(53 days)
Not Found
No
The description focuses on mechanical modifications to a nebulizer and performance testing based on established guidelines, with no mention of AI or ML.
No
The device is a nebulizer, which is used to administer medications in aerosol form, but it does not directly provide therapy itself. It is a delivery system for medical products.
No
The device is a nebulizer, which generates aerosols for patient breathing, and its intended use is for administering medical aerosol products. It does not perform any diagnostic functions.
No
The device description clearly states it is a nebulizer, which is a hardware device used to generate aerosols. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the product is a nebulizer used to generate aerosols for direct delivery to the patient for breathing. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components and modifications of a nebulizer, which is a drug delivery device.
- Performance Studies: The performance studies focus on the in-vitro performance of the nebulizer in terms of aerosol generation and equivalence to a predicate nebulizer. This is related to the device's function in delivering medication, not in performing a diagnostic test on a biological sample.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
Therefore, this device falls under the category of a medical device used for treatment (drug delivery), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This product is a nebulizer used to generate aerosols that are delivered directly to the patient for breathing. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer. This product is a single patient use, non-sterile prescription device and is designed to be used in either a hospital or homecare environment.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The Salter Labs Modified Nebulizer is a modification to the existing Salter Labs Nebutech Nebulizer (K961476). The Cone assembly has been changed to incorporate the lens deflector that was originally contained in the Lid assembly of the Nebutech Nebulizer and a horizontal baffle has been added. All materials used in the Modified Nebutech are identical to the original Nebutech product. The cone assembly fits against a molded stop so that it sits firmly on the base of the jar. There are no other modifications to this product. This product is designed to be a single patient use device.
The modified Nebutech Nebulizer is a hand-held pneumatically powered nebulizer that consists of a Nebulizer Top that is screwed onto a Nebulizer Cup. The bottom of the cup has a fitting to accept a source of nebulizing gas. A third component, the cone assembly, fits over a mating conical surface within the Nebulizer Cup. The device consists of two basic operational units: the nebulizer portion (which forms and conveys an aerosol) and a reservoir portion (which contain non-aerosolized drug).
The Nebulizer portion of the device consists of the following elements:
. the inlet port for the nebulizing gas;
. a liquid medication cup with a conical seat;
. a cone assembly, which rests on the seat and meters the liquid to the jet; and a jet which directs a high velocity stream of nebulizing gas and entrained liquid to an impact target which is integral to the cone assembly. A horizontal baffle is located directly above the impact target and helps transmit a consistent sized aerosol to the upper part of the nebulizer. This component is the primary modification to the existing Nebutech Nebulizer product, in that the target is now located on the cone assembly rather than on the aerosol reservoir section of the device.
The materials used in the Modified Nebutech Nebulizer are identical to the materials qualified for use in the original predicate Ultramist device, K961476.
The Aerosol Reservoir Section (Top) contains an internal reservoir for the aerosol. The reservoir is equipped with an inhalation valve that opens to admit ambient air when the patient inhales and which closes when the patient exhales. Exhaled breath is thereby routed to an expiratory port, such as an exhalation valve in a mouthpiece or an expiratory port of a mask that is attached to the nebulizer. The inhalation valve uses the identical valve assembly defined in the original Ultramist Nebulizer, K962476, in terms of design, specifications and materials used.
The Modified Nebutech Nebulizer contains a port for the fitting of an external mouthpiece that is identical to and serves the same purpose as the predicate Ultramist nebulizer. The mouthpiece, when attached, contains a breath-actuated exhalation valve which works in conjunction with the inhalation valve in the top of the nebulizer top to minimize re-breathing of expired gas. This allows the patient to utilize more of the aerosol that might otherwise be wasted if the nebulizer were connected to a conventional patient circuit.
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
physician or healthcare professional / hospital or homecare environment
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)
In-Vitro Performance Testing: Product performance testing was performed according to the "Reviewer Guidance t Product performance testing was portonned as a lotuators (10-01-93)," and Salter Labs testing requirements. Froudst tooling as more as a comment of the predicate device tested. All testing was performed in the Salter Labs R&D test laboratory according to All testing was performed in the Saltor Labor Labor Schools and Serformed on the Pari LC Plus Nebulizer. Test results demonstrated that the Modified Nebulizer was equivalent to the Pari LC Plus Nebulizer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 Modified Nebutech Nebulizer 510(k) Summary: 10.
In accordance with 21 CFR section 807.92 Salter Labs is submitting the following safety and effectiveness summary.
- Submitter Information
Duane Kazal Director Operations Salter Labs 100 W. Sycamore Road Arvin, CA 93203 (661) 854-6818
- Name of Device
Proprietary Name: Modified Nebutech Nebulizer (trade name to be determined) Common Name is Nebulizer Classification Name: Nebulizer
- Substantially equivalent to: Modification to the Ultramist Nebulizer, K961476.
-
- Device Description and System Overview:
The Salter Labs Modified Nebulizer is a modification to the existing Salter Labs Nebutech Nebulizer (K961476). The Cone assembly has been changed to incorporate the lens deflector that was originally contained in the Lid assembly of the Nebutech Nebulizer and a horizontal baffle has been added. All materials used in the Modified Nebutech are identical to the original Nebutech product. The cone assembly fits against a molded stop so that it sits firmly on the base of the jar. There are no other modifications to this product.
- Device Description and System Overview:
This product is designed to be a single patient use device.
| Nebulizer Component: | Salter Labs Ultramist
(Nebutech: K961476) | Salter Labs Modified
Nebutech |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Cup: material and Salter
Labs component material
specification number: | Polystyrene, FDA
Compliance Compound | Polystyrene, FDA
Compliance Compound
Same as Nebutech |
| Top: material and Salter
Labs component material
specification number: | Polypropylene | Polypropylene, Same as
Nebutech |
| Insert: material and Salter
Labs component material
specification number: | Polystyrene, FDA
Compliance Compound,
Transparent Green FDA
Compliance Colorant | Polypropylene, Same as
Nebutech
Transparent Green FDA
Compliance Colorant, Same
as Nebutech |
Table 1: Comparison of Modified Nebutech Materials to predicate Ultramist (Nebutech) Nebulizer:
1
5) Principles of operation:
The modified Nebutech Nebulizer is a hand-held pneumatically powered nebulizer that consists of a Nebulizer Top that is screwed onto a Nebulizer Cup. The bottom of the cup has a fitting to accept a source of nebulizing gas. A third component, the cone assembly, fits over a mating conical surface within the Nebulizer Cup. The device consists of two basic operational units: the nebulizer portion (which forms and conveys an aerosol) and a reservoir portion (which contain non-aerosolized drug).
Cup: Nebulizer Portion:
The Nebulizer portion of the device consists of the following elements:
- . the inlet port for the nebulizing gas;
- . a liquid medication cup with a conical seat;
- . a cone assembly, which rests on the seat and meters the liquid to the jet; and a jet which directs a high velocity stream of nebulizing gas and entrained liquid to an impact target which is integral to the cone assembly. A horizontal baffle is located directly above the impact target and helps transmit a consistent sized aerosol to the upper part of the nebulizer. This component is the primary modification to the existing Nebutech Nebulizer product, in that the target is now located on the cone assembly rather than on the aerosol reservoir section of the device.
The materials used in the Modified Nebutech Nebulizer are identical to the materials qualified for use in the original predicate Ultramist device, K961476.
Top: Aerosol Reservoir Section:
This portion of the Modified Nebulizer contains an internal reservoir for the aerosol. The reservoir is equipped with an inhalation valve that opens to admit ambient air when the patient inhales and which closes when the patient exhales. Exhaled breath is thereby routed to an expiratory port, such as an exhalation valve in a mouthpiece or an expiratory port of a mask that is attached to the nebulizer. NOTE: The inhalation valve uses the identical valve assembly defined in the original Ultramist Nebulizer, K962476, in terms of design, specifications and materials used.
The Modified Nebutech Nebulizer contains a port for the fitting of an external mouthpiece that is identical to and serves the same purpose as the predicate Ultramist nebulizer. The mouthpiece, when attached, contains a breath-actuated exhalation valve which works in conjunction with the inhalation valve in the top of the nebulizer top to minimize re-breathing of expired gas. This allows the patient to utilize more of the aerosol that might otherwise be wasted if the nebulizer were connected to a conventional patient circuit.
6) Operation:
The nebulizer is disassembled and assembled according to product labeling. Medication is placed in the nebulizer cup when the unit is disassembled. The Nebulizer Housing is screwed onto the Cup and seated snugly and the supply line from the nebulizing gas source is then connected to the bottom of the nebulizer cup.
2
When pressurized nebulizing gas is applied to the nebulizer, the solution in the cup when pressunzed nebuiling gas to upplied to the cup and overlaying cone assembly is sucked up between the mating ourlues on the liquid is broken into extremely
and ejected at great velocity against the target. The integral to the conn and ejected at great velocity against the targed it circular baffe integral to the cone
small particles, forming an aerosol. A horizontal circular baffler of the small particles, forming an acrosoft of homeones into the upper portion of the adapter prevents large acrosof particles from on the walls and internal baffler portiologic nebulizer. These larger dropieto form on the end in and and and and the particles in the hebuilter and fall back into the oup for subscription of the nebulizer and are more occupy the space in the uppor portion of the are consistently sized and meet the requirements for respirable aerosol.
-
- In-Vitro Performance Testing:
Product performance testing was performed according to the "Reviewer Guidance t Product performance testing was portonned as a lotuators (10-01-93)," and Salter for Nebulizers Metered Dood innalet the time demonstrates that the Modified Labs testing requirements. Froudst tooling as more as a comment of the predicate device tested.
- In-Vitro Performance Testing:
All testing was performed in the Salter Labs R&D test laboratory according to All testing was performed in the Saltor Labor Labor Schools and Serformed on the Pari LC Plus Nebulizer.
Test results demonstrated that the Modified Nebulizer was equivalent to the Pari LC Plus Nebulizer.
-
- Clinical Testing: No clinical testing was performed on this product.
-
- Software Validation: Not applicable: there is no software in this product.
-
- Sterilization Validation: Not applicable: this product is sold and used as a non-sterile product.
-
- Biocompatibility: All materials used in this device are identical to the Salter Labs Nebutech Droompanishilly. And are therefore appropriate for the intended use as described.
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 with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 01 2002
Mr. Duane Kazal Salter Labs 100 W. Sycamore Road Arvin, CA 93203
Re: K014056
Salter Labs Modified Nebutech Nebulizer Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II (two) Product Code: CAF Dated: January 17, 2002 Received: January 22, 2002
Dear Mr. Kazal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may , ateres, mains 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 (PMA), it rr your de rio to such additional controls. Existing major regulations affecting your device can may or days. It is Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Duane Kazal
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of advised that I Dr Pressunts of wour device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any I cochar statutes and registerients, including, but not limited to: registration and listing (21 Comply with an the 71et 31equirements, as a manufacturing practice requirements as set CFN Fart 607), labeling (21 OFR Part 820); and if applicable, the electronic forth in the quality systems (QD) roggisterials (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This iction will anow your to FDA finding of substantial equivalence of your device to a legally premarket notification: "The President 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 IT you desire specific ad roo for you witro diagnostic devices), please contact the Office of additionally 21 CFTC Far 80719 Additionally, for questions on the promotion and advertising of Compliance at (301) 59 ( 1 t t t t t t t t t t ) 594-4639. Also, please note the your device, prease connectance to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oincl general information of Small Manufacturer 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,
signature
Bram D Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
4. Indications for Use
Salter Labs Modified Nebutech Nebulizer
This product is a nebulizer used to generate aerosols that are delivered directly to the patient for breathing. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer. This product is a single patient use, non-sterile prescription device and is designed to be used in either a hospital or homecare environment.
Division of Cardiovascular & Respiratory Devices
510(k) Number 1019056