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510(k) Data Aggregation
(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.
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(45 days)
Vortex is indicated for use as a spacer/valved holding chamber for use in delivery of aerosol medication with metered dose inhalers.
Vortex is a new spacer/holding chamber designed to assist patients using metered dose inhalers (MDI) for aerosolized drug delivery. Vortex may provide enhanced drug delivery, ease of use and ability to clean/disinfect the device.
Vortex is a reusable device consisting of an aluminum cylinder with an elastomeric fitting on one end to accept metered dose inhalers and a valved mouthpiece on the other end to interface with the patient. The elastomeric fitting may be removed for cleaning and/or replacement.
Vortex will be available as a stand-alone item and will also be available packaged with a mask.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Vortex compared to Aerochamber) | Reported Device Performance (Vortex) |
|---|---|---|
| Drug Delivery (Respirable Drug) | Comparable to or greater than Aerochamber. | Respirable drug delivered through Vortex is "comparable to . or greater than Aerochamber." |
| Fit with MDI Elbows | Not explicitly stated as a comparative criterion, but implied to fit all. | Vortex "fit all MDI elbows evaluated." |
| Inhalation Resistance | Comparable to or less than Aerochamber, and less than 250 pascal at 30 lpm flow. | "Comparable to or less than Aerochamber. All results are less than 250 pascal at 30 lpm flow." |
| Exhalation Resistance | Comparable to or less than Aerochamber, and less than 250 pascal at 30 lpm flow. | "Comparable to or less than Aerochamber. All results are less than 250 pascal at 30 lpm flow." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for the "test set" (i.e., the number of devices or experimental replicates used in the non-clinical testing). It only states that "Testing to compare Vortex to Aerochamber was conducted."
The data provenance is retrospective, as the testing was conducted for the purpose of a 510(k) submission to demonstrate substantial equivalence to an already legally marketed device. The country of origin of the data is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable as the provided document describes non-clinical performance testing of a medical device (a valved holding chamber/spacer), not a diagnostic or AI-driven system that requires expert-established ground truth. The "ground truth" here is objective physical measurements (e.g., drug delivery, resistance).
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3. Adjudication methods are typically relevant for subjective assessments or when multiple experts review the same data, which is not the case for this non-clinical performance study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not completed/is not required to show substantial equivalence." MRMC studies typically involve human readers and clinical outcomes.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device (Vortex valved holding chamber) is a physical medical device, not an algorithm or AI system. Its performance is measured directly, not through an algorithm.
7. The Type of Ground Truth Used
The "ground truth" used for this device's performance assessment was based on objective physical measurements and established testing methodologies. For example:
- Drug delivery: Measured quantitatively according to FDA guidance.
- Fit with MDI elbows: An objective assessment of physical compatibility.
- Inhalation and exhalation resistance: Measured quantitatively using instruments (e.g., in pascal at a specific flow rate).
8. The Sample Size for the Training Set
This information is not applicable as the device is not an AI/ML algorithm that requires a training set. The performance testing was conducted on the physical device itself.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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