SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)

K961476 · Salter Labs · CAF · Jul 16, 1996 · Anesthesiology

Device Facts

• Record ID: K961476
• Device Name: SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)
• Applicant: Salter Labs
• Product Code: CAF · Anesthesiology
• Decision Date: Jul 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Pneumatic-powered disposable nebulizer; consists of nebulizer top and cup. Input: pressurized nebulizing gas and liquid medication. Operation: gas flow nebulizes liquid into aerosol for patient inhalation. Features internal aerosol reservoir, inspiration valve in top, and expiration valve in mouthpiece. Used in clinical or home settings; operated by patient or caregiver. Output: aerosolized medication. Benefits: facilitates respiratory drug delivery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Pneumatic-powered nebulizer; disposable; single-patient use. Components: nebulizer top, cup, internal reservoir, inspiration valve, expiration valve. Non-sterile. No software or electronic components.

Indications for Use

Indicated for patients requiring delivery of liquid medication in aerosol form via inhalation.

Regulatory Classification

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.

Predicate Devices

• Salter Labs Hand Held Pneumatic Powered (disposable) Nebulizer Model 8900 (K870027)

Submission Summary (Full Text)

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K961476
JUL 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: [phone]

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 top of 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

100 W. SYCAMORE ROAD · ARVIN, CALIFORNIA 93203-2300
PHONE: [phone]
FAX: [phone]

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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 N. Curti

End of 510(k) Summary

Salter Labs JNC 96022901

100 W. SYCAMORE ROAD • ARVIN, CALIFORNIA 93203-2300

PHONE: [phone]

FAX: [phone]