(36 days)
RotaFlow Centrifugal Pump (K991864)
No
The description focuses on the mechanical and hydraulic principles of the centrifugal pump and its components. There is no mention of AI, ML, or any software-driven decision-making or analysis based on data.
Yes
The device is used for cardiopulmonary bypass or temporary circulatory bypass during surgical procedures, which are therapeutic interventions.
No
This device is a centrifugal pump used for circulating blood in extracorporeal circuits, specifically for cardiopulmonary bypass or temporary circulatory bypass during surgical procedures. Its function is to facilitate blood flow, not to diagnose medical conditions or analyze biological data for diagnostic purposes.
No
The device description clearly details a physical centrifugal pump with a rotor, housing, ports, and a magnetic drive system. It is a hardware component of an extracorporeal circuit.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Rotaflow Centrifugal Pump is a mechanical device used to pump blood through an extracorporeal circuit during surgical procedures. It directly interacts with the patient's blood outside the body to facilitate circulation, not to analyze or test it.
- Intended Use: The intended use clearly states its purpose is for providing cardiopulmonary bypass or temporary circulatory bypass during surgery. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description focuses on the mechanical aspects of the pump and its function in moving blood. There is no mention of analyzing blood components or providing diagnostic information.
Therefore, based on the provided information, the Rotaflow Centrifugal Pump is a medical device used for extracorporeal circulation support, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Rotaflow Centrifygal Pump is a device that uses a method other to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
· Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or
· 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.
The Jostra RotaFlow Centrifuqal Pump with Safeline Coating 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.
Product codes (comma separated list FDA assigned to the subject device)
KFM
Device Description
The Jostra RotaFlow Centrifugal Pump with Safeline Coating is a sterile, nonpyrogenic device for single use only and is not to be re-sterilized by the user.
The RotaFlow Centrifugal Pump with Safeline Coating is indicated as a component of the extracorporeal circuit and is intended to be used exclusively in conjunction with the RotaFlow-Console, the RotaFlow Drive Unit and the RotaFlow Emergency Drive. The device is not designed or intended for use except as indicated. The centrifugal pump is indicated for single use as a pump for up to 6 hrs.
The RotaFlow is a blood pump that functions on the basis of the centrifugal principle, whereas the drive is based on a magnetic system. A sapphire ball and a PE calotte guarantee low friction bearing.
The centrifugal pump has a spinning rotor with flow channels which impart rotary motion to the incoming blood, directing it through a spiral housing to the outflow port. The Rotor is shrouded. It forms the flow channels with 4 fan-shaped members. The flow is guided from the center of the pump to the periphery of the pump, where it is then forced into the flow channel by means of a spiral flow channel the cross-section of which increases in the direction of flow. The RotaFlow Centrifugal Pump allows for pulsatile and non-pulsatile flow.
The RotaFlow Centrifugal Pump comes with an integrated flow probe connector.
The design principle minimizes blood traumatization and stress with optimum flow guidance. Additionally, the pump design results in no stagnant blood zones and a small priming volume of 32 ml which allows for minimal mean transit time (MTT).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart or great vessels, aorta or vena cava.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 and testing on safety and effectiveness was executed to demonstrate that the Jostra RotaFlow Centrifugal Pump with Safeline Coating described in this submission is substantially equivalent to the Jostra RotaFlow Centrifugal Pump as a pump and to the Quadrox Safeline Hollow Fiber Membrane Oxygenator regarding the Safeline coating.
The following areas have been tested and / or evaluated:
- Integrity of the RotaFlow ●
- Performance of the RotaFlow .
- Stability of the Coating ●
- Biocompatibility .
- . Sterility
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.
RotaFlow Centrifugal Pump (K991864)
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.
Quadrox Hollow Fiber Membrane Oxgenator Safeline (K992559, K030264)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo 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 Center - WO66-G609 Silver Spring, MD 20993-0002
June 16, 2016
Maquet Cardiopulmonary AG c/o Katrin Schwenkglenks Hechinger Strasse 38 Hirrlingen, Germany 72145
Re: K061072
Trade/Device Name: RotaFlow Centrifugal Pump System with Safeline Coating Regulation Number: 21 CFR 870.4360 Regulation Name: Non-Roller Type Cardiopulmonary Bypass Blood Pump Regulatory Class: Class II Product Code: KFM Dated: April 7, 2006 Received: April 17, 2006
Dear Ms. Schwenkglenks:
This letter corrects our substantially equivalent letter of May 23, 2006.
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
1
Page 2 - Ms. Katrin Schwenkglenks
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 (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" (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 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,
Eric E. Richardson -S
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K061072
Device Name
Rotaflow Centrifugal Pump with Safeline
Indications for Use (Describe)
The Rotaflow Centrifygal Pump is a device that uses a method other to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
· Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or
· 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
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3
QUET
510 (K) Summary [as required by 21 CFR 807.92(c)]
| Submitter: | Maquet Cardiopulmonary AG
Hechinger Strasse 38
72145 Hirrlingen
Germany |
|-----------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Katrin Schwenkglenks
Phone: +49 7478 921-151
Fax: +49 7478 921-400
E-mail: katrin.schwenkglenks@maquet-cp.com |
| Date Prepared: | April 07, 2006 |
| Device Trade Name: | RotaFlow Centrifugal Pump with Safeline Coating |
| Common/Usuai Name: | Centrifugal pump, coated |
| Classification Names: | Pump, blood, non-roller-type, cardiopulmonary;
(21 CFR 870.4360, product code: KFM) |
| Predicate Devices: | RotaFlow Centrifugal Pump (K991864)
Quadrox Hollow Fiber Membrane Oxgenator
Safeline (K992559, K030264) |
Device Description
The Jostra RotaFlow Centrifugal Pump with Safeline Coating is a sterile, nonpyrogenic device for single use only and is not to be re-sterilized by the user.
The RotaFlow Centrifugal Pump with Safeline Coating is indicated as a component of the extracorporeal circuit and is intended to be used exclusively in conjunction with the RotaFlow-Console, the RotaFlow Drive Unit and the RotaFlow Emergency Drive. The device is not designed or intended for use except as indicated. The centrifugal pump is indicated for single use as a pump for up to 6 hrs.
The RotaFlow is a blood pump that functions on the basis of the centrifugal principle, whereas the drive is based on a magnetic system. A sapphire ball and a PE calotte guarantee low friction bearing.
The centrifugal pump has a spinning rotor with flow channels which impart rotary motion to the incoming blood, directing it through a spiral housing to the outflow port. The Rotor is shrouded. It forms the flow channels with 4 fan-shaped members. The flow is guided from the center of the pump to the periphery of the pump, where it is then forced into the flow channel by means of a spiral flow channel the cross-section of which increases in the direction of flow. The RotaFlow Centrifugal Pump allows for pulsatile and non-pulsatile flow.
The RotaFlow Centrifugal Pump comes with an integrated flow probe connector.
4
MAQUET
The design principle minimizes blood traumatization and stress with optimum flow guidance. Additionally, the pump design results in no stagnant blood zones and a small priming volume of 32 ml which allows for minimal mean transit time (MTT).
Indications for Use:
The Jostra RotaFlow Centrifuqal Pump with Safeline Coating 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.
Statement of Technical Characteristics Comparison
The two devices differ in that the blood contacting surfaces of the Jostra RotaFlow Centrifugal Pump with Safeline Coating has been treated with the Safeline Coating. Otherwise, indications for use, materials, components, design, performance characteristics and sterilization for the two devices are the same. The safety of the Safeline Coating has been shown with the Quadrox Safeline Oxygenator (K992559). Due to equivalence of indications for use, materials, design and functional characteristics, the device raises no new safety or effectiveness issues.
Determination of Substantial Equivalence
Evaluation and testing on safety and effectiveness was executed to demonstrate that the Jostra RotaFlow Centrifugal Pump with Safeline Coating described in this submission is substantially equivalent to the Jostra RotaFlow Centrifugal Pump as a pump and to the Quadrox Safeline Hollow Fiber Membrane Oxygenator regarding the Safeline coating.
The following areas have been tested and / or evaluated:
- Integrity of the RotaFlow ●
- Performance of the RotaFlow .
- Stability of the Coating ●
- Biocompatibility .
- . Sterility
Conclusion
The data given demonstrate that the Jostra RotaFlow Centrifugal Pump with Safeline Coating is substantially equivalent to the named predicate devices which hold currently market clearance.