(20 days)
The BC110 Pressure Manifold is intended for use with 'positive pressure' breathing systems for pediatric patients. The device is placed upstream of the gas delivery to the patient in-line with the circuit and contains a pressure relief valve to protect the patient from excessive inspiratory pressure in the event of a downstream occlusion. The device also provides ports to allow the connection of external pressure monitoring devices and air/oxygen analyzers.
The device is intended for use with flow rates of 0-15 L/min. The relief pressure at 8 L/min is 17 cm H2O. The relief pressure at 15 L/min is 24 cm H2O.
The BC110 is disposable, single patient use and is prescription only.
The BC110 Pressure Manifold is an inline pressure relief device designed to protect pediatric/infant patients from excessive pressure in the event of a downstream occlusion occurring in positive pressure breathing systems. The BC110 pressure manifold also provides ports to allow the connection of external pressure monitoring devices and air/oxygen analyzers. The device consists of a rigid plastic tube, open at both ends, containing side ports and a side mounted pressure relief valve. The valve reacts instantaneously to an occlusion and automatically resets upon release of the occlusion. The inlet port for the gas source consists of a barbed connector, the outlet port for the patient connection is a 22/15 mm female.
The body of the BC110 is molded ABS plastic, the port caps are polyethylene. The overall length of the device is 134 mm, the overall diameter 25 mm and depth/height 58 mm. The inlet connector consists of a standard barbed O2 connector made from of mini: me and is supplied pre-fitted to the manifold. The outlet connector is part of the manifold body and is a dual connector consisting of a 22 mm female or 15 mm female port. The O2 analyzer port is also part of the manifold body and is a dual connector consisting of 22 mm male or 15 mm female port. The pressure ports, also part of the manifold body, consist of a female Luer and a 4 or 6 mm male push on. A flow direction arrow is molded into the side of the manifold body to indicate the correct setup position (this is supplemented by different connector sizes at each end). The ISO symbol for 'Single Use Only' is also molded into the side of the manifold. The pressure relief valve utilizes a stainless steel coil spring. An "anti-tampering" shroud covers the valve to ensure the factory set relief pressure (17 cm H2O at 8 Lpm) is not changed. Pressure relief at the maximum recommended flow rate of 15 Lpm is 24 cm H2O.
The provided document, K040366, is a 510(k) Summary of Safety and Effectiveness for a medical device called the "BC110 Pressure Manifold." This document does not contain information about an AI/ML powered device or a study proving its acceptance criteria in the context of an AI/ML system. Instead, it describes a mechanical device. Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML device from this document.
However, I can extract the acceptance criteria and performance of the BC110 Pressure Manifold based on the non-clinical tests described.
Here's the information about the BC110 Pressure Manifold:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Target Specification) | Reported Device Performance |
|---|---|
| Relief Pressure at 8 Lpm Flow Rate | 17 cm H2O (factory set and tested) |
| Relief Pressure at 15 Lpm Flow Rate (maximum recommended flow rate) | 24 cm H2O |
| Prevent excessive inspiratory pressure in downstream occlusion | The device is designed to react instantaneously to an occlusion and automatically resets upon release. The relief pressure values are stated to be "well within the limits for neonates in all relevant ventilator and resuscitation standards." |
| Operation with flow rates | Greater than 0 L/min up to, and including, 15 L/min. |
| Durability / Longevity | Accelerated life testing performed "over and above the time likely required for single use." (Specific duration not quantified in the summary, but implies meeting single-use requirements) |
| Leak Testing | Performed (Result not explicitly stated as pass/fail, but implied to be acceptable as part of demonstrating safety and effectiveness) |
| Response Time to an Occlusion | Performed (Result not explicitly stated as pass/fail, but implied to be acceptable as part of demonstrating safety and effectiveness; device "reacts instantaneously") |
| Performance on Wet Side of Humidification Chamber | Performed (Result not explicitly stated as pass/fail, but implied to be acceptable as part of demonstrating safety and effectiveness) |
| Calibration Testing of Test Equipment | Performed (Ensures accuracy of testing) |
| Factory Testing for Correct Operation of Pressure Relief Valve | Each pressure manifold is individually tested at the factory. |
| Tamper-Proof Pressure Setting | An "anti-tampering" shroud covers the valve to ensure the factory set relief pressure is not changed; "cannot be accidently or deliberately adjusted by the user." |
| Minimization of User Error | "The design of the valve and manifold minimises the chances of user error." User instructions specify conditions of use. |
| Single Patient Use and Disposable Labeling | Device is labeled clearly as single patient use and disposable. Also noted for prescription only use. |
The study proving the device meets these acceptance criteria involved a series of "Non-Clinical Tests" as described in section (b)(1):
- Change in relief pressure with flow rate
- Leak testing
- Response time to an occlusion
- Performance on wet side of humidification chamber
- Accelerated life testing
- Calibration testing of test equipment
The following points (2-9) are specifically for AI/ML device studies and are NOT applicable to the K040366 document because it describes a mechanical medical device, not an AI/ML powered device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as this is a mechanical device, not an AI/ML device with a test set of data.
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. Ground truth in the context of AI/ML data is not relevant for this mechanical device. The "ground truth" here is the physical performance of the device against engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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 standalone mechanical device, not an AI assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device, not an algorithm. Its performance is inherent to its design and manufacturing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for an AI/ML context. For this mechanical device, the "ground truth" corresponds to engineering specifications, physical measurements, and compliance with relevant standards (e.g., ventilator and resuscitation standards for neonates).
8. The sample size for the training set
- Not applicable. This is a mechanical device, so there is no "training set" in the AI/ML sense.
9. How the ground truth for the training set was established
- Not applicable.
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).