(266 days)
The FSC Anti-Static Valved Collapsible Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, (pMDIs).
Environment of use - Home, hospitals and clinics.
This product is intended for patients who can follow verbal instructions.
The FSC Anti-Static Valved Collapsible Holding Chamber is intended for use in the inhalation of medications delivered via an MDI and for which the medication is to be delivered to the upper and lower respiratory system. The device consists of a collapsible housing and mouth piece and a one-way valve to prevent exhaling into the chamber.
The FSC Anti-Static Valved Holding Chamber is intended to inhale aerosolized drugs of approved MDIs from the following groups of active substances:
- · Corticosteroids (anti-inflammatory medications)
- · Anti-cholinergics and ß2-sympathomimetics (bronchodilator medications)
- · Non-steroidal chromones (DNCG)
It is a single patient, multi-use, non-sterile device.
The provided text describes a 510(k) summary for the FSC Anti-Static Valved Collapsible Holding Chamber, which is a medical device used to administer aerosolized medication from Metered Dose Inhalers (pMDIs). The summary focuses on demonstrating substantial equivalence to predicate devices, namely the AeroChamber Plus Z-stat (K052332) and the E-Z Spacer (K933090).
However, the document does not outline specific, quantifiable acceptance criteria in the format of a table, nor does it provide a study that explicitly 'proves' the device meets such criteria in a typical clinical trial sense. Instead, it demonstrates equivalence to a predicate device through various non-clinical performance tests.
Therefore, the following information is extracted and presented as closely as possible to the requested format, acknowledging the limitations of the provided text.
Acceptance Criteria and Device Performance (Based on Equivalence Testing)
The document doesn't explicitly state numerical "acceptance criteria" but rather demonstrates performance that is "equivalent" or "better than" the predicate device, specifically the AeroChamber Plus Z-Stat (K052332), for particle characterization. For other tests, it states the device "passed or met its performance specifications."
| Acceptance Criteria Category | Specific Performance Parameter | Predicate Performance (K052332 or general) | Reported Device Performance (FSC Anti-Static Valved Collapsible Holding Chamber) |
|---|---|---|---|
| Particle Characterization | Total Respirable Dose Delivered (0.5-5.0 microns) @ 28 lpm (Ventolin HFA) | 37.5-46.8 ug/burst (MDI only for comparison) | 50.6-55.0 ug/burst (MDI - Spacer) - Demonstrated equivalent performance to predicate. |
| Total Respirable Dose Delivered (0.5-5.0 microns) @ 28 lpm (Atrovent HFA) | 7.5-8.1 ug/burst (MDI only) | 6.3-8.3 ug/burst (MDI - Spacer) - Demonstrated equivalent performance to predicate. | |
| Total Respirable Dose Delivered (0.5-5.0 microns) @ 28 lpm (QVAR 40) | 12.1-14.8 ug/burst (MDI only) | 10.7-15.4 ug/burst (MDI - Spacer) - Demonstrated equivalent performance to predicate. | |
| Material Biocompatibility | Cytotoxicity, Sensitization, Genotoxicity, Exhaustive Leachable/Extractable Testing | (Standard ISO 10993 requirements) | Passed required tests for External Communicating and Surface Contact classifications. |
| Simulated Lifetime | Pre and post-exposure, Cleaning | (Not specified, but predicate performance implied baseline) | Passed or met performance specifications. Demonstrated equivalent or better than predicate. |
| Environmental & Mechanical | High and Low temperature, Drop test | (Not specified) | Passed or met performance specifications. Demonstrated equivalent or better than predicate. |
| Anti-static Property | Surface resistivity | "Yes" (for K052332) | Passed or met performance specifications. Demonstrated equivalent or better than predicate. |
| Differential Pressure | Comparative testing | (Not specified) | Passed or met performance specifications. Demonstrated equivalent or better than predicate. |
Study Details:
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size for Particle Characterization:
- @ 28 lpm flow rate: 3 samples of the device, tested with 3 different drugs, 3 times each, for a total of 9 sample points for MDI-Spacer data. "MDI only" data used 3 samples tested with 3 drugs (number of times not specified, but implied to be comparable for a total of 9 tests or fewer for baseline).
- @ 12 lpm flow rate: 3 samples of the device, tested with 3 different drugs, 3 times each, for a total of 9 sample points.
- Data Provenance: Not explicitly stated, but the context of a 510(k) submission implies that these were laboratory-based, non-clinical tests conducted by or for FSC Laboratories, Inc. (the submitter). Therefore, it is prospective in the sense that it was conducted for this submission, and the country of origin would likely be the USA, where the company is based.
- Test Set Sample Size for Particle Characterization:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This was a non-clinical, in-vitro performance study. There were no human "experts" establishing a "ground truth" for a test set in the sense of medical diagnosis or interpretation. The ground truth was based on objective physical measurements (e.g., particle size, dose delivered) using a cascade impactor and established testing protocols.
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Adjudication method for the test set:
- Not applicable as this was a non-clinical, in-vitro performance test based on objective measurements rather than subjective assessment requiring adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, along with the effect size:
- No. This was a non-clinical device performance study, not a clinical study involving human readers or cases.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- "Standalone performance" in this context refers to the device's performance without a human in the loop, which is exactly what the non-clinical particle characterization and other mechanical/environmental tests represent. The data provided (Tables 4, 5, 6) are the results of the device performing its intended function in a laboratory setting. So, yes, standalone performance was assessed.
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The type of ground truth used:
- The "ground truth" for the particle characterization and dose delivery tests was based on direct, objective physical measurements obtained through standard laboratory techniques, such as using an 8-stage cascade impactor and measuring drug quantities. For other tests (like biocompatibility, anti-static properties), the ground truth was defined by meeting specific ISO standards or internal performance specifications.
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The sample size for the training set:
- Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set." The tests described are to validate the physical performance of the manufactured device.
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How the ground truth for the training set was established:
- Not applicable as 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).