K961894 · Mdi Tutor, Inc. · CCQ · Aug 14, 1996 · Anesthesiology
Device Facts
Record ID
K961894
Device Name
MDI TUTOR
Applicant
Mdi Tutor, Inc.
Product Code
CCQ · Anesthesiology
Decision Date
Aug 14, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 868.5640
Device Class
Class 1
Indications for Use
The MDI Tutor is intended for use as an accessory to metered dose inhalers (MDIs) to assist the user by monitoring the inhalation cycle and providing positive feedback (an auditory whistle) to corroborate correct inspiratory technique.
Device Story
Plastic cylinder accessory for metered dose inhalers (MDIs); fits over mouthpieces of specific inhalers (Proventil, Vanceril, Ventolin, Serevent, Albuterol). User-operated; provides auditory feedback via whistle mechanism. Whistle activates during correct inspiratory flow rate (0.13 L/sec) to encourage slow, continuous inhalation. Used by patients to improve MDI technique; provides real-time confirmation of correct breathing pattern. Does not alter MDI performance or add spacer volume.
Plastic cylinder; mechanical whistle mechanism; passive flow-activated; no energy source; dimensions designed to fit flush over specific MDI mouthpieces.
Indications for Use
Indicated for patients using metered dose inhalers (MDIs) who require assistance in maintaining correct inspiratory technique (slow, continuous inspiration) during medication administration.
Regulatory Classification
Identification
A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe.
Predicate Devices
AeroChamber
InspirEase
Submission Summary (Full Text)
{0}
K 961894
AUG 14 1996
510(k) SUMMARY
for
MDI Tutor Inc.'s MDI Tutor
1. DATE PREPARED
May 15, 1996
2. SPONSOR INFORMATION
Address: MDI Tutor, Inc.
782 West Euclid
Palatine, IL 60067
Contact: Dr. Jeffry W. Kreamer
Telephone: 847-358-1045
3. DEVICE NAME
Proprietary Name: MDI Tutor
Common/Usual Name: Metered Dose Inhaler Monitoring Accessory
Classification Name: Accessory to Medicinal Nonventilatory Nebulizer (Atomizer)
4. DEVICE DESCRIPTION AND INTENDED USE
The MDI Tutor is intended for use as an accessory to metered dose inhalers (MDIs) to assist the user by monitoring the inhalation cycle and providing positive feedback (an auditory whistle) to corroborate correct inspiratory technique. The device is a simple plastic cylinder designed to fit flush over the mouthpieces of inhalers supplied by Schering (Proventil and Vanceril), Allen and Hanburys (Ventolin and Serevent), and Warrick (Albuterol). A whistle mechanism on the device is activated by the user during inspiration. The accessory device does not introduce additional space to the metered dose inhaler or interfere with the performance of the inhaler. The whistle reminds the user to sustain a slow continuous inspiration when using the metered dose inhaler.
MDI Tutor - 510(k)
5/15/96
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# 5. COMPARISON TO PREDICATE DEVICES
The MDI Tutor is similar in design, function, and intended use to the whistles found on the AeroChamber® and the InspirEase® devices; both are accessories to metered dose inhalers. The whistles on these devices are also intended to help the patient monitor his/her own inspiratory cycle. The devices differ only in the manner of monitoring; the predicate devices whistle when the patient is breathing too quickly, whereas the MDI Tutor whistles when the patient is breathing correctly, thereby reminding the patient to sustain a continuous inspiration following actuation of the MDI. The whistles on the AeroChamber® and InspirEase® devices are incorporated on spacer attachments for metered dose inhalers, whereas the MDI Tutor is not.
# 6. DEVICE TESTING
Performance testing for the MDI Tutor was designed to determine the threshold pressure required to evoke the whistle (.13 L/sec). Results of the testing confirmed the suitability of the device for its intended use.
MDI Tutor - 510(k)
5/15/96
Page E-2
