(15 days)
OptiChamber Advantage Anti-Static Valved Holding Chamber is intended to be used in combination with Metered Dose Inhalers (MDIs) for respiratory drug delivery. This device, as is the case with other spacer devices, is intended to leave larger non-respirable drug particles within the device and allows smaller respirable particles to be delivered to the lungs.
OptiChamber Advantage Anti-Static (OCAS) is a Class II device. It is a valved holding chamber for use with metered dose inhalers (MDIs). The OCAS is a valved holding chamber utilizing the same operating principles as the OptiChamber (K962822) and the AeroChamber Z-Stat (K052322). The difference between the OCAS and the OptiChamber is that, like the AeroChamber Z-Stat, the OCAS is made of an anti-static plastic material. OptiChamber Advantage Anti-Static Valved Holding Chamber has a chamber and mouthpiece made of anti-static material. Non-anti-static valved holding chambers must be washed prior to use. The use of anti-static material in the aerosol path allows an unwashed device to produce the same drug delivery as a washed device.
The provided text describes a 510(k) submission for a medical device and therefore does not contain information about acceptance criteria and a study proving a device meets those criteria in the typical sense of AI/algorithm performance. Instead, it details a comparison of a new physical device (OptiChamber Advantage Anti-Static Valved Holding Chamber - OCAS) to predicate devices to establish substantial equivalence.
Here's an interpretation based on the provided text, focusing on the device characteristics compared for substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
For a physical medical device seeking 510(k) clearance, "acceptance criteria" are typically defined by the FDA's guidance documents and the characteristics of the predicate device. The "reported device performance" refers to how the new device compares to the predicate device against these characteristics.
| Acceptance Criteria (based on predicate device performance) | Reported Device Performance (OptiChamber Advantage Anti-Static) |
|---|---|
| Aerosol Characteristics: | |
| - Particle size distribution (Mass Median Aerodynamic Diameter - MMAD) allowing respirable particles to lungs and retaining larger non-respirable particles. | "Testing documentation shows that the aerosol characteristics of the OCAS and the AeroChamber Z-Stat are substantially equivalent." |
| - Delivers a therapeutically beneficial amount of drug to the lungs. | (Implied by substantial equivalence in aerosol characteristics and operating principle) |
| - Minimal drug deposition in the oropharynx. | (Implied by substantial equivalence in aerosol characteristics and operating principle) |
| Operating Principles: | "The three devices are also substantially equivalent in terms of their operating principle and indications for use." |
| Intended Use: | "The subject (OCAS) and predicate devices (OptiChamber, K962822 and AeroChamber Z-Stat, K052322) are indicated for the same intended use." |
| Anti-static property: | "The use of anti-static material in the aerosol path allows an unwashed device to produce the same drug delivery as a washed device." "The performance of the OCAS before and after washing are also substantially equivalent." |
| Material Composition: | Chamber and mouthpiece made of anti-static material (similar to AeroChamber Z-Stat predicate). |
| Portability and Lightweight: | "Both devices are portable and lightweight." (Referring to OCAS and AeroChamber Z-Stat) |
| Safety and Effectiveness: | "We have demonstrated that the OptiChamber Advantage Anti-Static Valved Holding Chamber is as safe and effective as a predicate device..." |
2. Sample size used for the test set and the data provenance
The text mentions "testing documentation" for aerosol characteristics but does not specify the sample sizes (e.g., number of devices tested, number of inhalations performed).
Data provenance is not explicitly stated. The testing was performed in the context of a 510(k) submission by Respironics New Jersey, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a technical performance comparison of physical devices, not an AI/algorithm study involving expert review for ground truth.
4. Adjudication method for the test set
Not applicable. This is a technical performance comparison of physical devices, not an AI/algorithm study requiring expert adjudication.
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
No, an MRMC comparative effectiveness study was not done. This submission is for a physical medical device, not an AI algorithm assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This relates to a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" here is the performance characteristics of the predicate devices, specifically the AeroChamber Z-Stat, which is considered legally marketed and effective. The new device's performance (e.g., particle size distribution) is compared to this established benchmark.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is a physical device comparison, not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a physical device.
§ 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).