SHINMED MODE SW-988 UNTRASONIC NEBULIZER

K031370 · Shining World Health Care Co., Ltd. · CAF · Sep 1, 2004 · Anesthesiology

Device Facts

• Record ID: K031370
• Device Name: SHINMED MODE SW-988 UNTRASONIC NEBULIZER
• Applicant: Shining World Health Care Co., Ltd.
• Product Code: CAF · Anesthesiology
• Decision Date: Sep 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Shinmed Ultrasonic Nebulizer SW-988 is intended to spray liquid medications in aerosol form into gases that are directly delivered to the patient.

Device Story

The SHINMED Model SW-988 is an ultrasonic nebulizer designed to convert liquid medications into an aerosol mist for inhalation. It utilizes ultrasonic transducer technology to vibrate liquid at high frequencies, creating fine particles for direct delivery to the patient's respiratory tract. The device is intended for use in clinical or home settings under the direction of a healthcare provider. It operates by receiving liquid medication, transforming it into an aerosol via ultrasonic vibration, and outputting the mist through a delivery interface (e.g., mask or mouthpiece). This process facilitates the administration of prescribed respiratory medications, potentially improving patient outcomes by ensuring effective drug delivery to the lungs.

Clinical Evidence

Bench testing only.

Technological Characteristics

Ultrasonic nebulizer; utilizes ultrasonic transducer for aerosol generation; class II device; product code CAF; 21 CFR 868.5630.

Indications for Use

Indicated for the delivery of aerosolized liquid medications to patients requiring respiratory therapy.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 1 2004

Mr. Jen Ke-Min Shining World Health Care Company, Limited ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun Street Hsin-Chu City CHINA (Taiwan) 300

Re: K031370

Trade/Device Name: SHINMED Model SW-988 Ultrasonic Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: July 29, 2004 Received: August 2, 2004

Dear Dr. Ke-Min:

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.

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Page 2 - Dr. Ke-Min

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 vour 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/dsma/dsmamain.html

Sincerely yours,

Qurs

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

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## 4. INDICATIONS FOR USE STATEMENT

Applicant : ___ Shining World Health Care Co., Ltd. 510(k) Number:____K031370 Device Name : SHINMED model SW-988 Ultrasonic Nebulizer

## Indications for Use :

- The Shinmed Ultrasonic Nebulizer SW-988 is intended to spray liquid medications in aerosol forn ● into gases that are directly delivered to the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)

| Prescription Use | <div style="display:inline-block; vertical-align:middle;">✓</div> |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Per 21 CFR 801.109 | |
| | OR |
| Over-The-Counter | ________________ |
| | (Optional Format 1-2-96) |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | K031370 |