(92 days)
The Nevoni Classic 6600-PO nebulizer is an ac powered portable compressor. This portable device uses a pneumatic piston that compresses uir, forcing it to flow into the nebulizer cup. The force of the air flowing into the nebulizer cup disperses the medicine into fine mist particles for the inhalation treatment based on a physician's prescription. This device is intended for single patient home therapy.
The Nevoni Classic nebulizer is a portable AC-powered respiratory device used for home therapy. It uses a compressor to process medicine into a breathable aerosolized mist which is collected into a facial mask and inhaled by the patient.
The device's nebulization process is achieved through a small wired AC-electric motor that forces an oil-free piston into motion. This motion oscillates a sealed diaphragm and compresses air into a small chamber. Air intake is supplied to the compressor using a felt filter. The compressed air flow is conducted through a thin flexible tube into a nebulizer cup in which a fine particle mist is created by the medicine's highly pressurized contact. The nebulizer cup is attached to an anatomical mask made of soft, non-toxic material. The medicine's mist accumulates within this mask where it is ready for inhalation by the patient.
The Nevoni Classic nebulizer package includes a compressor, air tubing, air filters and adult and child size masks.
This 510(k) summary (K082878) for the Nevoni Classic 6600-PO nebulizer does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the specifics of a study proving device performance. This document is a premarket notification for substantial equivalence, which primarily focuses on comparing the new device to existing legally marketed predicate devices, rather than presenting a full performance study with acceptance criteria.
However, I can extract the available information and highlight what is missing based on your prompt.
Missing Information:
The document does not describe a specific study with acceptance criteria for the Nevoni Classic 6600-PO. Instead, it relies on demonstrating substantial equivalence to pre-existing nebulizers by comparing product properties. Therefore, many of your requested points regarding a specific performance study cannot be answered from this document.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present formal "acceptance criteria" and "reported device performance" in the way one would expect from a dedicated performance study. Instead, it provides a "Comparative Product Table" to demonstrate substantial equivalence to predicate devices. The implicit "acceptance" is that the device's performance aligns with, or is comparable to, the predicate devices.
| Product Properties | Nevoni Classic Model 6600-PO Compressor | Salter Aire Compressor | DeVilbiss Model 3655 Compressor | Invacare Model IRC 1001 Aerosol Compressor | Implicit "Acceptance Criteria" (based on predicates) | Reported Performance (Nevoni Classic) |
|---|---|---|---|---|---|---|
| Compressor type | Piston | Piston | Piston | Piston | Piston | Piston |
| Voltage | 110V 50/60Hz, 0.5 Amps | 110V 60Hz, 2.5 amps | 110V 60Hz, amps | 115V 60 Hz, 1.6 amps | Within typical ranges for nebulizers | 110V 50/60Hz, 0.5 Amps |
| Free flow rate | 15 lpm | 11 lpm | 8 lpm | 8.5 lpm | Comparable to or better than predicates (>8 lpm) | 15 lpm |
| Operating flow rate | 8 lpm | 6.5 lpm | 5.5 lpm | 4.8 lpm | Comparable to or better than predicates (>4.8 lpm) | 8 lpm |
| Over-heating switch | No | Yes | Yes | Yes | (Not present on this device) | No |
| Portable | Yes | Yes | Yes | Yes | Yes | Yes |
| Case material | Plastic | Plastic | Plastic | Plastic | Plastic | Plastic |
| Warranty | 1 year | 1 year | 5 year | 5 year | 1 year (matches one predicate) | 1 year |
| Maximum operating temp. | 158 °F | 128.5 °F | 104 °F | 158 °F | Comparable to predicates (up to 158 °F) | 158 °F |
| Intended environment use | Home therapy | Home therapy and hospital | Home therapy | Home therapy | Home therapy | Home therapy |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This document does not describe a test set or a formal study with a patient or sample size. The comparison is based on device specifications of the new device and predicate devices.
- Data Provenance: Not applicable for a test set. The data presented are product specifications for the Nevoni Classic and three predicate devices (Invacare Model IRC 1001, Sunrise Medical Devilbiss Model 3655, Salter Labs Aire Compressor). There's no mention of country of origin for specific test data or whether it's retrospective/prospective, as no performance study is detailed.
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" or expert review of a test set is described in this 510(k) summary.
4. Adjudication method for the test set
- Not applicable. No test set or adjudication method is described.
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 device; it's a nebulizer. No MRMC study was conducted or is relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm.
7. The type of ground truth used
- Not applicable. No "ground truth" in the clinical or imaging sense is described. The equivalency is based on objective device specifications and intended use.
8. The sample size for the training set
- Not applicable. There is no training set for this type of device.
9. How the ground truth for the training set was established
- Not applicable. There is no training set or ground truth in this context.
§ 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).