(421 days)
The Levitronix CentriMag® Extracorporeal Blood Pumping System is indicated 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.q., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).
System - The Levitronix CentriMag® Extracorporeal Blood Pumping System is a fault-tolerant system comprised of four (4) main assemblies which are available separately:
- Blood Pump
- Remote Motor Drive Unit
- Control Console
- Ultrasonic Flow Sensor
Blood Pump - The Levitronix CentriMag® Extracorporeal Blood Pump is a sterile, single-use, disposable, non-pulsatile, non-roller pump that utilizes a rotor to impart energy to the blood in an extracorporeal circuit through centrifugal forces. The inlet to the pump runs concentric with the axis of the rotor. The outlet of the pump is perpendicular to the inlet and tangent to the outer diameter. Blood enters the pump housing via the pump's inlet port where it makes contact with the rotor. As the rotor turns, energy in the form of pressure and velocity is transferred from the rotor to the blood. The CentriMag® Extracorporeal Blood Pump moves the blood through the circuit at a desired pressure and flow rate by increasing or decreasing the speed of the rotor. This is accomplished by adjusting the The pump operates from the Levitronix Remote Motor Drive Unit and microprocessor-based console, located outside the sterile field.
Remote Motor Drive Unit - The CentriMag® Motor Drive Unit is positionable on an IV pole/mast or adjacent to the console using an optional utility post. The Motor Drive Unit holds the disposable blood pump and drives the rotor inside the blood pump.
Control Console - The Levitronix CentriMag Console is a microprocessorbased device, which drives and controls the speed of the blood pump in the extracorporeal circuit. The console also provides monitoring of motor speed, fluid flow, and pressure through the use of alphanumeric display, audible alarms and visible alarms.
Ultrasonic Flow Sensor - The Levitronix CentriMag® Extracorporeal Blood Pumping System includes an ultrasonic flow meter.
The provided text outlines the safety and effectiveness of the Levitronix CentriMag® Extracorporeal Blood Pumping System, focusing on its substantial equivalence to predicate devices rather than establishing specific acceptance criteria for a novel device performance. Therefore, a direct table of "acceptance criteria and reported device performance" as typically seen for AI/ML device evaluations is not explicitly present.
However, based on the narrative, the device's performance was evaluated through in-vitro bench testing and compared against established internal performance specifications and the performance of predicate devices. The primary goal was to demonstrate substantial equivalence to existing legally marketed devices.
Here's an attempt to structure the information based on your request, with an understanding that the original document is a traditional 510(k) summary for a non-AI/ML device, focusing on equivalence rather than detailed performance metrics against quantitative acceptance criteria for a new clinical claim:
Acceptance Criteria and Study Details for Levitronix CentriMag® Extracorporeal Blood Pumping System
The Levitronix CentriMag® Extracorporeal Blood Pumping System's acceptance criteria and performance were primarily established through substantial equivalence to predicate devices and adherence to relevant standards and internal specifications, as detailed in the K020271 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a non-AI/ML device demonstrating substantial equivalence, explicit quantitative acceptance criteria with corresponding reported performance metrics are not detailed in the same manner as for novel performance claims. Instead, the "acceptance criteria" are implied by the demonstration of:
- Technological Characteristics similar to predicate devices.
- Functional Characteristics the same or equivalent to predicate devices.
- Safety and Effectiveness not significantly affected compared to predicate devices.
- Compliance with relevant standards and guidance documents (e.g., software validation, biocompatibility, sterilization).
| Acceptance Criteria Category | Implied Criterion | Reported Device Performance |
|---|---|---|
| Overall Equivalence | Substantial equivalence to predicate devices (Bio-Pump, Model BPX-80, and Bio-Console, Model 550) in terms of indications for use, materials, design features, and functional characteristics. | "The Levitronix CentriMag® Extracorporeal Blood Pumping System is believed to be substantially equivalent to the following predicate devices..." and "In-Vitro bench testing demonstrates that when compared to the predicate devices (BPX-80 Bio-Pump), the Levitronix CentriMag® Extracorporeal Blood Pump does not significantly affect safety and effectiveness and is substantially equivalent to other commercially distributed centrifugal blood pumps." |
| In-Vitro Bench Testing | Performance comparable to predicate devices and Levitronix performance specifications. | "The performance characteristics... were tested and compared with Levitronix performance specifications established for the system and with commercially available predicate devices." No specific quantitative metrics reported in the summary but stated to be comparable. |
| Software Validation | Validation and verification in accordance with FDA Guidance. | "Software on-board the CentriMag® Console was validated and verified in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." |
| Biocompatibility | Biocompatibility and non-toxicity for intended use. | "Biocompatibility testing... performed in accordance with FDA Blue Book Memorandum - #395-1 and Biological Evaluation of Medical Devices Guidance - International Standard ISO 10993-1, and in accordance with United States Pharmacopoeia - XXIII." Results: "determined to be biocompatible and non-toxic and, therefore, safe for its intended use." |
| Sterilization | Sterility Assurance Level (SAL) of 10⁻⁶. | "Sterilization... has been validated to assure a sterility assurance level (SAL) of 10⁻⁶. EtO sterilized... in accordance with... ANSI/AAMI/ISO 11135-1994." |
| EtO Residuals | Meet specified limits for residual concentrations. | "EtO dissipation curves are used for routine product release to assure EtO sterilized CentriMag® Extracorporeal Blood Pumps meet the limits for residual concentrations of ethylene oxide (40 cc/min. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The primary "test set" was the Levitronix CentriMag® Extracorporeal Blood Pumping System itself, and its performance was evaluated through in-vitro bench testing.
- Sample Size: The document does not specify the number of devices or experimental replicates used in the in-vitro bench testing.
- Data Provenance: The testing was conducted internally by Levitronix, LLC. The provenance of the predicate device performance data used for comparison is not specified (e.g., publicly available specifications, internal testing of predicate devices). The data is retrospective in the sense that it evaluates the manufactured device against existing standards and predicate devices. No human patient data (prospective or retrospective) was used for performance evaluation as "Clinical testing was not performed on this system."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Ground Truth Establishment: This concept is not applicable in the context of this 510(k) submission. The "ground truth" for device performance (e.g., flow rate accuracy, pressure resistance, biocompatibility) is established by physically testing the device against defined engineering specifications, industry standards (e.g., ISO, USP, FDA guidance), and the known performance of predicate devices. It does not involve expert consensus on medical findings.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Performance testing for this type of device (e.g., durability, flow rates, pressure resistance, biocompatibility) is measured objectively and quantitatively against specifications, not through expert review and adjudication.
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
- MRMC Study: No. This study is not relevant as the device is a medical pump system, not an AI-based diagnostic or assistive technology for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the context of AI/ML algorithms. The "standalone performance" of the device refers to its physical and functional operation (e.g., pumping blood, monitoring flow, maintaining pressure) as an electromechanical system, which was evaluated through in-vitro bench testing. The console itself is microprocessor-based and governs the pump's operation.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the various performance aspects (e.g., safety, effectiveness, biocompatibility, sterilization, functional ranges) consists of:
- Engineering Specifications: Internal performance specifications established by Levitronix.
- Regulatory Standards: Compliance with FDA guidance (e.g., software validation, biocompatibility), international and national standards (e.g., ISO 10993-1, ISO 11135-1994, ISO 10993-7, ANSI/AIMI, USP XXIII), and FDA guidelines for residuals and pyrogens.
- Predicate Device Performance: The established operating characteristics and safety profiles of the legally marketed predicate devices (Medtronic Bio-Pump, Model BPX-80 and Medtronic Bio-Console, Model 550) serve as a benchmark for equivalence.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is not an AI/ML system that requires a "training set" in the computational sense. Its design and operational parameters are based on established engineering principles, fluid dynamics, and medical device regulations.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for an AI/ML algorithm involved. The "ground truth" for the device's design and manufacturing (analogous to a training process for an AI) is implicitly established through decades of engineering best practices for similar medical devices, adherence to quality systems (e.g., 21 CFR Part 820 Good Manufacturing Practice requirements), and the foundational knowledge of cardiovascular support systems.
§ 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.