THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT

K962749 · Diemolding Corp. · BWF · Oct 10, 1996 · Anesthesiology

Device Facts

• Record ID: K962749
• Device Name: THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT
• Applicant: Diemolding Corp.
• Product Code: BWF · Anesthesiology
• Decision Date: Oct 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5690
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

TheraPEP is a single-patient-use respiratory therapy device; consists of resistor, pressure range indicator, pressure port adapter, and mouthpiece or mask. Operates by providing positive expiratory pressure to patient airways. Used in clinical or home settings to assist in airway clearance and lung expansion. Healthcare provider or patient uses device to facilitate secretion removal and prevent/reverse atelectasis. Output is controlled expiratory resistance; optional pressure monitoring via port adapter allows tracking of therapy performance.

Clinical Evidence

No new clinical testing performed. Evidence relies on reference documents/literature supporting the efficacy of PEP therapy for the prevention and reversal of atelectasis.

Technological Characteristics

Single-patient-use respiratory device; includes resistor, pressure range indicator, pressure port adapter, and mouthpiece/mask interface. Mechanical operation; no energy source required. ISO 9001 certified manufacturing.

Indications for Use

Indicated for patients with Cystic Fibrosis, lung diseases with secretory problems, and for the prevention or reversal of atelectasis.

Regulatory Classification

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.

Predicate Devices

• DHD TheraPEP (K962749)

Submission Summary (Full Text)

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K962749

DHD
DIEMOLDING HEALTHCARE DIVISION

Corporate Offices:
125 Rasbach Street
Canastota, NY 13032 USA
[phone] [phone]
[phone] FAX

Manufacturing and Distribution Facilities:
One Madison Street
Wampsville, NY 13163 USA
[phone]
[phone] FAX

OCT 10 1996

# 510(k) SUMMARY
As Required by 807.92(c)
7-11-96

1. Submitter:
DHD Diemolding Healthcare Division
125 Rasbach Street
Canastota, NY 13032
Phone: [phone]
Fax: [phone]

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

3. 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.

ISO CERTIFIED 9001