(28 days)
The CAPIOX® RX Hollow Fiber Oxygenators with/without Hardshell Reservoir are 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(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 may also be used for Post-Operative Chest Drainage Procedures.
The CAPIOX® RX Oxygenators with/without Hardshell Reservoirs 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 L/min 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).
The CAPIOX® RX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min.
The modified and predicate Capiox® RX device oxygenator utilizes a 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 wound 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 and predicate Capiox® RX device have 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 blood, the modified and predicate Capiox® RX Reservoir relies upon mechanical entrapment of particulates and emboli within the filter mesh as a means to remove those particulates from the blood.
The design of the modified and predicate Capiox® RX devices both utilize an integrated oxygenator/heat exchanger module that provides for temperature control of blood as it enters the oxygenation phase. Each of the devices also utilizes a hardshell reservoir that is used to collect and store blood during a cardiopulmonary bypass procedure. The reservoirs each provide filtration of venous and cardiotomy blood as it enters the reservoir.
The document describes a 510(k) premarket notification for a medical device called the "Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir." This particular submission is a "Special 510(k)" due to modifications made to the hardshell reservoir and a change in the plasticizer used in certain PVC tubing.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Preamble: This 510(k) submission is for modifications to an existing device (Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir, previously cleared under K130333). Therefore, the "acceptance criteria" discussed are primarily focused on demonstrating that the modified device is substantially equivalent to the predicate device and that the changes do not raise new issues of safety or effectiveness. Clinical studies involving patients were explicitly deemed not necessary for this particular submission.
1. Table of Acceptance Criteria and the Reported Device Performance:
The document states that substantial equivalence is demonstrated with several in-vitro performance evaluations. While it doesn't present a table with specific pass/fail criteria and exact numerical results, it does list the types of performance evaluations conducted to ensure the modified device performs comparably to the predicate.
| Acceptance Criteria (Performance Evaluations) | Reported Device Performance |
|---|---|
| Air Handling Performance | Not explicitly detailed in numerical results, but implied to meet equivalence to the predicate. The stated intent of flared venous inlet drop tubes is to "help minimize air emboli generation," suggesting this performance aspect was evaluated and improved or maintained. |
| Hemolysis | Not explicitly detailed in numerical results, but implied to meet equivalence to the predicate. Evaluations would demonstrate that the modified device does not cause increased red blood cell damage compared to the predicate. |
| Venous Reservoir Pressure Drop | Not explicitly detailed in numerical results, but implied to meet equivalence to the predicate. Evaluated to ensure the modifications do not adversely affect blood flow dynamics through the reservoir. |
| Venous Defoaming | Not explicitly detailed in numerical results, but implied to meet equivalence to the predicate. The reservoir contains a "filter and defoamer to facilitate air bubble removal," and this function was evaluated. |
| Leak Testing | Not explicitly detailed in numerical results, but implied to meet equivalence to the predicate. Evaluated to ensure the device remains sealed and prevents fluid leakage. |
| Winged Adapter Circulation Testing | Not explicitly detailed in numerical results, but implied to meet equivalence to the predicate. Specifically for the modified 1/4" x 3/8" winged adapter for the RX15 3-Liter Reservoir, ensuring proper circulation. |
| 3-Liter Drainage Cage Dimensional Testing | Not explicitly detailed in numerical results, but implied to meet equivalence to the predicate. Evaluated to ensure the modified drainage cage accommodates the flared venous inlet drop tubes as intended. |
| Connections Testing | Not explicitly detailed in numerical results, but implied to meet equivalence to the predicate. Evaluated to ensure proper and secure connections of all components. |
| Package Testing | Not explicitly detailed in numerical results, but implied to meet equivalence to the predicate. Evaluated to ensure the packaging maintains device integrity and sterility. |
| Aged Evaluation | Not explicitly detailed in numerical results, but implied to meet equivalence to the predicate. Evaluated to ensure the device maintains performance over its expected shelf life. |
| Overall Conclusion of Substantial Equivalence | "Terumo Cardiovascular Systems concludes that the differences between the modified device and the predicate device do not affect the intended use of the device nor do they affect safety and effectiveness of the device when used as labeled." and "It is further concluded that any recognized differences noted during the assessments do not raise new issues of patient/user safety or product effectiveness." |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify exact sample sizes for each in-vitro test. It only lists the types of tests conducted. Since these are in-vitro performance evaluations, the "data provenance" would refer to the testing conditions and the specific samples of the device (modified vs. predicate) used in the lab tests. There is no mention of country of origin for data as it's not a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable as the document explicitly states: "Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the modified Capiox® RX device to the predicate Capiox® RX device." The testing described is in-vitro performance evaluation, not expert-adjudicated clinical or image-based ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reason as point 3.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The device is an oxygenator and reservoir system, not an AI-assisted diagnostic or therapeutic tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is not an algorithm or AI system.
7. The Type of Ground Truth Used:
For this device, the "ground truth" for the in-vitro performance evaluations would be:
- Engineering specifications and regulatory standards: The tests are designed to demonstrate that the device meets predefined engineering requirements and applicable regulatory standards for blood oxygenators and reservoirs.
- Performance of the predicate device: The modified device's performance is compared against the established performance of the previously cleared predicate device, aiming for substantial equivalence rather than an absolute ground truth in the sense of a disease diagnosis.
8. The Sample Size for the Training Set:
This information is not applicable as this is not an AI/machine learning device requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as this is not an AI/machine learning device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, which is a traditional symbol of medicine. The symbol is composed of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 03, 2015
Terumo Cardiovascular Systems Corporation Tierra Brown Regulatory Affairs Specialist 125 Blue Ball Road Elkton, Maryland 21921
Re: K153213
Trade/Device Name: Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ, DTN, DTR, DTP Dated: November 4, 2015 Received: November 5, 2015
Dear Tierra Brown:
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, 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Hilleman
for
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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Image /page/2/Picture/1 description: The image shows the logo for Terumo Corporation. The logo consists of a stylized letter 'T' inside a circle, with the word 'TERUMO' written vertically next to it. The logo is in a teal color.
novessaringinussipolises in 1 – koimans
| Indications for Use | 510(k) Number |
|---|---|
| Unknown at time of Submission | |
| Device Name | Indications for Use |
| Capiox® RX Hollow Fiber Oxygenator with/without Hardshell Reservoir | |
| Indications for Use as presented in the Instructions for Use:The CAPIOX RX is intended to be used during open heart surgical proceduresrequiring cardiopulmonary bypass for periods up to 6 hours.The CAPIOX RX25 is used with patients when required blood flow rate will notexceed 7 L/min. The CAPIOX RX15 is for use with patients when required bloodflow rate will not exceed 5 L/min (4L/min if using product codes CXRX15RW30 orCXRX15RE30). The CAPIOX RX Hardshell Reservoir is also intended for use invacuum assisted venous drainage procedure, in post-operative chest drainage andautotransfusion procedures to aseptically return the blood to the patient for bloodvolume replacement. | |
| Indications for Use as described in the 510(k):The CAPIOX® RX Hollow Fiber Oxygenators with/without Hardshell Reservoir areintended to be used to exchange gases between blood and a gaseousenvironment to satisfy the gas exchange needs of a patient duringcardiopulmonary bypass surgery.The integral heat exchanger is used to warm or cool blood and/or perfusion fluid asit 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 orvacuum assisted venous drainage procedures). The reservoir contains a venoussection that is comprised of a filter and defoamer to facilitate air bubble removal.The cardiotomy section of the reservoir contains a filter to remove particulatematter and a defoamer to facilitate air bubble removal. The reservoir may also beused for Post-Operative Chest Drainage Procedures.The CAPIOX® RX Oxygenators with/without Hardshell Reservoirs can be used inprocedures lasting up to 6 hours.The CAPIOX® RX15 is for use with patients when the required blood flow rate willnot exceed 5.0 L/min when used with a 4 Liter Reservoir; and when the requiredblood flow rate will not exceed 4.0 L/min when used with a 3 Liter Reservoir).The CAPIOX® RX25 is for use with patients when the required blood flow rate willnot exceed 7.0 L/min. | |
| Prescription Use(Part 21 CFR 801 Subpart D)XX | OROver-The-Counter Use(Part 21 CFR 807 Subpart C) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
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| Image: Terumo logo TERUMO |
|---|
| SECTION 5 – 510(k) Summary |
| Capiox® RX Oxygenator/Reservoir |
| 5.1 Submitter Information | ||
|---|---|---|
| Date of Preparation | November 3, 2015 | |
| Name | Terumo Cardiovascular Systems Corporation | |
| Address | 125 Blue Ball RoadElkton, MD 21921 | |
| Establishment Registration Number | 1124841 | |
| Name of Contact Person | Tierra A. Brown, MSRA, RAC | |
| Contact Person's Title | Regulatory Affairs Specialist | |
| Phone Number | 800-262-3304 ext. 7021 | |
| Fax Number | 410-392-7171 | |
| tierra.brown@terumomedical.com |
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| (T TERUMO |
|---|
| SECTION 5 – 510(k) Summary |
| Capiox® RX Oxygenator/Reservoir |
| 5.2 Name of Device | |
|---|---|
| Device Type | Blood Oxygenator with and/or without BloodReservoirDefoamerHeat Exchanger |
| Device Common Name | Blood ReservoirBlood Gas OxygenatorDefoamerHeat Exchanger |
| Device Trade Name | Capiox® RX Hollow Fiber Oxygenator with/withoutHardshell Reservoir |
| Predicate Device | Capiox® RX Hollow Fiber Oxygenator with/withoutHardshell Reservoir; Cleared by FDA with K130333 |
| Classification Regulation | Reservoir: 21 CFR § 870.4400Oxygenator: 21 CFR § 870.4350Defoamer: 21 CFR § 870.4230Heat Exchanger: 21 CFR § 870.4240 |
| Device Risk Classification | Reservoir: Class IIOxygenator: Class IIDefoamer: Class IIHeat Exchanger: Class II |
| FDA Product Codes | Reservoir: DTNOxygenator: DTZDefoamer: DTPHeat Exchanger: DTR |
| Reason for 510(k) Submission | Modification to Hardshell Reservoir |
| Substantial Equivalence Statement | The device submitted in this 510(k) maintainscharacteristics that are substantially equivalent inintended use, design, technology/principles ofoperation, materials and specifications to thepredicate device. |
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Device Information
5.3 Intended Use:
The intended use remains the same for the modified device and predicate device.
The CAPIOX® RX Hollow Fiber Oxygenators with/without Hardshell Reservoir are 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(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 may also be used for Post-Operative Chest Drainage Procedures.
The CAPIOX® RX Oxygenators with/without Hardshell Reservoirs 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 L/min 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).
The CAPIOX® RX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min.
5.4 Principles of Operation and Technology:
The principles of operation and technology remain the same for the modified device and predicate device.
The modified and predicate Capiox® RX device oxygenator utilizes a 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 wound 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 and predicate Capiox® RX device have 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 blood, the modified and predicate Capiox® RX Reservoir relies upon mechanical entrapment of particulates and emboli within the filter mesh as a means to remove those particulates from the blood.
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5.5 Design and Materials:
.
The design of the modified and predicate Capiox® RX devices both utilize an integrated oxygenator/heat exchanger module that provides for temperature control of blood as it enters the oxygenation phase. Each of the devices also utilizes a hardshell reservoir that is used to collect and store blood during a cardiopulmonary bypass procedure. The reservoirs each provide filtration of venous and cardiotomy blood as it enters the reservoir.
With respect to the design of the Oxygenator, the modified Capiox® RX 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 Hardshell Reservoir.
Differences in the design of the Capiox® RX devices are as follows:
- The design of the modified Capiox® RX device will include:
- flared venous inlet drop tubes o
- o The RX15 3-Liter Reservoir's drainage cage, that houses the flared venous inlet drop tubes, will be modified
- A full-length graduated side scale label (decal) o
- A modified 1/4" x 3/8" winged adapter (adapter is for the RX15 3-Liter Reservoir o only)
- The intent of the flared venous inlet drop tubes is to help minimize air emboli generation . in the venous section of the reservoir.
- The intent of the modified RX15 3-Liter Reservoir's drainage cage is to accommodate . the modified flared venous inlet drop tubes.
- . The full-length graduated side scale label (decal) enhancement offers greater visibility of blood volume during cardiopulmonary bypass.
- The modified 1/4" x 3/8" winged adapter (adapter for RX15 3-Liter Reservoir only) is ● used to provide attachment to the 1/4" arterial and venous line connections.
- The design of the predicate Capiox® RX device has: .
- straight venous inlet drop tubes o
- The RX15 3-Liter Reservoir's drainage cage is the original size from initial FDA o clearance.
- A half-length graduated side scale label (decal) O
- A 1/4" x 3/8" adapter o
Difference in the materials of the Capiox® RX devices are as follows:
- o The materials used in the construction of the modified Capiox® RX Hollow Fiber Oxygenator with/without Hardshell Reservoir device's venous inlet drop tubes along with the auxiliary drop tube, quick disconnect tubing, sampling manifold tubing, and purge line tubing will be PVC tubing with Tris-(2-Ethylhexyl) Trimellitat, identified as TOTM plasticizer.1
- . The materials used in the construction of the predicate Capiox® RX Hollow Fiber Oxygenator with/without Hardshell Reservoir device's venous inlet drop tubes along with the auxiliary drop tube, quick disconnect tubing, sampling manifold tubing, and
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Device Information
5.5 Design and Materials continued:
- purge line tubing is PVC tubing with Di-(2-ethylhexyhl) phthalate, identified as DEHP ● plasticizer.
- The intent of the PVC tubing plasticizer change to TOTM plasticizer is to address o potential safety concerns associated with the use of DEHP as a plasticizer.
The materials used in the construction of the modified and predicate Capiox® RX Hollow Fiber Oxygenator/Hardshell Reservoir devices include, but are not limited to, nylon, polycarbonate, silicone, stainless steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene and X-Coating™.
Terumo Cardiovascular Systems concludes that the differences between the modified device and the predicate device do not affect the intended use of the device nor do they affect safety and effectiveness of the device when used as labeled.
5.6 Performance Evaluations:
Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the modified Capiox® RX device to the predicate Capiox® RX device. Substantial equivalence is demonstrated with the following in-vitro performance evaluations:
- Air Handling Performance ●
- Hemolysis ●
- Venous Reservoir Pressure Drop .
- Venous Defoaming ●
- Leak Testing ●
- Winged Adapter Circulation Testing .
- 3-Liter Drainage Cage Dimensional Testing .
- Connections Testing ●
- Package Testing ●
- Aged Evaluation .
1 PVC tubing with Tris-(2-Ethylhexy) Trimellitate, identified as TOTM plasticizer, is used with Terumo's Capiox® FX15 Advance Oxygenator with Integrated Filter and Hardshell Reservoir, K151389.
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Device Information
5.7 Substantial Equivalence Comparison:
In demonstrating substantial equivalence of the modified Capiox® RX Hollow Fiber Oxygenator with/without Hardshell Reservoir to the predicate Capiox® RX Hollow Fiber Oxygenator with/without Hardshell Reservoir, Terumo has considered the following aspects to ensure equivalence between the predicate and the subject devices:
- Intended use .
- Target Population .
- Duration of use ●
- Product labeling ●
- Product design
- Materials .
- Principles of Operation and Technology ●
- Device Performance ●
5.8 Substantial Equivalence Statement:
The modified Capiox® RX Hollow Fiber Oxygenator with/without Hardshell Reservoir is substantially equivalent in intended use, target population, duration of use, labeling, design, materials, principles of operation and technology, and performance to the predicate Capiox® RX Hollow Fiber Oxygenator with/without Hardshell Reservoir. Any noted differences between the modified device and the predicate devices do not raise new issues of safety and effectiveness.
5.9 510(k) Summary Conclusion
Conclusion
Based upon the comparative studies and analyses, Terumo Cardiovascular Systems concludes that the modified Capiox® RX Hollow Fiber Oxygenator with/without Hardshell Reservoir is substantially equivalent to the predicate Capiox® RX Hollow Fiber Oxygenator with/without Hardshell Reservoir. It is further concluded that any recognized differences noted during the assessments do not raise new issues of patient/user safety or product effectiveness.
§ 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.”