(92 days)
The Aspiration Pump is intended for general suction use in hospitals or clinics.
The Aspiration Pump is a portable suction / aspirator / vacuum system which is used to remove debris, blood and other bodily fluids through the application of continuous negative pressure. The Aspiration Pump includes two suction / vacuum ports on the input side, each with individual flow control valves and standard 6% Luer taper connectors. A 500cc collection bag is attached to the output side of the Aspiration Pump for collection of removed debris, blood and bodily fluids.
The Rex Medical Aspiration Pump is a powered suction pump intended for general suction use in hospitals or clinics. The provided document is a 510(k) Summary, which details the device's characteristics and the testing performed to demonstrate its substantial equivalence to predicate devices.
Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria alongside performance data in a single, consolidated table. Instead, it lists various non-clinical performance tests and their outcomes (Pass/Fail) and compares the device's design features with predicate devices. Based on the "Summary of Aspiration Pump Backflow Testing," a specific acceptance criterion is stated:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No backflow when a 45psi minimum back pressure is applied. | All tests passed. The liquid aspiration pump did not allow any backflow of fluids. |
For other tests, such as pressure, battery life, voltage comparison, IPA resistance, flow rate, and maximum volume, the report simply states "Pass," indicating that the device met the predefined acceptance criteria for these tests, although the specific numerical criteria are not detailed in this summary.
Study Details
The document refers to a series of non-clinical performance tests (in vitro and in vivo studies, and testing to standards) to demonstrate the safety and effectiveness of the Rex Medical Aspiration Pump and its substantial equivalence to predicate devices. No human clinical trials were performed.
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Sample sizes used for the test set and the data provenance:
- Backflow Testing: Two liquid aspiration pumps were each tested three times, totaling 6 test runs.
- Other In-vitro and In-vivo testing: Specific sample sizes for other tests (Pressure Study, Battery Life Study, Flow Rate Study, Efficacy Study, etc.) are not specified in this summary.
- Data Provenance: The studies were internal company tests or performed by third-party testing labs (e.g., UL Test Report). The country of origin of the data is not explicitly stated, but given the FDA submission, it's likely conducted in the US or under internationally recognized standards. The studies are by nature prospective tests performed on the device prototypes or production samples.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- As this is a non-clinical device that performs a physical function (suction), the "ground truth" is established through engineering and scientific measurements and adherence to technical specifications, not through expert clinical consensus on interpretations. Therefore, there is no mention of experts establishing ground truth in the context of clinical interpretation, as it is not applicable. The tests would be performed by qualified engineers or technicians.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where subjective interpretations or disagreements among experts need to be resolved. For non-clinical performance tests, results are objectively measured against predefined specifications.
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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:
- Not applicable. This device is a physical medical instrument (a suction pump), not an AI algorithm for diagnostic imaging or similar applications where human readers' performance would be evaluated with or without AI assistance. No MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical medical instrument, not a software algorithm. Its performance is intrinsically standalone in the sense that it performs its function (suction) independent of human-in-the-loop diagnostic decision-making.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests is based on predefined engineering specifications, international standards (e.g., ISO, AAMI, ASTM), and the expected physical behavior of a medical suction pump, such as flow rates, vacuum pressure, battery life, and absence of backflow.
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The sample size for the training set:
- Not applicable. This device is a physical medical instrument subject to engineering testing. It does not involve a "training set" in the context of machine learning or AI.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for a physical medical device.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.