(79 days)
The BMR™-4500 Filtered Venous Reservoir is indicated for use during cardiopulmonary bypass surgery in the extracorporeal circuit to collect, store, filter and defoam the patient's blood.
The BMR™-4500 GOLD® Hard Shell Venous Reservoir with Duraflo® treatment is indicated for use during cardiopulmonary bypass surgery in the extracorporeal circuit to collect, store, filter and defoam the patient's blood. The BMR-4500 GOLD® is further intended for use when a heparin treated blood path is desired.
The BMR™-4500 GOLD® Filtered Venous Reservoir with Duraflo® Treatment is used during cardiopulmonary bypass surgery to collect, store, filter and defoam the patient's blood. All blood contacting surfaces of the device, with the exception of luer connectors, stopcock manifold and sample lines, are treated with Bentley's Duraflo® complex. This treatment is intended to enhance the blood compatibility of non-biological surfaces in the extracorporeal circuit.
Bentley's BMR™-4500 GOLD® will also be offered in a non-treated version. Designated BMR™-4500™, this device will not contain the Duraflo® complex. The indications for use for BMR™-4500™ are identical to the treated version of the device.
Bentley's BMR™-4500™ and BMR™-4500 GOLD® are intended to be used for blood flows of up to 7.0 LPM through the venous inlet, up to 5.0 LPM through the cardiotomy inlet or up to 7.0 LPM combined flow.
The provided document describes the 510(k) premarket notification for the BMR™-4500 and BMR™-4500 GOLD® Filtered Venous Reservoirs. The submission focuses on demonstrating substantial equivalence to a predicate device, the Bentley HSR™-4000 Venous Reservoir.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in a quantitative, pass/fail manner with specific numerical thresholds. Instead, it states that the test results "demonstrated no remarkable differences between the proposed vs. predicate populations." This implies that the acceptance criterion was functional equivalence or "no remarkable differences" compared to the predicate device for each assessed parameter.
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Venous and Cardiotomy Blood Damage | No remarkable difference compared to predicate (HSR™-4000) | "no remarkable differences between the proposed vs. predicate populations" |
| Filtration Efficiency | No remarkable difference compared to predicate | "no remarkable differences between the proposed vs. predicate populations" |
| Venous and Cardiotomy Breakthrough Volume | No remarkable difference compared to predicate | "no remarkable differences between the proposed vs. predicate populations" |
| Venous and Cardiotomy Residual Volume | No remarkable difference compared to predicate | "no remarkable differences between the proposed vs. predicate populations" |
| Defoaming Capability | No remarkable difference compared to predicate | "no remarkable differences between the proposed vs. predicate populations" |
| Patency of One-Way Valve | No remarkable difference compared to predicate | "no remarkable differences between the proposed vs. predicate populations" |
| Heparin Leaching (for GOLD® version) | No remarkable difference compared to predicate (if applicable) | "no remarkable differences between the proposed vs. predicate populations" |
| Biocompatibility | Compliance with ISO-10993-1 | "All components...were found to be biocompatible in compliance with ISO-10993-1." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states, "The number of devices tested was selected based on AAMI guidelines (AAMI OXY-D)." However, the specific number of devices tested is not provided.
- Data Provenance: The study was in-vitro. The country of origin of the data is not explicitly stated but can be inferred as the USA, given Baxter Healthcare Corporation's location and the FDA submission.
- Retrospective or Prospective: Not applicable as it's an in-vitro study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The study is an in-vitro performance test of a medical device, not a diagnostic or AI algorithm requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
Not applicable. This is an in-vitro performance study, not a clinical trial requiring adjudication of patient outcomes or interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes an in-vitro performance study for a physical medical device, not an AI algorithm. Therefore, an MRMC comparative effectiveness study was not conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The study describes the "standalone" performance of the BMR™-4500 and BMR™-4500 GOLD® devices themselves, as they are physical devices, not an AI algorithm. Their performance was evaluated independently in an in-vitro setting.
7. The Type of Ground Truth Used
The "ground truth" for this in-vitro study was essentially the measured performance parameters of the predicate device (Bentley HSR™-4000) under "worst case conditions," against which the performance of the proposed devices was compared. The implied ground truth is established industry standards and expected performance for such venous reservoirs.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning study, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device submission.
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.