(20 days)
The Instrumentation Industries, Inc. RTC 24-VP MDI Adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-VP MDI Adapter is intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 24-VP MDI Adapter is intended to be prescribed for any patient who is ventilator-dependent and to whom a metered dose inhaler has been prescribed. The expected clinical environment for the RTC 24-VP MDI Adapter is Critical Care and/or long term or short term ventilation. The RTC 24-VP MDI Adapter is intended for single patient reuse. This device is intended for sale by or on the order of a physician.
The Instrumentation Industries, Inc. RTC 24-VP metered dose inhaler adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in metered dose inhalers.
The provided text describes a submission for a medical device (RTC 24-VP Metered Dose Inhaler Adapter) to the FDA, focusing on its substantial equivalence to a predicate device. However, it does not describe an AI/ML-driven device or study. Therefore, most of the requested fields regarding AI/ML device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies are not applicable.
Below is the information that can be extracted or deduced from the provided text, primarily addressing the performance and comparison to a predicate device.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No significant impact on the rate of flow through the device. | "The decreased inlet port size on the RTC 24-VP has no significant impact on the rate of flow through the device..." |
| No significant impact on circuit back pressure. | "...or on the circuit back pressure." |
| Demonstrate substantial equivalence to the predicate device (RTC 24-V MDI adapter) in terms of function, materials, and safety. | The device found "substantially equivalent" to the RTC 24-V MDI adapter (K091111). Similarities include function, materials (latex-free Polystyrene Butadiene body, Thermoplastic Rubber cap), functional dimensions (Outlet – 15mm I.D. / 22 mm O.D.), and markings (molded-in arrow for flow direction). Performance testing showed "very little difference...in peak circuit back pressure." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document states "When a range of flow rates is used to ventilate air through both the new RTC 24-VP MDI adapter and the original RTC 24-V MDI adapter...", but no specific number of trials, devices, or flow rates is mentioned.
- Data Provenance: The testing was described as "laboratory testing." No country of origin for data or retrospective/prospective nature is specified, but it implies internal R&D testing by the manufacturer (Instrumentation Industries, Inc., located in Bethel Park, PA).
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)
- Not applicable. This device is a mechanical MDI adapter, and the evaluation is based on engineering performance metrics (flow rate, back pressure), not expert interpretation of data like medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/ML or diagnostic device requiring expert 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 not an AI/ML-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" (or reference standard) in this context would be the measured physical properties: peak circuit back pressure and flow rate, as determined by laboratory instruments under controlled conditions. This is an objective measurement rather than a subjective interpretation.
8. The sample size for the training set
- Not applicable. There is no training set for a mechanical device.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for a mechanical device.
§ 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).