(91 days)
Model 3002 "AEROMAX"
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No
The description details a simple air compressor for a nebulizer, with no mention of AI, ML, or any computational processing beyond basic operation.
No
The device is described as an air compressor designed to power a hand-held nebulizer, not as a device that directly delivers therapy itself. Its function is to provide air pressure and flow to another therapeutic device (the nebulizer).
No
The device is described as an air compressor designed to power a nebulizer, which is used for treatment (delivering medication), not for diagnosing a condition.
No
The device description clearly states it is a "small air compressor" and a "nebulizer compressor" with physical components like a housing, switch, filter housing, AC cord, air outlet barb, and internal compressor. This indicates a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The "Sport-Neb" is a compressor designed to power a nebulizer. A nebulizer is a device that turns liquid medication into a mist that can be inhaled. This is a method of delivering medication to the body, not testing specimens from the body.
- Intended Use: The intended use clearly states it provides air pressure and flow to power a nebulizer. This is a therapeutic or drug delivery function, not a diagnostic one.
Therefore, based on the provided information, the "Sport-Neb" is a medical device, but it falls under a different category than In Vitro Diagnostics. It's likely classified as a respiratory therapy device.
N/A
Intended Use / Indications for Use
The model 3050 "Sport-Neb" is a small air compressor designed to provide sufficient air pressure and flow to power a hand held nebulizer such as the Salter #8900.
Product codes
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Device Description
The Model 3050 "sport-Neb" is a small, lightweight, nebulizer compressor. It measures 7 1/2" X 7 1/2" X 4 1/2" The housing is grey. The housing is grey switch, filter housing, AC cord and the air outlet barb. An optional carry bag will be offered to store the patients hand held nebulizer. The handle is built into the housing. The operating components are located internally. The compressor, some minor wiring and the exhaust/intake plumbing are located inside.
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
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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
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Key Metrics
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Predicate Device(s)
Model 3002 "AEROMAX"
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
At this time, there are no intentions to modify the device.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo for Medical Industries America Inc. The logo features a stylized mountain graphic on the left, followed by the company name in bold, uppercase letters. Two horizontal lines underline the company name, emphasizing the text.
2879 R AVENUE ADEL, IOWA U.S.A. 50003-8055 TEL. (515) 993-5001 1-800-759-3038 FAX (515) 993-4172
K964078
JAN. 10, 1997
ENCLOSURE 'R'
EXECUTIVE SUMMARY OF THE MODEL 3050 "SPORT-NEB"
The model 3050 "Sport-Neb" is a small air compressor designed to provide sufficient air pressure and flow to power a hand held nebulizer such as the Salter #8900.
Nebulizer compressors are very basic devices comprising of a motor compressor assembly, wiring, switch, power cord and case. Nebulizer compressors have been on the market for many years. "Medical Industries America, Inc." is currently marketing two other nebulizer compressors - the "Aerosol Two" and the "AEROMAX". The "Sport-Neb" is virtually the same as the "AEROMAX" with the exception of the case which is smaller and more portable.
DEVICE DESCRIPTION:
The Model 3050 "sport-Neb" is a small, lightweight, nebulizer
compressor. It measures 7 1/2" X 7 1/2" X 4 1/2" The housing is groupe The housing is grey switch, filter housing, AC cord and the air outlet barb. An optional carry bag will be offered to store the patients hand held nebulizer.
The handle is built into the housing
The operating components are located internally. The compressor, some minor wiring and the exhaust/intake plumbing are located inside.
MODIFICATIONS:
At this time, there are no intentions to modify the device.
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Image /page/1/Picture/0 description: The image shows the logo for Medical Industries America Inc. The logo consists of a stylized mountain range to the left of the text. The text is in bold, sans-serif font and is underlined with two horizontal lines.
2879 R AVENUE ADEL. IOWA U.S.A. 50003-8055 TEL. (515) 993-5001 1-800-759-3038 FAX (515) 993-4172
ENCLOSURE ' B'
EXECUTIVE SUMMARY OF THE MODEL 3050 "SPORT-NEB" COMPRESSOR (CONTINUED)
DESCRIPTION OF THE MODEL 3002 "AEROMAX" (PREDICATE DEVICE)
The Model 3002 "AEROMAX" manufactured by "Medical Industries America, Inc. is also a small, lightweight nebulizer compressor.
approximately 12 x 8 1/2 X 4 1/2. It is grey in color. It measures
In the front of the device is the lid. Under the lid are the following components - switch, AC cord, filter housing and air outlet barb.
The "AEROMAX" has the operating components located internally also. The compressor, the intake/exhaust plumbing and the wiring system are located here.
INTENDED USE:
The Model 3002 "AEROMAX" has the same intended use as the Model 3050.
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