(281 days)
The Fisio Chamber Spacer is intended to be used by patients who are under the care of treatment of a licensed healthcare professional or physician. The device is intended to be used by these patients to administer aerosolized medication from pressurized Metered-Dose Inhalers, prescribed by a physician or healthcare professional.
Environments of use - Home care, nursing homes, sub-acute institutions, and hospitals
The Fisio Chamber Spacer 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 translucent housing and mouth piece or face mask and a one-way valve to prevent exhaling into the chamber.
The Fisio Chamber Spacer is intended to be used to inhale aerosolized drugs of approved MDIs from the following groups of active substances:
- · Corticosteroids (anti-inflammatory medications)
- · Anti-cholinergics and B2-sympathomimetics (bronchodilater medications)
- · Non-steroidal chromones (DNCG)
It is a single patient, multi-use non-sterile device.
Here's a breakdown of the acceptance criteria and study information for the Fisio Chamber Spacer, based on the provided text:
Acceptance Criteria and Device Performance
The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and performance against those criteria in a tabular format. The "acceptance criteria" here are implicitly defined by the performance of the predicate device, K070674 - Trudell AeroChamber Plus, particularly for particle characterization.
Implicit Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Derived from Predicate) | Reported Fisio Chamber Spacer Performance (Reported as Equivalence) |
|---|---|---|
| Particle Characterization | Equivalent particle characterization to K070674 - Trudell AeroChamber Plus. | Equivalent performance via Cascade Impactor testing. |
| Mechanical Integrity | Maintain performance after mechanical testing. | "Passed or met its performance specifications." |
| Environmental Stability | Maintain performance after environmental testing. | "Passed or met its performance specifications." |
| Simulated Life Cycle/Cleaning | Maintain performance after cleaning validation. | "Passed or met its performance specifications." |
| Biocompatibility | Meet ISO 10993 testing standards. | Not explicitly stated as "passed" for Fisio, but implied by overall equivalence claim for a similar device. The predicate device (K010680 - CT Spacer) also undergoes ISO 10993 testing. |
Study Information
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text. The comparative particle characterization testing was performed, but the number of devices or measurements is not mentioned.
- Data Provenance: The document does not specify the country of origin of the data. The study was conducted by the manufacturer, Koo (Shanghai) Industries Co., Ltd. The study appears to be a prospective test specifically designed to compare the Fisio Chamber Spacer against the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a medical device (spacer/holding chamber), not a diagnostic algorithm requiring expert-established ground truth from images or other complex data. The performance evaluation is based on objective physical and functional characteristics (e.g., particle size distribution, mechanical integrity).
4. Adjudication method for the test set:
- Not applicable. See point 3.
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. This is a physical medical device, not an AI or imaging-based diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for comparative performance, particularly for particle characterization, was the established, measured performance of the predicate device (K070674 - Trudell AeroChamber Plus), specifically its particle characterization via Cascade Impactor. For other tests (mechanical, environmental, cleaning), the "ground truth" was likely predefined performance specifications that the device needed to pass.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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).