(297 days)
Not Found
No
The document describes a standard medical device (ultrasonic nebulizer) and its performance testing based on established standards and guidance documents. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
Yes.
The device is intended to transform liquid medications into aerosol form for patient inhalation to treat respiratory conditions, which is a therapeutic purpose.
No.
The device is intended to transform liquid medications into aerosol form for patient inhalation, which is a treatment delivery function, not a diagnostic one.
No
The device description explicitly states it is a "small, compact, and battery powered potable nebulizer" and mentions hardware-related performance studies (electrical safety, electromagnetic compatibility), indicating it is a physical device with hardware components, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to transform liquid medications into aerosol form for patient inhalation. This is a therapeutic delivery method, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical characteristics and function of the nebulizer for delivering medication.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This nebulizer's function is to administer medication directly to the patient.
N/A
Intended Use / Indications for Use
The Ultrasonic Nebulizer is intended to transform liquid medications into aerosol form for patient inhalation. The device can be used by adult or pediatric patients for respiratory treatment in the home, hospital or healthcare environment.
Product codes
CAF
Device Description
The Ultrasonic Nebulizer is a small, compact, and battery powered potable nebulizer which transforms liquid medicines into aerosol form and delivers directly to patient for inhalation. It makes patient's respiratory treatment easier and more convenient.
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 or pediatric patients
Intended User / Care Setting
home, hospital or healthcare environment.
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)
The performance of the Ultrasonic Nebulizer is verified and validated according to FDA Guidance Document "Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators", dated October 1, 1993, and following recognized standards.
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- ANSI/AAMI ES60601-1:2005 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance
The Ultrasonic Nebulizer complies with to applicable ANSI/AAMI ES60601-1 requirements including general requirements, protection against electrical hazards, protection against mechanical hazards, protection against excessive temperatures, hazardous situations and fault conditions, and constructions,
- ANSI/AAMI ES60601-1:2005 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance
-
- ANSI/AAMI/IEC 60601-1-2:2007 Medical Electrical Equipment Part 1-2: General Requirements for Safety; Electromagnetic Compatibility
The Ultrasonic Nebulizer complies with applicable ANSI/AAMV/IEC 60601-1-2 requirements including radiated emission test, electrostatic discharge immunity test, radiated RF electromagnetic field immunity test, and power frequency magnetic field immunity test
- ANSI/AAMI/IEC 60601-1-2:2007 Medical Electrical Equipment Part 1-2: General Requirements for Safety; Electromagnetic Compatibility
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
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May 18, 2012
MAR 1 5 2013
K-jump®
K-jump Health Co., Ltd Pre-market Notification for Ultrasonic Nebulizer (Mesh Type)
510(k) Summary of Safety and Effectiveness
- Submitter
K-jump Health Co., Ltd No. 56, Wu Kung 5th Rd New Taipei Industrial Park New Taipei City 24890, Taiwan
Contact: JM. Lin, Regulatory Affairs Representative Phone: +886-2-2299-1378 ext. 237 Fax: +886-2-2299-1385 Email: jm@kjump.com.tw
2. Name of Device
Common/Usual Name: Ultrasonic Nebulizer (Mesh Type) Classification Name: Nebulizer (Direct Patient Interface) Regulatory Number: 21CFR 868.5630 Regulatory Class: II Product Code: CAF
3. Predicate Device
| Device Name | 510(k) Number | Decision Date |
|---|---|---|
| Omron Micro Air Vibrating mesh nebulizer | ||
| NE-U22 | K062263 | 02/23/2007 |
4. Device Description
The Ultrasonic Nebulizer is a small, compact, and battery powered potable nebulizer which transforms liquid medicines into aerosol form and delivers directly to patient for inhalation. It makes patient's respiratory treatment easier and more convenient.
5. Indications for Use
The Ultrasonic Nebulizer is intended to transform liquid medications into aerosol form for patient inhalation. The device can be used by adult or pediatric patients for respiratory treatment in the home, hospital or healthcare environment.
1
6. Technological Characteristics
The Mesh Type Ultrasonic Nebulizer utilizes ceramic resonator and mesh plate to transform liquid medications into aerosol form and deliver fine particles to the patients. The device is powered by two AA type batteries which make it ultra-light and quiet compared with traditional compressor and ultrasonic nebulizer.
7. Comparison to Predicate Device
The Ultrasonic Nebulizer is substantially equivalent to the predicate devices, K062263, Omron Micro Air Vibrating mesh nebulizer. The comparison of their technological characteristics is summarized in the table below.
| Characteristics | K-jump
Ultrasonic Nebulizer
(Mesh Type) | Omron
Micro Air
Vibrating Mesh Nebulizer |
|---------------------|-----------------------------------------------|--------------------------------------------------------|
| 510(K) Number | TBD | K062263 |
| Intended Use | Similar | Similar |
| Technology | Mesh Type | Vibrating Mesh |
| Characteristics | | |
| Vibrating Frequency | 190 kHz | 180 kHz |
| Button | ON/OFF Switch | Same |
| Ampoule Capacity | 7.0 ml | Same |
| Nebulization Rate | 0.3 ml/min(Typical) | 0.25-0.9 ml/min |
| Environment | | |
| Operation condition | 5°C 40°C,45°C
15%-93% RH
non-condensing | 0°C
30%-85% RH |
| Storage condition | -25°C70°C,70°C
Up to 93% RH
non-condensing | -25°C
10%-90% RH |
| Power | | |
| Power source | Two AA batteries | Two AA batteries
AC adapter AC 120V
(60Hz/DC 3V) |
| Power consumption | 1.0W | 1.5W |
| Power indicator | LED | LED |
5-2
2
K-jump®
| Characteristics | K-jump
Ultrasonic Nebulizer
(Mesh Type) | Omron
Micro Air
Vibrating Mesh Nebulizer |
|-----------------|-----------------------------------------------|------------------------------------------------|
| Physical | | |
| Dimensions | 35mm(W) x 60 mm(D) x 104
mm (H) | 38mm(W) x 51 mm(D) x 104
mm (H) |
| Weight | 90g (without batteries) | 97g (without batteries) |
8. Performance Summarv
The performance of the Ultrasonic Nebulizer is verified and validated according to FDA Guidance Document "Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators", dated October 1, 1993, and following recognized standards.
-
- ANSI/AAMI ES60601-1:2005 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance
The Ultrasonic Nebulizer complies with to applicable ANSI/AAMI ES60601-1 requirements including general requirements, protection against electrical hazards, protection against mechanical hazards, protection against excessive temperatures, hazardous situations and fault conditions, and constructions,
- ANSI/AAMI ES60601-1:2005 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance
-
- ANSI/AAMI/IEC 60601-1-2:2007 Medical Electrical Equipment Part 1-2: General Requirements for Safety; Electromagnetic Compatibility
The Ultrasonic Nebulizer complies with applicable ANSI/AAMV/IEC 60601-1-2 requirements including radiated emission test, electrostatic discharge immunity test, radiated RF electromagnetic field immunity test, and power frequency magnetic field immunity test
- ANSI/AAMI/IEC 60601-1-2:2007 Medical Electrical Equipment Part 1-2: General Requirements for Safety; Electromagnetic Compatibility
9. Conclusions
The Ultrasonic Nebulizer has similar intended use, similar fundamental scientific technology, and similar technological characteristics with the predicate device. Moreover, both devices comply with equivalent safety standards and have similar performance. All information described above can demonstrate the Ultrasonic Nebulizer is substantial equivalent to the predicate device.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 15, 2013
Mr. JM Lin Regulatory Affairs Representative K-Jump Health Company, Limited No. 56, Wu Kung 5th Road New Taipei Industrial Park New Taipei City Taiwan 24890
Re: K121520
Trade/Device Name: Ultrasonic Nebulizer (Mesh Type) Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: February 20, 2013 Received: February 28, 2013
Dear Mr. Lin:
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.
4
Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat 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,
Image /page/4/Picture/6 description: The image shows the text "Kwame O. Ulmer for". The text "Kwame" is in a bold, sans-serif font. The "O. Ulmer" part of the text is stylized with a geometric pattern. The word "for" is in a smaller, typewriter-style font.
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital,
Respiratory, Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: Ultrasonic Nebulizer (Mesh Type)
Indications For Use:
The Ultrasonic Nebulizer is intended to transform liquid medications into aerosol form for patient inhalation. The device can be used by adult or pediatric patients for respiratory treatment in the home, hospital or healthcare environment.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Albert E. Moyaliz 04.00×People,
42_19200300.100. 1.1=1300059331.
100.00 E2 Moval - S S 2013.03.14 11:30:15 -04'00' for LS
(Division Sign-Off)
vision of Anesthesiology, General Hospital Tection Control, Dental Devices
510(k) Number: K121520 Page 1 of _ 1
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