(195 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 centrifygal 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.
This document is a 510(k) summary for the LifeSPARC System, a non-roller-type blood pump used for cardiopulmonary bypass. It compares the LifeSPARC System to its predicate device, the TandemHeart System (K110493).
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance (LifeSPARC System) |
|---|---|
| Pressure-Flow operating envelope within TandemHeart Pump. | Performs at all points within the pressure-flow operating envelope of the TandemHeart Pump. |
| Blood damage (hemolysis) at equivalent rates to TandemHeart Pump. | Produces blood damage (hemolysis) at equivalent rates to the predicate TandemHeart Pump. |
| Reliable for the intended duration of use. | Reliable for the intended duration of use. |
| Biocompatible for the intended duration of use. | Biocompatible for the intended duration of use. |
| Supplied sterile with a Sterility Assurance Level (SAL) of $10^{-6}$. | Supplied sterile with a SAL of $10^{-6}$. |
| Software, Usability, Alarms, Electrical Safety, and Electromagnetic Compatibility show no safety/effectiveness concerns. | Test data provided for Software, Usability, Alarms, Electrical Safety, and Electromagnetic Compatibility demonstrate no concerns regarding safety and effectiveness from design changes. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state sample sizes for specific tests. It refers to "test data," "pressure-flow test data," and "testing of the LifeSPARC Controller," implying that these tests were conducted by the manufacturer as part of the device development and validation. The data provenance is internal to CardiacAssist, Inc. (dba TandemLife) and is prospective testing performed on the LifeSPARC System to demonstrate its equivalence to the predicate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. For non-clinical validation studies of medical devices like blood pumps, ground truth is typically established through recognized engineering standards, established test methodologies, and comparison to the performance of a legally marketed predicate device rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set:
This information is not provided. Given the nature of the non-clinical testing (e.g., pressure-flow, hemolysis, electrical safety), an adjudication method as typically used in clinical trials with human readers/assessors would not be applicable. The "adjudication" is essentially the direct measurement and comparison of performance parameters against established benchmarks or predicate device data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation where human readers are involved. The LifeSPARC System is a physical medical device (blood pump), and its performance is evaluated through engineering and biocompatibility testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The concept of "standalone performance" typically applies to AI algorithms. The LifeSPARC System is a physical device with some software components in its controller. The testing described (e.g., pressure-flow, hemolysis, electrical safety) evaluates the device's inherent performance. The "updated software/user interface technology" of the controller was tested for safety and effectiveness, but this isn't analogous to standalone AI algorithm performance.
7. The Type of Ground Truth Used:
The ground truth for the device's performance is established by:
- Engineering Standards and Benchmarks: For parameters like electrical safety, electromagnetic compatibility, and sterilization.
- Predicate Device Performance Data: For key performance characteristics directly comparable to the predicate TandemHeart System, such as pressure-flow characteristics and hemolysis rates. The predicate device's performance serves as the benchmark for "substantial equivalence."
- Biocompatibility Standards: To ensure the materials in contact with blood are safe.
8. The Sample Size for the Training Set:
This information is not applicable. The LifeSPARC System is a hardware device with embedded software; it is not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for such a system would involve its design, engineering, and manufacturing processes.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no "training set" in the context of AI/ML for this device. The development and validation of the device rely on established engineering principles, regulatory standards, and comparison to the predicate 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.