(259 days)
The PARI Sinus is a compressor nebulizer system, designed to aerosolize medication approved for nebulization and prescribed by a physician for delivery to the upper airways. The PARI Sinus is intended for adult and pediatric patients consistent with the indications for aerosol medication, in homes, hospitals, and sub-acute institutions.
The PARI Sinus is a single patient use, reusable aerosol therapy device for delivery of prescribed medications to the upper airway. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments. The PARI Sinus utilizes a combination of aerosol flow and vibration to effectively deliver aerosolized medications to the upper airway.
The PARI Sinus 510(k) submission primarily relies on non-clinical testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study with acceptance criteria in the traditional sense of a diagnostic or therapeutic efficacy study. Therefore, the "acceptance criteria" here refer to parity with predicate device performance in key engineering metrics, and the "study" is a series of non-clinical tests.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Metric) | Predicate Device Performance Description | PARI Sinus Reported Performance |
|---|---|---|
| MMAD (Mass Median Aerodynamic Diameter) | Not explicitly stated, implied to be within acceptable range. Comparable to predicate devices. | "PARI Sinus is comparable to the predicate devices." |
| Total Mass (Aerosolized Drug Output) | Not explicitly stated, implied to be within acceptable range. Comparable to predicate devices. | "PARI Sinus is comparable to the predicate devices." |
| Vibrating Pressure Amplitude | "Acapella predicate both generate comparable low-amplitude vibrating pressure." | "PARI Sinus is comparable to the predicate devices." |
| Aerosolization Method | "reusable, air compressor-driven jet nebulizers which use the same method of aerosolization." | "reusable, air compressor-driven jet nebulizers which use the same method of aerosolization." |
| Compressor Type | "Proneb Ultra compressor are both piston-driven, oil-less air compressors powered by shaded pole AC motors." | "piston-driven, oil-less air compressors powered by shaded pole AC motors." |
| Operating Pressure | "produce comparable operating pressure." | "produce comparable operating pressure." |
| Drug/Air Path Materials | "similar to the predicate LC Sprint device." | "similar to the predicate LC Sprint device." |
Important Note: The acceptance criteria are implicitly defined as "comparable" to the predicate devices' performance, without specific numerical thresholds being provided in this summary. This is common for 510(k) submissions demonstrating substantial equivalence for devices of this nature.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of human subjects or distinct data samples for a clinical test set. The "test set" here refers to the device itself being tested in a lab setting.
- Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory environment, likely by the manufacturer, PARI Respiratory Equipment, Inc. No information on country of origin of data in a human context, or retrospective/prospective status is relevant here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This submission solely reports on non-clinical engineering and performance characteristics. There is no human interpretative element or "ground truth" established by experts in the context of clinical outcomes or images.
4. Adjudication Method for the Test Set
- Not Applicable. As there is no human interpretation or subjective assessment involved, an adjudication method for a test set is irrelevant for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. A MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was not completed/is not required to show substantial equivalence."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. The device is a nebulizer system, not a software algorithm or AI-powered diagnostic tool. The concept of "standalone performance" for an algorithm is not relevant here.
7. The Type of Ground Truth Used
- Engineering Specifications and Standardized Test Methods: The "ground truth" for the non-clinical tests would have been established by comparing the PARI Sinus's performance against industry standards, internal specifications, and the known performance metrics of the predicate devices. For example, MMAD is measured using established aerosol science methods.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical medical device, not a machine learning model. 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 an algorithm, this question is not relevant.
In summary, the PARI Sinus 510(k) relies on demonstrating engineering comparability through non-clinical testing to legally marketed predicate devices, negating the need for clinical studies with human subjects or AI-specific evaluation metrics.
§ 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).