(89 days)
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 in its function.
Yes
The device is used to deliver liquids to a patient in an aerosol form, which implies a therapeutic purpose (e.g., administering medication for respiratory conditions).
No
The device is a nebulizer designed to deliver liquids to a patient in an aerosol form for therapeutic purposes, not to diagnose a condition.
No
The device description clearly states it is a disposable hardware device consisting of a nebulizer top and cup, 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 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 inhalation. This process is for administering medication or other substances directly to the patient's respiratory system.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the Model 8960 Series Nebulizers are medical devices used for drug delivery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Model 8960 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 masks and tubing which are industry standard devices used with nebulizers.
Product codes
Not Found
Device Description
Each of the Salter Labs 8960 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
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
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K96 1476
SALTER LABS
1 16 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 Summary Preparation: April 15, 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, 8960 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 8960 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
Salter Labs JNC 96022901
1
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 8960 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 masks and tubing which are industry standard devices used with nebulizers.
15.8 Difference(s) Between This Device and its Predicate Device:
The Model 8960 Series Nebulizers are the same as their predicate device except:
Each includes an internal reservoir for the aerosol, which eliminates the need for the external tee adapter and reservoir tube
Each includes an inspiration valve in the nebulizer top.
The Model 8960 includes an expiration valve in its mouthpiece.
None of these differences has a significant effect on the safety or effectiveness of the device.
15.9 Signature of contact person:
James M. Curte
James N. Curti
End of 510(k) Summary
Salter Labs JNC 96022901