← Product Code [CCQ](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ) · K961894 # MDI TUTOR (K961894) _Mdi Tutor, Inc. · CCQ · Aug 14, 1996 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K961894 ## Device Facts - **Applicant:** Mdi Tutor, Inc. - **Product Code:** [CCQ](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ.md) - **Decision Date:** Aug 14, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5640 - **Device Class:** Class 1 - **Review Panel:** Anesthesiology ## 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. ## Clinical Evidence Bench testing only. Performance testing determined threshold pressure required to evoke whistle (0.13 L/sec). ## Technological Characteristics Plastic cylinder; mechanical whistle mechanism; passive flow-activated; no energy source; dimensions designed to fit flush over specific MDI mouthpieces. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 Page E-1 {1} # 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 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K961894](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K961894) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com