(87 days)
The DHD TheraPEP is intended for use as a Positive Expiratory Pressure Device for patients suffering from Cystic Fibrosis, lung diseases with secretory problems, and to prevent or reverse atelectasis.
The DHD TheraPEP is a single-patient-use Respiratory Therapy device. The standard system consists of a resistor, pressure range indicator, pressure port adapter, and mouthpiece. The mask may be substituted for the mouthpiece. Pressure monitoring is optional, and the pressure port adapter is removable.
This document is a 510(k) summary for the DHD TheraPEP device, seeking to add a new claim to its intended use: "to prevent or reverse atelectasis."
Unfortunately, the provided text does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria. The document explicitly states:
- No technological changes are being made; the submission is only to add a claim.
- The "Summary of Studies" section simply says: "The clinical data (reference documents) supporting the added claims show that PEP therapy is effective for prevention and reversal of atelectasis." It does not provide details about a specific study, its methodology, or results related to the TheraPEP device itself.
- The "Conclusions Drawn from Studies" section states that the added indication "will not adversely affect the safety and effectiveness of the TheraPEP device when utilized for this application as TheraPEP is approved for PEP therapy." This is a conclusion drawn from general knowledge about PEP therapy rather than specific data from a study on the TheraPEP device for this new indication.
Therefore, I cannot populate the table or answer the specific questions based on the input provided. The document relies on the existing approval of the TheraPEP for general PEP therapy and the established effectiveness of PEP therapy for atelectasis prevention/reversal, without presenting a de novo study demonstrating the TheraPEP's performance against specific acceptance criteria for this new claim.
§ 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).