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The Model 8990 Series Nebulizers have the same intended use as their predicate device, The Salter Model 8900 Nebulizer, which was cleared for marketing by 510(k) No. K870027. The nebulizer is a disposable device which is used where liquids are to be delivered to a patient in an aerosol form. The device is not life-supporting or life-sustaining, nor is it implanted . It does not use software, nor is it sterile. The device is for single patient use. It is intended to be used with accessories, such as tubing which are industry standard devices used with nebulizers.

Each of the Salter Labs 8990 Series Nebulizers consists of a Nebulizer Top which is screwed onto a Nebulizer Cup. The bottom of the cup has a fitting to accept a source of nebulizing gas. Liquids to be nebulized are placed in the nebulizer cup. The nebulizer housing is then applied, and the supply line for the nebulizing gas source is then connected to the bottom of the nebulizer cup. After the pressurized nebulizing gas is applied to the nebulizer, the solution in the cup is nebulized and pushed from the unit in aerosol form that can be inhaled by the patient.

This 510(k) summary (K962085) for the Salter Labs Ultramist Nebulizer, 8990 Series, does not contain the detailed information typically found in modern AI/ML device submissions regarding acceptance criteria and performance studies. This is a submission from 1996 for a physical medical device (nebulizer), not an AI/ML-driven software device. Therefore, many of the requested categories are not applicable or the information is not provided in this document.

Here's an analysis based on the provided text, highlighting what is and isn't available:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This document does not describe specific acceptance criteria or quantitative performance metrics for the nebulizer in the way an AI/ML device would report sensitivity, specificity, etc. The submission focuses on substantial equivalence to a predicate device, not on specific performance targets established through a clinical study.

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

Not applicable. There is no mention of a "test set" or a specific study designed to measure performance against acceptance criteria in this document. The device is a physical medical device, not a software device, so clinical data collection for a "test set" in the context of an AI/ML study is not relevant here.

3. Number of Experts Used to Establish the Ground Truth and Qualifications

Not applicable. This submission predates the common methodologies for AI/ML device validation. "Ground truth" in the context of expert consensus or pathology is not relevant for a physical nebulizer device submission.

4. Adjudication Method

Not applicable. No adjudication method is mentioned as there's no diagnostic or interpretive 'ground truth' being established by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size

Not applicable. This is not an AI-assisted device, so an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

Not applicable. This is a physical nebulizer, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. The performance of a nebulizer is typically assessed through engineering specifications (e.g., particle size distribution, nebulization rate) and clinical safety/efficacy, not through "ground truth" derived from expert consensus, pathology, or outcomes data in the sense used for AI/ML diagnostic tools.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, and there is no "training set" in the context of AI/ML model development.

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

Not applicable. As above, no training set or ground truth in the context of AI/ML.

Summary of Information Provided in K962085 (Relevant to Device Description and Comparison):

• Device Name: Salter Labs Ultramist Nebulizer, 8990 Series
• Classification Name: Nebulizer (direct patient interface)
• Predicate Device: Salter Labs Hand Held Pneumatic Powered (disposable) Nebulizer Model 8900 (K870027)
• Intended Use: To deliver liquids to a patient in an aerosol form. Disposable, single-patient use. Not life-supporting/sustaining, not implanted, does not use software, not sterile.
• Key Difference from Predicate: The 8990 Series includes a "larger internal reservoir for the aerosol, which eliminates the need for the external tee adapter and reservoir tube."
• Claim regarding Difference: "This difference has no significant effect on the safety or effectiveness of the device."

The basis for clearance for this device, typical for 510(k) submissions of that era for non-AI devices, is substantial equivalence to a predicate device. The submission asserts that the minor design change (larger internal reservoir) does not significantly affect safety or effectiveness, implying that the performance of the new device is substantially equivalent to the cleared predicate device. This generally relies on bench testing and comparison of specifications rather than extensive clinical studies or "test sets" as defined for AI/ML.

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