(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.
§ 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.