(474 days)
The Space Chamber Plus and Compact Space Chamber Plus are intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The devices are intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include home, hospitals and clinics.
The Space Chamber Plus and Compact Space Chamber Plus are devices designed to assist patients with inhaling aerosolized medication dispensed through a Metered Dose Inhaler. The devices consist of a cylindrical chamber with an opening at each end. One opening is for the aerosol medication to be inserted, the other is tapered into a mouthpiece for inhalation. The mouthpiece can be used with or without a mask. The Compact Space Chamber Plus is a smaller version of the Space Chamber Plus that allows for easier storage and handling.
Here's a breakdown of the acceptance criteria and the study details for the Space Chamber Plus and Compact Space Chamber Plus devices, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The acceptance criteria for the Space Chamber Plus and Compact Space Chamber Plus devices are based on demonstrating substantial equivalence to the predicate device, AeroChamber Plus aVHC with Flow-Vu IFI (K070674), particularly with respect to particle size distribution and respirable dose. The study performed involved non-clinical testing of particle size distribution.
Table of Acceptance Criteria and Reported Device Performance (Summary of Equivalence)
| Performance Metric | Acceptance Criteria (Demonstrate Equivalence to Predicate) | Space Chamber Plus Reported Performance | Compact Space Chamber Plus Reported Performance |
|---|---|---|---|
| Particle Size, Mean MMAD, μm | Demonstrably equivalent to Aerochamber Plus Flow Vu Anti-static (predicate). Narrow 95% CI indicating consistent delivery. | Albuterol: 2.5 (0.04) | |
| Ipratropium Bromide: 0.93 (0.05) | |||
| Beclomethasone Dipropionate: 1.3 (0.02) | |||
| (All values are within a narrow 95% CI and comparable to the predicate's MMAD values: Albuterol 2.4 (0.03), Ipratropium Bromide 0.76 (0.05), Beclomethasone Dipropionate 1.3 (0.03)) | Albuterol: 2.3 (0.05) | ||
| Ipratropium Bromide: 0.80 (0.02) | |||
| Beclomethasone Dipropionate: 1.3 (NA^) | |||
| (All values are within a narrow 95% CI (where applicable) and comparable to the predicate's MMAD values: Albuterol 2.4 (0.03), Ipratropium Bromide 0.76 (0.05), Beclomethasone Dipropionate 1.3 (0.03)) | |||
| Mean Total Respirable Dose, μg | Demonstrably equivalent to Aerochamber Plus Flow Vu Anti-static (predicate). Narrow 95% CI indicating consistent delivery. | Albuterol: 286.9 (36.3) | |
| Ipratropium Bromide: 85.26 (3.3) | |||
| Beclomethasone Dipropionate: 328.05 (9.9) | |||
| (Comparable to predicate's values: Albuterol 292.2 (19.2), Ipratropium Bromide 55.28 (3.0), Beclomethasone Dipropionate 316.25 (17.6)) | Albuterol: 253.4 (38.7) | ||
| Ipratropium Bromide: 65.19 (2.1) | |||
| Beclomethasone Dipropionate: 308.29 (12.7) | |||
| (Comparable to predicate's values: Albuterol 292.2 (19.2), Ipratropium Bromide 55.28 (3.0), Beclomethasone Dipropionate 316.25 (17.6)) | |||
| Mean Respirable Fraction PF% (0.5-4.7) | Greater than pMDI alone and demonstrably equivalent to Aerochamber Plus Flow Vu Anti-static (predicate). Narrow 95% CI indicating consistent delivery. | Albuterol: 86.1 (0.9) | |
| (Predicate: 87.6 (0.7), pMDI alone: 79.7 (3.3)) | |||
| Ipratropium Bromide: 65.3 (0.9) | |||
| (Predicate: 60.0 (1.8), pMDI alone: 54.7 (1.7)) | |||
| Beclomethasone Dipropionate: 82.7 (0.8) | |||
| (Predicate: 83.9 (1.1), pMDI alone: 77.3 (2.4)) | Albuterol: 88.0 (0.6) | ||
| (Predicate: 87.6 (0.7), pMDI alone: 79.7 (3.3)) | |||
| Ipratropium Bromide: 61.9 (0.7) | |||
| (Predicate: 60.0 (1.8), pMDI alone: 54.7 (1.7)) | |||
| Beclomethasone Dipropionate: 83.7 (1.0) | |||
| (Predicate: 83.9 (1.1), pMDI alone: 77.3 (2.4)) |
^(NA: Not applicable when results for each individual run are the same)
Study Details Proving Acceptance Criteria
The study performed was a non-clinical performance study focused on the particle size distribution of aerosolized medication delivered by the Space Chamber Plus and Compact Space Chamber Plus, in comparison to the predicate device and the pMDI alone.
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Sample size used for the test set and the data provenance:
- The document does not explicitly state the specific numerical sample size for each test run (e.g., number of inhalations tested, number of devices tested). However, the presence of 95% Confidence Intervals (CI) suggests multiple replicates were performed for each measurement.
- Data Provenance: The study was conducted by Medical Developments International Limited, an Australian company. The testing was performed in accordance with relevant sections of the CDRH Guidance Document "Reviewers Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH/ODF/DCRD/ADDB -1993), implying a controlled laboratory environment. The data is retrospective to the submission date.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This was a non-clinical performance study involving physical measurements of particle size distribution, not an evaluation requiring expert interpretation of clinical images or patient data. The "ground truth" was established by the physical testing methodology itself, following established guidance.
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Adjudication method for the test set:
- Not Applicable. As this was a non-clinical, objective measurement study, there was no need for expert adjudication.
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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. This was a non-clinical performance study of a medical device (spacer/valved holding chamber) focused on drug delivery characteristics, not an AI-based diagnostic or imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance was involved.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This study assessed the physical performance of a mechanical medical device, not an algorithm.
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The type of ground truth used:
- The "ground truth" was established through objective physical measurements using scientific instruments (e.g., cascade impactors for particle size distribution) following the methodology outlined in the "Reviewers Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" and generating quantitative data for MMAD, respirable dose, and respirable fraction.
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The sample size for the training set:
- Not Applicable. This was a non-clinical performance validation against a predicate device, not a machine learning model requiring a training set.
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How the ground truth for the training set was established:
- Not Applicable. No training set was used.
§ 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).