(16 days)
The LifeSPARC System is intended 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.
The LifeSPARC Pump is a sterile, single-use, low prime volume centrifugal pump with an integrated motor and a single-point, pivot bearing. It is sterilized using ethylene oxide (EO) and sized to fit in the palm of the hand or to secure to the patient.
The LifeSPARC Controller provides the interface between pump and user, as well as the power and electrical signals to drive the pump. It is a microprocessor-based electromechanical pump drive system designed to operate on standard AC current (100/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport.
The provided text describes a 510(k) premarket notification for the LifeSPARC System, which is a nonroller-type blood pump used for cardiopulmonary bypass. The submission is a software update to an already cleared device, and thus the focus is on testing related to software and electromagnetic compatibility.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria or specific reported device performance metrics in a table format. It generally states that "Testing of the LifeSPARC Controller demonstrates that no concerns regarding safety and effectiveness result from the changes and updates to the technology; specifically, test data is provided regarding Software and Electromagnetic Compatibility." This implies the device met the necessary standards for these aspects.
| Acceptance Criteria Category | Reported Device Performance (Implied) |
|---|---|
| Software | No concerns regarding safety and effectiveness. |
| Electromagnetic Compatibility | No concerns regarding safety and 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 does not provide details on the sample size used for the test set or the data provenance. It only mentions "test data is provided regarding Software and Electromagnetic Compatibility" implying a test set was used but without specifying its characteristics.
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 document. Software and electromagnetic compatibility testing typically rely on engineering specifications and compliance standards rather than expert medical consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Given the nature of the testing (software and EMC), an adjudication method in the medical context (like for image interpretation) would not be applicable.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI systems that assist human readers in tasks like image interpretation, which is not the function of the LifeSPARC System. This submission is for a software update to a mechanical blood pump, focusing on its safe and effective operation, not its diagnostic or interpretative capabilities.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document implies that standalone testing was performed for the software and electromagnetic compatibility aspects of the device. The "Testing of the LifeSPARC Controller demonstrates that no concerns..." suggests the algorithm's performance was evaluated independently against predefined criteria.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For software testing, the ground truth would typically be the expected functional behavior and performance defined by engineering specifications and industry standards for medical device software. For Electromagnetic Compatibility, the ground truth is compliance with relevant EMC standards (e.g., IEC 60601-1-2).
8. The sample size for the training set
The document does not mention a "training set" because this is not an AI/ML-driven device in the context of learning from data. The software update is likely a deterministic program, not a model trained on a dataset.
9. How the ground truth for the training set was established
As there is no mention of a training set for an AI/ML model, this question is not applicable to the information provided. The ground truth for the device's functionality would be established through its design specifications and validated through testing.
§ 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.