blood during cardiopulmonary bypass surgery, not to diagnose a condition.
No
The device description clearly outlines physical components like hollow fibers, stainless steel pipes, a thermistor probe, and a reservoir, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery." This is a therapeutic and life-support function performed on the patient's blood outside the body during surgery.
- Device Description: The description details the physical components and how they interact with blood and gases for gas exchange and temperature control. This aligns with a device used for extracorporeal circulation.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze blood or other biological samples to diagnose a condition, monitor a disease, or determine a patient's health status. IVDs are specifically designed for these diagnostic purposes.
In summary, the CAPIOX® E Hollow Fiber Oxygenator is a medical device used for extracorporeal circulation and gas exchange during surgery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
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 air removal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
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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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 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 | --- | 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 filter
1 to outside filter
2 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 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 |
4
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.
6
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