(122 days)
Not Found
Not Found
No
The summary describes a standard ultrasonic nebulizer and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as training/test sets and performance metrics typically associated with AI/ML devices.
Yes
The device is designed to aerosolize medications for inhalation by patients, which is a therapeutic purpose.
No
The device is described as an ultrasonic nebulizer system designed to aerosolize medications for inhalation, which is a therapeutic function, not a diagnostic one. It aids in delivering medication, not in identifying diseases or conditions.
No
The device description explicitly states it is an "ultrasonic (vibrating mesh) nebulizer system," which is a hardware device designed to aerosolize medications.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aerosolize medications for inhalation by the patient." This describes a therapeutic device used to deliver medication directly to the patient's respiratory system.
- Device Description: The description reinforces this by stating it's an "ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This nebulizer is a drug delivery device.
N/A
Intended Use / Indications for Use
The ultrasonic mesh nebulizer model NM211A is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used by adult and pediatric patients at the discretion of their physician at home, hospital & sub-acute care setting.
Product codes
CAF
Device Description
The ultrasonic mesh nebulizer model NM211A is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient.
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
adult and pediatric patients
Intended User / Care Setting
physician at home, hospital & sub-acute care setting
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 eagle with three stripes representing human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
May 30, 2014
Foshan Gaunying Electronics Co., Ltd c/o Mr. Guenter Ginsberg President, Media Trade Corporation 11820 Red Hibiscus Drive Bonita Springs, FL 34135
Re: K140211
Trade/Device Name: Ultrasonic Mesh Nebulizer Model NM211A Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer (Direct Patient Interface) Regulatory Class: Class II Product Code: CAF Dated: May 7, 2014 Received: May 9, 2014
Dear Mr. Ginsberg:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 3 rotty people 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 commence prior to May 26, 7778, the eccordance 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. I ou may, increase of the Act include requirements for annual registration, listing of The general controls provisions and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Thease note. CDICP does not of that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class II (PMA), it If your device is classified (see above) into time major regulations affecting your device can be may be subject to additional believer and the 21, Parts 800 to 898. In addition, FDA may found in the Code of I seems togenceming your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA $ issualles of a subscribes with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decirimation that your correst by other Federal agencies. You must
1
Page 2 -- Mr. Ginsberg
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
hup://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.fdaggov/MedicalDevices/Safety/ReportalProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/8 description: The image contains text and what appears to be a logo. The text includes the name "Tejashri Purohit-Sheth, M.D." which is repeated twice. Additionally, the text "Clinical Deputy Director DAGRID/ODE/CDRH FOR" is present. The logo is partially visible and seems to be associated with the text.
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radioloģical Health
Enclosure
2
FOSHAN GAUNYING ELECTRONICS CO., LTD
Indications for Use
510(k) Number ( K140211 ):
Device Name:
Nebulizer NM211 1 A
Indications for Use:
The ultrasonic mesh nebulizer mode! NM211A is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient.
The device may be used by adult and pediatric patients at the discretion of their physician at home, hospital &sub-acute care setting.
_AND/OR Prescription Use J J ------------
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/2/Picture/13 description: The image shows the letters FDA in a stylized font. The letters are made up of small lines and dots, giving them a textured appearance. The letters are arranged horizontally, with the F on the left, the D in the middle, and the A on the right.
Anya C. Harry -S 2014.05.30 13:49:00 -04'00'
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