(88 days)
No
The description focuses on microprocessor-controlled functions based on factory-programmed parameters and standard spirometry measurements, with no mention of learning or adaptive algorithms.
Yes
The device delivers medication (modifying body function) and monitors lung function (assisting in diagnosis/treatment), fitting the definition of a therapeutic device.
Yes
The device functions as an electronic peak flow meter, determining peak expiratory flow rate (PEFR) and forced expiratory volume in one second (FEV), and stores this data for retrieval by a medical practitioner, indicating its use in assessing a patient's lung function as part of their asthma management.
No
The device description explicitly states it is composed of hardware components: a non-disposable, battery powered, portable SmartMist™ Controller and the SmartMist™ Spirometry Airway. It also mentions a microprocessor, pressure transducer, LEDs, and a liquid crystal display window.
Based on the provided text, 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.
- Device Function: The SmartMist™ Asthma Management System is a device that assists with drug delivery (metered dose inhaler accessory) and monitors lung function (peak flow meter). It interacts directly with the patient's respiratory system (inhaling and exhaling air).
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It measures physical parameters related to breathing.
Therefore, the SmartMist™ Asthma Management System falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
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Device Description
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 it; primary purpose of assisting with drug delivery and its secondary purpose of monitoring lung 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 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 (FEV). The peak flow rate is displayed to the patient in the liquid crystal display window.
A record of PEFR, FEV , 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 eceives 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
ARADIGM
SmartMist™ 510(k) Notification
1 AY 1 0 1996
MAY 1 0 1996 SUMMARY OF SAFETY AND EFFECTIVENESS
- Submitter's Information: Dated: 01/31/96
Aradigm Corporation 26219 Eden Landing Road Hayward, CA 94545 (510)783-0100 Fax (510)783-0410
Contact Person: Diane Jachinowski, Director of Quality Assurance, (510) 784-5033
Proprietary Name: SmartMist™ Asthma Management System, consisting of 2.
- SmartMist™ Controller, model number SM-100 i.
- ii. SmartMist™ Spirometry Airway, model number SA-100
Common or Usual Name: Metered dose inhaler accessory / peak flow meter
Accessory, Metered Dose It:haler, classification unknown / Classification Name: Meter, peak flow, spiromenry, 21 CFR § 868.1860
3. Predicate Devices:
- MEDTRAC Technologies, Inc. PeakLog™ Peak Flow Meter, K940835 i.
- Vitalograph Inc. A.I.M. Aerosol Inhalation Monitor, K893665 ii.
- 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 it; primary purpose of assisting with drug delivery and its secondary purpose of monitoring lung 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
1
ARADIGM
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 (FEV). The peak flow rate is displayed to the patient in the liquid crystal display window.
A record of PEFR, FEV , 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 eceives 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 solidstate 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.
01/31/96
2
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.