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510(k) Data Aggregation
(196 days)
BPX80 BIO-PUMP (BPX80)
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 ( |
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