(21 days)
The BMR1900 PH.I.S.I.O. is intended to be used in cardiac surgical procedures requiring extracorporeal support for periods of up to six hours.
The BMR1900 PH.I.S.I.O. is a sterile, non-pyrogenic softshell reservoir designed for use in cardiac surgical procedures requiring extracorporeal support for periods of up to six hours. The BMR1900 PH.I.S.I.O. can be operated at flow rates up to 6 liters per minute. The maximum operating volume is 1900 mL. The minimum operating volume is 300 mL. The softshell reservoir has a blood inlet port with an integral cardiotomy inlet on one side of the bag and a blood outlet port on the opposite side of the bag with respect to the vertical axis. Integral to the blood inlet port are connectors for measuring the temperature and saturation/hematocrit of the incoming blood using external monitoring equipment. At the top edge of the bag it is located a dual four-way stopcock assembly that is used to manually purge air from the bag. The stopcock assembly may also be used for the administration of drugs or other solutions, as needed during the cardiopulmonary bypass procedure. Blood enters the bag through the inlet port and passes through a polyester filter screen before exiting the bag through the outlet port. The purpose of the filter is to facilitate the removal of large air bubbles from the blood. The BMR1900 PH.I.S.I.O. is a modified version of the currently marketed SMARxT BMR1900 Closed Venous Reservoir Bag.
The provided document describes a Special 510(k) submission for the BMR1900 PH.I.S.I.O. device, a closed venous reservoir bag for cardiac surgical procedures. This submission focuses on demonstrating substantial equivalence to a predicate device (SMARxT BMR1900 Closed Venous Reservoir Bag) due to a modification in the blood-contacting coating.
The nature of this device (a medical device, not an AI/ML algorithm) means that many of the requested criteria related to AI/ML device evaluation (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types for AI models) are not applicable and therefore not present in the provided text.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The submission is for a medical device (a closed venous reservoir bag) and the "acceptance criteria" are related to biocompatibility and equivalent performance to a predicate device. The performance is demonstrated through in vitro testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Passed tests in accordance with ISO 10993-1 and FDA's May 1st, 1995 Memorandum. |
| Equivalence to Unmodified Device (SMARxT BMR1900) | Demonstrated through comparative in vitro testing. |
| Safety and Effectiveness | Met through in vitro testing, showing substantial equivalence to the predicate. |
| Material Properties (Coating) | Blood compatibility improved by PH.I.S.I.O. coating with the same claim of reduced platelet adhesion as SMARxT. |
| Operational Characteristics (unchanged from predicate) | Can be operated at flow rates up to 6 liters per minute, maximum operating volume 1900 mL, minimum operating volume 300 mL. |
| Sterility | Ethylene oxide sterilized. |
| Non-pyrogenic Fluid Path | Confirmed non-pyrogenic fluid path. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of "samples" in a clinical trial sense. The "test set" refers to physical devices used in in vitro testing. The document states "internal methods developed by the Manufacturer using sterilized devices aged up to 3 years." A specific number of devices tested is not provided.
- Data Provenance: The in vitro tests were carried out by the Manufacturer (Sorin Group Italia S.r.I.) using internal methods. The context implies these are laboratory tests performed within the company's facilities. This would be considered retrospective in the sense that it's testing manufactured devices, not prospective clinical data. Country of Origin: Italy (where Sorin Group Italia S.r.I. is located).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is not an AI/ML device where "ground truth" is established by expert review of data like images or patient records. The "ground truth" for this device's performance is derived directly from physical and chemical measurements during in vitro tests according to established standards (ISO 10993-1) and internal methods.
4. Adjudication method for the test set
- Not Applicable. As above, no expert adjudication process is described for in vitro laboratory test 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, not an AI system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This device is hardware; it does not involve algorithms or AI performance.
7. The type of ground truth used
- For biocompatibility: Adherence to established international standards (ISO 10993-1) and FDA guidance for biological evaluation of medical devices.
- For performance equivalence: Quantitative physical and chemical measurements derived from in vitro comparative testing against the predicate device.
8. The sample size for the training set
- Not Applicable. This device does not use machine learning, 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 an AI/ML algorithm, this question is not relevant.
§ 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.