(90 days)
Not Found
None
No
The device description and performance studies indicate a purely mechanical device that responds to pressure, with no mention of AI/ML terms or data processing.
No
A therapeutic device intends to treat or mitigate a disease. This device is an accessory that assists the user with proper inhalation technique, and does not directly treat a disease.
No
The MDI Tutor is an accessory device designed to assist with correct inspiratory technique by providing auditory feedback, not to diagnose a medical condition.
No
The device description clearly states it is a "simple plastic cylinder" with a "whistle mechanism," indicating it is a physical, hardware-based accessory, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- MDI Tutor Function: The MDI Tutor is an accessory that monitors the user's inhalation technique when using a metered dose inhaler. It provides auditory feedback based on the airflow during inspiration.
- No Biological Samples: The device does not interact with or analyze any biological samples from the user. Its function is purely mechanical and related to airflow.
Therefore, the MDI Tutor falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
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Device Description
The MDI Tutor 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5640 Medicinal nonventilatory nebulizer (atomizer).
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.
0
K 961894
AUG 1 4 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.
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 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.
Image /page/1/Picture/4 description: The image contains the text "MDI Tutor - 510(k)". The text is written in a simple, sans-serif font and is horizontally aligned. The text appears to be a title or heading, possibly related to a medical device or regulatory submission, given the reference to "510(k)".