(52 days)
Not Found
No
The document describes a mechanical medical device (oxygenator and reservoir) and its performance characteristics, with no mention of AI or ML technology.
Yes
This device is a therapeutic device because its intended use is to perform cardiopulmonary bypass during open-heart surgery and to return blood to the patient, directly treating a physiological condition.
No
The device is an oxygenator and hardshell reservoir used during open-heart surgery for cardiopulmonary bypass and blood management, not for diagnosing medical conditions.
No
The device description clearly indicates a physical device (Hollow Fiber Oxygenator with/without Hardshell Reservoir) and the performance studies focus on physical characteristics and interactions with blood, not software performance.
Based on the provided text, the Capiox RX15 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the device being used during open-heart surgical procedures requiring cardiopulmonary bypass and for procedures involving the direct handling and return of blood to the patient (vacuum assisted venous drainage, post-operative chest drainage, autotransfusion). This involves direct interaction with the patient's circulatory system.
- Device Description: The description details a hollow fiber oxygenator and hardshell reservoir, components used in extracorporeal circulation to oxygenate blood and manage blood volume outside the body but still connected to the patient.
- Performance Studies: The performance studies focus on the device's ability to perform its intended function in handling blood and gas exchange (Gas Transfer, Effects on Blood Components, Pressure Drop, etc.). These are not studies related to analyzing samples of bodily fluids or tissues for diagnostic purposes.
IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The Capiox RX15's function is to support the patient's physiological processes during surgery, not to analyze samples for diagnostic information.
N/A
Intended Use / Indications for Use
The Capiox RX15 is intended to be used during open-heart surgical procedures requiring cardiopulmonary bypass for period up to 6 hours. The Capiox RX15 is for use with patients when required blood flow rate will not exceed 5 L/min (4 L/min if using the CXRX15RW30 product code or CXRX15RE30 Product code).
The Capiox RX15 Hardshell Reservoir is also intended for use in vacuum assisted venous drainage procedures, in post-operative chest drainage, and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement.
Product codes (comma separated list FDA assigned to the subject device)
DTZ, DTR, DTN, DTP, JOD, DTL
Device Description
The design of the CAPIOX® RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir provides a semi-integral device whereby the oxygenator and heat exchanger are joined together, while the hardshell reservoir can be detached from the device assembly. The materials that are used in the construction of the CAPIOX® RX15 Hollow Fiber Oxygenator with without Hardshell Reservoir include, but are not limited to, polycarbonate, stainless steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene and X-Coating. Another difference between the new CAPIOX® RX15 and the predicate device is the orientation of the polypropylene fibers that comprise the oxygenator module. The predicate SX10 device is comprised of a fiber bundle, which is essentially a collection of individual fibers that are captured in urethane adhesive at either end of the bundle. By contrast, the new CAPIOX® RX15 design utilizes a wound fiber design whereby single strands of fiber are continuously wrapped around a supporting core.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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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)
It was necessary to demonstrate substantial equivalence of the subject device to the predicate devices. Substantial equivalence is demonstrated with the following in-vitro performance evaluations:
- Gas Transfer
- Effects on Blood Components (Hemolysis)
- Pressure Drop
- Mechanical Integrity
- Static Priming Volume
- Heat Exchanger Performance
- Defoaming
- Filtration Efficiency
- Flow Rate
- Tubing Connection Strength
Comparisons of the performance of the CAPIOX® RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir and the predicate devices were conducted. The comparisons demonstrated that there were no clinically significant performance differences between the devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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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12
SEP 15 2005
SECTION II 510(k) SUMMARY OF SAFETY And EFFECTIVENESS
| Submitter Information | 13 |
|---|---|
| Device Names | 13 |
| Identification of Predicate Device | 14 |
| Intended Use | 14 |
| Principles of Operation and Technology | 14 |
| Design and Materials | 14 |
| Performance Evaluations | 15 |
| Substantial Equivalence Comparison | 15 |
| Substantial Equivalence Summary | 16 |
| Additional Safety Information | 16 |
| Conclusion for 510(k) Summary | 17 |
1
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® SX10 Oxygenator K960074. *
- Terumo's CAPIOX® SX10 Hardshell Reservoir -- K030449. .
- Medtronic Minimax Plus Oxygenator K933586. .
Intended Use:
The CAPIOX® RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir is intended to I ho entrolenee 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 blood and/or perfusion fluid as it flows through the device.
The (detachable) hardshell reservoir(s) is (are) used to store blood during extra-corporeal circulation from both venous line and the cardiotomy line (via gravity or vacuum assisted venous drainage procedures). The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The Reservoir(s) may also be used for Post-Operative Chest Drainage procedures.
The CAPIOX® RX15 Oxygenator with/without Hardshell Reservoir can be used in procedures lasting up to 6 hours.
The CAPIOX® RX15 is for use with patients when the required blood flow rate will not exceed 5.0 Umin. when used with a 4 Liter Reservoir; and when the required blood flow rate will not exceed 4.0 L/min. when used with a 3 Liter Reservoir).
Principles of Operation and Technology:
The design of the CAPIOX® RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir is such that blood is collected into the reservoir via gravity or external vacuum. Blood may enter via the venous inlet port and/or the cardiotomy inlet port. The reservoir contains filtering devices to remove particulate matter and air. Blood is then pumped from the reservoir into the heat exchanger device whereby blood temperature is controlled. After the blood exits the heat exchanger, it enters the oxygenator device whereby gas transfer (introduction of oxygen and removal of carbon dioxide) occurs. After gas transfer has occurred, the blood exits the device and is pumped towards the patient.
Design and Materials:
The design of the CAPIOX® RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir provides a semi-integral device whereby the oxygenator and heat exchanger are joined together, while the hardshell reservoir can be detached from the device assembly.
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Section II 510(k) Summary and Certification Terumo Corporation Capiox RX15 Oxygenator/Reservoir
CAPIOX® RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir
Submitter Information:
This submission was prepared in July 2005 by: Garry A. Courtney, MBA, RAC Sr. Regulatory Affairs Specialist Terumo Cardiovascular Systems Corp. 125 Blue Ball Road Elkton, MD 21921 Telephone: 1-800-283-7866, Ext. 7420
This submission was prepared for: Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho Fujinomiya city, Shizuoka Pref. Japan 418-0015
| Device Names/Classifications:
| Proprietary Name | Classification Name | Common Name |
|---|---|---|
| CAPIOX® RX15 Hollow | ||
| Fiber Oxygenator | ||
| with/without Hardshell | ||
| Reservoir | Cardiopulmonary Bypass | |
| Oxygenator (Code: DTZ) | Oxygenator | |
| Cardiopulmonary Bypass | ||
| Heat Exchanger (Code: DTR) | Heat Exchanger | |
| Cardiopulmonary Bypass | ||
| Blood Reservoir (Code: DTN) | Blood Reservoir | |
| Cardiopulmonary Bypass | ||
| Defoamer (Code: DTP) | Defoamer | |
| Cardiopulmonary Bypass | ||
| Cardiotomy Suction Line | ||
| Blood Filter (Code: JOD) | Blood Filter | |
| Cardiopulmonary Bypass | ||
| Stopcock, Manifold, Fitting | ||
| (Code: DTL) | Sampling | |
| Manifold with | ||
| Stopcocks |
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The materials that are used in the construction of the CAPIOX® RX15 Hollow Fiber Oxygenator with without Hardshell Reservoir include, but are not limited to, polycarbonate, stainless steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene and X-Coating.
Performance Evaluations:
It cryor mance francessary to demonstrate substantial equivalence of the subject device to the predicate devices. Substantial equivalence is demonstrated with the following in-vitro performance evaluations:
- Gas Transfer .
- Effects on Blood Components (Hemolysis) .
- Pressure Drop .
- Mechanical Integrity •
- Static Priming Volume .
- Heat Exchanger Performance .
- Defoaming .
- Filtration Efficiency .
- Flow Rate .
- Tubing Connection Strength .
Substantial Equivalence Comparison:
The CAPIOX® RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir is substantially equivalent to the predicate devices as follows:
- Intended Use: The intended uses of the subject device and the predicate devices (Terumo's . SX10 devices) are essentially the same. The oxygenator devices are used to provide for gas exchange between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery.
Each of the integral heat exchangers is used to warm or cool blood and/or perfusion fluid as it flows through the device.
The respective hardshell reservoirs are each used to collect and store blood during the bypass procedure. Filters are present in each device to facilitate air and particulate removal.
- Principles of Operation and Technology: The technology of the subject device and the . predicate devices is essentially identical. The devices operate in a manner where blood is collected into the reservoir. The blood may enter the reservoir via the venous inlet or the cardiotomy inlet. The reservoirs each contain filtering/defoaming devices that facilitate the removal of particulate matter and air. Blood is then pumped from the reservoir into the heat exchanger device whereby blood temperature is controlled with the use of an external water bath. After the blood exits the heat exchanger, it enters the oxygenator device whereby gas transfer occurs (i.e., introduction of oxygen; removal of carbon dioxide). The transfer process occurs via diffusion across the walls of the hollow fiber membranes contained within the oxygenator. After gas transfer has occurred, the blood exits the devices and is pumped towards the patient.
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- Design and Materials: The design and the materials of the CAPIOX® RX15 Hollow Fiber . Oxygenator with/without Hardshell Reservoir and the predicate devices are essentially the same. The design of each device is similar in that they each contain a hardshell reservoir for collection of blood, a heat exchanger for temperature control, and an oxygenator for gas transfer. Such a design is common among oxygenating systems in the marketplace.
The devices are manufactured with variations of plastics, adhesives, urethanes, polypropylene, stainless steel, etc. The CAPIOX® RX15 device contains X-Coating, which poryproprenty alaxurface coating that reduces platelet adhesion to the device. The predicate device does not contain X-coating, although X-Coating is present on many Terumo devices that have been cleared by FDA. The use of X-Coating is well documented for being safe and effective, and it's inclusion in the proposed device raises no new issues of safety and/or effectiveness.
Another difference between the new CAPIOX® RX15 and the predicate device is the orientation of the polypropylene fibers that comprise the oxygenator module. The predicate SX10 device is comprised of a fiber bundle, which is essentially a collection of individual fibers that are captured in urethane adhesive at either end of the bundle. By contrast, the new CAPIOX® RX15 design utilizes a wound fiber design whereby single strands of fiber are continuously wrapped around a supporting core. The noted difference in the fiber bundle orientation does not present any new and/or additional risk or safety issues with the new design.
- Comparisons of the performance of the CAPIOX® RX15 Hollow Fiber Performance: . Oxygenator with/without Hardshell Reservoir and the predicate devices were conducted. The comparisons demonstrated that there were no clinically significant performance differences between the devices.
Substantial Equivalence Summary:
In summary, the CAPIOX® RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir and the predicate SX10 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 in accordance with AAMI guidelines to provide . 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.
- 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.
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- The polymer coating material that is applied to the blood-contacting surfaces of the device . was also evaluated in an in-vivo animal study. No adverse conditions were noted.
Conclusion:
In summary, the CAPIOX® RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir is substantially equivalent in intended use, principles of operation and technology, design and succeminance to the predicate Terumo SX10 Hollow Fiber Oxygenator (K960074) Terumo SX10 Hardshell Reservoir (K030449), and Medtronic Minimax Plus Oxygenator (K933586).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
SEP 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Terumo Cardiovascular Systems Corp. c/o Mr. Garry A. Courtney, MBA, RAC Senior Regulatory Affairs Specialist 125 Blue Ball Road Elkton, MD 21921
Re: K051997
Capiox RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: II (two) Product Code: DTZ Dated: July 21, 2005 Received: July 25, 2005
Dear Mr. Courtney:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to Conniner of May 20, 1978, 2017, 11:25 am accordance with the provisions of the Federal Food, Drug, devices that have boon require approval of a premarket approval application (PMA). and Cosmetic Treef the device, subject to the general controls provisions of the Act. The Tourmaly, therefore, thance and act include requirements for annual registration, listing of general controlly provisions of visitions and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is clubstion (sover of ols. Existing major regulations affecting your device can may be subject to saterial Regulations, Title 21, Parts 800 to 898. In addition, FDA may ou found in the OOD acements concerning your device in the Federal Register.
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Page 2 - Mr. Garry A. Courtney, MBA, RAC
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); good manufacturing practice requirements as set 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 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K051997 510(k) Number (if known):
Device Name:__Capiox RX15 Hollow Fiber Oxygenator with/without Hardshell Reservoir
Indications For Use:
The Capiox RX15 is intended to be used during open-heart surgical procedures requiring cardiopulmonary bypass for period up to 6 hours. The Capiox RX15 is for use with patients when required blood flow rate will not exceed 5 L/min (4 L/min if using the CXRX15RW30 product code or CXRX15RE30 Product code).
The Capiox RX15 Hardshell Reservoir is also intended for use in vacuum assisted venous drainage procedures, in post-operative chest drainage, and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement.
Garry A. Courtney Requlatory Affairs
Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
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510(k) Number 203177
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