AMSURE NEBULIZER

K070411 · Amsino International, Inc. · CAF · Oct 1, 2007 · Anesthesiology

Device Facts

• Record ID: K070411
• Device Name: AMSURE NEBULIZER
• Applicant: Amsino International, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Oct 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The AMSURE® Nebulizer is intended for the administration of various aerosol treatments in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs for nebulization, under the direction of a physician. It can be used for both pediatric and adult patient populations.

Device Story

Single-use nebulizer; connects to compressed gas source via flexible tubing. Operates via Venturi principle; draws liquid medication from refillable cup; aerosolizes fluid through impaction and baffling. Produces aerosol particles in 1.0µm to 5.0µm range. Used in homecare and hospital settings; operated by clinicians or patients under physician direction. Healthcare provider administers aerosolized treatment to patient; facilitates respiratory medication delivery.

Clinical Evidence

Bench testing only; performance and biocompatibility testing demonstrated safety and effectiveness.

Technological Characteristics

Single-use nebulizer; Venturi-based aerosolization; particle size 1.0µm to 5.0µm; compressed gas powered; flexible tubing interface.

Indications for Use

Indicated for pediatric and adult patients requiring aerosolized medication delivery in home or hospital settings. Contraindicated for use with non-FDA-approved drugs.

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

• Hudson RCI Micro Mist (K930525)

Submission Summary (Full Text)

{0}------------------------------------------------

AMSure® Nebulizer 510(K) Submission

K070411 page 1 of 1

## 510(K) Summary of Safety and Effectiveness

| Company: | Amsino International, Inc.<br>855 Towne Center Drive<br>Pomona, CA 91767<br>[phone] |
|----------------|--------------------------------------------------------------------------------------------|
| Contact: | Ching Ching Seah, Ph.D.<br>Director of Regulatory Affairs |
| Date Prepared: | August 8, 2007 |

OCT 1 2007

| Classification Name: | Nebulizer (Direct Patient Interface) (868.5630) |
|----------------------|-------------------------------------------------|
| Common Name: | Nebulizer |
| Proprietary Name: | <i>AMSure</i> ^® Nebulizer |
| Product Code: | CAF |
| Medical Specialty: | Anesthesiology |
| Device Class: | Class II |

| Predicate Devices: | Hudson RCI Micro Mist ^® (K930525) |
|--------------------|----------------------------------------------|
|--------------------|----------------------------------------------|

| Device Description: | The <i>AMSure</i> ^® Nebulizer is a single-use patient device, which is filled with fluid, typically respiratory medication and connected to a source of compressed via flexible tubing. The nebulizer delivers aerosolized fluids for patient inhalation in the respirable range of approximately 1.0µm to 5.0µm. It operates on a compressed gas source which draws liquids from a refillable cup by the Venturi Principle and aerosolizes it by impaction and baffling. |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Intended Use: | The <i>AMSURE</i> ^® Nebulizer is intended for the administration of various aerosol treatments in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs for nebulization, under the direction of a physician. It can be used for both pediatric and adult patient populations. |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Comparison to Predicate: | The <i>AMSure</i> ^® Nebulizer is similar to the predicate devices in operational principle, materials, design, technical characteristics and intended use. Any differences do not affect the intended use or the safety and effectiveness of the device. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Non-Clinical Testing: | Performance and biocompatibility testing has demonstrated that the <i>AMSure</i> ^® Nebulizer is safe and effective for its intended use. |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ching Ching Seah, Ph.D. Director of Research, Development and Regulatory Affairs Amsino International, Incorporated 855 Towne Center Drive Pomona, California 91767

OCT 1 2007

Re: K070411

Trade/Device Name: AMSURE® Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: September 19, 2007 Received: September 24, 2007

Dear Dr. Seah:

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 commerce prior to May 28, 1976, 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 general controls provisions 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{2}------------------------------------------------

Page 2 - Dr. Seah

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

| 510(k) Number: (if known) | K070411 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | AMSURE® Nebulizer |
| Indications for Use: | The AMSURE® Nebulizer is intended for the administration of various aerosol treatments in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs for nebulization, under the direction of a physician. It can be used for both pediatric and adult patient populations. |

## Indications for Use Statement

> Prescription Use_ (Per 21 CFR 801. 109) OR

510(k) Number:

Over-The-Counter Use

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concu(Division Sigro Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices