(29 days)
The Capiox SP Pump is used to facilitate blood flow in the extracorporeal circuit for circulatory support during extracorporeal circulation for up to 6 hours.
The Capiox® SP Pump is a sterile, single use device. The pump is a non-roller type pump that couples magnetically to, and is magnetically driven by the BioMedicus BioConsole Models 540, 550 and 560 via the pumphead adaptor. The device is a hardshell housing that contains a blood compartment (blood chamber) and a non-blood compartment (rear chamber). Within the blood chamber is a rotating impeller-type component that imparts centrifugal force upon blood as it enters the device. These centrifugal forces move the blood out of the device via the outlet port - and propel the blood through the bypass circuit.
Here is a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Terumo Capiox® SP Pump
Reason for Submission: To add an indication for use with the BioMedicus BioConsole Model 560.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Evaluation) | Reported Device Performance |
|---|---|
| Pump Load (Pressure differential Inlet v. Outlet) testing (comparative testing v. predicate) | Performance was equivalent to the predicate Terumo device and the Medtronic BPX-80 Bio-Pump® when used on the 560 console. No significant differences were noted. |
| 9-hour Durability Testing (attribute evaluation / not compared to predicate) | Demonstrated satisfactory durability (specific results not detailed, but implied to meet an acceptable level). |
| BioMed Flow Probe & Pressure Meter Accuracy testing (comparative testing v. predicate) | Performance was equivalent to the predicate Terumo device and the Medtronic BPX-80 Bio-Pump® when used on the 560 console. No significant differences were noted. |
| Decoupling (separation from drive system) testing (attribute evaluation / not compared to predicate) | Demonstrated satisfactory performance (specific results not detailed, but implied to meet an acceptable level). |
| Sterilization conditions validated to provide a Sterility Assurance Level (SAL) of 10⁻⁶ | Sterilization conditions have been validated in accordance with AAMI guidelines to provide a SAL of 10⁻⁶. |
| Biocompatibility of blood-contacting materials according to ISO 10993 | Terumo maintains biocompatibility studies for all blood-contacting materials as recommended in FDA G95-1. The materials are considered biocompatible. |
| Polymer coating material safety and effectiveness (evaluated in in-vivo animal study) | The polymer coating material (polymethoxyethyl acrylate) has been evaluated in an in-vivo animal study for previous devices. No adverse conditions were noted. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state numerical sample sizes for the "test set" for the performance evaluations. Instead, it mentions "in-vitro performance evaluations" which are typically laboratory-based tests. The data provenance is not explicitly linked to specific countries or retrospective/prospective clinical data, as the studies are stated to be in-vitro (bench testing), not clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this submission. The "ground truth" here is based on engineering specifications and performance benchmarks for medical devices, rather than expert interpretation of medical images or clinical outcomes. The "experts" would be the engineers and scientists conducting the in-vitro performance evaluations and comparing them against established technical standards and predicate device performance. Their qualifications are implicitly assumed to be appropriate for conducting such technical evaluations.
4. Adjudication Method for the Test Set
This information is not applicable, as the studies are in-vitro performance evaluations, not studies involving human interpretation or adjudication. The "results" are quantitative measurements directly from the device's operation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted. The submission explicitly states that "Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the subject device to the predicate device." The evaluations were limited to in-vitro performance testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical medical pump (Capiox® SP Pump), not an algorithm or AI software. The performance evaluated refers to the physical operation of the pump.
7. The Type of Ground Truth Used
The "ground truth" for the in-vitro performance evaluations appears to be a combination of:
- Predicate Device Performance: Direct comparison to the established performance of Terumo's Capiox® SP Pump (K012209 and K962981) and Medtronic's BPX-80 Bio-Pump® (K973011) when used on the BioMed 560 console.
- Established Engineering/Regulatory Standards: Implied adherence to safety (e.g., decoupling) and durability requirements for such devices, as well as AAMI guidelines for sterilization.
- Biocompatibility Standards: Adherence to FDA General Program Memorandum #G95-1 and ISO 10993.
8. The Sample Size for the Training Set
This information is not applicable. The submission describes a physical medical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this type of device submission.
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TERUMO
APR 1 7 2008
Submitter Information: This submission was prepared in March 2008 by: Garry A. Courtney, MBA, RAC Regulatory Affairs c/o Terumo Corporation 125 Blue Ball Road Elkton, MD 21921 Telephone: 1-800-283-7866, Ext. 7420
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
Centrifugal Pump
Capiox® SP Pump
Non-Roller, Cardiopulmonary Bypass Blood Pump (Code: KFM)
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:
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Substantial Equivalence Comparison:
Intended Use
The Capiox® SP Pump is used to facilitate blood flow in the extracorporeal circuit for circulatory support during extracorporeal circulation for up to 6 hours.
The Capiox® SP Pump is a sterile, single use device. The pump is a non-roller type pump that couples magnetically to, and is magnetically driven by the BioMedicus BioConsole Models 540, 550 and 560 via the pumphead adaptor.
Comparison to Predicate: The intended use of the Capiox® SP Pump remains essentially unaffected by the change proposed in this application. This new application, upon FDA clearance, allows the additional indication that the Capiox® SP Pump can be used in conjunction with the BioMed 560 console - in addition to the current indications that it can be used with the BioMed 540 and 550 consoles. Similarly, the Medtronic BPX-80 Bio-Pump® is indicated as a circulatory support device that is intended to pump blood through a bypass circuit during extracorporeal bypass procedures.
Duration of Use
The Capiox SP Pump is indicated for use in procedures lasting not more than 6 hours in duration.
Comparison to Predicate: There will be no differences noted in the 6-hour duration as a result of the added indication that the product can be used with the BioMed 560 console. Similarly, the Medtronic BPX-80 Bio-Pump® is also indicated for usage not to exceed 6 hours.
Labeling
Terumo Corporation currently provides labeling and adequate instructions for use with the Capiox® SP Pump. The instructions for use (IFU) are provided with each delivery of the product to the user facility.
Comparison to Predicate: The instructions manual for the Capiox® SP Pump will be updated to indicate that the device can be used with the BioMed 560 console. No additional significant changes are planned for the instructions or other labeling.
Principles of Operation and Technology
The Capiox® SP Pump performs it's function using centrifugal force technology. As blood enters the device via the blood inlet port, centrifugal forces created by the pump activity will propel the blood through the pump and out of the device via a blood outlet port.
Comparison to Predicate: The existing principles of operation and the technology employed by the Capiox® SP Pump remain unaffected by the added product indication. The employed technology utilized by the Medronic BPX-80 Bio-Pump® is essentially identical to that of the Terumo device. Both devices are "fed" via gravity drainage of blood into the device - followed by a pumping device that creates circulation throughout the bypass circuit. Both devices rely upon a console drive, as well as centrifugal force.
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TERUMO
Design and Materials
The design and materials of the Capiox SP Pump is such that the device meets it's stated intended use - and provides an acceptable level of performance and safety to the patient. The device is a hardshell housing that contains a blood compartment (blood chamber) and a non-blood compartment (rear chamber). Within the blood chamber is a rotating impeller-type component that imparts centrifugal force upon blood as it enters the device. These centrifugal forces move the blood out of the device via the outlet port - and propel the blood through the bypass circuit.
Comparison to Predicate: The design and manufacturing of the Capiox® SP Pump are not changing as a result of the added product indication. Further, the materials used in the manufacturing of the Capiox® SP Pump are not changing as a result of the added product indication. The proposed change included in this application is to add a new indication. There are no design changes, nor are there any material changes included in this application. When compared to the materials used in the predicate Medtronic BPX-80 Bio-Pump®, it is noted that there are differences between the two devices with the most significant difference being the coating materials that are applied to the blood contacting surfaces. The Terumo device is coated with polymethoxyethyl acrylate, whereas the Medtronic device is covered with Trillium or Carmeda® coating. While these surfactants may differ chemically from Terumo's X-Coating, the safety and effectiveness or each of these materials are well-recognized and have been extensively used in medical devices. Such noted differences are not thought to raise previously unrecognized issues of safety or effectiveness.
Performance Evaluations
Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the subject device to the predicate device. Performance studies for the intent of demonstrating safe and effective use of the Capiox® SP Pump with the BioMed 560 console is demonstrated with the following in-vitro performance evaluations:
- Pump Load (Pressure differential Inlet v. Outlet) testing (comparative testing v. predicate) .
- 9-hour Durability Testing (attribute evaluation / not compared to predicate) .
- BioMed Flow Probe & Pressure Meter Accuracy testing (comparative testing v. predicate) .
- Decoupling (separation from drive system) testing (attribute evaluation / not compared to . predicate)
Comparison to predicate: The performance of the Capiox® SP Pump with the added indication for use with the BioMed 560 console is equivalent to the performance of the predicate Terumo device and the Medtronic BPX-80 Bio-Pump® when used on the 560 console. No significant differences in performance were noted.
Conclusion:
In summary. Terumo deems the Capiox® SP Pump with the added indication for use with the BioMed 560 console as substantially equivalent to the established predicates with respect to intended use, duration of use, design, materials, principles of operation, performance and specifications. The only noted difference between the predicate and the proposal indicated in this application is that the Capiox® SP Pump can be used with a BioMed 560 console.
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Substantial Equivalence Statement:
The Capiox® SP Pump and the established predicates are substantially equivalent in intended use, principles of operation and technology, design and materials, and performance.
Additional Safety Information:
- Sterilization conditions have been validated in accordance with AAMI guidelines to provide . a Sterility Assurance Level (SAL) of 10°.
- Terumo maintains biocompatibility studies for all blood-contacting materials 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 are considered to be biocompatible.
- The polymer coating material that is applied to the blood-contacting surfaces of the devices . have been evaluated in an in-vivo animal study for previous devices submitted to FDA for marketing clearance. No adverse conditions have been noted.
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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 7 2008
Terumo Cardiovascular Systems Corporation c/o Mr. Garry A. Courtney Regulatory Management 125 Blue Ball Road Elkton, MD 21921
Re: K080774
Capiox® SP Pump (with or without X-Coating) Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-type cardiopulmonary bypass pump Regulatory Class: Class III Product Code: KFM Dated: March 14, 2008 Received: March 19, 2008
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, listing 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 - Mr. Garry A. Courtney
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
uma R. Vachner
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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TTERUMO
SECTION 4 Indications for Use
K080774 510(k) Number (if known):
CAPIOX® SP Pump Device Name:
Indications For Use:
The Capiox SP Pump is used to facilitate blood flow in the extracorporeal circuit for circulatory support during extracorporeal circulation for up to 6 hours.
Note: The Capiox SP Pump is a sterile, single use device. The pump is a non-roller type pump that couples magnetically to, and is magnetically driven by the BioMedicus BioConsole Models 540, 550 and 560 via the pumphead adaptor.
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)
Muna R. Vaches
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_k o 8077 4
§ 870.4360 Nonroller-type blood pump.
(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.