(245 days)
The COBE® REVOLUTION™ Centrifugal Blood Pump is intended to be used with a Stöckert Instrumente GmbH Centrifugal Pump console in cardiopulmonary bypass procedures for periods of up to six hours. The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., greater than six hours) as a bridge to transplant, for pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.
The COBE® Revolution™ Centrifugal Blood Pump is an extracorporeal blood pump that utilizes a rotating vaned impeller design to move blood by centrifugal force. The device is provided sterile with a nonpyrogenic fluid pathway, and is for single use only. It is indicated for use with a Stockert Instrumente GmbH Centrifugal Pump console in cardiopulmonary bypass procedures for periods of up to six hours. The device has not been qualified for longterm use (greater than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO). The Revolution Pump consists of a rotating vaned impeller within a pump housing. The pump housing has two components, a top and bottom case, and features a central, single-barbed, 3/8" inlet port and tangential, double-barbed, 3/8" outlet port. The vaned impeller is molded onto a steel shaft that supports it at its axis of rotation, with the shaft rotating on a bearing at each end. The device contains a multi-pole magnet that is fully enclosed within the magnet housing and thus does not contact the blood pathway. The magnet is designed to magnetically couple with the pump drive unit of the Stockert Instrumente GmbH Centrifygal Pump console. Rotation of the magnet causes the impeller to rotate and pump blood via centrifugal force.
The provided 510(k) summary (K011835) describes a medical device, the COBE® Revolution™ Centrifugal Blood Pump, and its claim of substantial equivalence to a predicate device, the Medtronic BP-80 BioPump® Centrifugal Blood Pump. However, it does not contain information about a study with specific acceptance criteria and detailed device performance metrics in the way that would typically be presented for an AI/ML powered device.
Instead, the submission focuses on comparing the technical characteristics of the new device to the predicate device to demonstrate substantial equivalence, which is a different type of evaluation. The "in-vitro test data" mentioned merely supports the claim of substantial equivalence, not a detailed performance study against specific acceptance criteria for an AI algorithm.
Therefore, many of the requested sections (2-7, 9) cannot be answered from the provided text as they pertain to AI/ML device studies that are not present.
Here's an attempt to answer the questions based only on the provided text, highlighting what information is available and what is not:
Acceptance Criteria and Study Information (Based on K011835)
This 510(k) submission establishes the substantial equivalence of the COBE® Revolution™ Centrifugal Blood Pump to the Medtronic BP-80 BioPump® Centrifugal Blood Pump. The "acceptance criteria" here are implicitly related to demonstrating that the new device performs comparably to the predicate device across critical functional and design parameters, rather than meeting specific performance thresholds for an AI algorithm.
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly state "acceptance criteria" in the format of predefined thresholds for performance metrics. Instead, it compares the characteristics of the new device to the predicate. The "reported device performance" is essentially the listed characteristics of the COBE Revolution Pump. The underlying acceptance criterion for the 510(k) process is "substantial equivalence" to the predicate.
| Parameter | Acceptance Criteria (Implicit: Comparable to Medtronic BP-80) | Reported COBE Revolution Pump Performance | Predicate Device (Medtronic BP-80) Performance |
|---|---|---|---|
| Priming Volume | Should be comparable to or within acceptable clinical range of predicate | 57 ml | 80 ml |
| Maximum Blood Flow Rate | Should be comparable to or within acceptable clinical range of predicate | 8 liters/minute | Not specified (for predicate) |
| Maximum Operating Pressure | Should be comparable to or within acceptable clinical range of predicate | 800 mm Hg | 900 mm Hg |
| Impeller Design | Not a direct numerical comparison; design explanation provided | Rotating vaned impeller | Vaneless rotating cones |
| Bearing Design | Not a direct numerical comparison; design explanation provided | No seals | Sealed bearings |
| Motor Interface | Should be functionally equivalent | Magnetic coupling | Magnetic coupling |
| Inlet/Outlet Port Diameters | Should be identical for compatibility | 3/8 inch | 3/8 inch |
| Sterilization Method | Should be an established and validated method | Ethylene Oxide | Gamma Radiation |
Note: The implicit acceptance criteria for substantial equivalence mean that the differences in these parameters should not raise new questions of safety or effectiveness.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "In-vitro test data" but does not specify the sample size, data provenance, or whether the study was retrospective or prospective. It is an in-vitro comparison, not a clinical study with patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the 510(k) summary. The "ground truth" for this type of device comparison would be established engineering and performance standards, not expert evaluation of AI output.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study was conducted or reported in this 510(k) submission, as it is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the established performance characteristics of the predicate device and engineering standards for blood pumps. It is not dependent on expert consensus, pathology, or outcomes data in the way an AI/ML diagnostic or prognostic device would be.
8. The sample size for the training set
Not applicable, as this is not an AI/ML powered device and therefore has no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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.