(219 days)
The BMR1900 PHISIO Closed Venous Reservoir Bag is intended to be used in cardiopulmonary bypass procedures for periods of up to six hours.
The BMR1900 PHISIO Closed Venous Reservoir Bag (hereinafter BMR1900) is a softshell, flexible, polyvinylchloride bag designed for use in cardiopulmonary bypass surgery for periods up to six hours. It is supplied sterile with non-pyrogenic fluid pathways, for single use only, and is not to be resterilized by the user. As for the unmodified device, the BMR1900 PHISIO. is composed of the following elements: - · A collapsible bag that serves as an in-line closed venous reservoir to contain blood volume. - · An integral 105 micron polyester filter screen which is mainly intended to facilitate the removal of large air bubbles from the blood. - A dual four-wav stopcock assembly used to manually purge the air captured by the filter screen or to administrate drugs or other solutions as needed during the cardiopulmonary bypass procedure. - A 1/2" venous blood inlet port and a 3/8" blood outlet port. - Connectors integral to the blood inlet port that are used to measure temperature and saturation/hematocrit of the incoming blood using external monitoring equipment, as needed. The BMR1900 PHISIO is designed with a 1900 mL maximum operating volume and a minimum operating volume equals to 300 mL and can be used at any flow rate up to 6 liter per minute. The venous blood inlet/outlet ports and the dual four-way stopcock assembly are opposite located with respect to the horizontal axis: the formers are placed in the bottom of the device while the latter at the top of the bag. Considering the vertical axis, both modified and unmodified devices present the blood inlet port with the integral cardiotomy inlet placed on one side of the bag while the blood outlet port is located on the opposite side of the bag. 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 PHISIO will be available with two configurations that differ only for the orientation of the venous blood inlet. The BMR1900 PHISIO. has the connector of the venous blood inlet right oriented (figure 1) while the BMR1900 L PHISIO. has the connector of the venous blood inlet left oriented (figure 2) The modified device is modified version of the currently marketed BMR1900 PH.I.S.I.O product
The provided text describes a 510(k) premarket notification for the BMR 1900 PHISIO Closed Venous Reservoir Bag, a medical device. This is a submission for a modified medical device, which is compared to its unmodified predicate device. The document focuses on demonstrating substantial equivalence rather than a device's initial performance study against clinical endpoints.
Therefore, the specific information requested in the prompt, such as acceptance criteria based on clinical outcomes, human reader improvement with AI, or detailed ground truth establishment for novel algorithms, is not applicable in this context. The study outlined here is a non-clinical performance study to show that the modified device is as safe and effective as the original, legally marketed device.
Here's the information that can be extracted and how it relates to the prompt's questions:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for a modified device, the "acceptance criteria" are effectively that the modified device performs equivalently to the unmodified predicate device across several non-clinical tests. The document states that the modified device "successfully met all acceptance criteria."
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Physical Integrity | Blood Path integrity | Successfully met (equivalent to predicate) |
| Connection Integrity | Successfully met (equivalent to predicate) | |
| Burst test | Successfully met (equivalent to predicate) | |
| Functional Performance | Ease of prime | Successfully met (equivalent to predicate) |
| Min/max blood volume | Successfully met (equivalent to predicate) | |
| Material Biocompatibility | Biocompatibility tests (per ISO 10993-1) | Successfully met (equivalent to predicate) |
| Material Properties | Surface coverage coating test | Successfully met (equivalent to predicate) |
| Leaching and flaking of coating test | Successfully met (equivalent to predicate) |
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 does not specify the sample size for each non-clinical test. The tests were performed on "sterile aged devices" equivalent to "at least 3 years" of aging. The provenance is not explicitly stated beyond the applicant being Sorin Group Italia S.R.L. and the tests being "in vitro testing." This implies laboratory-based tests rather than human patient data, and thus is more akin to prospective testing of manufactured devices.
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)
Not applicable. This is a non-clinical engineering and materials performance study, not a study involving human expert interpretation or ground truth establishment in a clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a non-clinical engineering and materials performance study, not a study requiring adjudication of expert opinions.
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 non-clinical performance study for a physical medical device (a blood reservoir bag) and does not involve AI or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context would be the established performance characteristics and safety profile of the unmodified BMR1900 PHISIO predicate device. The tests performed on the modified device aim to demonstrate that it functions identically to this established benchmark.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set. The "ground truth" for the non-clinical comparisons is the performance of the previously cleared predicate device, which would have been established through its own initial premarket submission and subsequent clinical use.
§ 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.