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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Predicate Device Range)	Reported Device Performance (Salter Aire Compressor)
Internal Temp: 80.5 to 134.8° F	Internal Temp: 92.3 to 128.5° F
Dead Head Pressure: 28 to 40 psi	Dead Head Pressure: 32 to 38.5 psi
Flow with Nebulizer: 6.2 to 7.1 LPM	Flow with Nebulizer: 6.7 to 7.5 LPM
Free Flow Rate: 7.3 to 12.1 LPM	Free Flow Rate: 11.3 to 12.8 LPM
Time to Nebulize 3 cc H2O: 8.5 minutes	Time to Nebulize 3 cc H2O: 8 minutes
Operating Life: 5 years	Operating Life: 5 years
Over-temperature Protection: Yes	Over-temperature Protection: Yes
Portable: Yes	Portable: Yes
Case Material: Plastic	Case Material: Plastic
Warranty: 1 year	Warranty: 1 year
Electromagnetic Compatibility: Conforms to UL 1431 (personal hygiene products)	Electromagnetic Compatibility: Conforms to UL 1431, and IEC 601-1

Summary of Device Performance: The Salter Aire Compressor met all design requirements and validation test requirements. Its performance characteristics, including internal temperature, pressure, flow rates, and nebulization time, fell within or outperformed the ranges of the predicate devices. It also met specified criteria for operating life, safety features, portability, and material.

Study Details:

2. Sample size used for the test set and the data provenance:
- The document implies a comparative performance test was done, but does not specify a sample size for the test set or the number of units tested for the Salter Aire Compressor or the predicate devices.
- Data Provenance: Not explicitly stated, but the comparison involves the Salter Aire Compressor and specified predicate devices ("MIA Sport-Neb Compressor"). The data appears to be from retrospective performance data for the predicate devices and prospective testing for the Salter Aire Compressor to demonstrate equivalence. The testing for the Salter Aire Compressor was conducted by Salter Labs ("Performance characteristics, as tested, are essentially equivalent to predicate devices").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a compressor, and its performance metrics (temperature, pressure, flow rate, nebulization time) are objective physical measurements. There is no human interpretation or subjective assessment involved that would require experts to establish a "ground truth" in the way it is used for medical image analysis or diagnostic studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. As stated above, the performance metrics are objective and directly measurable, not requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not a diagnostic device or an AI-enabled system. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit. The performance metrics (internal temperature, dead head pressure, flow rates, nebulization time) were measured directly from the device's function. The results are "algorithm only" in the sense that they represent the device's inherent physical output without human intervention during the measurement process, although humans operate the test equipment. This is effectively a "standalone performance" for a non-AI hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is established by objective, quantitative measurements of its physical output and characteristics (e.g., temperature, pressure, flow rates) using calibrated instruments and standard test methodologies. This is compared against the known performance data of legally marketed predicate devices.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device. There is no "training set" in the context of an algorithm. Design and engineering principles guide the device's development, not data-driven training.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set. The "ground truth" for the device's design and manufacturing is based on established engineering standards and specifications (e.g., UL 1431, IEC 601-1).

Summary

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K992285

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 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.

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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 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 HeadPressure inp.s.i.	32 to 38.5 psi	28 to 40 psi
Flow withNebulizer	6.7 to 7.5 LPM	6.2 to 7.1 LPM
Free Flow Ratein SLPM	11.3 to 12.8 LPM	7.3 to 12.1 LPM
Time toNebulize 3 ccH2O:	8 minutes	8.5 minutes

6) Comparative data concerning the Salter Aire Compressor and the defined benchmark predicate device:

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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 LabsCompressor	Medical IndustriesAmerica Sport-Neb Compressor	Medical IndustriesAmerica AeroMaxCompressor
1	Type of compressor:	piston	piston	piston
2	Input power:	110V 60Hz, 2.5amps	110V 60Hz, 1.8amps	110V 60Hz, 2.5amps
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 andhospital	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 UL1431, andIEC 601-1	conforms toUL 1431 (personalhygiene products)	conforms toUL 1431 (personalhygiene 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

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SALTER LABS

3. Intended Use

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

Regulation Number and Section

§ 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).