(62 days)
The Omron Compressor Nebulizer Systems include a compressor and nebulizer, Model NE-C28 uses a DC powered compressor and Model NE-C30 can operate with AC/DC power. The electrically powered compressor provides compressed air to the supplied pneumatic nebulizer to aerosolize drugs for inhalation by the patient.
The nebulizer is driven by the integral air compressor. The device may be used with pediatric and adult patients in the home, hospital, and sub-acute care settings.
Not intended for use with Pentamidine.
The Oniron Compressor Systems, model NE-C28 and NE-C30, consist of a nebulizer and AC powered piston-type compressor that's generates compressed air. The Model NE-C30 also includes a rechargeable battery pack and can be connected to DC voltage.
Both units utilize the same handheld nebulizer, which is a venturi type which converts the liquid medication into a fine aerosol which is inhaled by the patient via a mouthpiece of mask. The nebulizers can be cleaned and reused.
The provided document is a 510(k) premarket notification for Omron Compressor Systems, Models NE-C28 and NE-C30. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies or establishing detailed acceptance criteria based on performance studies.
Therefore, the document does not contain the information requested regarding acceptance criteria studies for a device with embedded AI or similar technologies that would require a detailed performance evaluation against a specific ground truth.
Specifically, the following information is not present in the document:
- A table of acceptance criteria and the reported device performance: The document lists device attributes (like drug delivery rate, reservoir size) and operating conditions, but these are specifications, not performance acceptance criteria against a clinical outcome or diagnostic accuracy.
- Sample size used for the test set and the data provenance: No test sets, clinical studies, or data provenance information is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is irrelevant in this type of submission.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is a compressor nebulizer system, which does not involve human readers or AI assistance in the way, for example, an AI diagnostic tool would.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document primarily focuses on:
- Device Description: What the device is and how it works.
- Intended Use/Indications for Use: What the device is for and for whom.
- Predicate Device Comparison: Demonstrating substantial equivalence to a previously cleared device (Omron NE-C09 - K914836) by comparing features and specifications.
- Safety Standards: Listing compliance with relevant electrical safety and risk management standards (IEC 60601-1, IEC 60601-1-2, UL 60601-1, FCC Part 15, ISO 14971).
The core of a 510(k) submission for this type of device is to show that it is "as safe and effective as, or substantially equivalent to, a legally marketed device" and does not typically involve the kind of performance studies with acceptance criteria, ground truth, and expert evaluation that would be required for a novel diagnostic device or an AI-powered system.
§ 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).