(457 days)
Not Found
Medtronic Bio-Medicus Bio-Pump Centrifugal Blood Pump BP 80, St. Jude Medical Pulse 2100 Centrifugal Pump Interface, Medtronic Bio-Probe DP-38
No
The summary describes a mechanical pump system and its components, with no mention of AI or ML capabilities in the device description, intended use, or performance studies.
Yes
The device is described as "intended for use in an extracorporeal perfusion circuit to pump blood during short duration cardiopulmonary bypass procedures." This direct interaction with the patient's circulatory system to perform a physiological function qualifies it as a therapeutic device.
No
The device is a centrifugal pump system intended for pumping blood in an extracorporeal perfusion circuit during cardiopulmonary bypass procedures, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states that the RotaFlow Centrifugal Pump System includes both hardware and disposables, listing specific hardware components like the RotaFlow Console, Drive Unit, and Emergency Drive.
Based on the provided information, the RotaFlow Centrifugal Pump System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is used "in an extracorporeal perfusion circuit to pump blood during short duration cardiopulmonary bypass procedures." This describes a device that interacts directly with the patient's blood outside the body for therapeutic purposes (pumping blood), not for analyzing or testing samples in vitro (in a lab setting).
- Device Description: The components listed are hardware and disposables designed for pumping blood in a bypass circuit (console, drive unit, pump). There are no components described that would be used for collecting, preparing, or analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any features related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or calibrators typically associated with IVD tests
The RotaFlow Centrifugal Pump System is a medical device used for extracorporeal circulation, which is a life-support procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
The RotaFlow Centrifugal Pump System is intended for use in an extracorporeal perfusion circuit to pump blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
Product codes (comma separated list FDA assigned to the subject device)
KFM
Device Description
The RotaFlow Centrifugal Pump System includes both hardware and disposables. The RotaFlow Centrifugal Pump System includes the following components:
RotaFlow Centrifugal Pump System (= RotaFlow System)
- Components to be used in combination with the RotaFlow Console:
1.1 Hardware
RotaFlow Console RFC 20-970
RotaFlow Drive Unit RFD 20-973
RotaFlow Emergency Drive RFE 20-976
1.2 Disposable
RotaFlow Centrifugal Pump RF-32 - Components to be used in combination with the Bio-Medicus Console:
2.1 Hardware
Magnet Adapter MA-32
2.2 Disposables
RotaFlow Centrifugal Pump RF-32F
External Flow Probe FP-32E
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)
The following tests were performed to demonstrate substantial equivalence between the RotaFlow Centrifugal Pump System and predicate devices (Medtronic, St. Jude):
Disposables:
- Function and Load testing in continuous and pulsatile mode
- Verification of the flow-pressure curves
- Mean Transit Time
- Heat generation
- Stagnant blood zones
- Validation Flowprobe
Magnet Adapter:
- Endurance Test
- Heat Generation
- Magnetic Clutch
RotaFlow System (Hardware):
- Clinical Assessment
- Functional Safety
- EMC
- Construction Safety
- Mains and Battery Operation
- Interface Testing Console with Jostra Heart-Lung Machine
- Emergency Unit Accuracy Testing
- Software Validation
The above listed testings demonstrated that the RotaFlow Centrifugal Blood Pump System is substantial equivalent to the compared predicate devices from Medtronic and St. Jude.
Biocompatibility and Blood Damage Testing:
Biocompatibility testing of the RotaFlow Centrifugal Pump was performed in accordance with the FDA Blue Book Memorandum - #G95-1 and Biological Evaluation of Medical Devices Guidance – International Standard ISO 10993-1, and in accordance with United States Pharmacopeia - XXIII.
Based on the results of the biocompatibility testing performed, the RotaFlow Centrifugal Pump was determined to be biocompatible and nontoxic and, therefore, safe for its intended use.
Blood Damage Testing has also been performed in comparison to the predicate device.
Sterility:
Sterilization of the RotaFlow Centrifugal Pump and Flowprobe have been validated to assure a sterility assurance level (SAL) of 10-6.
EtO sterilized RotaFlow Pump is sterilized in accordance with the American National Standards Institute, Inc. (ANSI) standard ANSI/AAMI/ISO 11135-1994 (Medical Devices -Validation and Routine Control of Ethylene Oxide Sterilization).
EtO Residuals:
RotaFlow Centrifugal Pump meets the limits for residual concentrations of ethylene oxide (
§ 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
AUG 3 1 2000
K991864 510/WBromark Notification JOSTRA MEDIZINTECHNIK AG - RotaFlow Centrifugal Pump System
SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) SUMMARY
COMPANY NAME AND CONTACT PERSON
May 21, 1999
Jostra Medizintechnik AG Hechinger Straße 38 72145 Hirrlingen Germany
Kathy Johnson, Product Manager tel. (610)932-7365 fax (610)932-7366
DEVICE NAME
RotaFlow Centrifugal Pump System Magnet Adapter MA-32 RotaFlow Centrifugal Pump RF-32 / RF-32F Flowprobe FP-32E
COMMON NAME
Cardiopulmonary Bypass Pump Console, Magnet Adapter Centrifugal Blood Pump Cardiovascular Blood Flowprobe
CLASSIFICATION NAME
Control, Pump Speed, Cardiopulmonary Bypass, Adapter, Stopcock, Manifold, Fitting, Pump, Blood, Non-roller-type, Cardiopulmonary Bypass, Flowprobe, Blood, Cardiovascular
1
PREDICATE DEVICE OR LEGALLY MARKETED DEVICE
Medtronic Bio-Medicus Bio-Console Model 550 Medtronic Bio-Medicus Bio-Pump Centrifugal Blood Pump BP 80 St. Jude Medical Pulse 2100 Centrifugal Pump Interface Medtronic Bio-Probe DP-38
DEVICE DESCRIPTION
......
The RotaFlow Centrifugal Pump System includes both hardware and disposables. The RotaFlow Centrifugal Pump System includes the following components:
| RotaFlow Centrifugal Pump System (= RotaFlow System) | |
|---|---|
| 1. Components to be used in combination with the RotaFlow Console: | |
| 1.1 Hardware | RotaFlow Console RFC 20-970 |
| RotaFlow Drive Unit RFD 20-973 | |
| RotaFlow Emergency Drive RFE 20-976 | |
| 1.2 Disposable | RotaFlow Centrifugal Pump RF-32 |
| 2. Components to be used in combination with the Bio-Medicus Console: | |
| 2.1 Hardware | Magnet Adapter MA-32 |
| 2.2 Disposables | RotaFlow Centrifugal Pump RF-32F |
| External Flow Probe FP-32E |
INTENDED USE
The RotaFlow Centrifugal Pump System is intended for use in an extracorporeal perfusion circuit to pump blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
2
TECHNOLOGICAL CHARACTERISTICS
Table 1. Comparison between RotaFlow System (Hardware) and Medtronic Bio-Medicus Bio-Console Type 550
| Name of Product | RotaFlow System
(Hardware) | Medtronic Bio-Medicus
Bio-Console Model 550 |
|----------------------------|----------------------------------|-----------------------------------------------------------------|
| Power supply Mains | 230 V~/ 50 Hz Stand
Alone
| 220-240 Vac with 50-60
Hz |
| Batteries Console: | + 24 V, NiCd | Two, series connected,
12 Vdc lead-acid gel;
rechargeable |
| Weight | app. 14.400 kg Console | 23.000 kg (50 lbs.) |
| Measurements
LxWxH/Size | 179 x 385 x 243 mm
Console | 420 x 230 x 360 mm |
Table 2. Comparison between RotaFlow Centrifugal Pump RF-32 / RF-32F and Medtronic Bio-Medicus Bio-Pump Centrifugal Blood Pump BP 80
| Name of Product | RotaFlow Centrifugal
Pump RF-32 / RF-32F | Bio-Pump Centrifugal
Blood Pump BP-80 |
|-------------------------------|---------------------------------------------|------------------------------------------|
| Priming Volume | 32 ml | 80 ml |
| Inlet/Outlet I. D. | 9,5 mm (3/8 inches) | 9,5 mm (3/8 inches) |
| Maximum Operating
Pressure | 750 mmHg | 900 mmHg |
| Surface Area | 190 cm² | 590 cm² |
| Rotor Diameter | 50 mm | 79 mm |
| System | Flowchannel | Vortex rotors |
| Connectors | 3/8" | 3/8" |
SOOR
3
| Name of Product | RotaFlow Centrifugal
Pump RF-32 / RF-32F | Bio-Pump Centrifugal
Blood Pump BP-80 |
|----------------------------|---------------------------------------------|------------------------------------------|
| materials: | | |
| Housing | polycarbonate | polyacryl |
| Rotor | polycarbonate | polyacryl |
| Connector | polycarbonate | polyacryl |
| Callote | polyethylene | unknown |
| Ball | sapphire | unknown |
| Magnet | neodymium | unknown |
| in. - and outlet caps 3/8" | HDPE | unknown |
SUMMARY OF PERFORMANCE DATA
The following tests were performed to demonstrate substantial equivalence between the RotaFlow Centrifugal Pump System and predicate devices (Medtronic, St. Jude):
Disposables:
- Function and Load testing in continuous and pulsatile mode
- Verification of the flow-pressure curves
- Mean Transit Time
- Heat generation
- Stagnant blood zones
- Validation Flowprobe
Magnet Adapter:
- Endurance Test
- Heat Generation
- Magnetic Clutch
RotaFlow System (Hardware):
- Clinical Assessment
- Functional Safety
- EMC
- Construction Safety
- Mains and Battery Operation
- Interface Testing Console with Jostra Heart-Lung Machine
- Emergency Unit Accuracy Testing
- Software Validation
The above listed testings demonstrated that the RotaFlow Centrifugal Blood Pump System is substantial equivalent to the compared predicate devices from Medtronic and St. Jude.
4
Biocompatibility and Blood Damage Testing:
Biocompatibility testing of the RotaFlow Centrifugal Pump was performed in accordance with the FDA Blue Book Memorandum - #G95-1 and Biological Evaluation of Medical Devices Guidance – International Standard ISO 10993-1, and in accordance with United States Pharmacopeia - XXIII.
Based on the results of the biocompatibility testing performed, the RotaFlow Centrifugal Pump was determined to be biocompatible and nontoxic and, therefore, safe for its intended use.
Blood Damage Testing has also been performed in comparison to the predicate device.
Sterility:
Sterilization of the RotaFlow Centrifugal Pump and Flowprobe have been validated to assure a sterility assurance level (SAL) of 106
EtO sterilized RotaFlow Pump is sterilized in accordance with the American National Standards Institute, Inc. (ANSI) standard ANSI/AAMI/ISO 11135-1994 (Medical Devices -Validation and Routine Control of Ethylene Oxide Sterilization).
EtO Residuals:
RotaFlow Centrifugal Pump meets the limits for residual concentrations of ethylene oxide (