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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.

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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