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.

AI/ML Overview

The provided document is a 510(k) summary for the Shinmed SW-966 Ultrasonic Nebulizer, focusing on its substantial equivalence to a predicate device. It contains very limited details regarding formal acceptance criteria or a dedicated study with statistical endpoints to "prove" the device meets acceptance criteria in the way a clinical trial for a new drug or algorithm would.

Instead, the document emphasizes equivalence in performance characteristics to a legally marketed predicate device. The "study" mentioned is a nebulizer characterization study, which compares the Shinmed device to the predicate device.

Here's an attempt to extract and present the requested information based on the provided text, with many fields being 'Not Applicable' or 'Not Specified' due to the nature of this type of regulatory submission (which focuses on equivalence rather than de novo performance proof).

Acceptance Criteria and Device Performance for Shinmed SW-966 Ultrasonic Nebulizer

The provided 510(k) summary for the Shinmed SW-966 Ultrasonic Nebulizer primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, the MicroSonic nebulizer (marketed as Lumiscope, K924081). The "acceptance criteria" can be inferred from the comparative performance data presented, which aims to show that the Shinmed device performs similarly to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Equivalence)	Reported Device Performance (Shinmed SW-966)
Maximum Particle Size (MPS) distribution data below 10 microns (FDA suggested)	Produced MPS distribution data below 10 microns.
Amount of drug delivered similar to predicate device	Amount of drug delivered was similar to the predicate device.
Intended Use: Spray liquid medications in aerosol form into gases for direct patient delivery	Intended Use (stated): "The Shinmed Ultrasonic Nebulizer is intended to spray liquid medications in aerosol form into gases that are directly delivered to the patient." (Matches predicate's intended use)
Principal of Operation: Ultrasonic nebulization	Principal of Operation (stated): "standard direct current - ultrasonic nebulizer system designed to atomize medications into gases for patient direct breathing." (Matches predicate's principal of operation)
Technological Characteristics: No significant differences from predicate	"There are no significant differences in the characteristics of the subject devices and the predicates."
Oscillation frequency: 1.63 MHz (matching predicate)	Provides an oscillation frequency of 1.63 MHz.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The document refers to "Nebulizer Characterization Studies" but does not detail the number of devices or measurement replicates used.
Data Provenance: The device is manufactured by Shining World Healthcare Co., Ltd. in Taiwan. The characterization studies were presumably conducted by or for the manufacturer. No country of origin for the specific data collection is stated, nor is it explicitly labeled as retrospective or prospective. Given it's a pre-market submission, it would be prospective for the purpose of the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not Applicable. This type of device (ultrasonic nebulizer) primarily relies on objective physical measurements (e.g., particle size, drug output) rather than expert interpretation or ground truth derived from expert consensus. The "ground truth" here is the physical performance measurement itself.

4. Adjudication Method for the Test Set

Not Applicable. As there are no expert interpretations involved in determining the core performance metrics, no adjudication method is necessary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for this type of device. There are no human readers or interpretations of output typically associated with ultrasonic nebulizers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This is a physical medical device, not a software algorithm. Its "standalone performance" is implicitly what the nebulizer characterization studies evaluated.

7. The Type of Ground Truth Used

Objective Physical Measurements: The ground truth for performance relied on direct physical measurements of the nebulizer's output, specifically:
- Median Particle Size (MPS) distribution (measured in microns).
- Amount of drug delivered.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of this physical device. The device's design and manufacturing processes are established, and its performance is verified through functional testing.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set, this question is not relevant.

Summary

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

3 1999 SEP

m dii

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

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.

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

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.

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

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.

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

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

{4}------------------------------------------------

m dii

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

Over the Counter Use

Consulting since 1978

Regulation Number and Section

§ 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).