(88 days)
Not Found
No
The document describes a mechanical device for cardiopulmonary bypass and does not mention any AI or ML components or functionalities.
No
The device is used to exchange gases and warm/cool blood during cardiopulmonary bypass surgery, and to store blood during extracorporeal circulation, which supports physiological function but does not directly treat a disease or condition.
No
The device is an oxygenator used to exchange gases in the blood during cardiopulmonary bypass surgery, and does not perform any diagnostic function.
No
The device description clearly outlines a physical medical device (oxygenator, heat exchanger, reservoir) used in cardiopulmonary bypass surgery, not a software-only application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that 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 direct intervention on the patient's blood within the body (or during extracorporeal circulation which is a temporary bypass of the body's normal function), not a test performed on a sample of blood or other biological material outside the body to diagnose a condition.
- Device Description: The description details a device for gas exchange and heat exchange with blood, consistent with its intended use during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on the device's mechanical and functional performance in handling blood and gases, not on its ability to diagnose a condition.
Therefore, the CAPIOX® RX05 Hollow Fiber Oxygenator with/without Hardshell Reservoir is a medical device used for therapeutic support during surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CAPIOX® RX05 Hollow Fiber Oxygenator with/without hardshell reservoir is intended to be 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 blood and/or perfusion fluid as it flows through the device.
The (detachable) hardshell reservoir is used to store blood during extracorporeal 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 CAPIOX® RX05 Oxygenator with/without hardshell reservoir can be used in procedures lasting up to 6 hours.
The CAPIOX® RX05 is for use with neonatal and infant patients when the required blood flow rate will not exceed 1.5 L/min.
Product codes (comma separated list FDA assigned to the subject device)
DTZ, DTR, DTN, DTP, JOD, DTL
Device Description
The design of the CAPIOX® RX05 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® RX05 Hollow Fiber Oxygenator with/without Hardshell Reservoir include, but are not limited to. polycarbonate, stainless steel, polyvinylchloride, polyurethane, polyester, polypropylene, polvethylene and X-Coating.
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
neonatal and 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 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:
- Gas Transfer
- Effects on Blood Components (Hemolysis) .
- Pressure Drop .
- Mechanical Integrity .
- . Static Priming Volume
- Heat Exchanger Performance ●
- Defoaming .
- Filtration Efficiency .
- Flow Ratc .
The comparisons demonstrated that there were no clinically significant performance differences between the devices.
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
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence starts with the letters 'KO', followed by the numbers '22115'. The characters are written in a simple, slightly slanted style, with varying stroke thicknesses.
Section II 510(k) Summary and Certification Terumo Corporation Capiox RX05
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
Section II 510(k) Summary and Certification Terumo Corporation Capiox RX05
SEP 2 7 2002
CAPIOX® RX05 Hollow Fiber Oxygenator with/without Hardshell Reservoir
Submitter Information:
This submission was prepared in June 2002 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 Name(s)/Classifications:
| Proprietary Name | Classification Name | Common Name |
|---|---|---|
| CAPIOX® RX05 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 |
2
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:
Medtronic Minimax Plus Oxygenator w/wo Hardshell Reservoir – (K933586). Cobe VPCML Plus Oxygenator with Hardshell Reservoir -- (K842908).
Intended Use:
The CAPIOX® RX05 Hollow Fiber Oxygenator with/without Hardshell Reservoir is intended to be 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 blood and/or perfusion fluid as it flows through the device.
The (detachable) hardshell reservoir is used to store blood during extracorporeal 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 CAPIOX® RX05 Oxygenator with/without Hardshell Reservoir can be used in procedures lasting up to 6 hours.
The CAPIOX® RX05 is for use with neonatal and infant patients when the required blood flow rate will not exceed 1.5 L/min.
Principles of Operation and Technology:
The design of the CAPIOX® RX05 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® RX05 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.
3
The materials that are used in the construction of the CAPIOX® RX05 Hollow Fiber Oxygenator with/without Hardshell Reservoir include, but are not limited to. polycarbonate, stainless steel, polyvinylchloride, polyurethane, polyester, polypropylene, polvethylene and X-Coating.
Performance Evaluations:
Clinical studies 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:
- Gas Transfer �
- Effects on Blood Components (Hemolysis) .
- Pressure Drop .
- Mechanical Integrity .
- . Static Priming Volume
- Heat Exchanger Performance ●
- Defoaming .
- Filtration Efficiency .
- Flow Ratc .
Substantial Equivalence Comparison:
The CAPIOX® RX05 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 . (Medtronic and Cobe) 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.
Each of the devices may be used with the neonatal patient population.
- . Principles of Operation and Technology: The technology of the subject device and the predicate devices (Medtronic and Cobe) are 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
4
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.
The CAPIOX® RX05 Hollow Fiber Oxygenator with/without Hardshell Reservoir may be used in procedures that utilize Vacuum Assist procedures to facilitate blood flow into the hardshell reservoir. Use of the device with Vacuum Assisted procedures does not raise any new issues of safety and/or effectiveness. To our knowledge, the Cobe and Medtronic devices are not used with Vacuum Assist procedures.
-
Design and Materials: The design and the materials of the CAPIOX® RX05 Hollow . Fiber Oxygenator with/without Hardshell Reservoir and the predicate device 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 devices on the market.
The devices are manufactured with variations of plastics, adhesives, urethanes, polypropylene, stainless steel, etc. The RX05 device contains X-Coating, which is a biocompatible surface coating that reduces platelet adhesion to the device. The use of X-Coating has been demonstrated as safe and raises no new issues of safety and/or effectiveness. -
Performance: Comparisons of the performance of the CAPIOX® RX05 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.
Substantial Equivalence Summary:
In summary, the CAPIOX® RX05 Hollow Fiber Oxygenator with/without Hardshell Reservoir and the predicate 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 (Medtronic Minimax, K933586 and Cobe VPCML, K842908) 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 106. Ethylene Oxide residues 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).
5
- Terumo conducted 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 conducted studies for materials characterization, including physico-chemical profiles of aged and nonaged devices.
- . 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® RX05 Hollow Fiber Oxygenator with/without Hardshell Reservoir is substantially equivalent in intended use, principles of operation and technology, design and materials, and performance to the predicate devices, the Medtronic Minimax (K933586) and the Cobe VPCML Plus (K842908).
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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 7 2002
Terumo Cardiovascular Systems Corporation c/o Gary A. Courtney, MBA, RAC Sr. Regulatory Affairs Specialist 125 Blue Ball Road Elkton, Maryland 21921
Re: K022115
Trade Name: CAPIOX® rx05 Hollow Fiber Oxygenator with/without Hardshell Reservoir Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II (two) Product Code: DTZ Dated: June 28, 2002 Received: July 1, 2002
Dear Mr. Courtney:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced 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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - 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 (OS) 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 CTFR Part 80) and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the (Mice of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely vours,
Natter
Bram D. Zuckerman. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
510(k) Number (if known):
CAPIOX® RX05 Hollow Fiber Oxygenator with/without Device Name: Hardshell Reservoir
Indications For Use:
The CAPIOX® RX05 Hollow Fiber Oxygenator with/without hardshell reservoir is intended to be 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 blood and/or perfusion fluid as it flows through the device.
The (detachable) hardshell reservoir is used to store blood during extracorporeal 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 CAPIOX® RX05 Oxygenator with/without hardshell reservoir can be used in procedures lasting up to 6 hours.
The CAPIOX® RX05 is for use with neonatal and infant patients when the required blood flow rate will not exceed 1.5 L/min.
Harry L. Cauthey 6-28-02
/s/ L.A. Cauthey, MBA, RAC
Garry A. Courtney, MBA. RAC Terumo Cardiovascular Systems
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K022115
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)