(501 days)
The PARI O-PEP is intended for use as a Positive Expiratory Pressure Device, and is designed to help patients improve secretion clearance. The PARI O-PEP is intended for adult and pediatric patients ages 5 and older, for use in home, hospital, and sub-acute institutions.
The PARI O-PEP (Oscillating Positive Expiratory Pressure) is a small, single patient use, reusable oscillating PEP therapy device. The PARI O-PEP is a respiratory therapy device designed for temporary application to mobilize secretions or mucous in the lower respiratory tract, strengthen the respiratory tract and alleviate shortness of breath. The patient exhales repeatedly into the device against a movable ball, causing a vibration that is transmitted to the lungs. This causes the deeper respiratory tract to open. By doing this, secretions are mobilized and able to move up the airways. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.
Here's a breakdown of the acceptance criteria and study information for the PARI O-PEP device based on the provided text, using the requested format.
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device's performance against predefined acceptance criteria from a comprehensive clinical trial. Therefore, much of the requested information regarding detailed study design, ground truth establishment, expert adjudication, or MRMC studies for AI devices is not applicable or not present in this type of submission. The performance assessment here is primarily non-clinical and comparative.
Acceptance Criteria and Device Performance (Based on Non-Clinical Comparative Testing)
The "acceptance criteria" for the PARI O-PEP, in the context of this 510(k) submission, are primarily defined by its ability to perform comparably to its predicate device (Flutter D and Flutter) in key functional metrics: oscillatory frequency and expiratory resistance. Biocompatibility and cleaning efficacy are also established.
Table 1: Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Proxy: Substantial Equivalence to Predicate) | Reported Device Performance (PARI O-PEP vs. Predicate Flutter/Flutter D) |
|---|---|---|
| Expiratory Resistance | Produce comparable expiratory pressure levels to the predicate Flutter device across a range of flow rates (5-30 LPM) and angular positions (0 and 30 degrees). | "PARI O-PEP expiratory pressure level was compared to the predicate Flutter device across a range of flow rates between 5 and 30 LPM and angular positions of 0 and 30 degrees, and was found to be substantially equivalent to the predicate device for all variables." |
| Oscillating Frequency | Produce comparable oscillation frequencies to the predicate Flutter device across a range of flow rates (5-30 LPM) and angular positions (0 and 30 degrees). | "PARI O-PEP oscillating frequency was compared to the predicate Flutter device across a range of flows between 5 and 30 LPM and angular positions of 0 and 30 degrees, and was found to be substantially equivalent to the predicate device for all variables." "Oscillation frequency of PARI O-PEP device is comparable to predicate Flutter across a range of flow rates between 5 and 30 LPM." |
| Biocompatibility | Meet requirements of ISO 10993-1, -5, -10. | "Testing demonstrates that the subject device meets requirements in accordance with: ISO 10993-1, ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (irritation and skin sensitization)." |
| Cleaning Efficacy | Meet requirements for cleaning of a reusable medical device in accordance with recognized guidelines (e.g., AAMI TIR No. 30, 2011). | "Testing demonstrates that the subject device meets requirements for cleaning of a reusable medical device in accordance with recognized guidelines, including: AAMI TIR No. 30, 2011: A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices." |
Study Details (Non-Clinical Comparative Testing)
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of devices. The testing involved comparing the PARI O-PEP device against the predicate Flutter device across a "range of flow rates between 5 and 30 LPM and angular positions of 0 and 30 degrees." This suggests multiple measurement points for each device.
- Data Provenance: The data is from non-clinical laboratory testing performed by the manufacturer, PARI Respiratory Equipment, Inc. The country of origin for the data is not specified, but it would be expected to be where PARI conducts its testing, likely the USA given their address. The data is prospective in the sense that the tests were specifically conducted for this 510(k) submission to demonstrate equivalence.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. This was a non-clinical, objective performance test comparing physical properties (pressure, frequency) of devices, not a diagnostic device requiring expert interpretation of results. The "ground truth" was the measured performance of the predicate device under controlled conditions.
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Adjudication Method for the Test Set:
- Not Applicable. No human adjudication was involved in comparing the physical performance parameters of the devices. The comparison was based on direct measurements.
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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 device is a mechanical respiratory therapy device, not an AI-powered diagnostic tool. Therefore, MRMC studies and the concept of "human readers improving with AI" are not relevant.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a mechanical medical device, not an algorithm or AI system.
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The Type of Ground Truth Used:
- For the performance tests (expiratory resistance, oscillating frequency): The "ground truth" was the measured physical performance of the legally marketed predicate device (Flutter/Flutter D) under standardized laboratory conditions. The PARI O-PEP's performance was measured and compared against these established values.
- For biocompatibility and cleaning efficacy: The "ground truth" was adherence to established regulatory standards (ISO 10993 series and AAMI TIR No. 30).
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The Sample Size for the Training Set:
- Not Applicable. This is a non-AI, mechanical device. There is no concept of a "training set." The device itself is manufactured based on engineering design.
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How the Ground Truth for the Training Set was Established:
- Not Applicable. As there is no training set for a mechanical device, there is no ground truth to establish for it in this context.
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).