(24 days)
The Medtronic Trillium™ BioPump Plus is indicated for use only with the Medtronic Bio-Console to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary byrass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of vena cava or aorta, liver transplants, etc.)
The Trillium® BioPump Plus is a centrifugal blood pump which is a single use, disposable, non-pvrogenic device designed to move blood through the extracorporeal circuit by centrifugal forces created by smooth rotating cones. It is the disposable portion of the pumping system and is electromechanically coupled to the BioConsole which is the instrument that monitors and displays the flow and pressure of the blood flow. Venous blood enters the inlet port of the Bio-Pump. The smooth cones rotate in the polycarbonate housing. As the cones rotate, energy in the form of pressure and velocity is transferred from the cones to the blood. The blood is gently accelerated towards the outlet of the pump. The Bio-Pump moves the blood through the circuit at a desired pressure and flow rate by increasing or decreasing the speed of the rotating cones. This is accomplished by adjusting the BioConsole's RPM (revolutions per minute). The arterial blood is returned to the patient from the extracorporeal circuit.
The provided text describes a "SPECIAL 510(k)" submission for a medical device called the Trillium® BioPump Plus. This submission aims to demonstrate that a modified version of an already marketed centrifugal pump is substantially equivalent to existing devices, primarily due to the addition of a Trillium coating to blood-contacting surfaces.
Here's an analysis based on the provided text, addressing your specific points:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantified, numerical table format, nor does it provide a direct "reported device performance" in terms of specific metrics. Instead, it relies on a comparative approach, stating that the Trillium® BioPump Plus should perform comparably to predicate devices.
The core "acceptance criteria" can be inferred as:
- Safety and Effectiveness Equivalence: The Trillium® BioPump Plus does not significantly affect safety and effectiveness when compared to the predicate devices.
- No New Safety/Effectiveness Questions: The technological characteristic (Trillium coating) does not raise new types of safety or effectiveness questions.
- Acceptable Scientific Methods: Acceptable scientific methods exist for assessing the effects of this new technological characteristic.
The reported device performance is qualitative: "The biocompatibility and in vitro bench testing demonstrated that when compared to the predicate devices, the Trillium®BioPump Plus does not significantly affect safety and effectiveness and is substantially equivalent to other commercially distributed extracorporeal cardiopulmonary devices."
Table of Inferred Acceptance Criteria and Reported Performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Qualitative) |
|---|---|
| No significant adverse effect on safety and effectiveness | "The biocompatibility and in vitro bench testing demonstrated that... does not significantly affect safety and effectiveness..." |
| No new types of safety or effectiveness questions | "...these 'technological characteristics do not raise new types of safety or effectiveness questions'." |
| Existence of acceptable scientific methods for assessment | "...there are acceptable scientific methods which exist for assessing effects of these new technological characteristics." |
| Substantial Equivalence to predicate devices (BPX80 BioPump Plus, AFFINITY® Hollow Fiber Oxygenator with Trillium® Biopassive Surface) | "...is substantially equivalent to other commercially distributed extracorporeal cardiopulmonary devices." and "These 'performance data demonstrate' that the Trillium® BioPump Plus is substantially equivalent to other marketed extracorporeal cardiopulmonary bypass devices." |
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 mentions "biocompatibility and in vitro bench testing," which implies a test set was used. However, it does not specify the sample size for these tests (e.g., number of devices tested, number of in vitro samples).
The data provenance is not explicitly stated regarding country of origin, retrospective/prospective nature, or whether it involved human or animal subjects (though "biocompatibility" often involves in vitro and sometimes in vivo studies). Given it's a "SPECIAL 510(k)" for a modification to an existing device, the testing would likely be focused on the impact of the coating.
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 section is not applicable to the provided document. The Trillium® BioPump Plus is a mechanical medical device (a centrifugal blood pump), not an AI or diagnostic imaging device that would typically involve human expert interpretation to establish a ground truth for a test set. The validation relies on engineering performance parameters, biocompatibility, and material equivalence rather than expert consensus on diagnostic interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used in studies where a "ground truth" needs to be established from subjective expert opinions, typically in diagnostic tasks like image interpretation. This device's testing would involve objective measurements against engineering specifications and biocompatibility standards.
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
This section is not applicable. An MRMC study is relevant for diagnostic devices (especially those involving AI for interpretation) where the performance of human readers, with and without AI assistance, is compared across multiple cases. The Trillium® BioPump Plus is a therapeutic/support device, not a diagnostic one involving human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical, mechanical blood pump, not an algorithm. The concept of "standalone" performance without human-in-the-loop is relevant for AI algorithms. The device functions as part of a human-controlled extracorporeal circuit.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the nature of the device, the "ground truth" would be established through objective scientific and engineering principles:
- Biocompatibility Standards: Compliance with recognized biocompatibility standards (e.g., ISO 10993 series) for materials in blood contact.
- In Vitro Bench Testing Parameters: Specific performance metrics like flow rates, pressure generation, hemolysis indices, thrombogenicity, and durability under simulated physiological conditions.
- Material Equivalence: Verification that the Trillium coating behaves as expected and is comparable to existing applications (e.g., AFFINITY® Hollow Fiber Oxygenator with Trillium® BioSurface) in terms of blood compatibility.
The document implicitly states that "acceptable scientific methods exist for assessing effects of these new technological characteristics," which refers to these types of objective tests and standards.
8. The sample size for the training set
This section is not applicable. The Trillium® BioPump Plus is a physical device, not an AI model that requires a "training set."
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as point 8.
§ 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.