(81 days)
Not Found
No
The device description and performance studies focus on the physical filtration properties of the device and do not mention any computational or learning-based components.
No.
The device is an accessory designed to filter exhaled aerosol products, not to administer or provide a therapeutic effect to the patient. It minimizes the amount of medical aerosol exhaled into the air, primarily for environmental protection.
No
Explanation: The device is an aerosol filter designed to minimize the amount of medical aerosol exhaled into the air, acting as an accessory to a nebulizer. It does not collect or analyze data from the body to diagnose a condition.
No
The device is described as a physical filter component made of a rectangular material preformed to fit into an injection molded plastic housing. It is an accessory to a nebulizer, designed to physically filter aerosol particles. There is no mention of software in the description.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to minimize the amount of medical aerosol exhaled into the air during nebulizer treatment. This is a therapeutic and environmental control function, not a diagnostic one.
- Device Description: The device is a filter designed to connect to a nebulizer mouthpiece to capture exhaled aerosol particles. It's described as an accessory to a nebulizer assembly.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on aerosol removal efficiency, which is relevant to its function as a filter, not a diagnostic test.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device's purpose is to manage the output of a medical treatment device (a nebulizer) for environmental and potentially patient safety reasons (by reducing exposure to exhaled aerosols).
N/A
Intended Use / Indications for Use
The Salter Labs Nebulizer Exhalation Aerosol Filter is indicated for all circumstances where the reduction of medical aerosols during nebulizer use is required or recommended. The Salter Labs Nebulizer Exhalation Aerosol Filter comes in two configurations: a disposable device, which has a filter contained within a permanently sealed plastic case, and a reusable device designed to be used with Salter Labs nebulizer product. The Salter Labs Exhalation Aerosol Filter is intended to be used to reduce the amount of unused medical aerosols exhaled by the patient using the Salter Labs 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
73 CAF
Device Description
The Salter Labs Aerosol Filter is designed to connect to the exhalation valve of the Salter Labs nebulizer mouthpiece. 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. There are two design configurations: disposable and reusable. The reusable configuration allows the filter to be easily inserted and removed after each use. The filter 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 is ≥ 6.0 square inches, resulting in a specified resistance (exhalation force) of ≤ 2,0 cm Ho0 from the patient. Product design performance has been validated using product design specifications according to Salter Labs procedures and validation requirements.
There are two defined product configurations for this device: disposable and reusable.
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
Home Care & Hospital
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Brief Description of Non-Clinical Tests Identified in the Premarket Notification:
- performance validation to design specification 0
- 0 aerosol removal testing and validation
Clinical Tests submitted: None.
Conclusions of all Testing: The Salter Labs Nebulizer Expiratory Aerosol Filter (in both the disposable and reusable configurations) 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 .01 microns to 9.9 microns. Typical aerosol sizes generated during nebulization range from 1 micron to 5 microns.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 .01 microns to 9.9 microns. Typical aerosol sizes generated during nebulization range from 1 micron to 5 microns.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Salter Labs Nebulizer Aerosol Expiration Filter 510(k) Summary 9.2
In accordance with 21 CFR section 807.92 Salter Labs is submitting the following safety and effectiveness summary.
- Submitter Information
Salter Labs 100 W. Sycamore Road Arvin, CA 93203 (805) 854-3166
- Name of Device
Proprietary Name: Salter Labs Nebulizer Exhalation Aerosol Filter Common Name is Exhalation Filter Classification Name: Breathing Circuit Bacterial Filter
-
Substantially equivalent to Pari Exhalation Filter, K926455.
-
Device Description and System Overview:
The Salter Labs Aerosol Filter is designed to connect to the exhalation valve of the Salter Labs nebulizer mouthpiece. 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. There are two design configurations: disposable and reusable. The reusable configuration allows the filter to be easily inserted and removed after each use. The filter 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 is ≥ 6.0 square inches, resulting in a specified resistance (exhalation force) of ≤ 2,0 cm Ho0 from the patient. Product design performance has been validated using product design specifications according to Salter Labs procedures and validation requirements.
There are two defined product configurations for this device: disposable and reusable.
-
- Statement of Intended Use:
The Salter Labs Nebulizer Exhalation Aerosol Filter is indicated for all circumstances where the reduction of medical aerosols during nebulizer use is required or The Salter Labs Nebulizer Exhalation Aerosol Filter comes in two recommended. configurations: a disposable device, which has a filter contained within a permanently sealed plastic case, and a reusable device designed to be used with Salter Labs nebulizer product. The Salter Labs Exhalation Aerosol Filter is intended to be used to reduce the amount of
- Statement of Intended Use:
1
unused medical aerosols exhaled by the patient using the Salter Labs 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.
-
- Comparative data concerning the Salter Labs Nebulizer Aerosol Filter and competitive products follows:
- a) Technological Characteristics and Comparison:
| | Salter Labs:
Disposable Filter | Salter Labs:
Reusable Filter | Pari | Marquest | King Systems |
|------------------------------------|----------------------------------------------------|-------------------------------------------------------|----------------------------------------------------------|----------------------------------------------|----------------------------------------------|
| Brand Name: | Exhalation
Aerosol Filter | Exhalation
Aerosol Filter | Exhalation
Filter | Respirguard II
Filter | Virobac II Filter |
| Model #: | TBD | TBD | unknown | 303 | 20800 |
| Filter Type: | Hydrophobic
Filter | Hydrophobic
Filter | Hydrophobic
Filter | Hydrophobic
Filter | Hydrophobic
Filter |
| Filter
Manufacturer: | 3M | 3M | 3M | 3M | 3M |
| Filter Material: | 0.3 micron
Filtrete Material | 0.3 micron
Filtrete
Material | 0.3 micron
Filtrete
Material | 0.3 micron | 0.3 micron |
| Total Filter
Area: | ≥ 6.0 sq. inches
(rectangular) | ≥ 6.0 sq.
inches
(rectangular) | approximately
4 sq. inches
(circular) | approximately
4 sq. inches
(circular) | approximately
4 sq. inches
(circular) |
| Single-Use/
Reusable: | Disposable | Reusable
(1 year) | Reusable
(1 year) | Disposable | Disposable |
| Reuse Claims: | none | 1 year | 1 year | none | none |
| Sterile/Non-
Sterile: | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile |
| Intended Use: | Nebulizer | Nebulizer | Nebulizer | Nebulizer,
humidifier, O₂
Concentrator | Nebulizer,
humidifier, O₂
Concentrator |
| Target
Population: | Home Care &
Hospital | Home Care &
Hospital | Home Care &
Hospital | Home Care &
Hospital | Home Care &
Hospital |
| Aerosol
Filtration? | Yes | Yes | Yes | Yes | Yes |
| Bacterial
Filtration? | No | No | Yes (but used
primarily as
aerosol filter) | Yes | Yes |
| Exhalation
Resistance
Force: | 0.8 cm/H₂O** | 0.8 cm/H₂O** | 0.8 cm/H₂O
(no valve)
7.0 cm/H₂O
(with valve)** | 1.2 cm/H₂O | unknown |
| Connector
Size: | .794" (non-
standard Salter
sized connector) | .794" (non-
standard Salter
sized
connector) | 22mm | 22mm | 22mm |
2
- b) Brief Description of Non-Clinical Tests Identified in the Premarket Notification:
- performance validation to design specification 0
- 0 aerosol removal testing and validation
- c) Clinical Tests submitted: None.
- The Salter Labs Nebulizer Expiratory Aerosol Filter d) Conclusions of all Testing: (in both the disposable and reusable configurations) 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 .01 microns to 9.9 microns. Typical aerosol sizes generated during nebulization range from 1 micron to 5 microns.
Cleaning and Reuse:
Only the Reusable Aerosol Filter is intended for reuse. The Salter Labs Reusable Nebulizer Exhalation Aerosol Filter is designed to be cleaned prior to each use. Cleaning instructions are contained in product literature and include directions for washing, chemical cleaning and short term autoclaving. 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.
3
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-like figure with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 1998
Mr. Duane Kazal Salter Labs Inc. 100 W. Sycamore Road Arvin, CA 93203
Re : K983403 Salter Labs Nebulizer Exhalation Aerosol Filter Regulatory Class: II (two) Product Code: 73 CAF Dated: September 15, 1998 September 28, 1998 Received:
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 leqally 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 Existing major regulations affecting your device additional controls. 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 requlation 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.
4
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 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,
Thomas J. Callahon
Thomas J. Callahan, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K983403 510(k) Number: Unknown -C
Device Name: Salter Labs Nebulizer Exhalation Aerosol Filter.
Indications For Use:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Usen ﺖ (Per 21 CFR 801.109)
OR
Over-The Counter-Use (Optional Format 1-2-96)
Zank Medoo 12-16-98
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number ...