Search Results
Found 1 results
510(k) Data Aggregation
(196 days)
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).
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.
Here's an analysis of the acceptance criteria and the study that demonstrates the device meets them, based on the provided text:
BPX-80 Bio-Pump® Centrifugal Blood Pump
This document describes the safety and effectiveness summary for a medical device submitted for 510(k) clearance, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device (i.e., substantially equivalent). The approval is based on demonstrating substantial equivalence, not necessarily meeting stringent, pre-defined acceptance criteria for novel devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a discrete table of acceptance criteria with specific numerical targets. Instead, it demonstrates substantial equivalence by comparing the BPX-80 Bio-Pump to predicate devices (BP-80 Bio-Pump and CBBP-80 Bio-Pump) across various in-vitro tests and demonstrating compliance with established standards for biocompatibility and sterilization. The "acceptance criteria" are implied by the performance of the predicate devices and relevant industry standards.
| Acceptance Criteria (Implied) | Reported Device Performance (BPX-80 Bio-Pump) |
|---|---|
| Substantial Equivalence to Predicate Devices | In-vitro bench testing demonstrated that 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, specifically the BP-80 Bio-Pump and CBBP-80 Bio-Pump. |
| Hydraulic Performance (comparable to predicate) | Included in "In-vitro Bench Testing," implying comparable performance to predicate devices. |
| Priming Volume (comparable to predicate) | Included in "In-vitro Bench Testing," implying comparable performance to predicate devices. |
| Chemical Resistance (adequate for intended use) | Included in "In-vitro Bench Testing," implying acceptable resistance with new polycarbonate material. |
| Environmental Performance (adequate for intended use) | Included in "In-vitro Bench Testing," implying acceptable performance. |
| Carmeda® Coating Performance (if applicable) | Included in "In-vitro Bench Testing." For CBBPX-80 Bio-Pump, biocompatibility of Carmeda® surface substantiated by over 8 years of use on similar products with polycarbonate housings. |
| Complement Activation (acceptable levels) | Included in "In-vitro Bench Testing," implying acceptable levels. |
| Hemolysis (HIMA standard compliant) | "HIMA Hemolysis Testing" conducted, implying compliance with HIMA standards. |
| Biocompatibility (non-toxic, safe for intended use) | Determined to be biocompatible and nontoxic and, therefore, safe for its intended use, in accordance with FDA Blue Book Memorandum - #G95-1, ISO 10993-1, and USP - XXIII. |
| Sterility Assurance Level (SAL) (10⁻⁶) | Sterility validated to assure a SAL of 10⁻⁶. Gamma sterilization in accordance with ANSI/AAMI/ISO 11137. EtO sterilization in accordance with ANSI/AAMI/ISO 11135-1994. |
| EtO Residuals (<25ppm EO, <25ppm ECH, <250ppm EG) | Routine product release assures EtO sterilized Bio-Pumps meet the limits for residual concentrations of ethylene oxide (<25ppm), ethylene chlorohydrin (<25ppm), and ethylene glycol (<250ppm) as published in ANSI Standard Number ANSI/AAMI/ISO 10993-7. |
| Pyrogens (<0.5 EU/ml) | Routine Pyrogen Testing performed using the LAL method, with product testing and release criteria less than 0.5 EU/ml in accordance with December 1987 FDA Guideline. |
Summary of Study:
The study was primarily an in-vitro bench testing and biocompatibility assessment comparing the modified BPX-80 Bio-Pump to its predicate devices. The modifications were material change (acrylic to polycarbonate), dimensional change (internal port dimensions), and UV adhesive in place of solvent bond. The study aimed to demonstrate that these changes did not negatively impact the safety and effectiveness, thus maintaining substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify exact sample sizes for each in-vitro test (e.g., number of pumps tested for hydraulic performance). It broadly states "In-vitro bench testing" was conducted.
- Data Provenance: The studies were conducted by Medtronic Bio-Medicus Inc. and are presumed to be prospective testing of the BPX-80 Bio-Pump and CBBPX-80 Bio-Pump. The country of origin for the data is not explicitly stated but is implied to be the United States, given the company's location (Eden Prairie, MN) and FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of submission (510(k) for a mechanical device) does not typically involve "experts" establishing a "ground truth" in the way an AI diagnostic device would. Instead, the "ground truth" for the performance metrics is established by recognized engineering and biological standards and the performance of the predicate device.
- No specific number of human "experts" with medical qualifications (like radiologists) were used to establish ground truth for this device's performance tests. The evaluation relies on established scientific methods and adherence to regulatory standards.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation of medical images or data requiring adjudication. The tests performed are objective laboratory measurements and adherence to specified standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human reader performance is a key metric. The BPX-80 Bio-Pump is a mechanical blood pump.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance assessment was conducted in the sense that the device's technical specifications and performance were evaluated intrinsically without human intervention in its operation for the purpose of the tests described (e.g., hydraulic performance, biocompatibility). It's an "algorithm" in the sense of the physical properties and design of the pump, tested on its own.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Performance of Legally Marketed Predicate Devices: The BP-80 Bio-Pump and CBBP-80 Bio-Pump, which set the standard for "substantially equivalent" performance.
- Established Industry Standards and Regulations: Such as FDA Blue Book Memorandum - #G95-1, ISO 10993-1, USP - XXIII for biocompatibility, ANSI/AAMI/ISO 11137 and 11135-1994 for sterilization, ANSI/AAMI/ISO 10993-7 for EtO residuals, HIMA standards for hemolysis, and FDA guidelines for pyrogen testing.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical blood pump, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1