(87 days)
DHD TheraPEP
Not Applicable
No
The summary describes a mechanical respiratory therapy device with no mention of AI or ML components or capabilities.
Yes
The device description and intended use clearly state that it is a respiratory therapy device used to treat patients with lung diseases and to prevent or reverse atelectasis. This aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is described as a "Positive Expiratory Pressure Device" used for therapy (treating respiratory problems and preventing atelectasis), not for diagnosing conditions.
No
The device description explicitly lists physical components like a resistor, pressure range indicator, pressure port adapter, and mouthpiece, indicating it is a hardware device.
Based on the provided information, the DHD TheraPEP is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's a "Positive Expiratory Pressure Device for patients suffering from Cystic Fibrosis, lung diseases with secretory problems, and to prevent or reverse atelectasis." This describes a therapeutic device used to treat respiratory conditions, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details components like a resistor, pressure range indicator, pressure port adapter, mouthpiece, and mask. These are all components of a respiratory therapy device used for physical treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to in vitro examination.
Therefore, the DHD TheraPEP falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
868.5690
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The clinical data (reference documents) supporting the added claims show that PEP therapy is effective for prevention and reversal of atelectasis.
Key Metrics
Not Found
Predicate Device(s)
DHD TheraPEP
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo for DHD, which stands for Diemolding Healthcare Division. The logo features a black circle with a white figure inside, followed by the letters "DHD" in large, bold font. Below the letters is the text "DIEMOLDING HEALTHCARE DIVISION" in a smaller font.
Rasbach Stree ota, NY 13032 USA 221 (800) 847-8000
nufacturing and Distribution Faci e Madison Street Wampsville, NY 13163 USA 15) 363-2330 (315) 363-9462 FAX
OCT 10 1996
510(k) SUMMARY As Required by 807.92(c)
7-11-96
- Submitter: DHD Diemolding Healthcare Division 125 Rasbach Street Canastota, NY 13032
Phone: 315-697-2221 Fax: 315-697-8083
Contact: Jean Wallace, Manager, Regulatory Affairs
2. Device Name
.
- Trade Name TheraPEP® . -
- Common name Positive Expiratory Pressure (PEP) device -
- Classification name Incentive Spirometer - 868.5690 -
-
- Predicate Device: DHD TheraPEP (addition to claims only).
4. Device Description
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.
5. Intended Use
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. (Note that added claims are indicated in italics.)
6. Technological Information
No technological changes - submission is only to add claim.
7. Summary of Studies
The clinical data (reference documents) supporting the added claims show that PEP therapy is effective for prevention and reversal of atelectasis.
8. Conclusions Drawn from Studies
The added indication (to prevent or reverse atelectasis) for PEP therapy will not adversely affect the safety and effectiveness of the TheraPEP device when utilized for this application as TheraPEP is approved for PEP therapy.