(490 days)
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Not Found
No
The summary describes a standard ultrasonic nebulizer and contains no mention of AI, ML, or related concepts.
Yes
The device is intended to spray liquid medications in aerosol form directly to the patient, which is a therapeutic application.
No
Explanation: The device is intended to spray liquid medications in aerosol form, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states "SHINMED model SW-988 Ultrasonic Nebulizer," which is a hardware device. The summary does not mention any software component as the primary or sole medical device.
Based on the provided information, the Shinmed Ultrasonic Nebulizer SW-988 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 device used for drug delivery to a patient's respiratory system, not for testing samples taken from the human body (which is the core function of an IVD).
- Device Description: The description is simply "SHINMED model SW-988 Ultrasonic Nebulizer," which aligns with a medical device for respiratory therapy.
- Lack of IVD Indicators: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
Therefore, the Shinmed Ultrasonic Nebulizer SW-988 is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes
CAF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The seal is black and white and has a circular shape.
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.
1
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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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
2
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 | ✓ |
|---|---|
| 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 |