(128 days)
The Sarns® Centrifugal Pump with or without X-Coating™ is a sterile, single use device, used as an extracorporeal blood pump for use in cardiopulmonary bypass procedures for up to 6 hours. The pump is intended for use with the Sarns® Centrifugal Systems or may be used with Stöckert Centrifugal Pump Systems by attaching the Sarns® Centrifugal Pump Adapter.
The Sarns® Centrifugal Pump (with or without X-Coating™) is a single use, sterile and disposable device. It is used to pump blood through the extracorporeal circuit during cardiopulmonary bypass surgery and may be used for up to 6 hours. The pump has a priming volume of 48ml. The pump rotational speed is 0-3600 RPM resulting in a flow capacity of 0-9.9 LPM. With this submission, the sterile disposable Sarns® Centrifugal pump may be used with Stöckert Centrifugal pump systems when the reusable Sarns® Centrifugal Pump Adapter is used. The Sarns® Centrifugal Pump Adapter is a device designed with geometries that mate the Stöckert centrifugal systems to the Sarns® Centrifugal pump. The housing is a hard plastic (acetal) that slides easily onto the Sarns® Centrifugal pump then clips into place. The adapted pump is then mounted onto the Stöckert Centrifugal pump systems.
Here's a summary of the acceptance criteria and study information for the Sarns® Centrifugal Pump, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria/Test | Reported Device Performance |
|---|---|---|
| Flow Curves (performance of disposable pump with reusable adapter on Stöckert Centrifugal Pump System) | Back pressure ranges for proposed device configuration are within range of predicate device configuration. | PASS: Back pressure ranges for the proposed device configuration are within range of the predicate device configuration. |
| Reusable Sarns® Centrifugal Pump Adapter clip fatigue test (lifetime use of 7 years) | Clipping mechanism rated for lifetime use of 7 years. | PASS: The reusable adapter has passed test meeting the lifetime use of 7 years. |
| Reusable Sarns® Centrifugal Pump Adapter change out time test (comparison to predicate device) | Change out time of pump on proposed device configuration similar to predicate device configuration. | PASS: The change out time between the predicate device configuration and the proposed device configuration showed no statistical difference. |
| Shipping and Durability test (Sarns® Centrifugal Pump Adapter) | No signs of damage after shipment and functions as intended. | PASS: Sarns® Centrifugal Pump Adapter showed no signs of damage and functioned as intended following testing. |
| Hemolysis test (effect on plasma free hemoglobin, white blood cell count, platelet count with/without reusable adapter) | No statistical difference in effect on plasma free hemoglobin, white blood cell count, and platelet count. | PASS: No adverse statistical differences found between plasma free hemoglobin, white blood cell count and platelet count while using the sterile disposable Sarns® Centrifugal Pump with or without adapter. |
| Reusable Sarns® Centrifugal Pump Adapter disconnection force (comparison to predicate device) | Force necessary to disconnect proposed device (with adapter) is similar or stronger than disconnecting from predicate. | PASS: The average disconnection force required to separate the Sarns® Centrifugal Pump from the reusable Sarns® Centrifugal Pump Adapter was greater than the force required to separate the predicate Sarns® Centrifugal Pump. |
| Reusable Sarns® Centrifugal Adapter, Interaction with the Sorin Heart Lung Machine (interference with control and safety components of Stöckert system) | Usage of reusable Sarns® Centrifugal Pump Adapter does not interfere with control and safety components of the Stöckert system. | PASS: Usage of the reusable Sarns® Centrifugal Pump Adapter did not interfere with control and safety components of the Stöckert system. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each test. The studies appear to be prospective in nature, as they involve testing the "proposed device" configuration against "predicate device" configurations or established standards. There is no information regarding the country of origin of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The studies described are engineering and performance validation tests, not clinical evaluations requiring expert interpretation of medical images or data to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. The studies described are engineering and performance validation tests with objective pass/fail criteria, not clinical evaluations requiring adjudication from multiple experts.
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:
Not applicable. This is a medical device (centrifugal pump) and not an AI-powered diagnostic or assistive technology that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a mechanical pump, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for these tests is based on pre-defined performance standards, technical specifications, and comparisons to the legally marketed predicate device's established performance. For example:
- Flow curves: Comparison to predicate device's established flow characteristics.
- Clip fatigue: Designed lifetime use specification (7 years).
- Change out time: Statistical similarity to predicate device's change out time.
- Shipping and durability: Absence of damage and intended function, likely against internal or industry standards.
- Hemolysis: Absence of statistical difference in blood parameters compared to performance without the adapter.
- Disconnection force: Greater than or similar to predicate device.
- Interaction with HLM: No interference with control and safety components.
8. The sample size for the training set:
Not applicable. This device does not use machine learning or AI, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of 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.