(274 days)
The PediMag Blood Pump is indicated for use with the CentriMag Console and Motor to pump blood through a complete extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours) for surgical procedures such as a mitral valve reoperation. It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, surgery of the vena cava or aorta, liver transplants etc.).
The PediMag Pump can generate a maximum pump flow equal to 1.5 liters per minute, limiting its use to pediatric patients.
The Levitronix PediMag Blood Pump is indicated for use only with the Levitronix CentriMag Console and Motor.
The PediMag Blood Pump is a sterile, single-use, disposable, non-coated, polycarbonate centrifuqal blood pump. The pump has a 14 ml priming volume. The pump inlet is on the rotational axis of the impeller whereas the pump outlet is perpendicular to the inlet and tangent to the outer diameter. Both the inlet and outlet ports include standard 1/4 inch barbed connectors for easy mating to standard medical grade 1/4 inch tubing. The Pump is designed to move blood by centrifuqal force created by the magnetically suspended rotating impeller.
The acceptance criteria and study details for the Levitronix PediMag Blood Pump are as follows:
The provided document is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance acceptance criteria in the way one might for a novel diagnostic algorithm. The primary "acceptance criteria" here are that the device performs functionally as expected and is substantially equivalent to existing predicate devices regarding safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional equivalence to predicate devices | "The Levitronix PediMag Blood Pump has successfully undergone functional testing demonstrating substantial equivalence to the predicate devices." (Section H. Summary of Performance Data) |
| Technological Characteristics | "The technological characteristics of the Levitronix PediMag Blood Pump are the same as the predicate devices." (Section F. Technological Characteristics) |
| Safety and Effectiveness Issues | "The device raises no new safety or effectiveness issues." (Section G. Comparison to Predicate Devices) |
| Intended Use | Matches the intended use of predicate devices, specified for "extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours)" and other extracorporeal support systems up to six hours, with a maximum pump flow suited for pediatric patients. |
2. Sample Size Used for the Test Set and Data Provenance:
No specific "test set" or patient data is mentioned. The submission relies entirely on functional testing of the device itself and comparison to predicate devices, without clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. No clinical test set or expert ground truth was established as the submission relies on functional testing and substantial equivalence, not clinical performance data.
4. Adjudication Method for the Test Set:
Not applicable. No clinical test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No. Clinical testing was explicitly not performed on this system: "Clinical testing was not performed on this system." (Section I. Clinical Performance). Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. This device is a blood pump, not an AI algorithm. Its performance is intrinsic to the device's mechanical and fluid dynamics, not algorithmic output.
7. The Type of Ground Truth Used:
For the functional testing, the "ground truth" would implicitly be engineering specifications and established performance characteristics of the predicate devices. For example, a flow rate measurement would be compared against a target flow rate or the known performance range of predicate devices.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable. No training set was used.
§ 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.