(295 days)
The RotaFlow Centrifugal Pump is indicated as a component of the extracorporeal circuit for pumping liquid matter e.g. blood and can be used in conjunction with the RotaFlow Console. The utilization period of this device is restricted to six hours. The device is not designed or intended for use except as indicated.
The RotaFlow Centrifugal Pump is a non-occlusive pump. The pump has a spinning rotor with flow channels which imparts rotary motion to incoming liquid, directing it through a spiral housing to the outflow port.
This submission (K090515) is for a medical device called the MAQUET RotaFlow Centrifugal Pump with Softline Coating. It's important to note that this 510(k) summary does not contain acceptance criteria or a study proving the device meets those criteria in the way you've outlined for AI/software-driven devices.
This is a premarket notification for a Class III physical medical device (a centrifugal pump for cardiopulmonary bypass). The submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, not on showing performance against specific, quantifiable acceptance criteria typically associated with software or AI performance.
Therefore, many of your specific questions are not applicable to the information provided in this 510(k) summary. I will address the relevant sections and explain why others cannot be answered from the provided text.
1. A table of acceptance criteria and the reported device performance
This information is not provided in the 510(k) summary for K090515. For physical devices like this, the "performance" demonstrated for substantial equivalence typically involves engineering tests (e.g., flow rates, pressure handling, durability, biocompatibility) rather than quantifiable metrics like sensitivity or specificity seen in diagnostic AI. The summary states that "Performance" was evaluated, but it does not present specific criteria or results in a table.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. As this is a physical device, "test sets" in the context of data points for algorithm evaluation are not relevant here. The evaluation would involve physical prototypes or manufactured units of the pump.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided and is not applicable to a physical medical device submission like this. Ground truth, in the context of expert consensus, is typically for diagnostic interpretation, not for evaluating the mechanical function of a pump.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable.
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 provided and is not applicable. This type of study relates to the performance of diagnostic AI with human readers, not a physical pump.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided and is not applicable. There is no algorithm discussed for diagnostic or interpretative purposes in this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided and is not applicable in the way you've described. For a physical pump, "ground truth" might refer to engineering specifications, validated test methods for flow, pressure, material integrity, and biocompatibility standards. The submission highlights that "Integrity", "Performance", "Biocompatibility", and "Sterility" were evaluated, implying various testing methodologies were used, but details are not given.
8. The sample size for the training set
This information is not provided and is not applicable. There is no training set for an AI/ML algorithm in this submission.
9. How the ground truth for the training set was established
This information is not provided and is not applicable.
Summary of Relevant Information from the K090515 Submission:
- Device Name: RotaFlow Centrifugal Pump with Softline Coating
- Submission Type: 510(k) Premarket Notification
- Purpose of Study/Evaluation: To demonstrate substantial equivalence to legally marketed predicate devices.
- Predicate Devices:
- Key Differences from Predicate: The only stated difference from the primary predicate is the coating (Softline instead of BIOLINE). The Softline coating itself is identical to a coating already approved in another predicate device.
- Evaluated Areas (for demonstrating substantial equivalence):
- Integrity
- Performance
- Biocompatibility
- Sterility
- Conclusion: The data demonstrated that the RotaFlow Centrifugal Pump with Softline Coating is substantially equivalent to the named predicate devices.
In essence, this 510(k) is for a manufacturing change (a new coating) on an already cleared device, leveraging the prior approval of both the pump design and the specific coating material on other devices. It does not involve AI or software development that would require the kind of performance metrics and study designs you've detailed.
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MAQUET
510(k) Summary [as required by 21 CFR 807.92(c)]
DEC 1 8 2009
| Submitter | MAQUET Cardiopulmonary AGHechinger Strasse 3872145 HirrlingenGermany |
|---|---|
| Contact Person | Frank Moehrke |
| Phone: 011 49 7478 921 229 | |
| Fax: 011 49 7478 921 400 |
Date Prepared February 24, 2009
Device Trade Name
C
Centrifugal Pump
Common/Usual Name
Classification Names
Nonroller-type cardiopulmonary bypass blood pump (21 CFR 870.4360 - Product Code: KFM)
Legally Marketed Devices .
- RotaFlow Centrifugal Pump with BIOLINE Coating (K080470),
RotaFlow Centrifugal Pump
with Softline Coating
- QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating (K082117)
Device Description
The RotaFlow Centrifugal Pump is a non-occlusive pump. The pump has a spinning rotor with flow channels which imparts rotary motion to incoming liquid, directing it through a spiral housing to the outflow port.
Indications for Use
The RotaFlow Centrifugal Pump is indicated as a.component of the extracorporeal circuit for pumping liguid matter e.g. blood and can be used in conjunction with the RotaFlow Console. The utilization period of this device is restricted to six hours. The device is not designed or intended for use except as indicated.
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MAQUET
Statement of Technical Comparison
The RotaFlow Centrifugal Pump with Softline Coating is identical to the RotaFlow Centrifugal Pump with BIOLINE Coating with the only exception that the RotaFlow Centrifugal Pump with Softline Coating has been coated with Softline Coating instead of BIOLINE Coating. However, the Softline Coating is the same as with the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating. Besides this difference the RotaFlow Centrifygal Pump with Softline Coating is the same in design, intended use, method of operation, components, packaging, and fundamental scientific technology as compared to the RotaFlow Centrifugal Pump with BIOLINE Coating.
Determination of Substantial Equivalence
Evaluation on safety and effectiveness was executed to demonstrate that the RotaFlow Centrifugal Pump with Softline Coating described in this submission is substantially equivalent to the RotaFlow Centrifugal Pump with BIOLINE Coating as pump and to the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating regarding the Softline Coating.
The following areas have been evaluated:
- Integrity .
- Performance
- Biocompatibility .
- Sterility -
Conclusion
The data given demonstrate that the RotaFlow Centrifugal Pump with Softline Coating is substantially equivalent to the named predicate devices which hold currently market clearance.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Maquet Cardiopulmonary AG c/o Mr. Frank Moehrke Regulatory Affairs Manager Hechinger Strasse 38 72145 Hirringen Germany
DEC 1 8 2009
Re: K090515
Maquet RotaFlow Centrifugal Pump with Softline Coating Model BO-RF-32 Regulation Number: 21 CFR 870.4360 Regulation Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Regulatory Class: Class III (three) Product Code: KFM Dated: November 23, 2009 Received: November 25, 2009
Dear Mr. Moehrke:
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 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. Frank Moehrke
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part.807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutiFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ram D/Zuckerman, M.D. Directo Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): كاركار 09 0510
Device Name:
RotaFlow Centrifugal Pump with Softline Coating
Indications for Use:
The RotaFlow Centrifugal Pump is indicated as a component of the extracorporeal circuit for pumping liquid matter e.g. blood and can be used in conjunction with the RotaFlow Console. The utilization period of this device is restricted to six hours. The device is not designed or intended for use except as indicated.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign/Off)
Division of Cardiovascular Devices
510(k) Number K090513
§ 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.