(90 days)
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No
The document describes a mechanical device for cardiopulmonary bypass and does not mention any computational or algorithmic components that would suggest AI/ML.
Yes.
The device facilitates gas exchange for a patient during cardiopulmonary bypass surgery, directly supporting physiological function and treatment.
No
The device is used to exchange gases and warm/cool blood during cardiopulmonary bypass surgery, and to store and filter blood. These are therapeutic and life-support functions, not diagnostic ones.
No
The device description clearly details physical components like hollow fibers, a heat exchanger with stainless steel tubes, a hardshell reservoir, filters, defoamers, and stopcocks, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for "exchang[ing] gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery." This is a therapeutic function, directly interacting with the patient's blood outside the body during a surgical procedure.
- Device Description: The description details components like an oxygenator, heat exchanger, and reservoir for handling and modifying blood flow during surgery. These are all related to extracorporeal circulation and gas exchange, not diagnostic testing.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood or other biological samples to provide information for diagnosis, monitoring, or screening. The sampling system is for withdrawing samples, not for performing analysis within the device itself.
IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a person's health. This device's function is to support a surgical procedure by managing blood flow and gas exchange, which is a therapeutic intervention, not a diagnostic one.
N/A
Intended Use / Indications for Use
The CAPIOX® SX25 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 CAPIOX SX25 Hardshell Reservoir (detachable) is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal.
Product codes
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Device Description
CAPIOX® SX25 Hollow Fiber Oxygenator contains an integrated heat exchanger and a detachable Hardshell Reservoir. This design permits an integrated system for ease of use as well as independent use of the oxyegnator and of the Hardshell reservoir to accommodate a variety of circuit configurations.
The SX25 oxygenator is a membrane oxygenator consisting of microporous hollow fibers with an integrated heat exchanger, consisting of stainless steel tubes.
The detachable Hardshell reservoir has a rotatable connection with the oxygenator which permits optimum positioning for connections in the circuit. The venous blood inlet port is also rotatable 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 total capacity of the reservoir is 4,000 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.
A detachable sampling system is positioned at the top of the hardshell reservoir which contains 3 three-way stopcocks. These stopcocks can be used for sampling. The sampling system contains a one-way valve permitting withdrawal of liquid samples but prohibiting entry of air into the blood exiting the oxygenator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison of the SX25 and SX18 performance was conducted. The following tests were performed:
- Gas Transfer (short term and 6-hour)
- Effect on Blood Components
- Pressure Drop
Performance testing for the heat exchanger and the detachable hardshell reservoir was presented in K922799. Additionally, the effect on blood components of the cardiolomy section was presented.
In summary, the expected increase of gas transfer and decreased pressure drop was observed for the SX25 due to the increased surface area. Effect on blood components was substantially equivalent.
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.
Not Found
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K962067
Oct. 7, 1996
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE
| Proprietary Device Name: | CAPIOX® SX25 Hollow Fiber Oxygenator
with detachable Hardshell Reservoir |
|--------------------------|-------------------------------------------------------------------------------------------------------|
| Classification Name: | Cardiopulmonary bypass oxygenator, heat exchanger, reservoir,
defoamer, blood filter and manifold. |
Intended Use:
(
The CAPIOX® SX25 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 CAPIOX SX25 Hardshell Reservoir (detachable) is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal.
Description
CAPIOX® SX25 Hollow Fiber Oxygenator contains an integrated heat exchanger and a detachable Hardshell Reservoir. This design permits an integrated system for ease of use as well as independent use of the oxyegnator and of the Hardshell reservoir to accommodate a variety of circuit configurations.
The SX25 oxygenator is a membrane oxygenator consisting of microporous hollow fibers with an integrated heat exchanger, consisting of stainless steel tubes.
The detachable Hardshell reservoir has a rotatable connection with the oxygenator which permits optimum positioning for connections in the circuit. The venous blood inlet port is also rotatable 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 total capacity of the reservoir is 4,000 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.
1
II - Summary and Certification Summary of Safety and Effectiveness
A detachable sampling system is positioned at the top of the hardshell reservoir which contains 3 three-way stopcocks. These stopcocks can be used for sampling. The sampling system contains a one-way valve permitting withdrawal of liquid samples but prohibiting entry of air into the blood exiting the oxygenator.
Substantial Equivalence
ー
The CAPIOX® SX25 Oxygenator and Hardshell Reservoir are substantially equivalent to the CAPIOX SX18 Oxygenator and Hardshell Reservoir as follows:
Intended use: same
Design and Materials:
The basic device design and all materials for the SX25 and the SX18 are the same.
The CAPIOX SX25 has a larger membrane surface area than the SX18.
Both the CAPIOX SX25 and the CAPIOX SX18 have the same integrated heat exchangers and the same detachable hardshell reservoir.
Technology and Principles of Operation
These devices (SX18 and SX25) use hollow fiber membrane technology and 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. Some form of pumping mechanism is utilized to transfer blood from the reservoir component to the oxygenator component.
The technology and principles of operation for the SX25 and the SX18 are the same.
2
- II Summary and Certification Summary of Safety and Effectiveness
Specifications
The priming volume for the SX25 is slightly higher than that for the SX18 (340 versus 270 mL, respectively) because of the increased membrane area The membrane surface area of the SX25 is 2.5 m3 and that for the SX18 is 1.8 m2. This difference does not affect the substantial equivalence of the devices since both provide adequate gas exchange for clinical use.
Maximum blood flow rate for both devices is 7 LPM for venous flow and 5 LPM for cardiotomy flow.
The heat exchanger and the detachable hardshell reservoir are the same for both devices.
Performance
Comparison of the SX25 and SX18 performance was conducted. The following tests were performed:
- ·Gas Transfer (short term and 6-hour)
- · Effect on Blood Components
- ·Pressure Drop
Note: The heat exchanger and the detachable hardshell reservoir are the same for both devices. Performance testing for these components was presented in K922799. Additionally, the effect on blood components of the cardiolomy section was presented.
In summary, the expected increase of gas transfer and decreased pressure drop was observed for the SX25 due to the increased surface area. F:ffect on blood components was substantially equivalent.
The SX25 and the SX18 are substantially equivalent in intended use, design and materials, technology/principles of operation, and specification with the exception of the increased membrane surface arca. Differences as described above do not taise new issues of safety or effectiveness.
3
- II Summary and Certification Summary of Safety and Effectiveness
Additional Safety Information
·Sterilization conditions have been validated to provide a Sterility Assurance Level (SAL) of 10 *
· Ethylene oxide residuals will not exceed the maximum residuc 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 are acceptable 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 June 30, 1996
| Prepared by: | Sandi Hartka, M.A.S., R.A.C.
Submissions Supervisor
Regulatory Affairs |
| -------------- | ------------------------------------------------------------------------------ |
|---|
- for : Terumo Medical Corporation 2100 Cottontail Lane Somerset, NJ 08873