(295 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not suggest the use of AI/ML.
Yes
The device is indicated for pumping liquid matter such as blood as part of an extracorporeal circuit, suggesting it's used to support bodily functions outside the body, which is a therapeutic application. The mention of evaluation for safety and effectiveness further supports its role in patient treatment.
No
The device is described as a component of an extracorporeal circuit for pumping liquid matter (e.g., blood), indicating a therapeutic or supportive function rather than a diagnostic one.
No
The device description clearly describes a physical pump with a spinning rotor and housing, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "pumping liquid matter e.g. blood" as a component of an extracorporeal circuit. This describes a device that interacts directly with the patient's blood flow outside the body, not a device used to examine specimens (like blood, urine, or tissue) in vitro (in a lab setting) to provide diagnostic information.
- Device Description: The description of the centrifugal pump and its mechanism of action (imparting rotary motion to liquid) aligns with a mechanical pump used in medical procedures, not a diagnostic test.
- Lack of Diagnostic Information: There is no mention of the device being used to analyze samples, detect biomarkers, or provide any kind of diagnostic result.
- Performance Studies: The performance studies focus on the safety and effectiveness of the pump itself and its coating, not on the accuracy or reliability of a diagnostic test.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device's function is purely mechanical and related to circulating blood.
N/A
Intended Use / 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.
Product codes
KFM
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.
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
Not Found
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)
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAQUET
510(k) Summary [as required by 21 CFR 807.92(c)]
DEC 1 8 2009
| Submitter | MAQUET Cardiopulmonary AG
Hechinger Strasse 38
72145 Hirrlingen
Germany |
|----------------|----------------------------------------------------------------------------------|
| 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.
1
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.
2
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.
3
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
4
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