SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100

K960593 · Aradigm Corp. · CCQ · May 10, 1996 · Anesthesiology

Device Facts

• Record ID: K960593
• Device Name: SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100
• Applicant: Aradigm Corp.
• Product Code: CCQ · Anesthesiology
• Decision Date: May 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5640
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Aradigm Corporation SmartMist™ Asthma Management System is intended for use by asthma patients who self medicate with metered dose inhalers (MDI) and who measure peak expiratory flow rate (PEFR) as part of their asthma management programs.

Device Story

SmartMist™ is a portable, battery-powered MDI accessory and electronic peak flow meter. Device accepts standard MDI canisters without modification. During inhalation, a pressure transducer monitors flow rate and volume; microprocessor triggers MDI actuation only when parameters meet factory-programmed thresholds. Visual feedback (red/green LEDs) guides patient inhalation technique. During exhalation, device measures PEFR and FEV1, displaying results on an LCD. Device stores dosing and spirometry data for practitioner retrieval to monitor patient compliance. Used by patients for self-medication and technique training; provides objective data for clinical asthma management.

Clinical Evidence

Bench testing only. Device tested against American Thoracic Society (ATS) recommendations for monitoring spirometry and for average weight of metered spray from an MDI. Testing followed Reviewer Guidance for Respiratory Devices and Reviewer Guidance for Computer Controlled Medical Devices. Results confirm compliance with ATS standards and accepted spray weight standards.

Technological Characteristics

Battery-powered, portable electromechanical device. Components: SmartMist™ Controller (SM-100) and Spirometry Airway (SA-100). Sensing: Solid-state pressure transducer. Output: LED indicators (flow rate feedback) and LCD (spirometry results). Memory: Internal storage for PEFR, FEV1, and dosing events. Connectivity: Data retrieval by medical practitioner.

Indications for Use

Indicated for asthma patients who self-administer medication via metered dose inhalers (MDI) and require monitoring of peak expiratory flow rate (PEFR) as part of their asthma management program.

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

• MEDTRAC Technologies, Inc. PeakLog™ Peak Flow Meter (K940835)
• Vitalograph Inc. A.I.M. - Aerosol Inhalation Monitor (K893665)
• Monaghan Medical AeroChamber® MDI Accessory (K872037)

Submission Summary (Full Text)

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ARADIGM
K960593
SmartMist™ 510(k) Notification
MAY 10 1996

# SUMMARY OF SAFETY AND EFFECTIVENESS
MAY 10 1996

1. Submitter's Information: Dated: 01/31/96
Aradigm Corporation
26219 Eden Landing Road
Hayward, CA 94545
[phone] Fax [phone]

Contact Person: Diane Jachinowski, Director of Quality Assurance, [phone]

2. Proprietary Name: SmartMist™ Asthma Management System, consisting of
i. SmartMist™ Controller, model number SM-100
ii. SmartMist™ Spirometry Airway, model number SA-100

Common or Usual Name: Metered dose inhaler accessory / peak flow meter

Classification Name: Accessory, Metered Dose Inhaler, classification unknown / Meter, peak flow, spirometry, 21 CFR § 868.1860

3. Predicate Devices:
i. MEDTRAC Technologies, Inc. PeakLog™ Peak Flow Meter, K940835
ii. Vitalograph Inc. A.I.M. - Aerosol Inhalation Monitor, K893665
iii. Monaghan Medical AeroChamber® MDI Accessory, K872037

4. Description of Device:

The Aradigm Corporation SmartMist™ Asthma Management System is a single patient use prescribed metered dose inhaler (MDI) accessory and peak flow meter. The SmartMist™ is composed of the non-disposable, battery powered, portable SmartMist™ Controller and the SmartMist™ Spirometry Airway. In addition to its primary purpose of assisting with drug delivery and its secondary purpose of monitoring lung function, a tertiary function of patient compliance monitoring is available.

The SmartMist™ Asthma Management System is designed to work with a particular style of MDI, without modification. The entire MDI--canister and plastic actuator--is inserted into the SmartMist™ without the introduction of any flaps or valves. The MDI is easily removed for cleaning or for manual dosing should the SmartMist™ become inoperable.

As the patient inhales through their prescribed MDI that they have inserted into the SmartMist™, the device's microprocessor monitors the inhalation flow rate and volume detected by the system's pressure transducer. If the inhalation flow rate and volume fall within

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SmartMist™ 510(k) Notification

the factory programmed parameters, the microprocessor triggers its mechanism to actuate the MDI canister; aerosol medication is delivered to the patient.

Feedback regarding the inhalation flow rate is provided to the patient in the form of red and green LEDs. When the green LED is illuminated, the patient is breathing at the recommended inhalation rate for aerosol drug delivery.

The SmartMist™ Asthma Management System also functions as an electronic peak flow meter. When the user exhales through the Spirometry Airway, the device’s microprocessor determines the peak expiratory flow rate (PEFR) and forced expiratory volume in one second (FEV₁). The peak flow rate is displayed to the patient in the liquid crystal display window.

A record of PEFR, FEV₁, and dosing (inhalation) events is stored in the SmartMist™ memory for later retrieval, if desired, by a trained medical practitioner. Therefore, the SmartMist™ also provides patient compliance monitoring at the option of the practitioner.

Use of MDI medications with the SmartMist™ provides to the patient continual inhalation technique training. Since the SmartMist™ will not deliver the medication unless the patient’s inhalation is at the proper flow rate, the patient receives technique feedback each time the SmartMist™ is used for delivery of medication. Red and green indicators provide easily understood flow rate feedback to the patient.

## 5. Statement of Intended Use:

The Aradigm Corporation SmartMist™ Asthma Management System is intended for use by asthma patients who self medicate with metered dose inhalers (MDI) and who measure peak expiratory flow rate (PEFR) as part of their asthma management programs.

## 6. Statement of Technological Characteristics:

The SmartMist™ Asthma Management System has no significant change in design, materials, energy source or other technological characteristics compared to the predicate devices. The SmartMist™ Asthma Management System is similar in function to other such devices. The SmartMist™ combines functions that historically have been available to patients only as separate device. The SmartMist™, then, is compared to three separate predicate devices: the MDI medication delivery functions of the SmartMist™ are compare to the Monaghan Medical AeroChamber® MDI Accessory; the spirometry functions are compared to the MEDTRAC Technologies PeakLog™ Peak Flow Meter; and the training functions are compared to the Vitalograph A.I.M. Aerosol Inhalation Monitor.

As an accessory to MDI medication delivery, the SmartMist™ differs from the predicate in that the SmartMist™ is an active electromechanical device rather than a passive mechanical device. For the spirometry functions, the primary difference is the method of pressure measurement. Whereas the predicate device utilizes heated wire technology, the SmartMist™ utilizes solid-state pressure transducer technology. For the training functions, the SmartMist™ trains the patient each time they use the device to inhale their MDI medication. The predicate device only trains in the practitioner’s office using a custom placebo MDI.

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## 7. Summary of Testing:

In addition to standard device testing, such as that found in the Reviewer Guidance for Respiratory Device and the Reviewer Guidance for Computer Controlled Medical Devices, the SmartMist™ was tested against the American Thoracic Society recommended standards for monitoring spirometry and was tested for the average weight of a metered spray from an MDI. The results of the testing show that SmartMist™ meets the ATS recommendations and delivers a spray which is within the accepted standards.

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