(59 days)
The Enchant AllPEP is intended for use as a Positive Expiratory Pressure (PEP) by patients aged 18 years and older. Patients must be capable of generating an exhalation flow of 10 lpm for 3-4 seconds to promote secretion clearance. This device may be used to prevent or reverse atelectasis and as an inspiratory, deep breathing positive exerciser. It may be used in hospital and clinical settings.
AllPEP provides PEEP during user exhalation and features a mechanism which provides oscillations during exhalation as well.
Principle of Operation: The oscillating positive exhalation pressure device, AllPEP, includes a housing, a top cover, and an oscillating mechanism. The patient inhales room air through a one-way valve and when exhaling the exhaled gas is directed through the upper portion of the device which contains a swinger mechanism to oscillate the air, causing the air to vibrate.
The provided text is a 510(k) premarket notification FDA review letter for the "AllPEP" device, classified as an Incentive Spirometer. It addresses the substantial equivalence of the AllPEP device to a predicate device, DHD Acapella K991561.
The document details the device's indications for use, patient population, environment of use, and a comparison of its features and performance to the predicate device. Crucially, it highlights non-clinical bench testing as the primary method to demonstrate substantial equivalence, rather than clinical studies involving human participants or MRMC studies.
Therefore, the following is a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria based only on the information provided in the document.
Acceptance Criteria and Device Performance for AllPEP
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance (AllPEP) | Notes on Comparison to Predicate |
|---|---|---|---|
| Bench Testing | Aging and post-aging performance | Performed, results "similar to the predicate and within pre-defined acceptance criteria." | Results similar to predicate. |
| Cleaning validation | Performed, results "similar to the predicate and within pre-defined acceptance criteria." | Results similar to predicate. | |
| Post-cleaning performance | Performed, results "similar to the predicate and within pre-defined acceptance criteria." | Results similar to predicate. | |
| Transportation - shock and vibration | Performed | Not explicitly stated for predicate. | |
| Frequency (Hz) (at various flow rates: 5, 10, 15, 20, 25, 30 lpm) | 5lpm - 9.82; 10lpm - 9.96; 15lpm - 11.85; 20lpm - 13.01; 25lpm - 14.89; 30lpm - 16.32 | Predicate "Not published" for specific values, but "Similar based on bench testing of subject device and predicate." | |
| Amplitude (cmH2O) (at various flow rates: 5, 10, 15, 20, 25, 30 lpm) | 5lpm - 3.24; 10lpm - 6.31; 15lpm - 8.31; 20lpm - 9.42; 25lpm - 9.12; 30lpm - 9.17 | Predicate "Not published" for specific values, but "Similar based on bench testing of subject device and predicate." | |
| Lowest Pressure (cmH2O) (at various flow rates: 5, 10, 15, 20, 25, 30 lpm) | 5lpm - 0.50; 10lpm - 0.78; 15lpm - 2.09; 20lpm - 4.00; 25lpm - 7.26; 30lpm - 10.75 | Predicate "Not published" for specific values, but "Similar based on bench testing of subject device and predicate." | |
| Highest Pressure (cmH2O) (at various flow rates: 5, 10, 15, 20, 25, 30 lpm) | 5lpm - 3.74; 10lpm - 7.10; 15lpm - 10.40; 20lpm - 13.42; 25lpm - 16.38; 30lpm - 19.92 | Predicate "Not published" for specific values, but "Similar based on bench testing of subject device and predicate." | |
| Biocompatibility | ISO 10993-5:2009 - Cytotoxicity | Met applicable requirements | Based on direct contact materials. |
| ISO 10993-10:2010 Sensitization and Intracutaneous Reactivity | Met applicable requirements | Based on direct contact materials. | |
| ISO 10993-11:2017 Material-Mediated Pyrogenicity | Met applicable requirements | Based on direct contact materials. | |
| ISO 10993-18:2020 Chemical Characterization and Risk Assessment | Met applicable requirements | Based on direct contact materials. | |
| ISO 18562-2:2018 Particulate Matter testing | Met applicable requirements | Based on direct contact materials. | |
| ISO 18562-3:2018 Volatile Organic Compounds (VOC) with risk assessment | Met applicable requirements | Based on direct contact materials. | |
| Other | Indications for Use | Similar to predicate, with added detail for clarity (environment/target population). | Similar, no different questions of safety/effectiveness. |
| Technology and Construction | Similar principle of operation (oscillation during exhalation). | Similar, no different concerns of safety/effectiveness. | |
| Environment of Use | Hospital and clinical settings | Similar (predicate also includes home care, but this difference is discussed as not raising new concerns). | |
| Patient Population | Patients 18+ capable of 10 lpm exhalation for 3-4s. | Similar. | |
| Prescriptive | Yes | Similar. | |
| Single Patient, multi-use | Yes | Similar. | |
| Patient Interface | Mouthpiece | Similar. | |
| Basic Components | Swinging Flap valve, one-way valve, mouthpiece. | Similar (predicate uses "Rocker," but principle of oscillation is similar). | |
| Cleaning method | Neutral dishwashing agent | Similar (predicate cleaning instructions not provided, but similarity based on bench testing). | |
| Type of patient contact with materials | Externally communicating/Tissue Surface contact/mucosa, prolonged duration (>24 hours, |
§ 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).