(106 days)
The Access Point, LLC Deluxe Nebulizer is intended to provide a source of compressed air for medical purposes for use in home health care. The Deluxe Nebulizer is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders.
The Deluxe Nebulizer, consist of four components. The nebulizer main unit, air compressor, air filters and nebulizer kit (hand held nebulizer with mouthpiece). The Nebulizer atomizes medicinal liquid into tiny fog droplets by compressing air. Patients inhale the compressed air for optimal internal medicinal delivery.
This 510(k) summary for the Deluxe Nebulizer does not contain the acceptance criteria or results from a study proving it meets specific performance criteria designed for a diagnostic or AI-driven device.
This submission is for a medical device that provides compressed air for nebulizer therapy. Its performance is evaluated against recognized consensus standards for safety and electrical compatibility, rather than through clinical or diagnostic accuracy studies.
Here's why the requested information for an AI/diagnostic device is not present in this document:
- Device Type: The Deluxe Nebulizer is a compressor for a nebulizer. It's a mechanical device, not an AI, diagnostic, or imaging device designed to provide a specific output value, classification, or prediction.
- Performance Metrics: The "performance" of this device is related to its ability to safely and reliably produce compressed air according to engineering and safety standards, not to its diagnostic accuracy (e.g., sensitivity, specificity, AUC).
Therefore, I cannot populate the table or answer many of the questions as they pertain to clinical performance studies for AI/diagnostic devices.
However, I can extract the available information related to the device's conformance to standards based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards for Conformance) | Reported Device Performance |
|---|---|
| IEC 60601-1 (1998): Medical Electrical Equipment - Part 1: General Requirements for Safety | Designed to conform to applicable sections of this standard. (Specific results not detailed, but conformance is implied by submission) |
| IEC 60601-1-2 (2001): Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard; Electromagnetic Compatibility – Requirements and Tests (General) | Designed to conform to applicable sections of this standard. (Specific results not detailed, but conformance is implied by submission) |
| FDA Document Number 784 (1993): Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators | Designed to conform to applicable sections of this guidance. (Specific results not detailed, but conformance is implied by submission) |
2. Sample size used for the test set and the data provenance: Not applicable. This is a mechanical device, not an AI or diagnostic device that uses a "test set" of data for performance evaluation in the way a diagnostic algorithm would. Testing would involve engineering verification and validation against the specified standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the diagnostic sense is established for this type of device. Conformance to engineering and safety standards is verified.
4. Adjudication method 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 not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: Not applicable in the context of diagnostic accuracy. The "truth" here is compliance with established engineering and safety standards.
8. The sample size for the training set: Not applicable. This is not an AI device that requires a "training set."
9. How the ground truth for the training set was established: Not applicable.
Summary of Device Performance as Stated:
The document explicitly states: "The Deluxe Nebulizer was designed to conform to the applicable sections of the following recognized consensus standards. The testing included verifying conformance to these standards and the published specifications."
The Conclusion reinforces this by stating: "The Deluxe Nebulizer is as safe and effective as the predicate devices when used according to the instructions in the directions for use supplied with the devices." This implies that the testing performed demonstrated compliance with these standards, establishing its safety and effectiveness. The "study" for this device revolves around engineering and safety verification and validation, rather than clinical efficacy trials or diagnostic accuracy trials.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).