(150 days)
The NESSI Spacer is intended to be used by patients who are under the care of treatment of a licensed healthcare professional or physician. The device is intended to be used by these patients to administer aerosolized medication from pressurized Metered-Dose Inhalers, prescribed by a physician or healthcare professional.
The NESSI is a spacer intended for use in the inhalation of MDIs for the therapy of the upper and lower respiratory system. The device consists of a translucent housing a back piece and mouth piece.
The NESSI Spacer can be used to inhale aerosolized drugs of approved MDIs from the following groups of active substances:
- · Corticosteroids (anti-inflammatory medications)
- · Anti-cholinergics and ß2-sympathomimetics (bronchodilater medications)
- · Non-steroidal chromones (DNCG)
It is a single patient, multi-use device.
The provided document describes a 510(k) premarket notification for the NESSI Spacer, which is a medical device. 510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than conducting extensive new clinical studies to prove acceptance criteria in the same way a PMA (Premarket Approval) would. Therefore, the information requested regarding a "study that proves the device meets the acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or reader improvement, or details on training/test sets, ground truth, and expert adjudication, is largely not applicable or present in this type of document.
A 510(k) focuses on demonstrating that the new device is as safe and effective as a predicate device through comparison of indications for use, technological characteristics, materials, and other attributes.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, "acceptance criteria" are generally based on demonstrating "substantial equivalence" of the new device's attributes to those of predicate devices. The "reported device performance" is a comparison to the predicate devices.
| Attribute/Acceptance Criteria (Similarity to Predicates) | NESSI Spacer Performance (Compared to Predicates) |
|---|---|
| Indications for Use: | Similar to K010680 (CT Spacer) and K070674 (Trudell AeroChamber Plus) |
| Technology: | Similar to K010680 (CT Spacer) |
| Materials: | Identical to those used in 510(k) K082092, with identical exposure characteristics. ISO 10993 testing provided for biocompatibility. |
| Environment of Use: | Identical to K070674 (Trudell AeroChamber Plus) |
| Patient Population: | Similar to K070674 (Trudell AeroChamber Plus) |
| Safety/Effectiveness Differences: | No significant differences that affect the safety or effectiveness of the intended device when compared to predicate devices. |
| Anti-static claim: | Yes (Similar to K070674 - Trudell AeroChamber Plus, which also has an anti-static claim; K010680 does not) |
| Other shared attributes: | Used with mouthpiece or face mask (Yes), Used with pressurized metered dose inhalers (Yes), Single patient reusable (Yes), Prescriptive (Yes - all predicates are) |
Note: The "acceptance criteria" here are inherently tied to satisfying the substantial equivalence requirements by closely matching or being demonstrably as safe and effective as the predicates.
Regarding items 2-9 from your request:
The provided document does not contain information typically associated with a study proving clinical performance using specific metrics, test sets, ground truth establishment, or expert adjudication, as would be expected for a device requiring higher levels of clinical evidence. This is because the NESSI Spacer is a Class II device seeking 510(k) clearance based on substantial equivalence to existing predicate devices. The review focuses on comparing the new device's characteristics to the predicates, as detailed in the table above, not on a new clinical efficacy study with performance metrics in the way your questions imply for AI/software devices.
Therefore, the following points are not applicable (NA) or not provided in this 510(k) submission:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
* NA: No clinical performance study with a test set of data is detailed. The substantial equivalence is based on device characteristics, materials, and indications, not a data-driven performance test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
* NA: No test set or ground truth established by experts is mentioned for performance evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
* NA: No test set or adjudication method mentioned.
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
* NA: This is not an AI/software device, and no MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* NA: This is a physical medical device (spacer), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
* NA: No ground truth in the context of clinical performance evaluation is used. The "ground truth" for this submission is that the predicate devices are legally marketed and considered safe and effective for their intended use.
8. The sample size for the training set
* NA: No training set mentioned.
9. How the ground truth for the training set was established
* NA: No training set or ground truth mentioned.
Summary Rationale:
The NESSI Spacer received 510(k) clearance (K091862) based on demonstrating substantial equivalence to predicate devices (K010680 - CT Spacer and K070674 - Trudell AeroChamber Plus). This process generally involves comparing product descriptions, indications for use, technological characteristics, materials, and other non-clinical factors. For devices like this spacer, extensive new clinical performance studies with metrics, test sets, and expert adjudication (as typically required for AI/software or novel high-risk devices) are usually not part of the 510(k) submission. Therefore, the specific types of "acceptance criteria" and "study" details requested are not relevant or present in this document for this type of device and regulatory pathway.
§ 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).