(36 days)
Not Found
No
The device description focuses on mechanical and material properties for gas exchange, temperature control, and filtration. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device directly interacts with the patient's blood to oxygenate it, remove carbon dioxide, and control its temperature, which are active therapeutic interventions during open-heart surgery.
No
The device is an oxygenator used during open-heart surgery to transfer oxygen and remove carbon dioxide from blood, control blood temperature, and filter particles; these functions are therapeutic or supportive, not diagnostic.
No
The device description clearly details physical components made of various materials (nylon, polycarbonate, stainless steel, etc.) and describes mechanical functions (gas transfer, heat exchange, filtration, pressure relief valve). This indicates a hardware-based medical device, not a software-only one.
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 during open heart surgical procedures to directly interact with blood for oxygen transfer, carbon dioxide removal, and temperature control. This is a therapeutic and life-support function, not a diagnostic one.
- Device Description: The description details the physical components and mechanisms for gas exchange, heat exchange, and filtration of blood. These are all related to directly modifying the blood during bypass, not analyzing it to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing blood samples, detecting biomarkers, or providing information for diagnosis or monitoring of a patient's condition through in vitro analysis.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body's circulation during bypass) and performs a therapeutic function.
N/A
Intended Use / Indications for Use
The (modified) Capiox FX05 device is intended to be used during open heart surgical procedures to transfer oxygen and remove carbon dioxide from blood and to control the blood temperature uring cardiopulmonary bypass for periods up to 6 hours. The Capiox FX05 is a Neonate/Infant orgenator intended for use in procedures up to a maximum flow of 1.5 L/min. The roatient weight and BSA should be considered upon use.
The FX05 Hardshell Reservoir is also intended for use in vacuum assisted venous drainage procedures.
The integrated arterial filter is intended to filtrate non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit.
Product codes (comma separated list FDA assigned to the subject device)
DTZ
Device Description
The modified Capiox FX05 Oxygenator utilizes porous fiber technology to facilitate the transfer of gases between a blood-phase environment and a gas-phase environment for the intent of satisfying the gas exchange needs of a patient during cardiopulmonary bypass surgery. A fiber bundle offers the porous membrane surface to sufficiently permit the movement of gases through the walls of the hollow fibers via diffusion.
The modified Capiox FX05 device has an integrated heat exchanger that is comprised of stainless steel encased in a polycarbonate housing. The stainless steel acts as a heat transfer material that permits heat that is generated from a temperature controlled external water bath to transverse across the walls of the stainless steel to effect the necessary temperature change upon circulating blood.
With respect to the filtration of arterial blood, the modified Capiox FX05 Oxygenator/Arterial Filter relies upon mechanical entrapment of particulates and emboli within the filter mesh as a means to remove those particulates from the blood.
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
Neonate/Infant
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)
Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the subject device to the predicate devices. Substantial equivalence is demonstrated with the following in-vitro performance evaluations:
- Pressure Relief Valve-to-Reservoir Interface Testing .
- Relief Valve performance following application of vacuum to the reservoir .
- Assessment of reservoir pressure during simulated bypass procedure at flow rates of . 1,2,3,4 and 5 liters per minute
- Sterilization Assessment .
- Drop Testing .
- Vibration Testing .
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.”
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TERUMO
MAR 1 3 2013
SECTION 5 – 510(k) Summary Modified Capiox FX05 Oxygenator/Reservoir
| Submitter Information | 24 |
|---|---|
| Device Names | 24 |
| Identification of Predicate Device | 24 |
| Intended Use | 25 |
| Principles of Operation and Technology | 25 |
| Design and Materials | 25 |
| Performance Evaluations | 26 |
| Substantial Equivalence Comparison | 26 |
| Substantial Equivalence Statement | 27 |
| Additional Safety Information | 27 |
| Conclusion for 510(k) Summary | 28 |
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TERUMO
Submitter Information:
This submission was prepared in December 2012 by: Garry A. Courtney, MBA, RAC Manager, Regulatory Affairs Terumo Corporation/Terumo CVS 125 Blue Ball Road Elkton, MD 21921 Telephone: 1-800-283-7866, Ext. 7486
This submission was prepared for: Terumo Corporation (Ashitaka Factory) Manufacturer/Sterilizer 150 Maimaigi-cho Fujinomiya City, Shizuoka Pref. Japan 418-0015 Registration #9681834
Device Names/Classifications: Proprietary Name
Classification Name
Common Name
Capiox FX05 Hollow Fiber Oxygenator/Reservoir
Cardiopulmonary Bypass Oxygenator (Code: DTZ) Oxygenator
Cardiopulmonary Bypass Blood Reservoir (Code DTN) Blood Reservoir
Predicate Device:
The device submitted in this 510(k) maintains characteristics that are substantially equivalent in intended use, design, technology/principles of operation, materials and specifications to the following devices:
. Terumo's Capiox® FX05 Oxygenator/Reservoir - K071572.
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Intended Use:
The (modified) Capiox FX05 device is intended to be used during open heart surgical procedures to transfer oxygen and remove carbon dioxide from blood and to control the blood temperature uring cardiopulmonary bypass for periods up to 6 hours. The Capiox FX05 is a Neonate/Infant orgenator intended for use in procedures up to a maximum flow of 1.5 L/min. The roatient weight and BSA should be considered upon use.
The FX05 Hardshell Reservoir is also intended for use in vacuum assisted venous drainage procedures.
The integrated arterial filter is intended to filtrate non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit.
Principles of Operation and Technology:
The modified Capiox FX05 Oxygenator utilizes porous fiber technology to facilitate the transfer of gases between a blood-phase environment and a gas-phase environment for the intent of satisfying the gas exchange needs of a patient during cardiopulmonary bypass surgery. A fiber bundle offers the porous membrane surface to sufficiently permit the movement of gases through the walls of the hollow fibers via diffusion.
The modified Capiox FX05 device has an integrated heat exchanger that is comprised of stainless steel encased in a polycarbonate housing. The stainless steel acts as a heat transfer material that permits heat that is generated from a temperature controlled external water bath to transverse across the walls of the stainless steel to effect the necessary temperature change upon circulating blood.
With respect to the filtration of arterial blood, the modified Capiox FX05 Oxygenator/Arterial Filter relies upon mechanical entrapment of particulates and emboli within the filter mesh as a means to remove those particulates from the blood.
Design and Materials:
With respect to the design of the oxygenator, the design of the modified Capiox FX05 oxygenator device is unaffected by the changes being incorporated at this time. The subject of this Special 510(k) is a modification being made to the detachable Hardshell Reservoir.
With respect to the design of the Arterial Filter, the filter contained within the oxygenator module is unaffected by the changes being incorporated at this time. The subject of this Special 510(k) is a modification being made to the detachable Hardshell Reservoir.
With respect to the design of the Hardshell Reservoir component remains identical to the design of the original reservoir that was cleared by FDA with K071572 - except that a positive pressure relief valve will be included on the lid of the reservoir. The intent of the relief valve is to eliminate excessive pressure that could accumulate in a reservoir during bypass procedures.
The materials that are used in the construction of the Capiox FX05 Hollow Fiber Oxygenator/Hardshell Reservoir includes, but are not limited to, nylon, polycarbonate, stainless
3
steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene terephthalate, polyethylene and X-Coating™.
Performance Evaluations:
Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the subject device to the predicate devices. Substantial equivalence is demonstrated with the following in-vitro performance evaluations:
- Pressure Relief Valve-to-Reservoir Interface Testing .
- Relief Valve performance following application of vacuum to the reservoir .
- Assessment of reservoir pressure during simulated bypass procedure at flow rates of . 1,2,3,4 and 5 liters per minute
- Sterilization Assessment .
- Drop Testing .
- Vibration Testing .
Substantial Equivalence Comparison:
The information presented in this section depicts a comparison between the subject of this 510(k) submission, the modified Capiox FX05 Oxygenator/Reservoir, and the predicate (unmodified) Capiox FX05 Oxygenator/Reservoir.
. Comparison of Intended Use:
The modified Capiox FX05 devices and the predicate Capiox FX05 devices are exact in their intended uses:
Use during open heart surgical procedures to transfer oxygen and remove carbon dioxide from blood and to control the blood temperature during cardiopulmonary bypass procedures for periods up to 6 hours. Both the new and predicate devices are neonate/infant oxygenators intended for use in procedures requiring a maximum blood flow rate of 1.5 L/min. Both devices indicate that the patient weight and BSA should be considered upon use.
The Hardshell Reservoir that is used with both the modified FX05 device and the predicate FX05 device may be used in vacuum assisted venous drainage procedures.
The indications for arterial blood filtration between the modified Capiox FX05 devices and the predicate devices are exactly the same. Both filters are intended to filter non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through a cardiotomy bypass circuit.
Duration of Use: .
The modified Capiox FX05 device and the predicate device can both be used in procedures lasting up to 6 hours.
. Comparison of Labeling:
Both the modified Capiox FX05 devices and the predicate Capiox FX05 devices are offered with adequate Instructions for Use and other product labeling as required by regulation. The
4
TERUMO
Instructions for Use for the modified Capiox FX05 device are presented in the Appendices of this submission; the Instructions for Use for the predicate Capiox devices are also presented in the Appendices of this submission.
Comparison of Principles of Operation & Technology: .
Both the modified Capiox FX05 Hollow Fiber Oxygenator and the predicate Capiox FX05 devices utilize the exact same technologies and principles of operation. The technology of the Capiox FX05 has not changed as a result of the product modification that is the subject of this application.
The predicate Capiox FX05 and the predicate device are exactly the same with respect to operation and technology.
. Comparison of Design:
With respect to the design of the modified Capiox FX05 device, there have been no design changes except that the modified device will be available with a pressure relief valve attached to the lid assembly of the hardshell reservoir.
The design of the oxygenator module and other components of the assembled device remain unaffected by the modification to include a pressure relief valve.
. Comparison of Materials:
With respect to materials of construction, the subject reservoir and the predicate reservoir are constructed of the exact same materials. The positive pressure relief valve that is included with the modified reservoir is constructed of polycarbonate and nylon.
. Comparison of Performance:
The modified Capiox FX05 device exhibits equivalent performance to the unmodified predicate device - as there have been no changes made to the finished device that would alter the performance of the device.
Conclusion:
In summary, Terumo deems the modified Capiox FX05 device is substantially equivalent to the predicate unmodified Capiox FX05 device with respect to intended use, duration of use, design, materials, principles of operation, performance and specifications. It is further noted that any recognized differences do not raise any unattended issues of patient/user safety or product effectiveness.
Substantial Equivalence Statement:
The modified Capiox FX05 devices and the predicate Capiox FX05 devices are substantially equivalent in intended use, principles of operation and technology, design and materials, and performance. Any noted differences between the subject device and the predicate devices do not raise new issues of safety and effectiveness.
Additional Safety Information:
- Sterilization conditions have been validated to provide and ensure a Sterility Assurance . Level (SAL) of 10°. Terumo further asserts that the ethylene oxide residues will not exceed the maximum residue limits at the time of product distribution.
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- Terumo maintains biocompatibility studies as recommended in 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 Exposure (≤ 24 hours) Contact Duration]. The blood contacting materials were found to be biocompatible.
TERUMO
Conclusion:
In summary, the modified Capiox FX05 devices are substantially equivalent in intended use, principles of operation and technology, design and materials, and performance to the predicate devices (unmodified Capiox FX05) identified in this application.
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of what appears to be an abstract human form or symbol, composed of curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 13, 2013
Terumo Cardiovascular Systems Corporation c/o Garry A. Courtney 125 Blue Ball Road Elkton, MD 21921
Re: K130280
Trade/Device Name: CAPIOX FX05 Hollow Fiber Oxygenators/Reservoirs with Integrated Arterial Filter (with X-Coating) Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: February 14, 2013 Received: February 19, 2013
Dear Mr. Courtney:
We have reviewed your Section 510(k) premarket notification of intent to market the device for use stated above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
7
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1000.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOR (2) 11 11 10 17 for for for for for for for for for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, Jease note the regulation entitled, "Misbranding by reference to premarket notification" (11CFR Preat 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolly free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours.
Matthew G. Hillebrenner
for
B.
for Director Division of Cardiovascular Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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Image /page/8/Picture/0 description: The image shows the Terumo company logo. The logo consists of a circle with the letter 'T' inside, followed by the word 'TERUMO' in all capital letters. There is a small dot above and to the right of the letter 'O'.
SECTION 4 - Indications for Use Modified Capiox FX05 Oxygenator/Reservoir
K130280
510(k) Number (if known): Unknown at time of Submission
CAPIOX® FX05 Hollow Fiber Oxygenator with Integrated Arterial Filter Device Name: and Hardshell Reservoir
Indications For Use:
The Capiox FX05 device is intended to be used during open heart surgical procedures to transfer oxygen and remove carbon dioxide from blood and to control the blood temperature during cardiopulmonary bypass for periods up to 6 hours. The Capiox FX05 is a Neonate/Infant oxygenator intended for use in procedures up to a maximum flow of 1.5 L/min. The patient weight and BSA should be considered upon use.
The FX05 Hardshell Reservoir is also intended for use in vacuum assisted venous drainage procedures.
The integrated arterial filter is intended to filtrate non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit.
Prescription Use XX (Part 21 CFR 801 Subpart D) OROver-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Matthew G. Hillebrenner
22