(168 days)
The Watchhaler is a holding chamber intended to administer aerosolized medication with a Metered Dose Inhaler. For pediatric patients (3 years and older). The environment of use includes home care, nursing homes, sub-acute institutions, and hospitals
The Watchhaler is a spacer primarily used in the pediatric population for the inhalation of approved MDIs for the therapy of the upper and lower respiratory system. The design of the device is held in the shape of a colored toy animal to address its users, the children. The device consists of a balloon which is enclosed by a translucent housing. During inhalation the balloon collapses with the speed of deflation controlled by a mechanical valve. The fixed volume of the balloon and the low inhalation flow provided by the valve help to ensure a constant drug delivery.
This document is a 510(k) Premarket Notification for a medical device (Watchhaler) and does not describe a clinical study or present data demonstrating the device meets acceptance criteria. Instead, it aims to establish substantial equivalence to predicate devices. Therefore, most of the requested information cannot be extracted from this document.
However, based on the provided text, here's what can be gathered regarding acceptance criteria and the comparison to predicate devices, recognizing that this is not a study proving the device meets performance criteria, but rather a submission arguing for substantial equivalence based on attributes:
1. A table of acceptance criteria and the reported device performance
The document doesn't present "acceptance criteria" in the traditional sense of performance metrics with thresholds that were tested against. Instead, it lists attributes of the proposed Watchhaler and implicitly argues that these attributes are substantially equivalent to predicate devices. The "reported device performance" would be the listed attribute itself.
| Attribute | Value for Proposed Watchhaler | Implied "Acceptance Criteria" (Substantial Equivalence) |
|---|---|---|
| Indications for Use | Administer aerosolized medication with a Metered Dose Inhaler (all have except pentamidine) | Equivalent to predicate devices' indications for use (specifically noting the absence of pentamidine). |
| Environments of use | Home care, nursing home, sub-acute institutions or hospitals | Equivalent to predicate devices' environments of use. |
| Patient population | Pediatric (3 years and older) | Equivalent to predicate devices' patient population (pediatric, 3 years and older). |
| Single patient, multi-use | Yes | Equivalent to predicate devices' multi-use capability. |
| Used with mouthpiece | Yes | Equivalent to predicate devices' use with a mouthpiece. |
| Used with most pressurized Metered Dose Inhalers | Yes | Equivalent to predicate devices' compatibility with most pressurized MDIs. |
| Feedback | Visual | Comparable to predicate devices, particularly those with visual feedback mechanisms (e.g., Flow-Vu IFI mentioned in a predicate). |
| Flow control / maximum flow rate | Yes / 15 Lpm | Comparable to predicate devices in having flow control and a similar maximum flow rate. |
| Materials | ISO 10993 tested | Biocompatibility testing to ISO 10993 standards, aligning with typical requirements for medical devices and implicitly similar to predicate materials. |
| Inhalation volume | Maximum 300 ml | Comparable to predicate devices' typical inhalation volume. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document does not describe a test set or data generation.
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 information is not provided. The document does not discuss ground truth established by experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. The document does not describe an adjudication method for a test set.
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
A MRMC comparative effectiveness study was not done. The device is a physical medical device (spacer/holding chamber), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
A standalone performance study was not done. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable as there is no mention of a study generating data against a "ground truth" in the device's performance. The basis for approval is substantial equivalence to legally marketed predicate devices, meaning its attributes and intended use are similar enough to devices already deemed safe and effective.
8. The sample size for the training set
This information is not provided. The document does not describe a training set.
9. How the ground truth for the training set was established
This information is not provided. The document does not describe how ground truth for a training set was established.
§ 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).