(172 days)
Single patient use device intended for neonate, infant or child with a body mass of less than 10 Kg requiring a pressure limitation system to eliminate excessive pressure should an obstruction occur between gas supply and exhalation port during continuous gas flow therapy up to 12 liters per minute in hospital critical care unit.
The Book Plus" single patient use Pressure Limitation Manifold is an accessory to the Book Plus" Infant Nasal Cannula System cleared for sale in K093716. The device is designed to protect patients up to 10 Kg from excessive pressure should a downstream occlusion occur in a positive pressure breathing system. The device is offered in 10 cm H2O and 15 cm HsO pressure relief valve configurations. The device is supplied with oxygen senor port, fresh gas inlet and a 1 meter length of gas supply tubing. The device connector molded in a rigid plastic to which a pressure relief valve is mounted on the vertical axis, the fresh gas inlet and oxygen senror port are located adgacent to each other on the hporzontial axis. The device relieves pressure cause by an occlusion before the expiratory port and automatically resets upon correction of the occlusion. The outlet port of the device is a 22 mm inside diameter connection in compliance with ISO 5356-1, Version 3.
The provided document is a 510(k) Summary of Safety and Effectiveness Information for the Babi.Plus™ Pressure Limitation Manifold. This document focuses on demonstrating substantial equivalence to predicate devices and does not describe acceptance criteria or a study proving the device meets them in the context of diagnostic performance or clinical efficacy.
Instead, the document details non-clinical bench testing to demonstrate the device's functional performance against its design claims. Therefore, a table of acceptance criteria and reported device performance isn't applicable in the way it would be for a diagnostic or therapeutic device that has a "performance" in terms of accuracy, sensitivity, or specificity.
However, I can extract information related to the device's functional claims and the tests performed.
Here's a breakdown based on the provided text, addressing the points where information is available or noting its absence:
1. Table of Acceptance Criteria and Reported Device Performance
General performance claims for the Babi.Plus™ Pressure Limitation Manifold:
| Claim/Parameter | Type of Test Performed |
|---|---|
| Device Performance: Pressure Relief Accuracy | Accuracy of pressure relief for each offered configuration (10.0, 12.5, 15.0 cm H2O) at gas flow rates of 1 to 15 liters per minute, using dry air. The document states: "this application: 2. Accuracy of pressure relief for each offered configuration at gas flow rates of one (1) to fifteen (15) liters per minute, dry air... Additionally, the each Pressure Limitation Manifold is tested at the time of manufacture at the minimum, mean and maximum gas flow rates to assure accuracy." While specific acceptance thresholds (e.g., "within ±X cm H2O") are not explicitly stated, the implication is that the device met the intended pressure relief values accurately across the tested flow rates. The document also mentions that "The Babi.Plus™ Pressure Limitation Manifold performance (ability to relieve pressure... is substantially equivalent to Predicate K040366." |
| Material Degradation/Shelf-Life | Accelerated shelf-life testing, simulating a one (1) year shelf life. (Implies the device maintained its integrity and function after simulated aging.) |
| Durability/Service Life | Service life testing of twenty-eight (28) days at a gas flow rate of 15 LPM simulating a downstream obstruction twelve (12) times per hour. (Implies the device can withstand repeated activation over its expected service life.) |
| Ability to Supply Fresh Gas | Not explicitly detailed as a separate test, but implied as a fundamental function and stated as "substantially equivalent to Predicate K040366." |
| Ability to Connect an Oxygen Sensor | Functionality of the oxygen sensor port. Stated as "substantially equivalent to Predicate K040366." |
| Ability to Connect to a Humidifier | Functionality of connecting to a humidifier. Stated as "substantially equivalent to Predicate K040366." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated. The described tests are bench tests performed on device units. For "accuracy of pressure relief" and "service life testing," multiple units would typically be tested, but the exact number isn't provided.
- Data Provenance: Not applicable in terms of country of origin of patient data, as these are non-clinical bench tests. The tests were performed by "A Plus Medical." Retrospective or prospective classification is also not applicable for these types of engineering/bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically understood for clinical/diagnostic devices (e.g., expert consensus on medical images) is not relevant for these non-clinical functional performance tests. The "ground truth" here would be established by validated test equipment and engineering specifications.
4. Adjudication method for the test set
- Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication.
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
- No, a MRMC comparative effectiveness study was not done. This device is a mechanical pressure limitation manifold, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm-based device. The "standalone" performance here refers to the device's inherent mechanical function. The described bench tests assess this standalone performance.
7. The type of ground truth used
- For the functional bench tests (e.g., pressure relief accuracy), the ground truth is established by engineering specifications and measurements from calibrated testing equipment. For example, a calibrated pressure sensor would measure the actual pressure at which the device relieves, and this would be compared against the intended relief pressure.
8. The sample size for the training set
- Not applicable. This device does not involve machine learning or AI models, 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 this device.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).