(78 days)
The DHD Stealth Metered Dose Inhaler (MDI) Spacer (Without Integral Actuator) assists with the delivery of aerosolized medications when used in conjunction with commercially available Metered Dose Inhaler (MDI) canisters with their associated actuator elbows. In addition, for convenience, the MDI canister/elbow, may be stored inside of the Stealth when not in use (the spacer acts as the MDI canister/elbow holding chamber). Pilot is a one piece, silicone rubber face mask that may be attached to the Stealth MDI holding chamber as an interface between the Stealth MDI and the patient's face/mouth region.
The Pilot device is a mask attachment for the Stealth Metered Dose Inhaler (MDI) Spacer. The Pilot mask fits directly onto the Stealth MDI Spacer. Pilot is a single piece, injection molded, silicone rubber piece. It is intended for single patient use and may be disassembled from the Stealth MDI for convenient cleaning the device, by hand, in warm soapy water. The Pilot mask will be available in several sizes. and large masks. The mask sizes are designed to fit comfortably to a users face. The masks also include a tapered fitting designed to mate with the Stealth mouthpiece. The tapered fitting includes a small ledge which serves as a stop, preventing the mask from being advanced too far onto the Stealth mouthpiece.
The provided 510(k) summary for the "Stealth/Pilot (Final Name to Be Determined) MDI Spacer with Facemask" does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would typically be described. Instead, the submission relies on demonstrating substantial equivalence to predicate devices and addressing technological characteristics with "no testing required" for most points.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Technological Information) | Reported Device Performance (Summary of Studies) |
|---|---|
| 6.1 The mask must fit securely to the Stealth MDI spacer and be easily removed for cleaning. The tapered interface between the Pilot mask and Stealth mouthpiece meets this requirement. | Pilot meets this requirement. (No actual testing described; assertion made based on design.) |
| 6.2 The mask shall be available in three sizes. As shown by the drawings in the device description, the Pilot mask will be available in small, medium and large sizes. | Pilot meets this requirement. (No actual testing described; assertion made based on design and availability.) |
| 6.3 The mask must not interfere with MDI spacer performance. The mask system does not contain any valving, nor does the mask interface interfere with any of the functional areas of the Stealth spacer. | Pilot meets this requirement. (No actual testing described; assertion made based on design principles ["no valving," "no interference"]). |
| 6.4 The mask shall be manufactured from a clear or translucent elastomer. The Bayer LSR 20 series of silicone rubber is clear/translucent. | Pilot meets this requirement. (No actual testing described; assertion made based on material specification.) |
2. Sample size used for the test set and the data provenance
The document explicitly states: "There were no specific studies completed in association with this submission."
Therefore, there is no information on:
- Sample size used for a test set.
- Data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no studies involving a test set and ground truth establishment were described.
4. Adjudication method for the test set
Not applicable, as no studies involving a test set were described.
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 device is a mechanical medical device (MDI spacer with a facemask), not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a mechanical device, not an algorithm.
7. The type of ground truth used
Not applicable, as no studies involving ground truth were described.
8. The sample size for the training set
Not applicable, as no training set was used (e.g., for an AI algorithm).
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
Summary of the Study and Device Acceptance:
The submission for the "Stealth/Pilot" facemask does not include any performance studies or clinical trials with acceptance criteria and measured device performance in the traditional sense. Instead, the device's acceptance is based on demonstrating substantial equivalence to existing predicate devices ("ACE" MDI Spacer and "Stealth" MDI Spacer) and confirming that its technological characteristics meet basic design requirements without interfering with the primary function of the MDI spacer.
The "Summary of Studies" section explicitly states, "There were no specific studies completed in association with this submission," and the "Conclusions Drawn from Studies" section states "None."
The acceptance criteria listed in Section 6 ("Technological Information") are essentially design requirements that the manufacturer asserts are met by the Pilot mask's design, materials, and intended function. The FDA's 510(k) clearance process often allows for substantial equivalence determinations without new clinical or performance data if the new device is sufficiently similar to legally marketed predicate devices. In this case, the Pilot mask is an accessory that interfaces with an already cleared MDI spacer, and the manufacturer argued successfully that its design characteristics inherently met the stated requirements, thus "no testing is required."
§ 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).