(89 days)
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No
The device description explicitly states that it does not use software, which is a prerequisite for AI/ML implementation. The device is purely mechanical, relying on pressurized gas to create an aerosol.
Yes
The device is used to deliver liquids to a patient in an aerosol form, which implies a medical or therapeutic purpose.
No
Explanation: The device is a nebulizer designed to deliver liquids in aerosol form and is not described as being used to diagnose medical conditions.
No
The device description clearly states it is a physical, disposable nebulizer consisting of a top, cup, and fittings, and explicitly mentions it does not use software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to deliver liquids to a patient in an aerosol form for inhalation. This is a therapeutic delivery method, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details how the device nebulizes liquids for patient inhalation. This process is for administering medication or other substances, not for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, the Model 8990 Series Nebulizers, as described, function as a drug delivery device and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Model 8990 Series Nebulizers have the same intended use as their predicate device, The Salter Model 8900 Nebulizer, which was cleared for marketing by 510(k) No. K870027. The nebulizer is a disposable device which is used where liquids are to be delivered to a patient in an aerosol form. The device is not life-supporting or life-sustaining, nor is it implanted . It does not use software, nor is it sterile. The device is for single patient use. It is intended to be used with accessories, such as tubing which are industry standard devices used with nebulizers.
Product codes
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Device Description
Each of the Salter Labs 8990 Series Nebulizers consists of a Nebulizer Top which is screwed onto a Nebulizer Cup. The bottom of the cup has a fitting to accept a source of nebulizing gas. Liquids to be nebulized are placed in the nebulizer cup. The nebulizer housing is then applied, and the supply line for the nebulizing gas source is then connected to the bottom of the nebulizer cup. After the pressurized nebulizing gas is applied to the nebulizer, the solution in the cup is nebulized and pushed from the unit in aerosol form that can be inhaled by the patient.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for Salter Labs. The logo consists of a stylized "S" on the left and the words "SALTER LABS" on the right. The text is in a bold, sans-serif font.
AUG 26 1996
15. 510(k) Summary
15.1 Purpose:
This summary of 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
15.2 Submitter Identification:
Salter Labs 100 W. Sycamore Arvin, CA 93203
Telephone: (805) 854-3166
Contact Person: James N. Curti
15.3 Date of Summarv Preparation: April 22, 1996
15.4 Name of Device:
15.4.1 Classification Name: Nebulizer (direct patient interface)
15.4.2 Trade Name: Nebulizer
15.4.3 Proprietary Name: Salter Labs Ultramist Nebulizer, 8990 Series
15.5 Identification of Predicate Device:
Salter Labs Hand Held Pneumatic Powered (disposable) Nebulizer Model 8900, which was cleared for marketing by 510(k) No, K870027.
15.6 Description of the Device:
Each of the Salter Labs 8990 Series Nebulizers consists of a Nebulizer Top which is screwed onto a Nebulizer Cup. The bottom of the cup has a fitting to accept a source of nebulizing gas.
Liquids to be nebulized are placed in the nebulizer cup. The nebulizer housing is then
Salter Labs JNC 96032001
1
applied, and the supply line for the nebulizing gas source is then connected to the bottom of the nebulizer cup.
After the pressurized nebulizing gas is applied to the nebulizer, the solution in the cup is nebulized and pushed from the unit in aerosol form that can be inhaled by the patient.
15.7 Intended Use:
The Model 8990 Series Nebulizers have the same intended use as their predicate device, The Salter Model 8900 Nebulizer, which was cleared for marketing by 510(k) No. K870027. The nebulizer is a disposable device which is used where liquids are to be delivered to a patient in an aerosol form. The device is not life-supporting or life-sustaining, nor is it implanted . It does not use software, nor is it sterile. The device is for single patient use. It is intended to be used with accessories, such as tubing which are industry standard devices used with nebulizers.
15.8 Difference(s) Between This Device and its Predicate Device:
The Model 8990 Series Nebulizers are the same as their predicate device except each includes a larger internal reservoir for the aerosol, which eliminates the need for the external tee adapter and reservoir tube
This difference has no significant effect on the safety or effectiveness of the device.
15.9 Signature of contact person:
Jame N. Cuta
James N. Curti
End of 510(k) Summary