(55 days)
Funhaler is intended for use primarily in the pediatric population. Funhaler is used in combination with a Metered Dose Inhaler for respiratory drug delivery.
The Funhaler® V201 is basically a Spacer, similar in function and construction to commonly used Spacers. It is nearly identical and functionally equivalent to the predicate device (Funhaler®, Infamed Ltd; K042546) the device consists of a Mouthpiece, cylindrical Spacer. tapered on each end, incentive module and a molded connector compatible with approved Metered Dose Inhalers.
The provided document describes the Funhaler V201, a spacer device intended for use with Metered Dose Inhalers (MDIs) primarily in the pediatric population. The submission focuses on demonstrating substantial equivalence to a predicate device (Funhaler®, K042546) and compliance with various performance standards.
Here's an analysis of the acceptance criteria and the study information as requested:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance |
|---|---|---|
| Quality Systems | 21CFR820 Quality System Regulation | Meets/Exceeds |
| ISO 13485 - Quality Systems, Medical Devices | Meets/Exceeds | |
| Biocompatibility | ISO 10993-10; Biological Evaluation of Medical Devices; Tests for irritation and sensitization | Meets/Exceeds |
| ISO 10993-5; Biological Evaluation of Medical Devices; Tests for Cytotoxicity (MEM) | Meets/Exceeds | |
| Risk Management | EN 14971 - Risk Analysis | Meets/Exceeds |
| Device Performance (In vitro) | FDA Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers, and Actuators; October 1, 1993 | "Performance of Funhaler® with respect to particle size distribution has been confirmed to be better than or equal to the predicate device." |
| FDA division of Bioequivalence Guidance for the In-Vitro Portion of Bioequivalence requirements for Metaproterenol Sulfate and Albuterol Inhalation Aerosols (Metered Dose Inhalers) | Tested for particle size, distribution, and drug delivery with a variety of MDIs and drugs in accordance with FDA Guidance. Performance confirmed to be better than or equal to the predicate device. | |
| Pediatric Considerations | Guidance for Industry and FDA Staff-Premarket Assessment of Pediatric Medical Devices: May 2004 | Meets/Exceeds |
| Consumer Product Safety | 16CFR 1500:1501- Consumer Product Safety, as applicable for products intended for use with children. | Meets/Exceeds |
| Labeling | 21CFR801 - Labeling | Meets/Exceeds |
| Clinical Performance (Compliance - specifically stated for "pediatric patients") | Improved compliance with pediatric patients using the Funhaler® when compared to the predicate device. | "Limited clinical testing has demonstrated improved compliance with children using the Funhaler® when compared to the predicate device." |
Study Information
The document provides limited details regarding specific studies, primarily relying on demonstrating substantial equivalence to the predicate device and compliance with general standards.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not explicitly stated for either the particle size distribution/drug delivery testing or the "limited clinical testing."
- Data Provenance: Not specified. The submitter (InfaMed Ltd) is based in Western Australia.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The studies mentioned (particle size, drug delivery, and compliance) would likely rely on objective measurements or the assessment of healthcare professionals, but the specific number or qualifications of "experts" for ground truth establishment are not detailed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not described in the provided text.
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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, an MRMC comparative effectiveness study was not done. The device (Funhaler V201) is a medical device spacer, not an AI-powered diagnostic or interpretive tool that would involve human readers. Its primary reported benefits are improved compliance and proper medication delivery, not diagnostic accuracy.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The Funhaler V201 is a physical medical device, not an algorithm. Therefore, a "standalone" algorithm-only performance study is not applicable. The device's performance relates to its mechanical and functional characteristics, such as particle size distribution and drug delivery when used with an MDI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For particle size distribution and drug delivery, the ground truth would typically be established through in-vitro analytical measurements using standardized laboratory equipment (e.g., cascade impactors for particle size, chemical analysis for drug delivered).
- For improved compliance, the ground truth would likely be based on observational data gathered during the "limited clinical testing," potentially through direct observation by clinicians or objective measures of engagement with the device's feedback mechanisms. The document doesn't specify the exact method.
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The sample size for the training set:
- Not applicable as this is a physical medical device, not a machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable for the same reason as above.
§ 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).