(90 days)
The NESSI OTC Spacer is intended to be used to administer aerosolized medication from pressurized Metered-Dose Inhalers, which are over-the-counter (OTC), e.g., bronchodilator / epinephrine.
The NESSI is a spacer intended for use in the inhalations which are provided by OTC MDIs. The device consists of a translucent housing a back piece and mouth piece or face mask. It is a single patient, multi-use device.
This 510(k) summary describes the NESSI OTC Spacer, intended for use with over-the-counter (OTC) Metered-Dose Inhalers (MDIs) like bronchodilators/epinephrine. The device is being compared to a predicate PharmaCaribe NESSI Rx Spacer (K091862) and a Primatene Mist OTC MDI.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided document doesn't explicitly state numerical "acceptance criteria" for the NESSI OTC Spacer in terms of specific performance metrics like particle size distribution targets or usability scores. Instead, it frames the performance evaluation as demonstrating "equivalence" to predicate devices and appropriateness for OTC use.
Therefore, the table below will summarize the types of performance testing conducted and their general reported findings, rather than specific numerical criteria and results.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Particle Characterization: Equivalent particle delivery to a predicate spacer, or that any differences do not raise new safety/efficacy issues. | Particle Characterization: "The NESSI OTC spacer was testing via Anderson Cascade Impactor testing for particle characterization and found to be equivalent and any differences did not raise any new safety or efficacy issues." (Compared to MDI with and without spacer.) |
| Usability: Instructions for use are clear and users can effectively utilize the spacer for OTC designation. | Usability Study: "In addition a Usability study was performed to demonstrate that the instructions for use and ability of users to utilize the spacer were found to be appropriate for OTC designation." |
| Substantial Equivalence: Indication for Use, Technology, Materials, Environment of Use, and Patient Population are similar or identical to predicate devices. | Indications: "Similar to predicates - K091862 – PharmaCaribe NESSI Rx spacer but for use with OTC MDIs, i.e., Primatene Mist a bronchodilator / epinephrine which is sold OTC." |
| Technology: "Identical to predicate - K091862 - PharmaCaribe NESSI Rx spacer" | |
| Materials: "Identical to predicate - K091862 - PharmaCaribe NESSI Rx spacer" | |
| Environment of Use: "Identical to predicate – K091862 – PharmaCaribe NESSI Rx spacer" | |
| Patient Population: "Identical to predicates – K091862 – PharmaCaribe NESSI Rx spacer and Primatene Mist OTC MDI" |
2. Sample size used for the test set and the data provenance
- Particle Characterization (Test Set): The document does not specify the sample size used for the Anderson Cascade Impactor testing. It also doesn't provide information about the data provenance (e.g., country of origin, retrospective/prospective).
- Usability Study (Test Set): The document does not specify the sample size used for the Usability study or the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The document describes technical and usability testing, but not a process that would involve medical experts establishing a "ground truth" in the way it might for a diagnostic imaging device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. The performance tests described (particle characterization, usability) are not typically assessed using adjudication methods like 2+1 or 3+1, which are common in clinical trial settings for expert review of images or data.
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
This information is not applicable. The NESSI OTC Spacer is a medical device (spacer/holding chamber) designed to aid in the delivery of aerosolized medication, not an AI-powered diagnostic tool. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers with and without AI assistance would not be relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The NESSI OTC Spacer is a physical medical device, not an algorithm, and does not operate in a "standalone" algorithmic capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For Particle Characterization: The "ground truth" implicitly refers to established scientific methods for measuring particle size distribution (Anderson Cascade Impactor) and comparative data from predicate devices or MDIs. It's based on physical measurements and engineering principles.
- For Usability Study: The "ground truth" for usability would be derived from structured observations and feedback from users interacting with the device and its instructions, assessing their ability to correctly and effectively use the product as instructed. This doesn't typically involve expert medical consensus or pathology in the same way as a diagnostic tool.
8. The sample size for the training set
This information is not applicable/provided. This device is not an AI/machine learning device that would require a "training set."
9. How the ground truth for the training set was established
This information is not applicable. As it's not an AI/machine learning device, there is no training set or associated ground truth establishment process in that 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).