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.

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.

AI/ML Overview

Here's an analysis of the K-jump® Ultrasonic Nebulizer based on the provided text, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table of "acceptance criteria" for performance that would typically be found in a detailed validation study. Instead, the document focuses on demonstrating substantial equivalence to a predicate device by comparing technological characteristics and compliance with general safety and performance standards.

However, we can infer some performance characteristics and compliance requirements:

Characteristic/Acceptance Criteria (Implied)	Reported Device Performance (K-jump Ultrasonic Nebulizer)	Predicate Device Performance (Omron Micro Air)
Safety and Essential Performance	Complies with ANSI/AAMI ES60601-1:2005	Implied compliance with equivalent standards
Electromagnetic Compatibility (EMC)	Complies with ANSI/AAMI/IEC 60601-1-2:2007	Implied compliance with equivalent standards
Nebulization Rate	0.3 ml/min (Typical)	0.25-0.9 ml/min
Vibrating Frequency	190 kHz	180 kHz
Ampoule Capacity	7.0 ml	7.0 ml
Operation Temperature	5°C ~40°C	0°C~45°C
Operation RH	15%-93% RH (non-condensing)	30%-85% RH
Storage Temperature	-25°C~70°C	-25°C~70°C
Storage RH	Up to 93% RH (non-condensing)	10%-90% RH
Overall Intended Use	Similar to predicate	Similar
Overall Technology	Similar to predicate (Mesh Type)	Similar (Vibrating Mesh)

Important Note: The document emphasizes "similar performance" and "compliance with equivalent safety standards" rather than showing specific quantitative performance targets met by the K-jump device and then presenting raw data to prove those targets were met. This is typical for a 510(k) submission where substantial equivalence to a legally marketed predicate device is being demonstrated.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a sample size for a "test set" in the context of clinical or performance data for this device. The submission relies on demonstrating compliance with recognized standards and similarity in technological characteristics to a predicate device.

Sample size for test set: Not specified/applicable in this document's context.
Data Provenance: The document does not describe patient or clinical data that would have a provenance (e.g., country of origin, retrospective/prospective). The data presented for the K-jump device are engineering specifications and compliance declarations.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The document does not describe a study involving expert-established ground truth for a test set. This type of submission focuses on engineering specifications and regulatory compliance, not typically on diagnostic accuracy or interpretation by human experts.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a test set requiring adjudication in this document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an ultrasonic nebulizer, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is outside the scope of this submission.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a medical apparatus, not an algorithm, so "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

Not applicable. The "ground truth" concept (e.g., pathology, outcomes data) is not relevant for this type of device submission, which focuses on device functionality, safety, and equivalence to a predicate. The "truth" here is established through engineering testing and compliance with recognized standards.

8. The Sample Size for the Training Set

Not applicable. The K-jump Ultrasonic Nebulizer is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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K121526

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 nebulizerNE-U22	K062263	02/23/2007

4. Device Description

5. Indications for Use

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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-jumpUltrasonic Nebulizer(Mesh Type)	OmronMicro AirVibrating 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,15%-93% RHnon-condensing	0°C~45°C30%-85% RH
Storage condition	-25°C~70°C,Up to 93% RHnon-condensing	-25°C~70°C10%-90% RH
Power
Power source	Two AA batteries	Two AA batteriesAC adapter AC 120V(60Hz/DC 3V)
Power consumption	1.0W	1.5W
Power indicator	LED	LED

5-2

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K-jump®

Characteristics	K-jumpUltrasonic Nebulizer(Mesh Type)	OmronMicro AirVibrating Mesh Nebulizer
Physical
Dimensions	35mm(W) x 60 mm(D) x 104mm (H)	38mm(W) x 51 mm(D) x 104mm (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.

1. 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,
1. 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

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.

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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.

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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

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Indications for Use

510(k) Number (if known):

Device Name: Ultrasonic Nebulizer (Mesh Type)

Indications For Use:

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

Regulation Number and Section

§ 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).