(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 ( |
§ 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.