(91 days)
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.
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.
This document describes a medical device, the Model 3050 "Sport-Neb" compressor, and references a predicate device, the Model 3002 "AEROMAX". However, it does not contain information about acceptance criteria, device performance metrics, or any studies proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information in the format of a table or answer the specific questions about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document primarily focuses on:
- Device Description: Physical characteristics and internal components of the "Sport-Neb" and its predicate, the "AEROMAX".
- Intended Use: Stating that the "Sport-Neb" has the same intended use as the "AEROMAX."
- Comparison to Predicate: Highlighting that the "Sport-Neb" is "virtually the same as the 'AEROMAX' with the exception of the case which is smaller and more portable."
To answer your questions, additional documentation detailing performance specifications and testing would be required.
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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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§ 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).