(120 days)
The Levitronix CentriMag Back-Up Console is indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System and as a back-up to the CentriMag Primary Console. The 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 unloading of the ventricle during surgery of the vena cava or aorta, liver transplants etc).
The Levitronix CentriMag Back-Up Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in calculations and alarms. An alphanumeric screen is used to display monitored data. The CentriMag Back-Up Console uses single phase AC power and is capable of a flow rate of up to one of eld replaceable internal battery. In addition, each Back-Up Console contains a non-rechargeable, field replaceable internal battery that is capable of maintaining Back-Up Console functionality in the event of a loss of AC Power.
Here's an analysis of the provided text regarding the Levitronix CentriMag Back-Up Console, focusing on the requested aspects of acceptance criteria and study details.
Important Note: The provided text is a 510(k) summary for a medical device. These summaries are designed to establish "substantial equivalence" to a predicate device, not necessarily to provide detailed clinical trial data. Therefore, many of the requested data points (like specific sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, effect sizes, and detailed ground truth establishment for training) are not present in this type of document. The focus here is on demonstrating that the device performs similarly to a previously cleared device.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are implicitly met by demonstrating "substantial equivalence" to the predicate device in terms of functional characteristics. The "reported device performance" is a general statement of equivalency rather than specific metrics.
| Acceptance Criteria Category | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Overall Performance & Safety | The device must be "substantially equivalent" to the predicate device (Levitronix CentriMag Console, K020271) regarding indications for use, materials, design features, and functional characteristics. It should raise no new safety or effectiveness issues. | "The Levitronix CentriMag Back-Up Console has indications for use which are substantially equivalent to the predicate device, is composed of the same or equivalent materials as the predicate device, has equivalent design features as the predicate device, and has functional characteristics which are the same or equivalent to those of the predicate device. Due to the equivalency... the device raises no new safety or effectiveness issues." |
| Functional Characteristics | Must have functional characteristics "the same or equivalent to those of the predicate device." Differences are limited to flow and pressure capabilities and associated alarm schemes but ultimately must not impact substantial equivalence. (Implied: The back-up console's motor control, sensor monitoring, display outputs, and alarm functions perform as expected). | "The performance characteristics of the Levitronix CentriMag Back-Up Console were tested and compared with the commercially available predicate device." (No specific metrics provided, but implies satisfactory comparison). |
| Power & Battery Functionality | Must use single phase AC power and capable of a flow rate of up to one [unit not specified, likely referring to flow through the system] - though this seems to be a typo for "flow rate up to a certain maximum." Must also contain a non-rechargeable, field-replaceable internal battery capable of maintaining functionality upon loss of AC power. | "The CentriMag Back-Up Console uses single phase AC power... Console contains a non-rechargeable, field-replaceable internal battery that is capable of maintaining Back-Up Console functionality in the event of a loss of AC Power." |
| Technological Characteristics | Must have technological characteristics similar to the predicate device, with differences limited to "flow and pressure capabilities and associated alarm scheme" that do not impact substantial equivalence. | "The Levitronix CentriMag Back-Up Console has technological characteristics similar to the predicate device. The differences between the proposed capabilities and associated alarm scheme are limited to flow and pressure capabilities and associated alarm scheme." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. The summary only states that "The performance characteristics... were tested and compared with the... predicate device."
- Data Provenance: Not explicitly stated. Given it's a 510(k) for a device like a pump console, testing would typically involve bench testing and possibly animal or in-vitro models to compare performance characteristics. Clinical human data is not generally required for a 510(k) unless there are significant differences that raise new safety or effectiveness concerns. The summary does not mention any human or clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the 510(k) summary. For device performance testing of this nature (comparing functional characteristics), "ground truth" would likely refer to established engineering specifications, performance standards for the predicate device, or measurements obtained from gold-standard testing equipment, rather than expert consensus on interpretive data.
4. Adjudication Method for the Test Set
- This information is not provided as the type of study described (comparison of device performance characteristics) does not typically involve expert adjudication in the way medical imaging or diagnosis studies do.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., radiology images). The Levitronix CentriMag Back-Up Console is a cardiopulmonary bypass pump console, not a diagnostic imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, in spirit, standalone performance was assessed. The testing described is intrinsic device performance ("performance characteristics... were tested and compared"). While the device assists human clinicians, its core function is automated (microprocessor control, sensor monitoring, alarm generation). The "standalone" testing here refers to the device operating according to its design specifications, not necessarily an AI algorithm. There is no mention of a human-in-the-loop study to evaluate its effectiveness.
7. The Type of Ground Truth Used
- Engineering Specifications / Established Performance of Predicate Device: The ground truth for this type of device comparison would be the independently verified performance specifications of the predicate device and the engineering requirements established for the new device. For example, if the predicate device has a specified flow rate accuracy, the new device would be tested against that established accuracy. The summary states, "The performance characteristics of the Levitronix CentriMag Back-Up Console were tested and compared with the commercially available predicate device." This implies the predicate's performance serves as the "ground truth" or benchmark.
8. The Sample Size for the Training Set
- This information is not applicable/not provided. The device described is a hardware medical device with microprocessor control, not a machine learning or AI-driven system that would typically have a "training set" in the computational sense. Its functionality is based on programmed logic and physics, not trained on data.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable/not provided for the same reasons as #8.
§ 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.