K-jump Health Co., Ltd. Ultrasonic Nebulizer System includes a DC powered ceramic resonator and a fan that provides a source of mist for home health care use. The device is used with a pneumatic nebulizer to convert certain inhaled drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatric patients.

Device Description

The KN-9210 uses the ultrasound vibration technique in which a piezeoelectric ceramic installed as a generator of ultrasound wave when powered key pressed and system been powered on. The medicine solution on the semi-oval cup can be converted to mist through the water medium which propagated the ultrasound from resonator on the device. Then, a mini fan on the device drives the mist or aerosol through the air flow chamber and mouth piece installed on the top cover to the patient. The patient can use this aerosol for his/her respiratory therapy with two-safety valve installed on the mouthpiece which is standed on the top of drug ampoule.

The device consists of a piezeoelectric ceramic, a fan, a plastic body (including a top cover, a main body, a rear cover, an inlet filter, a filter cover, a nebulization chamber and an air-flow chamber), a medicine cup, a printed circuit board with electronic components, a DC socket, an AC adapter power source (or a rechargeable battery assembly as an optional power source), and a key for ON/OFF operation.

AI/ML Overview

The provided submission is for an Ultrasonic Nebulizer System (Model KN-9210), which is a medical device and not an AI/ML software device. Therefore, the requested information regarding acceptance criteria and studies proving the device meets them, especially those related to AI/ML performance, is not directly applicable in the typical sense for this document.

However, based on the provided text, I can extract and infer information relevant to the device's performance characteristics and the non-clinical tests conducted to demonstrate substantial equivalence to predicate devices.

Here's a breakdown of the available information, adapted to the requested structure where possible, but noting the absence of AI-specific details:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a nebulizer, the acceptance criteria relate to its physical performance in delivering medication. The "reported device performance" are the results of the performance testing conducted.

Performance Characteristic	Acceptance Criteria (Implied/Standard for Nebulizers)	Reported Device Performance
Particle Size Range	0.5 to 5 microns (stated as equivalent to predicate)	The Mass Median Aerodynamic Diameter (MMAD) and respirable fraction (% mass between 1 and 5 microns) were measured for three different medications (Atrovent, Bricanyl, Pulmicort). Specific values are not provided in the summary but were measured in the testing.
Mean Flow Rates	0.7 ml/min (stated as equivalent to predicate)	Measured as part of performance testing. Specific measured values are not provided in the summary.
Total Mass of Medication Delivered	Not explicitly stated, but measured in performance testing	Measured for three different medications. Specific measured values are not provided in the summary.
Respirable Mass	Not explicitly stated (mass of drug between 1 and 5 microns), but measured in performance testing	Measured for three different medications. Specific measured values are not provided in the summary.
Cleaning/Disinfection Effectiveness	Device should be compatible with and effectively cleaned/disinfected by recommended methods.	Investigated using three commercially available disinfectants recommended by CDC and HICPAC. No specific "performance" results are detailed in the summary.
Biocompatibility	Components in contact with gas path and patient must be biocompatible.	Cytotoxicity Test, Rabbit Skin Irritation Test, and Skin Sensitization Test were conducted on Nebulizer Adult & Pediatric Masks, Mouthpiece, and gas path components. No specific "performance" results are detailed in the summary.
EMC, Electrical, Mechanical, Environmental Performance	Must meet relevant safety and performance standards for respiratory devices.	Required testing was performed. No specific "performance" results are detailed in the summary.
Mode of Operation	45min ON/45 min OFF (stated as equivalent to predicate)	Conforms to 45min ON/45 min OFF.
Capacity	5 ml (stated as equivalent to predicate)	Conforms to 5 ml.

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

Sample Size for performance tests: Not explicitly stated. The document mentions tests were conducted on "three medicines" (Atrovent, Bricanyl, Pulmicort), implying at least three distinct test cases for the nebulization performance metrics. For biocompatibility and other engineering tests, typical sample sizes are generally smaller and defined by applicable standards.
Data Provenance: Not explicitly stated, but the testing would have been conducted by or for K-jump Health Co., Ltd., likely in Taiwan (country of origin of the company). The studies are non-clinical, bench-top performance tests, making them prospective in the sense that they were specifically designed and executed to evaluate the device.

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

This device is a mechanical/electronic medical device (nebulizer), not an AI/ML diagnostic tool requiring expert interpretation for "ground truth." The performance metrics (e.g., particle size, flow rates) are measured objectively by laboratory instruments and protocols, rather than through expert consensus.
Hence, this criterion is Not Applicable in the context of this device and submission.

4. Adjudication Method for the Test Set

Again, this criterion is Not Applicable for a hardware device like a nebulizer. Adjudication methods like 2+1 or 3+1 are used in studies where human readers review and provide consensus on findings (e.g., medical images for AI ground truth).

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

This is Not Applicable. An MRMC study is relevant for AI/ML diagnostic tools that assist human readers. The K-jump Ultrasonic Nebulizer System is a therapeutic device that delivers medication; it does not involve human readers interpreting a "case" in the diagnostic sense.

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

This is Not Applicable. This concept applies to AI/ML algorithms, not a physical medical device like a nebulizer.

7. The Type of Ground Truth Used

For the performance testing, the "ground truth" would be established by objective measurements from calibrated laboratory equipment according to recognized standards (e.g., for particle size distribution, flow rates).
For biocompatibility, the "ground truth" is determined by standardized laboratory tests for cytotoxicity, irritation, and sensitization, with results compared against pass/fail criteria from relevant international standards (e.g., ISO 10993).
For EMC, Electrical, Mechanical, and Environmental Testing, the "ground truth" is compliance with relevant national and international safety and performance standards.

8. The Sample Size for the Training Set

This is Not Applicable. As a physical medical device, there is no "training set" in the AI/ML sense. Design and development would follow engineering principles, not machine learning training.

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

This is Not Applicable for the same reason as point 8.

Summary

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: __ K083256

JUN 26 2009

1. Submitter's Identification:

K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien, 248, Taiwan Tel: +886-2-22991378 Fax: +886-2-22331386

Contact: Mr. Jason Cheng Date Summary Prepared: October 6, 2008

2. Name of Device:

K-jump Health Co., Ltd. Ultrasonic Nebulizer System, Model KN-9210

3. Common or Usual Name:

Ultrasonic Nebulizer

4. Predicate Device Information:

K051365, Compressor Nebulizer System, Model KN-9321, K-jump Health Co., Ltd, Taiwan
K974379, ULTRANEB, Bremed Italia s.r.l., Italy

5. Device Description:

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EXHIBIT 1

6. Intend Use:

The KN-9210 is intended to be a source of ultrasonic nebulizer which, when driven by its built-in ceramic resonator and fan, nebulizes specific inhalable drugs for inhalation by patient for treatment of respiratory disorders, such as allergies, asthma, cystic fibrosis, COPD, etc. It can be used with adult and pediatric patients.

7. Comparison to Predicate Devices:

The subject device is substantially equivalent to the predicate devices, K#051365, Compressor Nebulizer System, Model KN-9321 on Nebulizer materials and to the K#974379, ULTRANEB Ultrasonic Nebulizer, Bremed Italia s.r.l. on Ultrasonic Nebulizer. These predicate devices were cleared with the same indication for use as K-jump device.

Characteristics	K-jump Device (SubjectDevice)	Compressor NebulizerSystem, Model KN-9321,K#051365, K-jump Health Co.,Ltd.
Main body	ABS Resin, POLYLACPA-707, Supplier: CHI MEICORPORATION	ABS Resin, POLYLAC PA-707,Supplier: CHI MEICORPORATION
Air filter holder	ABS Resin, POLYLACPA-707, Supplier: CHI MEI	ABS Resin, POLYLAC PA-707Supplier: CHI MEI

The substantial equivalence chart is provided as follows:

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	CORPORATION	CORPORATION
Filter	Polyurethane foam, K329,Supplier: Sanchian	Polyurethane foam, K329,Supplier: Sanchian
Top Cover	Polycardbonate L-1225Y,Supplier: Teijin Chemicals Ltd.	Polypropylene Resin Profax,6331, Supplier: TAIWANPOLYPROPYLENE CO., LTD.
NebulizationChamber	Polycardbonate L-1225Y,Supplier: Teijin Chemicals Ltd.	Polypropylene Resin Profax,6331, Supplier: TAIWANPOLYPROPYLENE CO., LTD.
Air-Flow Chamber	Polycardbonate L-1225Y,Supplier: Teijin Chemicals Ltd.	N/A
Drug Ampoule	Polyehtylene Terphthalate,A-PET, Supplier: Dong GuanSen Yuan EnvironmentalPlastic Co., Ltd.	Polypropylene Resin Profax,6331, Supplier: TAIWANPOLYPROPYLENE CO., LTD.
Mouth piece	Polycardbonate L-1225Y,Supplier: Teijin Chemicals Ltd.	Polypropylene Resin Profax,6331, Supplier: TAIWANPOLYPROPYLENE CO., LTD.
Mask	PVC Compound 65PHR,Supplier:Jieh-Ming Plastics MfgCo., Ltd.	PVC Compound 65PHR,Supplier:Jieh-Ming Plastics MfgCo., Ltd.

Characteristics	K-jump Device(Subject Device)	ULTRANEB, Bremed Italia s.r.l.,K#974379
Model No.	KN-9210	ULTRANEB
Nebulization Type	Ultrasonic	Ultrasonic
Dimension	85X56X130mm(3.35"X2.20"X5.12")	83X50X110mm(3.27"X1.97"X4.33")
Weight	0.437 lbs. (198g)	0.463 lbs. (210g)
ElectricalRequirements	100-240 V/15VDC (withAC/DC switchingadapter)50/60Hz, or 12 VDCRechargeablebattery(optional), or Carconnection cable (optional)	100-240 V/15VDC (with AC/DCswitching adapter)50/60Hz, or 12VDC Rechargeablebattery(optional), or Carconnection.cable (optional)
Power consumption	12 watts	12 watts
Power indicator	LED	LED
ON/OFF Switch	Push Button	Push Button
Filter	Inlet	Inlet
Mode of Operation	45min ON/45 min OFF	45min ON/45 min OFF
Safety valve onmouthpiece	Two-valve system	Two-valve system
Particle Size Range	0.5 to 5 microns	0.5 to 5 microns
Capacity	5 ml	5 ml
Mean Flow Rates	0.7 ml/min	0.7 ml/min

. ·

・・・・・・

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8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

The following performance testing was conducted:

The mean Mass Median Aerodynamic Diameter (MMAD), respirable fraction (% mass ● between 1 and 5 microns), total mass of medication delivered, and respirable mass (mass of drug between 1 and 5 microns) was measured. The nebulized particle size test was conducted in three medicines:
- Anti-cholinergic bronchodilator: Atrovent;
- Beta-agonist bronchodilator: Bricanyl;
- Anit-inflammatory: Pulmicort
The three commercially available disinfectants recommended by CDC and HICPAC are ● investigated in Cleaning/Disinfection Test.
Biocompatibility Testing conducted on the Nebulizer Adult & Pediatric Masks, Mouthpiece . and the components which contact the gas path of the patients:
- Cytotoxicity Test
- Rabbit Skin Irritation Test
- Skin Sensitization Test
. Respiratory Devices Branch Required EMC, Electrical, Mechanical and Environmental Testing

9. Discussion of Clinical Tests Performed:

Not Applicable

10. Conclusions:

K-jump Health Co., Ltd. Ultrasonic Nebulizer System, Model KN-9210 has the same intended use and similar characteristics as the predicate devices. Moreover, bench testing contained in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the K-jump Health Co., Ltd. Ultrasonic Nebulizer System, Model KN-9210 is substantially equivalent to the predicate devices.

Page 4 of 4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The eagle is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Public Health Service

JUN 26 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jason Cheng Product Planning Specialist K-Jump Health Company Limited No. 56 Wu Kung 5th Road, Wu Ku Industrial Park. Taipei Hsien China (TAIWAN) 248

Re: K083256

Trade/Device Name: Ultrasonic Nebulizer System, Model KN-9210 · Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: May 21, 2009 Received: May 22, 2009

Dear Mr. Cheng:

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.

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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Page 2- Mr. Cheng

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Susan Runser
Susan Runser, DDS, MS

Susan Runner, D.D.S., M. Acting Director Division of Anesthesiology, General Hospital, · Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

1 age of 1

K083256 510(k) Number (if known):

Device Name: K-jump Health Co., Ltd. Ultrasonic Nebulizer System, Model KN-9210

Indications for Use:

Susan Quone

(Division Sign-Off) Division of Anesthesiology, General Hospital Intection Control, Dental Devices

510(k) Number: kaf3256

Prescription Use ___x OR (Per 21 CFR 801 Subpart D)

Over-The Counter Use (21 CFT 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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).