(196 days)
Not Found
No
The description focuses on the mechanical function of a centrifugal blood pump and its interaction with a console, with no mention of AI or ML.
Yes.
The device pumps blood through an extracorporeal bypass circuit for circulatory support, which directly treats a physiological condition (cardiopulmonary bypass, valvuloplasty, etc.), thereby providing therapy.
No
The device is a blood pump used for extracorporeal circulatory support, moving blood through a bypass circuit. It performs a physiological function (pumping blood) rather than detecting, measuring, or analyzing physiological parameters for diagnosis.
No
The device description clearly details a physical, disposable blood pump with components like housing, cones, magnets, and a bearing/shaft assembly. It is designed to move blood through an extracorporeal circuit using centrifugal force, which is a mechanical process. The summary also mentions sterilization methods (gamma radiation, EtO gas) and biocompatibility testing, which are relevant to physical devices, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support." This is a mechanical function performed on blood outside the body, not a diagnostic test performed on a sample of blood to gain information about a patient's health.
- Device Description: The description details a mechanical pump with rotating cones designed to move blood. It does not describe any components or processes related to analyzing or testing blood samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes) in samples
- Providing information for diagnosis, monitoring, or screening
- Reagents, calibrators, or controls
The device is a medical device used for circulatory support during surgical procedures. It is not used to perform diagnostic tests on blood samples.
N/A
Intended Use / Indications for Use
The Medtronic Bio-Medicus Bio-Pump centrifugal blood pump is indicated for use only with the Medtronic Bio-Medicus Bio-Console to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).
Product codes (comma separated list FDA assigned to the subject device)
KFM
Device Description
The BPX-80 Bio-Pump centrifugal blood pump is a single use, disposable, non-pyrogenic device designed to move blood through the extracorporeal circuit by centrifugal force created by smooth rotating cones. Venous blood gravity drains into the inlet port of the Bio-Pump". The smooth cones rotate in the polycarbonate housing. As the cones rotate, energy in the form of pressure and velocity is transferred from the cones to the blood is gently accelerated toward the outlet of the pump. The Bio-Pump moves the blood through the circuit at a desired pressure and flow rate by increasing the speed of the rotating cones. This is accomplished by adjusting the Bio-Console's RPMs (revolutions per minute). Arterial blood is returned to the patient from the extracorporeal circuit.
The BPX-80 Bio-Pump consists of a housing and backplate, three smooth surface cones, a magnet, and a bearing/shaft assembly. The plastic components of the BPX-80 Bio-Pump are molded from polycarbonate. The joints are bonded with an ultraviolet light cured adhesive. The inlet port (3/8") is located at the top center of the Bio-Pump", and the outlet port (3/8") is located tangentially on the outer diameter. Notches on the backplate allow the BPX-80 Bio-Pump® to be securely locked onto the pump receptacle of the Bio-Console . The BPX-80 Bio-Pump is designed to be used only with Medtronic Bio-Medicus Bio-Consoles®
The BPX-80 Bio-Pump® centrifugal blood pump can be sterilized by either gamma radiation or ethylene oxide (EtO) gas. The Bio-Pump is also available with a heparin bonded (nonleaching) Carmeda® Bioactive Surface.
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)
In-vitro bench testing demonstrated that when compared to the predicate devices (BP-80 Bio-Pump and CBBP-80 Bio-Pump"), the BPX-80 Bio-Pump and CBBPX-80 Bio-Pump do not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed centrifugal blood pumps. The in-vitro bench testing included analysis of:
- Hydraulic Performance and Priming Volume Tests
- Chemical Resistance Tests
- Environmental Tests
- Carmeda® Coating Tests
- Complement Activation
- HIMA Hemolysis Testing
Biocompatibility testing of the BPX-80 Bio-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 Pharmacopoeia - XXIII.
Based on the results of the biocompatibility testing performed, the BPX-80 Bio-Pump was determined to be biocompatible and nontoxic and, therefore, safe for its intended use. Biocompatibility on the CBBPX-80 Bio-Pump has been substantiated by over 8 years of the Carmeda Bioactive Surface being applied to Cardiopulmonary bypass products, many of which have polycarbonate housing materials.
Sterilization of the BPX-80 Bio-Pump® has been validated to assure a sterility assurance level (SAL) of 10-6.
Gamma radiated Bio-Pumps® are sterilized in accordance with ANSI/AAMI/ISO 11137 - Method 1, Sterilization of Health Care Product Requirements for Validation and Routine Control - Radiation Sterilization.
EtO sterilized Bio-Pumps are 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 dissipation curves are used for routine product release to assure EtO sterilized Bio-Pumps meet 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
SUMMARY OF SAFETY AND EFFECTIVENESS
FEB 2 5 1998
510(k) SUMMARY
COMPANY NAME AND CONTACT PERSON
August 12, 1997
Medtronic Bio-Medicus Inc. 9600 West 76th Street Eden Prairie, MN 55344 tel. (612)944-7784 fax (612)944-7557
Thomas K. Johnsen Product Regulations Manager
DEVICE NAME
BPX-80 Bio-Pump®
COMMON NAME
Centrifugal Blood Pump
CLASSIFICATION NAME
Non-roller type cardiopulmonary bypass blood pump (21 CFR - 870.4360)
PREDICATE DEVICE OR LEGALLY MARKETED DEVICE
Medtronic Bio-Medicus, Inc. - BP-80 Bio-Pump® (K852698)
Medtronic Cardiopulmonary - CBBP-80 Bio-Pump® (K852698, K891687 and K896978)
1
DEVICE DESCRIPTION
The BPX-80 Bio-Pump centrifugal blood pump is a single use, disposable, non-pyrogenic device designed to move blood through the extracorporeal circuit by centrifugal force created by smooth rotating cones. Venous blood gravity drains into the inlet port of the Bio-Pump". The smooth cones rotate in the polycarbonate housing. As the cones rotate, energy in the form of pressure and velocity is transferred from the cones to the blood is gently accelerated toward the outlet of the pump. The Bio-Pump moves the blood through the circuit at a desired pressure and flow rate by increasing the speed of the rotating cones. This is accomplished by adjusting the Bio-Console's RPMs (revolutions per minute). Arterial blood is returned to the patient from the extracorporeal circuit.
The BPX-80 Bio-Pump consists of a housing and backplate, three smooth surface cones, a magnet, and a bearing/shaft assembly. The plastic components of the BPX-80 Bio-Pump are molded from polycarbonate. The joints are bonded with an ultraviolet light cured adhesive. The inlet port (3/8") is located at the top center of the Bio-Pump", and the outlet port (3/8") is located tangentially on the outer diameter. Notches on the backplate allow the BPX-80 Bio-Pump® to be securely locked onto the pump receptacle of the Bio-Console . The BPX-80 Bio-Pump is designed to be used only with Medtronic Bio-Medicus Bio-Consoles®
The BPX-80 Bio-Pump® centrifugal blood pump can be sterilized by either gamma radiation or ethylene oxide (EtO) gas. The Bio-Pump is also available with a heparin bonded (nonleaching) Carmeda® Bioactive Surface.
INTENDED USE
The Medtronic Bio-Medicus Bio-Pump® centrifugal blood pump is indicated for use only with the Medtronic Bio-Medicus Bio-Console to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc). . 我在
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2
TECHNOLOGICAL CHARACTERISTICS
The technological characteristics are identical to the BP-80 Bio-Pump®, with the exception of the following modifications; material change (acrylic to polycarbogate), dimensional change (internal dimensions of the port), and UV adhesive in place of solvent bond. The packaging material, sterilization methods/cycles, optional heparin bonding (Carmeda® Coating), drive magnet, bearing assembly, internal seal and component specifications are identical to the currently marketed BP-80 Bio-Pump®.
SUMMARY OF PERFORMANCE DATA
In-vitro Bench Testing:
In-vitro bench testing demonstrated that when compared to the predicate devices (BP-80 Bio-Pump and CBBP-80 Bio-Pump"), the BPX-80 Bio-Pump and CBBPX-80 Bio-Pump do not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed centrifugal blood pumps. The in-vitro bench testing included analysis of:
- Hydraulic Performance and Priming Volume Tests .
- Chemical Resistance Tests .
- Environmental Tests .
- Carmeda® Coating Tests .
- Complement Activation .
- HIMA Hemolysis Testing �
Biocompatibility:
Biocompatibility testing of the BPX-80 Bio-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 Pharmacopoeia - XXIII.
Based on the results of the biocompatibility testing performed, the BPX-80 Bio-Pump was determined to be biocompatible and nontoxic and, therefore, safe for its intended use. Biocompatibility on the CBBPX-80 Bio-Pump has been substantiated by over 8 years of the Carmeda Bioactive Surface being applied to Cardiopulmonary bypass products, many of which have polycarbonate housing materials.
નદ
3
Sterilization:
Sterilization of the BPX-80 Bio-Pump® has been validated to assure a sterility assurance level (SAL) of 10°.
Gamma radiated Bio-Pumps® are sterilized in accordance with ANSI/AAMI/ISO 11137 - Method 1, Sterilization of Health Care Product Requirements for Validation and Routine Control - Radiation Sterilization.
EtO sterilized Bio-Pumps are 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:
EtO dissipation curves are used for routine product release to assure EtO sterilized Bio-Pumps meet the limits for residual concentrations of ethylene oxide (