This product is indicated for use whenever the physician or healthcare professional administering or prescribing medical aerosol products to a patient with a Salter Labs nebulizer wishes to minimize the amount of medical aerosol exhaled into the air.

Device Description

The Salter Labs Single Patient Use Aerosol Filter is designed to connect to the exhalation valve of the Salter Labs nebulizer mouthpiece for the expressed purpose of removing nonrespired aerosols. Since the exhalation valve of the Salter Labs Nebulizer product is designed with a non-standard diameter, the Salter Labs Nebulizer Exhalation Aerosol Filter is configured in such a way that it only fits the Salter Labs nebulizer product line: this device is not intended to be used with any other product. Product labeling clearly defines this product as an accessory to the Salter Labs nebulizer assembly.

The aerosol filter is a rectangular component that has been preformed to fit into an injection molded plastic housing. The single patient use configuration allows the filter to be easily inserted and removed after each use. The filter element is specified as a bacterial filter, although the intended use of the device is to remove aerosol particles, only. The surface area of the filter element is ≥ 6.0 square inches, resulting in a specified resistance (exhalation force) of ≤ 2.0 cm H20 from the patient. Product design performance has been validated using product design specifications according to Salter Labs procedures and validation requirements.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Salter Labs Single Patient Use Nebulizer Exhalation Aerosol Filter, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
At least 95% effectiveness at aerosol removal	> 95% rate of aerosol removal efficiency
	Average efficiency rating exceeding 99%
Resistance (exhalation force) of ≤ 2.0 cm H2O	0.8 cm H2O

Study Details

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated. The document mentions "aerosol removal testing and validation" and "simulated use and cleaning verification," implying that a test set was used, but the specific number of units or test runs is not provided.
Data Provenance: Not explicitly stated. Given that it's a submission by Salter Labs (based in Arvin, CA, USA) to the FDA, it is highly likely that the testing was conducted prospectively by the manufacturer or a contracted lab in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not Applicable. This device is a filter, and its performance is measured objectively through physical testing (aerosol removal efficiency, exhalation resistance) rather than through subjective interpretation by human experts. Therefore, no human experts were involved in establishing ground truth for the test set in the traditional sense of clinical diagnosis or image interpretation.

4. Adjudication Method for the Test Set

Not Applicable. As mentioned above, the assessment criteria are objective physical measurements, not requiring human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study (MRMC) is relevant for diagnostic imaging AI or other interpretative tasks where human readers' performance is being evaluated with and without AI assistance. This device is a passive filter, and its effectiveness is measured directly through physical tests, not through human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence. The testing of the filter's aerosol removal efficiency and exhalation resistance is a standalone evaluation of the device's physical performance, independent of human interaction beyond the initial setup of the test. The "algorithm" in this context would be the physical design and material properties of the filter, and its performance was measured directly.

7. The Type of Ground Truth Used

Objective Physical Measurements. The ground truth for the device's performance was established through:
- Aerosol Removal Testing: Quantifying the reduction of aerosol particles in the air after passing through the filter. The document states "aerosols in the .1 to 10 micron range" and that "aerosol sizes monitored varied from .1 microns to 9.9 microns."
- Resistance Measurement: Measuring the pressure drop (exhalation force) across the filter element.

8. The Sample Size for the Training Set

Not Applicable. This device is a physical product (a filter), not an AI algorithm that requires a "training set" of data. Its performance is inherent in its design and materials, and validated through physical testing, not machine learning.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for a physical device, this question is not relevant. The "ground truth" for the design of such a device stems from engineering principles, material science, and prior knowledge of aerosol filtration, which are then validated through the performance tests described.

Summary

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In accordance with 21 CFR section 807.92 Salter Labs is submitting the following safety and effectiveness summary.

992986

1. Submitter Information
  Salter Labs 100 W. Sycamore Road Arvin, CA 93203 (805) 854-3166

Name of Device

Proprietary Name: Salter Labs Single Patient Use Nebulizer Exhalation Aerosol Filter Common Name is Exhalation Filter

Classification Name: Breathing Circuit Bacterial Filter

1. Substantially equivalent to Salter Labs Exhalation Aerosol Filter, K983403.
1. Device Description and System Overview:

1. Statement of Intended Use:
  The Salter Labs Single Patient Use Nebulizer Exhalation Aerosol Filter is indicated for all circumstances where the reduction of medical aerosols during nebulizer use is required or recommended. This Exhalation Aerosol Filter is intended to be used to reduce the amount of unused medical aerosols exhaled by the patient using the Salter Labs

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nebulizer system. The product specification calls for at least a 95% effectiveness at aerosol removal. No claims of bacterial filtration effectiveness are made or intended.

The single patient use configuration of this product is intended to be used by one patient only, and has been designed to operate within specified performance limits for the equivalent of one month's use. The unit must be cleaned with warm water, non-lemon soap and rinsed in warm water or with a mild sanitizer. The unit must not be subjected to high temperatures, such as a dishwasher or autoclave: such exposure will render the device unusable. Cautions on product labels clearly caution the user against exposing this product to high temperature conditions.

1. Comparative product data:

	Salter Labs:Single PatientUse Filter	Salter Labs:Disposable Filter	Salter Labs:ReusableFilter	Pari	Marquest
Brand Name:	ExhalationAerosol Filter	ExhalationAerosol Filter	ExhalationAerosol Filter	ExhalationFilter	Respirguard IIFilter
Model #:	TBD	TBD	TBD	unknown	303
Filter Type:	HydrophobicFilter	HydrophobicFilter	HydrophobicFilter	HydrophobicFilter	HydrophobicFilter
FilterManufacturer:	3M	3M	3M	3M	3M
Filter Material:	0.3 micronFiltrete Material	0.3 micronFiltrete Material	0.3 micronFiltrete Material	0.3 micronFiltrete Material	0.3 micronFiltrete Material
Total FilterArea:	≥ 6.0 sq. inches	≥ 6.0 sq. inches	≥ 6.0 sq. inches	approximately4 sq. inches	approximately4 sq. inches
Single-Use/Reusable:	Single PatientUse (40 days)	Disposable	Reusable(1 year)	Reusable(1 year)	Disposable
Reuse Claims:	40 days, 1patient	none	1 year	1 year	none
Sterile/Non-Sterile:	Non-Sterile	Non-Sterile	Non-Sterile	Non-Sterile	Non-Sterile
Intended Use:	Nebulizer	Nebulizer	Nebulizer	Nebulizer	Nebulizer,humidifier, O2Concentrator
TargetPopulation:	Home Care &Hospital	Home Care &Hospital	Home Care &Hospital	Home Care &Hospital	Home Care &Hospital
AerosolFiltration?	Yes	Yes	Yes	Yes	Yes
BacterialFiltration?	No	No	No	Yes	Yes
ExhalationResistanceForce:	0.8 cm/H2O**	0.8 cm/H2O**	0.8 cm/H2O**	0.8 cm/H2O(no valve)7.0 cm/H2O(with valve)**	1.2 cm/H2O
ConnectorSize:	.794" (non-std.connector)	.794" (non-std.connector)	.794" (non-stdconnector)	22mm	22mm

a) Technological Characteristics and Comparison:

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b) Brief Description of Non-Clinical Tests Identified in the Premarket Notification:
- . performance validation to design specification
- . aerosol removal testing and validation
- simulated use and cleaning verification .
c) Clinical Tests submitted: None.
The Salter Labs Single Patient Use Nebulizer d) Conclusions of all Testing: Expiratory Aerosol Filter met all design requirements and passed all validation test requirements. It was shown to have a > 95% rate of aerosol removal efficiency, with aerosols in the .1 to 10 micron range, with an average efficiency rating exceeding 99%. Aerosol sizes monitored varied from .1 microns to 9.9 microns. Typical aerosol sizes generated during nebulization ranged from 1 micron to 5 or more microns.

Cleaning and Reuse:

The Salter Labs Single Patient Use Nebulizer Exhalation Aerosol Filter is designed to be cleaned at least once per day. Cleaning instructions are contained in product literature and include directions for washing. Since this device is incorporated in the exhalation path of the Salter Labs Nebulizer family, this device is provided and intended to be used in a non-sterile condition.

Product Warranty:

Standard product warranties apply to the disposable product. The reusable product is warranted for one year. All products are warranted to be free of defects at time of receipt.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.

Public Health Service

SEP 2 4 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Duane Kazal Director of Operations Salter Labs 100 W. Sycamore Road Arvin, CA 93203-2300

Re: K992986 Single Labs Single Patient Use Exhalation Aerosol Filter Requlatory Class: II (two) Product Code: 73 CAF Dated: August 26, 1999 Received: September 3, 1999

Dear Mr. Kazal:

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 requlation (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 In addition, FDA may publish further announcements regulatory action. 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. Duane Kazal

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 regulation (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,

Thomas J. Callahan

Thomas J. Callahah, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 10 of 38

510(k) NUMER (IF KNOWN) : This Special 510(k) Submission based upon 510(K) number K992986

Salter Labs Single Patient Use Exhalation Aerosol Filter DEVICE NAME:

INDICATIONS FOR USE:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices

Prescription Use(Per 21 CFR 801.109	510(k) Number _______	Over-The Counter-Use(Optional Format 1-2-96)
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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).