(126 days)
Not Found
No
The description focuses on the physical mechanism of ultrasonic nebulization and does not mention any AI or ML components or functionalities.
Yes
The device is designed to "aerosolize medications for inhalation by the patient," which is a therapeutic function for delivering medication to treat respiratory conditions.
No
This device is designed to aerosolize medications for inhalation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components such as a mesh screen, piezoelectric member, power supply, operating and display unit, and breathing parts, indicating it is a hardware device with potential software control, not a software-only device.
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 details how the device works to create an aerosol from liquid medication for inhalation. It focuses on the physical process of nebulization and delivery to the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is used on the body to deliver medication.
N/A
Intended Use / Indications for Use
The ultrasonic mesh nebulizer model NE403 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient.
The device may be used by adult patients at home, hospital & sub-acute care settings.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
Nebulizer NE403 is a mesh screen ultrasonic nebulizer which was used ultrasonic Vibrating Mesh Technology (VMT). The device creates aerosols of liquid medication by ejection of droplets from a mesh vibrated at ultrasonic frequencies. As with other mesh screen ultrasonic nebulizers, the mesh is caused to vibrate by fluidic contact with a ultrasonic piezoelectric member that is energized by application of a high frequency alternating voltage. The VMT nebulizer is portable and quiet. This nebulizer is powered by four AA alkaline batteries or a cable connecting to an AC adapter.
Nebulizer NE403 consists of several function units: liquid medication containment, liquid nebulization and ejection, nebulized medicine (brume) channel (breathing parts), power supply, operating and display unit.
liquid medication is poured into medicinde container, transformed into something like brume, which is inhaled by patient via breathing parts, thus, the intended use of device is achieved.
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 patients
Intended User / Care Setting
at home, hospital & sub-acute care settings.
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)
The NE403 did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Non-clinical testing was performed in order to validate the design according to the company's specified design requirements, and to assure conformance with the following voluntary design standards:
IEC 60601-1 "Medical electrical equipment - Part 1: General requirements for safety". IEC 60601-1-2 "Medical electrical equipment - Part 1-2: General requirements for safety -Collateral Standard"
EN 13544-1:2007 "Respiratory therapy equipment - Part 1: Nebulizing systems and their components".
In addition, according to FDA guidance (reviewer guidance for nebulizers,metered dose inhalers, spacers andactuators), the Aerosol Performance Comparison Testing of the proposed device(NE403) and predicate device(NE-U22) , as well as the Intra-Sample and Inter-Sample Dose and Particle Size Variability Testing of NE403 were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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
ATTACHMENT 5
Image /page/0/Picture/1 description: The image contains a company logo and name. The logo is on the left side of the image and consists of three curved lines. The company name is "QUATEK" and is written in a bold, sans-serif font. Below the company name is the Chinese translation of the company name, followed by the English translation: "FOSHAN GAUNYING ELECTRONICS CO.,LTD".
Section 05-510 (k) Summary Version: 1.2
AUG
510(k) SUMMARY
- Sponsor:
Date of Submission Preparaton: 02/20/2012
510(k) S ubmitter's Na me: Foshan Gaunying Electronics Co.,Ltd.
Address: 4F, #4 IndustryCountry, ChengNanPark of Foshan Hi-tech Industrial Development Zone
- 510(k) Correspondent contact:
510(k) Correspondent Shenzhen ZYTC consulting Co., Ltd.
Address:05C.fuhai kangle building Nanshan district Shenzhen, CHINA 518000
Telephone: +86-755-8606 9197
Fax: +86-755-8606 9197
E-mail: cefda13485 @163.com
Contact person: Field.Fu
3.Proposed Device:
Trade Name: Nebulizer NE403 Classification Name: Nebulizer (Direct Patient Interface) Regulation Number: 868.5630 Product Code: CAF Device Class: II
- Predicate Device:
Predicate Device: Micro Air Vibrating Mesh Nebulizer 510(k) Number: K062263 Manufacturer: Omron Healthcare Inc.
- Description of Proposed Device:
Nebulizer NE403 is a mesh screen ultrasonic nebulizer which was used ultrasonic Vibrating Mesh Technology ( VMT). The device creates aerosols of liquid medication by ejection of droplets from a mesh vibrated at ultrasonic frequencies. As with other mesh screen ultrasonic nebulizers, the mesh is caused to vibrate by fluidic contact with a ultrasonic piezoelectric member that is energized by application of a high frequency alternating
Section 05 Page 1 of 3
1
魔雷子有限公司
Section 05-510 (k) Summary Version: 1.2
UNVING ELECTRONICS CO.,LTD
voltage. The VMT nebulizer is portable and quiet. This nebulizer is powered by four AA alkaline batteries or a cable connecting to an AC adapter.
Nebulizer NE403 consists of several function units: liquid medication containment, liquid nebulization and ejection, nebulized medicine (brume) channel (breathing parts), power supply, operating and display unit.
liquid medication is poured into medicinde container, transformed into something like brume, which is inhaled by patient via breathing parts, thus, the intended use of device is achieved.
6. Statement of indications for Use:
The ultrasonic mesh nebulizer model NE403 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient.
The device may be used by adult patients at home, hospital & sub-acute care settings.
7. Biocompatibility Certification:
Biocompatibility Testing conducted on the Masks, Mouthpiece and the components which contact the gas path of the patients according to ISO10993-1, ISO10993-3, ISO10993-5, ISO10993-6, ISO10993-10.
8. Comparison to predicate device
Both the nebulizer and the Predicate device have the same intended use and fundamental technology. They have the same energy type, nebulizing method, particle size, etc. although differences between them in the respect of the target population, nebulizing rate, those items of nebulizer NE403 fall into the range of predicate device. A side-by-side comparison of the NE403 and the cited predicate devices is included in the 510(k) submission (Section 09). The NE403 is substantially equivalent to the technological features as the predicate devices.
9. Discussion of Non -Clinical Tests Perf ormed for Determi nation of Substantial Equivalence are as follows:
The NE403 did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Non-clinical testing was performed in order to validate the design according to the company's specified design requirements, and to assure conformance with the following voluntary design standards:
IEC 60601-1 "Medical electrical equipment - Part 1: General requirements for safety". IEC 60601-1-2 "Medical electrical equipment - Part 1-2: General requirements for safety -Collateral Standard"
EN 13544-1:2007 "Respiratory therapy equipment - Part 1: Nebulizing systems and their components".
In addition, according to FDA guidance (reviewer guidance for nebulizers,metered dose inhalers, spacers andactuators), the Aerosol Performance Comparison Testing of the proposed device(NE403) and predicate device(NE-U22) , as well as the Intra-Sample and Inter-Sample Dose and Particle Size Variability Testing of NE403 were conducted.
2
AN GAUNYING ELECTRONICS CO.,LTD
Section 05-510 (k) Summary Version: 1.2
10. Conclusions:
The NE403 has the same intended use and technological characteristics as the predicate device. Moreover, bench testing and safety report documentation supplied in this submission demonstrates that the difference in the submitted models could maintain the same safety and effectiveness as that of predicate device. In the other words, those engineering difference do not affect the intended use or alter the fundamental scientific technology of the device. Thus, the NE403 is substantially equivalent to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three tail feathers, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Foshan Gaunying Electronics Company, Limited C/O Mr. Guenter Ginsberg Media Trade Corporation 11820 Red Hibiscus Drive Bonita Springs, Florida 34135
AUG 20 2012
Re: K121154
Trade/Device Name: Nebulizer NE403 Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: July 7, 2012 Received: July 10. 2012
Dear Mr. Ginsberg:
We have reviewed vour 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.
4
Page 2- Mr. Ginsberg
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
th fa.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
ATTACHMENT 4
Section 04- Indications for use Version: 1.1
Indications for Use
510(k) Number (
):
Device Name:
Nebulizer NE403
Indications for Use:
The ultrasonic mesh nebulizer model NE403 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient.
The device may be used by adult patients at home, hospital & sub-acute care setting.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
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)
L. Schult
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Section 04 -Page 1 of 1 ·