(447 days)
Not Found
K/DEN numbers are not found in the provided text.
No
The document describes a compressor nebulizer, a mechanical device for administering medication. There are no mentions of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
This device, a compressor nebulizer, is used to administer prescribed medical aerosol products for treatment, indicating a therapeutic purpose.
No
The device is described as a compressor nebulizer used to administer aerosol treatments, not to diagnose a condition.
No
The device is described as a "Compressor Nebulizer," which is a hardware device used to administer medication. The summary does not mention any software component that functions independently as a medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "administer various aerosol treatments" and "administer or prescribes medical aerosol products to a patient using a Small Volume Nebulizer." This describes a device used for delivering medication to a patient, which is a therapeutic function, not a diagnostic one.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such tests.
- Device Description (or lack thereof): While the device description is "Not Found," the intended use is sufficient to determine its function.
- Other Sections: The absence of information related to image processing, AI/ML, imaging modality, anatomical site, training/test sets, performance studies, and key metrics further supports that this is not a diagnostic device.
Therefore, the Stronghealth Compressor Nebulizer MCN-S600XX is a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Stronghealth Compressor Nebulizer MCN-S600XX is used to administer various aerosol treatments of medicine. Stronghealth Compressor Nebulizer MCN-S600XX is used to administer physician prescribed medical aerosol products to a patient using a Small Volume Nebulizer. The intended environment for use of the product is in the patient's home on the order of a physician.
Product codes
CAF
Device Description
Not Found
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
patient's home on the order of a physician.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administratio 10903 New Hampshire Avenue Document Control Center - WO6 Silver Spring, MD 20993-0002
December 19, 2013
Dongguan Aidisy Machinery & Electronic Equipment Co., Ltd C/O Mr. Leon Lu Director of Quality and Regulatory Affairs MEDevice Services, LLC 3500 South Dupont Highway DOVER DE 19901
Re: K123030
Trade/Device Name: Stronghealth Compressor Nebulizer MCN-S600XX Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer (direct patient interface) Regulatory Class: II Product Code: CAF Dated: November 6, 2013 Received: November 8, 2013
Dear Mr. Lu:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Mr. Lu
ﻟﻤﺘﻮﺍﺻﻠﻴﻦ ﺍﻟﻤﺴﺎﺑﻘﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID
FOR
Erin Keith, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K12303D
Devica Name
Stronghealth Compressor Nebulizer MCN-S600XX
Indications for Use (Describe)
Indications for USS (Desabe)
Stronghealth Compressor Nebulizer MCN-S600XX is used to administer various acrosol treatments of alle Subgream Compressor Nebulizer MCN-30007X is 350 a idinister or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.
The intended environment for use of the product is in the patient's home on the order of a physician.
Type of Use (Select one or both, as applicable)
[x] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
12 - 12 -FOR FDA USE ONLY ------- : , Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Anva C. Harry -ട
2013.12.18 、 16:07:52 -05'00'
FORM FDA 3881 (9/13)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
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