(89 days)
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.
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.
The provided text is a 510(k) summary for a medical device (nebulizer). It does not contain information about acceptance criteria, performance studies, or any of the other requested details regarding an AI/ML medical device.
The document describes a mechanical device (nebulizer) and compares it to a predicate device, focusing on its physical characteristics and intended use. There is no mention of algorithms, software, AI, or any data analysis that would require the information requested in your prompt (e.g., sample sizes, expert ground truth, adjudication methods, MRMC studies, training sets).
Therefore, I cannot fulfill your request based on the provided input.
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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
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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
§ 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).