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510(k) Data Aggregation
(149 days)
iPEP System and vPEP
The D R Burton iPEP Therapy System or vPEP is intended for use as a Positive Expiratory Pressure (PEP) by patients capable of generating an exhalation flow of 10 lpm for 3-4 seconds and an Incentive Spirometer as an inspiratory, deep breathing positive exerciser.
Intended for single-patient, multi-use.
iPEP System for hospital and clinical settings vPEP for hospital, clinical, and home care setting
D R Burton Healthcare as indicated above proposes to offer 2 devices which we will refer to as the:
- iPEP (integrated Incentive spirometer with PEP) system and ●
- . vPEP which is a standalone PEP therapy device
iPEP system
- Volumetric Incentive Spirometer up to 4000 cc
- Oscillatory PEP module (cartridge) ●
The design of the iPEP system permits the PEP cartridge to be removed and used as an independent PEP device, which we refer to as the Pocket PEP.
In order to use the Pocket PEP the iPEP system includes a separate mouthpiece, carrying / storage case and dust cover which are needed when one wants to use the PEP cartridge independent of the iPEP systems (Pocket PEP).
When the PEP cartridge is removed from the iPEP system, one can insert a cover where the PEP cartridge has been removed to allow the incentive spirometer to be used one its own.
vPEP
- The vPEP is the standalone device that is pre-assembled and is not intended to be used in the iPEP ● System. The vPEP incorporates the identical internal components of the PEP cartridge of the iPEP system.
The provided document is a 510(k) Summary for the D R Burton iPEP System and vPEP, which are devices intended for Positive Expiratory Pressure (PEP) therapy and as Incentive Spirometers. The study described is a non-clinical bench testing and usability study, focused on demonstrating substantial equivalence to predicate devices. There is no clinical study described.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents two comparison tables (Table 1 for PEP function, Table 2 for Incentive Spirometer function) comparing the proposed device against its predicates. The acceptance criteria for the proposed device are implicitly set by its performance falling within a certain range (e.g., 15%) of the predicate devices' performance.
| Attribute | Acceptance Criteria (Implicit from Predicate Performance) | Reported Device Performance (Proposed iPEP System and vPEP) |
|---|---|---|
| PEP Function (Table 1) | ||
| Mean Frequency (Hz) @ 5 lpm | 7.0 Hz (Predicate: DHD Acapella) | 8.0 Hz |
| Mean Frequency (Hz) @ 25 lpm | 13.7 Hz (Predicate: DHD Acapella) | 13.0 Hz |
| Mean Amplitude / Pressure (cmH2O) @ 5 lpm | 5.9 cmH2O (Predicate: DHD Acapella) | 5.5 cmH2O |
| Mean Amplitude / Pressure (cmH2O) @ 25 lpm | 23.2 cmH2O (Predicate: DHD Acapella) | 22.7 cmH2O |
| Min Pressure (cmH2O) @ 5 lpm | 0 cmH2O (Predicate: DHD Acapella) | 0 cmH2O |
| Min Pressure (cmH2O) @ 25 lpm | 2.9 cmH2O (Predicate: DHD Acapella) | 2.5 cmH2O |
| Max Pressure (cmH2O) @ 5 lpm | 5.9 cmH2O (Predicate: DHD Acapella) | 5.5 cmH2O |
| Max Pressure (cmH2O) @ 25 lpm | 26.1 cmH2O (Predicate: DHD Acapella) | 25.1 cmH2O |
| Incentive Spirometer Function (Table 2) | ||
| Volume range | 2500 cc and 5000 cc (Predicate: DHD Cliniflo / Coach) | 4000 cc |
| Volume accuracy @ 2500 cc | 14 – 21% (Predicate: DHD Cliniflo / Coach) | Not directly comparable at 2500cc. |
| Volume accuracy @ 5000 cc | 16 – 21% (Predicate: DHD Cliniflo / Coach) | Not directly comparable at 5000cc. |
| Volume accuracy @ 4000 cc | Implies similar accuracy to predicate models at comparable volumes. (Predicate values are 14-21% at similar volumes.) | 1.6 to 2.2% (Significantly better than reported predicate range, but applied to a different volume. The summary states "The results demonstrated equivalent performance," implying this accuracy is considered acceptable and substantially equivalent to the predicate's performance range.) |
Note on "Criteria within 15%": This phrase appears in Table 1 for Frequency and Amplitude/Pressure, suggesting that the proposed device's performance metrics were expected to be within 15% of the predicate device's values. The reported values for the iPEP and vPEP appear to meet this implicit criterion.
Additional Bench Testing:
- Aging, Simulated Life (cleaning), Drop Testing, Cleaning: Performed with pre- and post-exposure evaluation.
- Biocompatibility Materials: Cytotoxicity, sensitization, and irritation testing for materials with limited duration (
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