(606 days)
No
The description details a standard ultrasonic nebulizer with no mention of AI or ML components or functionality.
Yes
The device is intended to spray liquid medications in aerosol form into gases for direct delivery to the patient, which falls under the definition of a therapeutic intervention.
No
The device is described as an ultrasonic nebulizer intended to deliver liquid medications in aerosol form, which is a therapeutic function, not a diagnostic one. It atomizes medication for patient breathing, rather than collecting or analyzing information about a patient's health condition.
No
The device description clearly outlines hardware components such as a tabletop high-frequency main unit, a medicine cup, a flexible hose, and a mask or mouthpiece. This indicates it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "spray liquid medications in aerosol form into gases that are directly delivered to the patient." This describes a therapeutic delivery method, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a system for atomizing and delivering medication for breathing. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The provided information does not include any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes (biomarkers, pathogens, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The Shinmed Ultrasonic Nebulizer is a medical device used for drug delivery, which falls under a different regulatory category than IVDs.
N/A
Intended Use / 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.
Product codes
CAF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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3 1999 SEP
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Shinmed SW-966 UltraSonic Nebulizer 510(k) Notification Attachment 1
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
| Phone: | (516) 482-9001 |
|---|---|
| Fax: | (516) 482-0186 |
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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Image /page/1/Picture/1 description: The image contains four lowercase letters: 'm', 'd', and 'i'. The letters are in a simple, sans-serif font with a bold outline. The letters are evenly spaced and aligned horizontally.
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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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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.
(Please Do Not Write Below this Line/Continue on Another Page if Needed)
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