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Single patient use adjustable positive end expiratory pressure (PEEP) valves for use in hospital, transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions. For use with neonates to adults.

The proposed Galemed Disposable Adjustable PEEP valves are identical to their predicate PEEP Valves, K.082092, except we have replaced some components that were magnetic with nonmagnetic material in order to meet the requirements for MR conditional environments of use. Otherwise the PEEP valves are identical.

Galemed disposable adjustable PEEP valves elevate the pressure in a patient's lungs above atmospheric pressure at the end of exhalation.

The Galemed disposable adjustable PEEP valve for use in MR environments is identical to our predicate, K082092, disposable PEEP valve, except we have replaced the materials in 2 components, a push rod and the springs to materials which are less magnetic. Other than these 2 changes, the device is identical to the predicate. These changes / modifications have been evaluated and demonstrated that they do not alter nor change the performance or safety profile of the new device as compared to the predicates.

This 510(k) summary describes a Disposable Adjustable PEEP Valve for use in MR environments. The submission claims substantial equivalence to two predicate devices: the Galemed PEEP valve (K.082092) and the Mercury Medical PEEP Valve (K081266) for its MR conditional characteristics.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria:

• For Leakage, Pressure/Resistance Accuracy, Drop Test, Environmental Conditions, Transportation, and Age Testing, the document states "met the pass/fail criteria" or "met its performance specifications criteria" without explicitly detailing the numerical boundaries of these criteria in the provided text. The criteria are only fully detailed for the MR Conditional test.
• The MR Conditional acceptance criteria for the proposed device (3.0 Tesla, 720 gauss/cm) represent an improvement in capability over the Mercury Medical predicate (1.5 Tesla, 450 gauss/cm).

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size for the test sets used in the non-clinical testing (e.g., how many PEEP valves were tested for leakage, MR compatibility, etc.). It refers to "the device" or "the sample," implying at least one, but without specific counts.

• Sample Size: Not explicitly stated (implied to be one or more for each test).
• Data Provenance: The tests were performed by the manufacturer, Galemed Corp., in China, as indicated by the company address. These appear to be prospective tests performed specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This device is a medical device, not an AI or diagnostic imaging device. Therefore, the concept of "ground truth established by experts" as typically applied to AI models for classification or detection tasks does not directly apply here. The "ground truth" for this device's performance is objective measurements against engineering specifications and recognized standards (e.g., ASTM F2052-02).

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, this is not a diagnostic device requiring expert adjudication of results. Performance is measured against predefined objective physical and engineering criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

Not applicable. This is a physical medical device (PEEP valve), not an AI or imaging system, so an MRMC study is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is objective engineering measurements against:

• Recognized Standards: Specifically, ASTM F2052-02 for MR conditional properties.
• Performance Specifications: Internal specifications for leakage, pressure/resistance accuracy, and durability (drop test, environmental, transportation, age testing). These specifications are based on the predicate device's performance and industry requirements for PEEP valves.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model requiring a training set. The device itself is manufactured, and its performance is verified through testing, not trained.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical medical device.

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