SHINMED MODEL SW-966 ULTRASONIC NEBULIZER

K980024 · Shining World Health Care Co., Ltd. · CAF · Sep 3, 1999 · Anesthesiology

Device Facts

• Record ID: K980024
• Device Name: SHINMED MODEL SW-966 ULTRASONIC NEBULIZER
• Applicant: Shining World Health Care Co., Ltd.
• Product Code: CAF · Anesthesiology
• Decision Date: Sep 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Shinmed Ultrasonic Nebulizer is intended to spray liquid medications in aerosol form into gases that are directly delivered to the patient.

Device Story

Tabletop ultrasonic nebulizer system; uses high-frequency oscillation (1.63 MHz) to atomize liquid medications into aerosol; patient inhales aerosol via mask or mouthpiece connected to main unit via flexible hose; 30 cc disposable medicine cup; intended for direct patient breathing; device operates as a standard DC-powered system; provides medication delivery for respiratory therapy.

Clinical Evidence

Bench testing only. Nebulizer characterization studies compared the subject device to the predicate, measuring Mass Particle Size (MPS) distribution and drug delivery amounts. Both devices produced MPS distribution data below the 10-micron threshold and demonstrated similar drug delivery performance.

Technological Characteristics

Tabletop ultrasonic nebulizer; 1.63 MHz oscillation frequency; 30 cc disposable medicine cup; DC power source; mask/mouthpiece interface with flexible hose; no significant differences in technological characteristics compared to predicate.

Indications for Use

Indicated for patients requiring delivery of liquid medications 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

• MicroSonic nebulizer (Lumiscope) (K924081)
• Oxygen mask (Dadsun Corp., LTD) (K851466)

Submission Summary (Full Text)

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3 1999 SEP

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Shinmed SW-966 UltraSonic Nebulizer 510(k) Notification Attachment 1

K980024

### Shining World Healthcare Co., LTD Shinmed SW-966 Ultrasonic Nebulizer

#### Submitter Information:

Shining World Healthcare Co., Ltd. PO Box 32, Lu-Chou Taipei, Hsien, Taiwan R.O.C.

#### 510(k) Summary Prepared by:

Carolann Kotula Official Correspondent for MSI c/o mdi Consultants, Inc. 55 Northern Boulevard Great Neck, NY 11021

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| Fax: | [phone] |

Date 510(k) Summary Prepared:

December 22, 1997

#### Name/Classification of the Device:

Classification Name:

Common Name:

Proprietary Name:

Classification/Panel:

Nebulizer, 21 CFR 868.56300

Ultrasonic Nebulizer

Shinmed Model SW-966 Ultrasonic Nebulizer

Nebulizers have been classified by the Anesthesiology Panel as Class II devices.

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Identification of the Legally Marketed Device to which the Submitter Claims Equivalence: Comparative Information: The Shimed Ultrasonic Nebulizer Model SW-966 is substantially equivalent in intended use, principal of operation, performance as the MicroSonic nebulizer, manufactured by Medel Electronmedicali, Parma, Italy and legally marketed in the United States as the Lumiscope under K924081. The mask and mouthpiece are identical to the oxygen mask legally marketed by Dadsun Corp., LTD under K851466.

Description of the Subject Device: The Shinmed Ultrasonic Nebulizer is a standard direct current - ultrasonic nebulizer system designed to atomize medications into gases for patient direct breathing. The device consists of a tabletop high-frequency main unit which provides an occillation frequency of 1.63 MHz. The 30 cc disposable medicine cup in the main unit. A mask or mouthpiece is attached to the main unit with a flexible hose. The patient breaths the medicine through the mask or mouthpiece.

Intended_Useof the Subject Device: The Shinmed Ultrasonic Nebulizer is intended to spray liquid medications in aerosol form into gases that are directly delivered to the patient.

Technological Characteristics of the Subject Device: There are no significant differences in the characteristics of the subject devices and the predicates. Nebulizer Characterization Studies completed on the subject device and the predicate found both nebulizers produced MPS distribution data below the (FDA suggested) maximum of 10 microns. The amount of drug delivered by each of the nebulizers was similar.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 1999

Ms. Carolann Kotula Shining World Health Care Co., Ltd. c/o MDI Consultants, Inc. 55 Northern Boulevard Great Neck, NY 11021

Re: K980024 Shinmed SW 966 Ultrasonic Nebulizer Requlatory Class: II (two) . Product Code: 73 CAF August 24, 1999 Dated: Received: August 26, 1999

Dear Ms. Kotula:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Ms. Carolann Kotula

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan, Ph.D.

Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known):

Device Name: Shinmed SW-966 Ultrasonic Nebulizer

Indications for Use:

The Shinmed Ultrasonic Nebulizer is intended to spray liquid medications in aerosol form into gases that are directly delivered to the patient.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Lo Allesterson s
(Division Sign-Off)

510(k) Number K980024

Prescription Use

OR

Over the Counter Use

Consulting since 1978