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510(k) Data Aggregation
(189 days)
OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER
The OptiChamber Diamond Valved Holding Chamber device is intended to be used by patients who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. The intended environments for use include the home, hospitals and clinics.
For Single Patient Use .
Recommended Patient Population:
OptiChamber Diamond: Age 5 and up
OptiChamber Diamond with Small LiteTouch mask: 0 to 18 months
OptiChamber Diamond with Medium LiteTouch mask: 1 to 5 years
OptiChamber Diamond with Large LiteTouch mask: 5 years +
The OptiChamber Diamond Valved Holding Chamber (VHC) is a Class II device. It is intended to be used in combination with most pressurized Metered Dose Inhalers (pMDIs) to assist in respiratory drug delivery.
The OptiChamber Diamond Valved Holding Chamber is a device utilizing the same operating principles as the AeroChamber Plus Z-Stat Valved Holding Chamber (K052332). Both the AeroChamber Plus Z-Stat and the OptiChamber Diamond are available with and without mask.
The valved holding chamber (VHC) is designed to assist patients who cannot correctly coordinate actuation of the pressurized metered dose inhaler (pMDIs) with inhalation. The VHC works by 'holding' the aerosol cloud emitted from the pMDI inside the chamber so that the larger aerosol particles are removed from the aerosol cloud by impaction into the chamber walls and sedimentation under the influence of gravity.
The OptiChamber Diamond Valved Holding Chamber is made of antistatic plastic materials alleviating any need to wash prior to first use. OptiChamber Diamond is comprised of: the mouthpiece, the chamber, the adapter (end cap) with inhalation flow alert, the exhaust valve, the inhalation valve, the valve retaining ring, and the cap.
The provided text describes testing conducted for the OptiChamber Diamond Valved Holding Chamber, a device intended to assist in respiratory drug delivery with pressurized Metered Dose Inhalers (pMDIs).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The submission claims substantial equivalence to the predicate device AeroChamber Plus Z-Stat Valved Holding Chamber (K052332) based on in vitro testing. The acceptance criteria are implicitly that the OptiChamber Diamond's performance (MMAD, GSD, FPD, FPF) should be comparable to or within acceptable limits relative to a pMDI alone and presumably similar to the predicate device, although direct comparative values for the predicate are not specified in this summary.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Fine Particle Dose (FPD) | Determined for categories: >4.7um, ≤4.7um, and ≤1.0um. Specific values for the OptiChamber Diamond with pMDI were measured and used to demonstrate performance. |
| Fine Particle Fraction (FPF) | Fraction of dose entering impactor ≤ 4.7um. Specific values were measured and used to demonstrate performance. |
| Mass Medium Aerodynamic Diameter (MMAD) | Geometric mean aerodynamic diameter. Specific values were measured and used to demonstrate performance. |
| Geometric Standard Deviation (GSD) | Measure of dispersion in lognormal distribution. Specific values were measured and used to demonstrate performance. |
| Comparison to pMDI Alone | Performance with OptiChamber Diamond VHC was compared to a pMDI alone. |
| Drug Formulations | Evaluated with albuterol, fluticasone propionate, and ipratropium bromide. |
| Simulated Breathing Patterns | Tested at 15 LPM (pediatric) and 30 LPM (adult). |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The pMDI was actuated 10 times into each device (OptiChamber Diamond VHC and pMDI alone) for each test. With three drug formulations and two flow rates, this implies a total of 60 actuations for the OptiChamber Diamond (10 actuations * 3 formulations * 2 flow rates) and another 60 for the pMDI alone.
- Data Provenance: The study was an in vitro test, meaning it was conducted in a lab setting, not on human or animal subjects. Details on the country of origin are not explicitly stated, but the submitter is "Respironics New Jersey, Inc." in Parsippany, New Jersey, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable for this type of in vitro performance testing. The "ground truth" is established through standardized laboratory measurements and analytical techniques (HPLC assays, NGI analysis).
4. Adjudication Method for the Test Set
Not applicable. This was an in vitro engineering performance study, not a clinical study requiring expert adjudication of patient outcomes or imaging.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This was an in vitro performance study of a physical device, not an AI or diagnostic imaging device that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone in vitro performance study was done. The device's performance was evaluated independently without human interaction influencing the drug delivery mechanics during the measurement.
7. The Type of Ground Truth Used
The "ground truth" for this in vitro study was based on analytical measurements and established standards for aerosol drug delivery. This includes:
- HPLC assays: Quantifying drug deposition in various parts of the Next Generation Impactor (NGI).
- Next Generation Impactor (NGI): A standardized instrument used to measure the aerodynamic particle size distribution of aerosols, which forms the basis for MMAD, GSD, FPD, and FPF calculations.
- CITDAS software: Used for the calculation and analysis of aerosol performance parameters.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not a machine learning or AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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(15 days)
OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER
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.
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(90 days)
OPTICHAMBER
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