ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210

{0}------------------------------------------------ ### 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: {1}------------------------------------------------ ## EXHIBIT 1 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. ### 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 (Subject<br>Device) | Compressor Nebulizer<br>System, Model KN-9321,<br>K#051365, K-jump Health Co.,<br>Ltd. | |-------------------|----------------------------------------------------------------|----------------------------------------------------------------------------------------| | Main body | ABS Resin, POLYLAC<br>PA-707, Supplier: CHI MEI<br>CORPORATION | ABS Resin, POLYLAC PA-707,<br>Supplier: CHI MEI<br>CORPORATION | | Air filter holder | ABS Resin, POLYLAC<br>PA-707, Supplier: CHI MEI | ABS Resin, POLYLAC PA-707<br>Supplier: CHI MEI | The substantial equivalence chart is provided as follows: {2}------------------------------------------------ | | CORPORATION | CORPORATION | EXHIBIT | |-------------------------|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|---------| | Filter | Polyurethane foam, K329,<br>Supplier: Sanchian | Polyurethane foam, K329,<br>Supplier: Sanchian | | | Top Cover | Polycardbonate L-1225Y,<br>Supplier: Teijin Chemicals Ltd. | Polypropylene Resin Profax,<br>6331, Supplier: TAIWAN<br>POLYPROPYLENE CO., LTD. | | | Nebulization<br>Chamber | Polycardbonate L-1225Y,<br>Supplier: Teijin Chemicals Ltd. | Polypropylene Resin Profax,<br>6331, Supplier: TAIWAN<br>POLYPROPYLENE CO., LTD. | | | Air-Flow Chamber | Polycardbonate L-1225Y,<br>Supplier: Teijin Chemicals Ltd. | N/A | | | Drug Ampoule | Polyehtylene Terphthalate,<br>A-PET, Supplier: Dong Guan<br>Sen Yuan Environmental<br>Plastic Co., Ltd. | Polypropylene Resin Profax,<br>6331, Supplier: TAIWAN<br>POLYPROPYLENE CO., LTD. | | | Mouth piece | Polycardbonate L-1225Y,<br>Supplier: Teijin Chemicals Ltd. | Polypropylene Resin Profax,<br>6331, Supplier: TAIWAN<br>POLYPROPYLENE CO., LTD. | | | Mask | PVC Compound 65PHR,<br>Supplier:Jieh-Ming Plastics Mfg<br>Co., Ltd. | PVC Compound 65PHR,<br>Supplier:Jieh-Ming Plastics Mfg<br>Co., Ltd. | | | Characteristics | K-jump Device<br>(Subject Device) | ULTRANEB, Bremed Italia s.r.l.,<br>K#974379 | |-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | Model No. | KN-9210 | ULTRANEB | | Nebulization Type | Ultrasonic | Ultrasonic | | Dimension | 85X56X130mm<br>(3.35"X2.20"X5.12") | 83X50X110mm<br>(3.27"X1.97"X4.33") | | Weight | 0.437 lbs. (198g) | 0.463 lbs. (210g) | | Electrical<br>Requirements | 100-240 V/15VDC (with<br>AC/DC switching<br>adapter)50/60Hz, or 12 VDC<br>Rechargeable<br>battery(optional), or Car<br>connection cable (optional) | 100-240 V/15VDC (with AC/DC<br>switching adapter)50/60Hz, or 12<br>VDC Rechargeable<br>battery(optional), or Car<br>connection.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 on<br>mouthpiece | 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 | . · . · ' ・・・・・・ . . : {3}------------------------------------------------ # 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 {4}------------------------------------------------ #### 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. {5}------------------------------------------------ #### 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 {6}------------------------------------------------ ## 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: 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. 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)