(90 days)
The InspiraChamber® Anti-Static Valved 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 where patients may require the use of a holding chamber with pMDIs.
The intended patient population is 3 years and older who have been prescribed pMDI medications.
The InspiraChamber® 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 InspiraChamber® 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.
This document describes the InspiraChamber® Anti-Static Valved Holding Chamber, a device designed to assist in the inhalation of medications delivered via Metered Dose Inhalers (MDIs). The device's performance was evaluated through non-clinical testing, primarily focusing on comparative particle characterization.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied through the comparison to the predicate device, K872037 - Trudell AeroChamber. The presented data demonstrates the InspiraChamber's performance in terms of aerosol characteristics, aiming for equivalence with or suitable performance compared to MDI only or the predicate.
| Performance Metric | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (InspiraChamber® - 95% Confidence Intervals) | Comments |
|---|---|---|---|
| Particle Characterization (28 lpm) | Equivalent to MDI only or predicate device | Particle size and dose metrics reported for three drugs. See Tables 1, 2, 3 below. | |
| Total Respirable Dose Delivered (0.5-5.0 microns) ug/burst (ProAir HFA) | Implied to be effective for drug delivery | 40.9 - 59.3 (MDI-Spacer) vs. 37.5 - 46.8 (MDI only) | Improved or comparable respirable dose with spacer. |
| Total Respirable Dose Delivered (0.5-5.0 microns) ug/burst (Atrovent HFA) | Implied to be effective for drug delivery | 5.3 - 7.0 (MDI-Spacer) vs. 7.5 - 8.1 (MDI only) | Slightly lower but potentially acceptable respirable dose with spacer. |
| Total Respirable Dose Delivered (0.5-5.0 microns) ug/burst (QVAR 40) | Implied to be effective for drug delivery | 9.4 - 11.7 (MDI-Spacer) vs. 12.1 - 14.8 (MDI only) | Slightly lower but potentially acceptable respirable dose with spacer. |
| Total Delivered Dose - ug/burst (ProAir HFA) | Similar to MDI only or predicate device | 55.0-69.4 (MDI-Spacer) vs. 102.7-104.8 (MDI only) | Expected reduction in total dose with spacer, as some drug deposits in chamber. |
| Total Delivered Dose - ug/burst (Atrovent HFA) | Similar to MDI only or predicate device | 11.2-13.3 (MDI-Spacer) vs. 19.0-21.0 (MDI only) | Expected reduction in total dose with spacer. |
| Total Delivered Dose - ug/burst (QVAR 40) | Similar to MDI only or predicate device | 21.4-25.3 (MDI-Spacer) vs. 33.6-38.4 (MDI only) | Expected reduction in total dose with spacer. |
| Particle Size (MMAD) (um) (ProAir HFA, 28lpm) | Within acceptable range for respiratory delivery | 1.52-1.68 | Fine particle size, suitable for lung deposition. |
| Particle Size (MMAD) (um) (Atrovent HFA, 28lpm) | Within acceptable range for respiratory delivery | 1.54-1.77 | Fine particle size, suitable for lung deposition. |
| Particle Size (MMAD) (um) (QVAR 40, 28lpm) | Within acceptable range for respiratory delivery | 0.44-0.52 | Very fine particle size, suitable for deep lung deposition. |
| Particle Characterization (12 lpm) | Equivalent to MDI only or predicate device | Particle size and dose metrics reported for three drugs. See Table 4 below. | |
| Mechanical Testing | Meets relevant standards for durability | Performed as part of Simulated life cycle testing | Includes high/low temperature, drop test. Implied successful. |
| Environmental Testing | Meets relevant standards for environmental conditions | Performed as part of Simulated life cycle testing | Implied successful. |
| Simulated Life Cycle (Cleaning) | Maintains performance after repeated cleaning | Performed (Pre and post-exposure) | Implied successful. |
| ISO 10993 Testing (Biocompatibility) | Meets ISO 10993 for indirect contact (aerosol) and direct (skin) contact | Cytotoxicity, Sensitization, Intracutaneous Irritation. BPA extractables - non-BPA. | Implied successful, indicating biocompatibility. |
| Anti-static surface resistivity | Within acceptable range | Performed | Implied successful. |
| Differential Pressure | Comparable to predicate | Performed (comparative) | Implied successful, indicating proper valve function. |
| Performance of Auditory alert | Functional and effective | Performed | Implied successful. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size:
- For particle characterization at 28 lpm: 3 samples of the device were tested with 3 drugs, 3 times for a total of 9 sample points.
- For particle characterization at 12 lpm: 3 samples of the device were tested with 3 drugs, 3 times for a total of 9 sample points.
- For MDI only tests: 3 samples were tested with 3 drugs.
- Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Given the context of a 510(k) submission, this is typically new data generated specifically for the submission and would be considered prospective for the purpose of demonstrating substantial equivalence. The testing was performed internally or by a contracted lab for InspiRx, Inc., a company based in New Brunswick, NJ, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of device (valved holding chamber) does not typically involve expert ground truth establishment in the same way an imaging AI device would. The "ground truth" for its performance is established through quantitative physical and chemical measurements (e.g., particle size, dose delivery) using standardized laboratory methods (e.g., cascade impaction, ISO 10993 biocompatibility tests). Therefore, there were no "experts" in the clinical sense establishing ground truth in terms of diagnoses or interpretations. The expertise lies in the certified laboratory technicians and engineers who performed the tests and analyzed the data according to established protocols.
4. Adjudication Method for the Test Set
Not applicable. As explained above, the "ground truth" is based on objective laboratory measurements, not expert consensus or clinical 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
Not applicable. This device is a medical accessory (valved holding chamber) and not an AI-powered diagnostic or interpretive device that would involve human readers or an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as it is not an algorithm-based device. The device's performance is standalone in the sense that it mechanically modifies aerosol delivery.
7. The Type of Ground Truth Used
The ground truth used for this study is based on objective, quantitative laboratory measurements using established scientific and engineering methodologies, including:
- Particle Characterization: Measured using an 8-stage cascade impactor according to standard protocols (e.g., those referenced in USP ). This provides quantitative data on particle size distribution (MMAD, GSD) and dose delivery (total dose, respirable dose).
- Biocompatibility: Evaluated against ISO 10993 standards, using tests like cytotoxicity, sensitization, and intracutaneous irritation.
- Mechanical and Environmental Testing: Standardized tests for durability, temperature stability, drop resistance, etc.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in the conventional sense. The development of the device would involve engineering design and iterative physical testing, but not data-driven training of an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an algorithm, there is no corresponding ground truth to be established for it.
§ 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).