(126 days)
The Better-Bladder™ is a device that isolates pressure transducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures.
The BB consists of a unitary length of tubing, a section of which has been processed to form an enlarged diameter with a thinner wall. The enlarged section is very responsive to pressure differences across its thin wall. Because the entire device is made from a single length of smooth perfusion tubing, there are no connections between the thinker wall tubing portions. This unique design eliminates both physical and material (chemical) discontinuities. The thin walled section in its housing can withstand over 1500 mmHg (three times the maximum pressure expected under worst-case clinical conditions). The BB does not incorporate vent tubes for air aspiration or drug infusion. These can be added by placing a perfusion connector with a dual Luer fitting (e.g. Avecor Model # DL1414) at the inlet to the BB, see Fig. 7b.
Here's an analysis of the provided text regarding the "Better-Bladder™" device's acceptance criteria and studies:
Summary of Device Acceptance Criteria and Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance | Study Type/Evidence |
|---|---|---|---|
| Functional Equivalence | Pressure measurement noninvasively with BB vs. invasively. | Equivalent to invasively measured pressure. | Bench tests |
| Performance Comparison | Comparable or superior performance to predicate devices. | Comparable or superior to predicate devices (Quest PMS-2, SciMed R30 Assist Reservoir). | Bench tests |
| Pressure Withstand (Thin-Walled Section) | Withstand over 1500 mmHg (3x max clinical pressure). | Withstood over 1500 mmHg. | Bench tests |
| Internal Pressure Test (Individual Unit) | Withstand an internal pressure of 900 mmHg (1.8x max clinical pressure). | Each BB individually tested to 900 mmHg. | Individual unit testing during manufacturing |
| Housing Pressure Test (Individual Unit) | Withstand a housing pressure of 900 mmHg. | Each BB individually tested to 900 mmHg. | Individual unit testing during manufacturing |
| Sterilization, Sterilant Residuals, Pyrogenicity | Compliance with established standards. | See K964337 (implies previous FDA clearance or established protocol). | Cross-reference to previous submission |
| Biocompatibility | Compliance with ISO 10993 Part-1. | Blood path material (polyvinyl chloride) passed biocompatibility tests in accordance with ISO 10993 Part-1. | Material testing (implied by passing standard) |
| General Safety | Compliance with established standards. | See K964337. | Cross-reference to previous submission |
| Quality Assurance | Compliance with established standards. | See K964337. | Cross-reference to previous submission |
| Design Integrity (Bond) | Bond between tubing and housing external to blood path. | Bond is external to blood path, no blood compatibility concerns. | Design characteristic (verified by inspection/design review) |
Detailed Study Information:
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Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document primarily refers to "bench tests" and "individual unit testing" for functional evaluations. Specific sample sizes for these tests are not provided.
- The data provenance is not explicitly stated (e.g., country of origin). The testing appears to be prospective as it describes evaluations performed on the Better-Bladder™ to demonstrate its performance against predefined criteria and predicate devices.
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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 device is a physical medical device (pressure monitoring/blood reservoir) and the "ground truth" for its functional performance (e.g., pressure measurement accuracy, pressure withstand, biocompatibility) is established through objective physical measurements and adherence to engineering/biological standards, not through expert review of data like imaging. Therefore, the concept of "experts establishing ground truth for a test set" in the context of human interpretation is not applicable here. The "experts" involved would be engineers, materials scientists, and quality control personnel following established protocols.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Again, this device is a physical, non-AI medical device. The "adjudication method" in the context of human interpretation of results (like in clinical trials or image analysis) is not applicable. Objective measurements and adherence to predetermined specifications are used.
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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:
- No, an MRMC comparative effectiveness study was not done. This is a physical device, not an AI-assisted diagnostic tool involving human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit, a standalone performance was done, as the device's functional integrity and performance were evaluated on its own (bench tests, individual unit tests) against established engineering and biological standards, without human interpretation in the loop as part of its primary function. The device's function is to objectively measure pressure and act as a reservoir, not to process data for human interpretation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the device's performance is based on objective engineering measurements (e.g., pressure equivalence to invasive methods, maximum pressure withstand, material properties conforming to ISO 10993 Part-1). For comparison, the predicate devices themselves serve as a benchmark for performance.
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The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. This device does not use machine learning or AI, so there is no "training set" or ground truth for one.
§ 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.