(184 days)
Not Found
No
The description focuses on the mechanical function of a piston-type air compressor and does not mention any AI/ML components or capabilities.
No.
The device only generates pressurized air for a nebulizer; it does not directly provide a therapeutic effect or treat a medical condition.
No
The device is an air compressor used to deliver aerosolized medication via a nebulizer. It does not diagnose any condition.
No
The device description clearly states it is an AC-powered, piston-type air compressor, which is a physical hardware device, not software.
Based on the provided information, the Salter Aire Compressor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to generate pressurized air for use with a nebulizer to produce an aerosol for patients. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the mechanical function of the compressor (generating pressurized air) and its physical characteristics. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
The Salter Aire Compressor is a medical device used for drug delivery (nebulization), which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The Salter Aire Compressor is an AC-powered, piston type air compressor that generates pressurized air for use with a small volume nebulizer to produce an aerosol. This product is intended to be used primarily by patients in the home care market, although it may also be used by trained hospital staff personnel as well.
The Salter Aire Compressor is a prescription use, non-sterile, durable device.
Product codes
73 CAF
Device Description
The Salter Labs Salter Aire Compressor is an AC powered, piston-type compressor that generates pressurized air for a nebulizer. It is designed to be small, light weight and portable. The device is manufactured by Salter Labs to Salter Labs design specifications.
The Salter Aire Compressor will be available in both 115 and 220 VAC models. The units have been designed and built according to applicable requirements of UL 1431 for USA models and IEC 601-1 for European models. All USA versions of the device will be 115VAC.
The Salter Aire Compressor is a prescription device and is designed to be a durable, reusable device that is intended to be used by hospital, clinic and home care markets. It has a 5 year warranty.
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
This product is intended to be used primarily by patients in the home care market, although it may also be used by trained hospital staff personnel as well.
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
Not Found
Summary of Performance Studies
Verification and Validation testing to design specifications. .
. Back pressure, flow rate and temperature testing and comparative product testing.
Shipping test, including multiple container drops from a height of 4 feet onto a . concrete floor.
UL testing to UL 1431 Standard. .
The Salter Labs Salter Aire Compressor met all design requirements and passed all validation test requirements. The device functioned properly and exhibited a predictable flow rate and pressure at an acceptable internal case temperature. The device was demonstrated to possess equivalent performance to predicate devices tested.
Key Metrics
| Test Reading: | Salter Aire Compressor | MIA Sport-Neb |
|---|---|---|
| Internal Temp. | 92.3 to 128.5° F | 80.5 to 134.8° F |
| Dead Head Pressure in p.s.i. | 32 to 38.5 psi | 28 to 40 psi |
| Flow with Nebulizer | 6.7 to 7.5 LPM | 6.2 to 7.1 LPM |
| Free Flow Rate in SLPM | 11.3 to 12.8 LPM | 7.3 to 12.1 LPM |
| Time to Nebulize 3 cc H2O: | 8 minutes | 8.5 minutes |
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
13. Salter Aire Compressor 510(k) Summary:
In accordance with 21 CFR section 807.92, Salter Labs is submitting the following safety and effectiveness summary.
1) Submitter Information
Salter Labs 100 W. Sycamore Road Arvin, CA 93203 (805) 854-3166
2) Name of Device
Proprietary Name: Salter Labs Salter Aire Compressor Common Name is Portable Air Compressor Classification Name: Portable Air Compressor
3) Substantially equivalent to: Medical Industry America Sport-Neb Compressor.
4) Device Description and System Overview:
The Salter Labs Salter Aire Compressor is an AC powered, piston-type compressor that generates pressurized air for a nebulizer. It is designed to be small, light weight and portable. The device is manufactured by Salter Labs to Salter Labs design specifications.
The Salter Aire Compressor will be available in both 115 and 220 VAC models. The units have been designed and built according to applicable requirements of UL 1431 for USA models and IEC 601-1 for European models. All USA versions of the device will be 115VAC.
The Salter Aire Compressor is a prescription device and is designed to be a durable, reusable device that is intended to be used by hospital, clinic and home care markets. It has a 5 year warranty.
System Similarities and Differences to Currently Marketed Devices
The Salter Aire Compressor and the predicate devices upon which equivalence is sought share the same purpose: to provide the source of compressed air used to provide pressurized airflow in a nebulizer for the production of aerosol. Like the predicate devices reviewed, the Salter Aire Compressor is intended for the home care market and the hospital market.
1
All comparative products are essentially equivalent, and many share similar components and have similar output specifications.
Performance characteristics, as tested, are essentially equivalent to predicate devices, and all products share the same basic size and weight. The Salter Aire Compressor has been designed and tested to comply with all appropriate sections of the UL 1431 Standard for Personal Hygiene and Health Care Appliances, and complies with IEC 601-1 for European 220 volt versions.
Other than basic configuration and dimensional differences between the Salter Aire and predicate devices, there are no appreciable differences between units in terms of function, performance or utility.
5) Statement of Intended Use:
The Salter Aire Compressor is an AC-powered, piston type air compressor that generates pressurized air for use with a small volume nebulizer to produce an aerosol. This product is intended to be used primarily by patients in the home care market, although it may also be used by trained hospital personnel.
The Salter Aire Compressor is a prescription use, non-sterile, durable device.
| Test Reading: | Salter Aire Compressor | MIA Sport-Neb |
|---|---|---|
| Internal Temp. | 92.3 to 128.5° F | 80.5 to 134.8° F |
| Dead Head | ||
| Pressure in | ||
| p.s.i. | 32 to 38.5 psi | 28 to 40 psi |
| Flow with | ||
| Nebulizer | 6.7 to 7.5 LPM | 6.2 to 7.1 LPM |
| Free Flow Rate | ||
| in SLPM | 11.3 to 12.8 LPM | 7.3 to 12.1 LPM |
| Time to | ||
| Nebulize 3 cc | ||
| H2O: | 8 minutes | 8.5 minutes |
6) Comparative data concerning the Salter Aire Compressor and the defined benchmark predicate device:
2
b. Predicate Devices:
| Product: | Manufacturer: | 510(k) Number: |
|---|---|---|
| Sport-Neb | Medical Industry America | K964078 |
| Aeromax | Medical Industry America | K942444 |
Table 3.1 Predicate Devices
c. Comparative Product Matrix
The chart below compares Salter Aire Compressor with predicate devices:
| item: | Characteristic: | Salter Labs
Compressor | Medical Industries
America Sport-
Neb Compressor | Medical Industries
America AeroMax
Compressor | |
|-------|---------------------------------------|------------------------------------------|--------------------------------------------------------|-------------------------------------------------------|--------|
| 1 | Type of compressor: | piston | piston | piston | |
| 2 | Input power: | 110V 60Hz, 2.5
amps | 110V 60Hz, 1.8
amps | 110V 60Hz, 2.5
amps | |
| 3 | Maximum output pressure at nebulizer: | 6.5 lpm | 6 lpm | approx. 6 lpm | |
| 4 | Maximum flow: | 4 | 11 lpm | 11 lpm | 13 lpm |
| 5 | Operating Environment: | home care and
hospital | home care | home care | |
| 6 | Maximum operating temperature: | 128.5° F | 134.8° F | 130 ° F | |
| 7 | Designed to conform to UL 1431 | Yes | unknown | unknown | |
| 8 | Operating Life: | 5 years | 5 years | 5 years | |
| 9 | Over-temperature Protection? | Yes | Yes | Yes | |
| 10 | Portable? | Yes | Yes | Yes | |
| 11 | Case material: | Plastic | Plastic | Plastic | |
| 12 | Warranty: | 1 year | 1 year | 1 year | |
| 13 | Electromagnetic Compatibility: | conforms to UL
1431, and
IEC 601-1 | conforms to
UL 1431 (personal
hygiene products) | conforms to
UL 1431 (personal
hygiene products) | |
d. Brief Description of Non-Clinical Tests Identified in the Premarket Notification:
- Verification and Validation testing to design specifications. .
- . Back pressure, flow rate and temperature testing and comparative product testing.
- Shipping test, including multiple container drops from a height of 4 feet onto a . concrete floor.
- UL testing to UL 1431 Standard. .
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- e. Clinical Tests submitted: None.
f. Conclusions of all Testing:
The Salter Labs Salter Aire Compressor met all design requirements and passed all validation test requirements. The device functioned properly and exhibited a predictable flow rate and pressure at an acceptable internal case temperature. The device was demonstrated to possess equivalent performance to predicate devices tested.
- g. Software Validation: Not applicable: there is no software in this product.
- h. Sterilization Validation: Not applicable: this product is sold and used as a nonsterile product.
- Biocompatibility: There are no biocompatible issues. No direct patient contact. All i. air lines are clean and oil-free. A replaceable foam filter maintains air cleanliness.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three wavy lines, which is the symbol of the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2000
Mr. Gus Bock Salter Labs 100 W. Sycamore Road Arvin, CA 93203-2300
Re: K992285 Salter Aire Compressor Regulatory Class: II (two) Product Code: 73 CAF Dated: November 9, 1999 Received: November 12, 1999
Dear Mr. Bock:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Gus Bock
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Jeanne A Waterhouse for
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
SALTER LABS
3. Intended Use
The Salter Aire Compressor is an AC-powered, piston type air compressor that generates pressurized air for use with a small volume nebulizer to produce an aerosol. This product is intended to be used primarily by patients in the home care market, although it may also be used by trained hospital staff personnel as well.
The Salter Aire Compressor is a prescription use, non-sterile, durable device.
Please refer to section 7 of this submission for product use, testing and results.
to Hunter
(Division Sign Division of Cardie and Neurologica 510(k) Numbe
prescription use
Salter Labs 510(k) Submission for Salter Aire Compressor