(40 days)
MD Turbo is intended to assist with the delivery of aerosolized medications when used in conjunction with commercialized pressurized metered dose inhalers (pMDI). MD Turbo is also intended for use by patients to count the number of doses remaining in their pMDI.
The Respirics Inc. MD Turbo™ is a prescription accessory device designed for use with specific pressurized metered dose inhalers (pMDI). The MD Turbo™ is comprised of a triggering mechanism and dose counter. In addition to its primary function of assisting with the delivery of medications from pMDIs, the secondary function monitors the quantity of medication remaining in the pMDI canister. MD Turbo™ is designed to work with a number of different style pMDIs, without modification. The entire pMDI, i.e., canister and plastic actuator, is inserted into the MD Turbo™. If necessary, the pMDI can be removed for cleaning or if the MD Turbo™ becomes inoperable. Once the pMDI has been placed into the MD Turbo™, the device is prepared for use by the depression of a loading lever. After the loading lever is depressed, the pMDI can be triggered to deliver the prescribed medication through either breath-actuation or manual actuation. For breathactuation, the patient inhales through the pMDI actuator mouthpiece that has been inserted into the MD Turbo™. When the inspiratory flow of the patient reaches the target inspiratory flow rate, the device mechanism is triggered to actuate the pMDI canister and the medication is delivered to the patient. Alternatively, the patient can trigger MD Turbo™ to actuate the pMDI canister by depressing a recessed button on the back of the device. The MD Turbo™ also functions as a dose counter. Once a pMDI has been inserted into MD Turbo™, the patient selects the number of doses contained in the pMDI canister. The number is displayed on an LCD on the side of the device. Every time the MD Turbo™ is activated, the counter decrements appropriately. When the counter reaches 20 or fewer doses, the number display will start to flash.
The MD Turbo is a metered dose inhaler accessory. The available documentation does not contain information on specific quantitative acceptance criteria for the device's performance related to its primary function (assisting with medication delivery) or its secondary function (dose counting). The submission focuses on demonstrating substantial equivalence to predicate devices through comparative testing of physical characteristics.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Feature | Acceptance Criteria (Implied/Compared to Predicate) | Reported Device Performance |
|---|---|---|
| Medication Delivery: | ||
| Total Dose Output | Similar to Pocket Spacer™ with pMDI, and pMDI alone | Results from HPLC analysis were used for comparison. (Specific values not provided, conclusion is "similar performance characteristics") |
| Particle Size Distribution | Similar to Pocket Spacer™ with pMDI, and pMDI alone | Results from Cascade Impaction tests were used for comparison. (Specific values not provided, conclusion is "similar performance characteristics") |
| Dose Counting: | ||
| Dose Counter Accuracy | Similar to Meditrack Products Doser™ | MD Turbo™ functions as a dose counter, decrementing appropriately and flashing when 20 or fewer doses remain. (No specific accuracy metrics provided for comparison, but implied to be equivalent to predicate) |
| Biocompatibility: | Meet ISO 10993 standards (implied by tests) | Cytotoxicity, Sensitization, Irritation/Intracutaneous, Bioburden tests performed on patient-contacting and airway-continuity materials, with results documented in Appendix 3. (Specific pass/fail criteria and results not detailed, but submission implies they met accepted standards). |
| Technological Characteristics: | No significant change in design, materials, energy source, or other technological characteristics compared to predicate devices. | MD Turbo™ is functionally similar to predicate devices, combining features previously separate. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the sample sizes used for the cascade impaction tests or HPLC analysis.
- Data Provenance: The studies were performed by Respirics Inc. The country of origin and whether the studies were retrospective or prospective are not explicitly stated, but they appear to be laboratory-based performance tests rather than clinical studies on patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the studies described are laboratory performance tests comparing physical characteristics, not diagnostic or clinical efficacy studies requiring expert ground truth establishment.
4. Adjudication method for the test set:
This information is not applicable for the reasons stated above.
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:
- No MRMC comparative effectiveness study was done. The device, MD Turbo, is a mechanical accessory for metered dose inhalers and a dose counter, not an AI-assisted diagnostic or decision-support tool. Therefore, the concept of "human readers improving with AI assistance" is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone performance was done in the sense that the device's mechanical functions (medication delivery and dose counting) were evaluated in a laboratory setting without human intervention beyond operating the device for the tests. However, it's important to clarify that this is not an "algorithm-only" performance as would be relevant for an AI device. The MD Turbo is primarily a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the medication delivery performance (total dose output and particle size distribution), the "ground truth" was established by comparing the MD Turbo™ in conjunction with a pMDI to a predicate device (Pocket Spacer™ with pMDI) and to the pMDI alone. This is a comparative performance study against established methods/devices. The inherent performance of the pMDI alone and the predicate spacer serve as the reference.
- For the dose counting function, the ground truth would be the actual number of doses actuated, measured directly, and compared to the device's counter display. No specific details about this "ground truth" establishment are given, but it would likely be through direct observation of manual actuations.
- For biocompatibility, the ground truth is adherence to established biocompatibility standards (e.g., ISO 10993 series), for which the specified tests (Cytotoxicity, Sensitization, Irritation/Intracutaneous, Bioburden) provide the evidence.
8. The sample size for the training set:
- Not applicable. The MD Turbo is an accessory device that does not use machine learning or AI algorithms requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. (See point 8).
§ 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).