(119 days)
The VibraPEP™ Mucus Clearing Device is a Positive Expiratory Pressure, PEP Device. It was designed to exercise patient's lungs and to improve secretion clearance.
Patient - Patients who have been prescribed PEP therapy
Environment - Hospital, clinics, physician offices, home setting
The VibraPEP™ is a Positive End Expiratory (PEP) device in which the user exhales through the device and the device generates expiratory pressure (resistance) and the Tube Valve oscillates creates a range of frequencies within the air column to the patient which help to promote secretion clearance. The VibraPEP™ has been designed to be very similar to the predicate RC-Cornet device (K983308). The basic design, form, function and performance have been compared to the predicate and have been demonstrated to be functionally equivalent and with the same intended use as the predicate.
The device is comprised of several components:
- Curved tube
- Cap for end of Tube ●
- Mouthpiece with selector ●
- Valve tube
- Drying tool ●
The provided text describes the 510(k) summary for the VibraPEP™ device, which is an incentive spirometer. This document focuses on demonstrating substantial equivalence to a predicate device (Pari – RC-Cornet – K983308) rather than presenting a standalone study with defined acceptance criteria for a novel AI/device performance.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable in this context, as this is a traditional medical device submission based on substantial equivalence to an existing device, not an AI or imaging device requiring extensive performance studies against clinical ground truth.
However, based on the provided text, I can infer the acceptance criteria by comparing the proposed device's performance to the predicate device, as this is the basis for demonstrating substantial equivalence. The "study" proving acceptance is the "Comparative Bench Testing".
Here's the information extracted and inferred from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate Device K983308 Performance Range) | Reported Device Performance (VibraPEP™ Range) |
|---|---|---|
| At 10 lpm Flow Rate: | ||
| Average Pressure (cmH2O) | 11 – 14 | 10 – 13 |
| Average Pressure Amplitude (cmH2O) | 6 – 19 | 7 – 17 |
| Average Flow Rate (lpm) | 6 – 16 | 8 – 16 |
| At 20 lpm Flow Rate: | ||
| Average Pressure (cmH2O) | 17 – 21 | 18 – 21 |
| Average Pressure Amplitude (cmH2O) | 21 – 27 | 22 – 28 |
| Average Flow Rate (lpm) | 12 – 18 | 12 – 17 |
| At 40 lpm Flow Rate: | ||
| Average Pressure (cmH2O) | 23 – 44 | 27 – 41 |
| Average Pressure Amplitude (cmH2O) | 46 – 80 | 51 – 76 |
| Average Flow Rate (lpm) | 15 – 21 | 19 – 22 |
| Cleaning Method | Soap / water and Boiling water (same as predicate) | Soap / water and Boiling water |
| Material Biocompatibility (ISO 10993) | Identical to predicate (Surface Contact, Mucosal membrane, Permanent > 30 days) | Identical materials - K983308 (Same characterization) |
Note on Acceptance Criteria: The acceptance criteria are implicitly met if the proposed device's performance falls within or is sufficiently similar to the predicate device's performance ranges, demonstrating "functional equivalence." The document states: "The comparative bench testing demonstrated that the VibraPEP™ is equivalent to the predicate K983308 - RC-Cornet."
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a "sample size" in the context of patients or discrete cases. The testing was comparative bench testing, implying a certain number of devices were tested and measurements taken over various flow rates. The text notes "a number of performance tests" were done.
- Data Provenance: Not applicable in the traditional sense of human data. This was bench testing performed by the manufacturer, Medica Holdings, LLC.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. This was bench testing of a physical device's mechanical performance (pressure, flow rate, amplitude). There was no "ground truth" established by human experts in the way it would be for an AI diagnostic algorithm. The "ground truth" would be the measured physical properties of the predicate device under controlled conditions.
4. Adjudication Method for the Test Set
- Not applicable. This was bench testing against a predicate device's measured performance. There was no human expert adjudication of results.
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 (incentive spirometer), not an AI diagnostic tool involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device. There is no "algorithm" in the context of AI independent of human use here. The performance described is the standalone performance of the physical device itself.
7. The Type of Ground Truth Used
- The "ground truth" for comparison was the measured performance data (average pressure, average pressure amplitude, average flow rate, material composition, cleaning validation, age testing, mechanical/drop test results) of the predicate device (Pari – RC-Cornet – K983308) under controlled bench test conditions.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, no training set was used.
§ 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).