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510(k) Data Aggregation
(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.
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(304 days)
The 3M™ Sarns™ Centrifugal Pumps with Duraflo® II Treatment are indicated as extracorporeal pumps for use in cardiopulmonary bypass procedures only and for use exclusively with Sams™ centrifugal control systems.
The Sarns™ Centrifygal Pump is a centrifugal pump which imparts velocity to blood through action of a rotating impeller. The pump is comprised of two chambers. The pump chamber contains the impeller with vanes, seals components, inlet port and outlet port for connection to tubing. The rear chamber contains bearings used to support and align the magnet rotor. The rear chamber is sealed off from the pump chamber. The rear chamber is isolated from atmosphere via a hermetic seal of the housing components forming this chamber. The Duraflo® II Treatment provides a heparin-based blood path containing up to 400 USP units of heparin. This treatment improves the blood compatibility of non-biological surfaces in the extracorporeal circuit.
This document describes a 510(k) summary for the 3M™ Sarns™ Centrifugal Pump with Duraflo® II Treatment. It does not describe an AI/ML device or its performance characteristics, but rather a medical device and its physical and biological performance. Therefore, many of the requested fields are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Blood Compatibility | Hemolysis | Not explicitly stated as a numerical threshold, but implied to be within acceptable ranges based on predicate and previous testing. | "some change noted in hemolysis between the two groups" but "results are in line with results from previous centrifugal pump testing at worst case conditions." |
| Platelet Depletion | No statistical difference between coated and uncoated units. | "no statistical difference in %PLT depletion...between the coated and uncoated units." | |
| White Blood Cell Depletion | No statistical difference between coated and uncoated units. | "no statistical difference...in average % WBC depletion between the coated and uncoated units." | |
| Heparin Leaching | Not explicitly stated, but implied to be within safe/effective levels. | Results were satisfactory (implicit, as no adverse findings are noted). | |
| Heparin Quantitation | Not explicitly stated, but implied to be within desired range for the "up to 400 USP units of heparin" treatment. | Results were satisfactory (implicit, as no adverse findings are noted). | |
| Functional Performance | 12-hour Life Test | Device must pass the test (remain functional). | "All Duraflo® II treated pumps passed these tests." |
| Burst Test | Device must pass the test (withstand over-pressurization without failure). | "All Duraflo® II treated pumps passed these tests." |
2. Sample size used for the test set and the data provenance
- Hemolysis, Platelet Depletion, White Blood Cells, Heparin Leaching, Heparin Quantitation: The specific sample sizes for these in vitro tests are not explicitly stated. The text mentions a comparison to "a study that was conducted in early 1995 on the predicate device (K915363)," suggesting the data is retrospective in the sense of comparing against historical predicate data. The provenance is likely internal testing by the manufacturer.
- 12-hour Life Test: n=16
- Burst Test: n=16
- Data Provenance: The tests are described as in vitro studies conducted by the manufacturer. No country of origin is specified for the data, but it's generated by the company (Baxter Healthcare Corporation, Bentley Division, Irvine, California).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device performance study, not an AI/ML study requiring expert ground truth establishment for a diagnostic output. The ground truth for this device's performance is derived from physical and biological measurements against predefined test protocols.
4. Adjudication method for the test set
Not applicable. This is a medical device performance study, not an AI/ML study requiring human adjudication of results.
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 performance study for a physical pump, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device performance study for a physical pump.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's performance is established through physical and biological measurements obtained from in vitro testing, following established test methods based on the proposed "Special Control Protocol for Evaluation of Blood Trauma Caused by Extracorporeal Centrifugal Pumps." For the functional tests (Life and Burst), the ground truth is simply whether the device passed the defined operational requirements.
8. The sample size for the training set
Not applicable. This is not an AI/ML device; there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for a training set.
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