(127 days)
The RespiConnect Adapter is designed to be used with RESPIMAT™ SOFT MIST INHALERS to facilitate the delivery of bronchodilator aerosol medication to mechanically ventilated patients. The single patient use adapter is intended to be left in the inspiratory limb of a 22 mm ventilator circuit.
The RespiConnect Adapter is a single-patient use device intended to provide a self-sealing access port in a ventilator circuit to facilitate the administration of Respimat™ Soft Mist inhaler medication to mechanically ventilated patients.
This document is a 510(k) premarket notification for the RespiConnect Adapter. It aims to demonstrate substantial equivalence to a predicate device. The information provided does not describe a study involving a particular device that requires the detailed acceptance criteria and study design requested. Instead this is a 510(k) submission for a non-AI medical device for which the following information is provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of performance thresholds with numerical values for a specific study. Instead, it describes general non-clinical tests performed and concluded that the device performs "satisfactorily" and "does not raise any new safety or efficacy related issues."
Non-Clinical Test Summary:
| Test Type | Acceptance Criteria / Performance Conclusion |
|---|---|
| Mechanical Testing | "characterize the operating parameters (leakage) of the RespiConnect Adapter device. The results (in Section 11, Attachment 4) demonstrate that the RespiConnect Adapter device performs satisfactorily, and does not raise any new safety or efficacy related issues." (Specific leakage values or thresholds are not provided in this summary.) |
| Biocompatibility | "materials of construction were tested for biocompatibility and do meet the requirements of ISO 10993-1:2009, Biological evaluation of medical devices." (Specific results of cytotoxicity, sensitization, and irritation/intracutaneous reactivity are not provided in this summary, only the conclusion of meeting the standard.) |
| Aerosol Testing | "characterize cascade impactor performance data for total delivered dose, respirable fraction and respirable particle mass using the subject device. Review of the performance results indicate no new safety or efficacy issues were raised as a result of the testing. Expected performance results have been added to the instructions for the RespiConnect Adapter for user reference." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical testing of a device rather than a study with a "test set" of patient data. Therefore, this information is not applicable in the context of the provided document. The tests seem to be performed on the physical device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as there is no "test set" of patient data requiring expert ground truth in this submission. The tests were for device performance characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as there is no "test set" of patient data requiring adjudication.
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 a submission for a non-AI medical device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a submission for a non-AI medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the sense of medical diagnosis. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles for mechanical leakage, biocompatibility standards (e.g., ISO 10993-1), and aerosol delivery characteristics.
8. The sample size for the training set
Not applicable. This is a non-AI medical device; there is no AI algorithm to train.
9. How the ground truth for the training set was established
Not applicable. This is a non-AI medical device; there is no AI algorithm to train.
§ 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).