DDI ULTRASONIC NEBULIZER SYSTEM

{0}------------------------------------------------ K090307 # 510(k) Summary 807.92(c) JUN 18 2009 # SPONSOR 807.92(a)(1) Company Name: Company Address Diagnostic Devices Inc. 93030 Harris Corner Parkway Suite 450 Charlotte, NC 28269 Telephone: Fax: 704-285-6400 704-285-6475 Rick Admani Contact Person: Summary Preparation Date: February 5, 2008 ## DEVICE NAME Trade Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class: DDI Ultrasonic Nebulizer System Nebulizer Nebulizer (Direct Patient Interface) CFR21 868,5360 CAF Class II ## PREDICATE DEVICE ## 807.92(a)(3) 807.92(a)(4) Legally Marketed Equivalent Device 510(k) # Product Company Micro Air Vibrating Mesh Nebulizer K062263 Omron Healthcare Inc. Ultrasonic Nebulizer System Model HL 100 K081738 Health & Life Co., Ltd. #### DEVICE DESCRIPTION The DDI Ultrasonic Nebulizer System is a mesh screen ultrasonic nebulizer that operates in an identical fashion as other mesh screen nebulizers. The device creates aerosols of liquid medication by ejection of droplets from a mesh vibrated at ultrasonic frequencies and provide fine particles to the patient's lungs. The DDI Ultrasonic Nebulizer System is powered by a cable connecting to a 115 VAC power source with the AC adapter or two AA alkaline batteries. # DEVICE INTENDED USE ## 807.92(a)(5) Indicated Use: The DDI Ultrasonic Nebulizer System is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. ## 807.92(a)(2) {1}------------------------------------------------ # Patient Population: The device may be used with pediatric and adult patients in the home, hospital, and sub-acute care settings. Environment of Use: Home, hospital, and sub-acute care Contraindications: None ## COMPARISON OF TECHNICAL CHARACTERISTICS 807,92(a)(6) | Parameters | New Device | Predicate Device | Predicate Device | |--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | DDI Ultrasonic Nebulizer System | Health & Life Co.<br>Ultrasonic Nebulizer System<br>Model HL 100 | Omron Micro-Air<br>Vibrating Mesh Nebulizer | | 510(k) Number | N/A | K081738 | K062263 | | Indented Use<br>Statement | The DDI Ultrasonic<br>Nebulizer System is an<br>ultrasonic (vibrating mesh)<br>nebulizer system designed<br>to aerosolize medications<br>for inhalation by the patient. | The Ultrasonic Nebulizer<br>System is an ultrasonic<br>(vibrating mesh) nebulizer<br>system designed to aerosolize<br>medications for inhalation by<br>the patient. | The Ultrasonic Nebulizer<br>System is an ultrasonic<br>(vibrating mesh) nebulizer<br>system designed to<br>aerosolize medications for<br>inhalation by the patient | | Target<br>Population | Pediatric and adult | Pediatric and adult | Pediatric and adult | | Environment of<br>use | Home, hospital, sub-acute<br>care | Home, hospital, sub-acute care | Home, hospital, sub-acute<br>care | | Mode of Operation | | | | | Anatomical Site | Mouth | Mouth | Mouth | | Mode of<br>Operation | Ultrasonic | Ultrasonic | Ultrasonic | | Energy Type | Electricity | Electricity | Electricity | | Energy Source | 115 VAC or 2 AA<br>Alkaline batteries | 115 VAC or 2 AA Alkaline<br>batteries | 115 VAC or 2 AA Alkaline<br>batteries | | Battery Life | 4 Hours | 4 Hours | 4 Hours | | Aerosolization<br>Element | Metal Mesh | Metal mesh | Metal Mesh | | Nebulizing<br>method | Vibrating mesh | Vibrating mesh | Vibrating mesh | | Nebulization<br>rate | 0.2 ml/min | 0.2 ml/min | 0.25 ml/min | | Particle Size<br>(MMAD) | Approx 5 microns | Approx 5 microns | Approx 5 microns | | User Interface | | | | | Patient<br>Connector | Mouthpiece<br>Optional Mask | Mouthpiece<br>Optional Mask | Mouthpiece<br>Optional Mask | | Patient Interface | Hand-held | Hand-held | Hand-held | | Use | Single patient | Single patient | Single patient | | Physical Description | | | | | Dimensions (in | 4.3" x 2.2" x 1.7" | 4.3" x 2.2" x 1.7" | 4.1" x 2.1" x 1.5" | | Weight | 98 grams (Excluding<br>batteries) | 98 grams (Excluding batteries) | 97 | | Portable | Yes | Yes | Yes | | Reservoir (mL) | 8 ml maximum | 8 ml maximum | 7 ml maximum | | Ultrasonic | Yes | Yes | Yes | | Nebulizer | | | | | Nebulizer<br>components<br>cleanable | Yes | Yes | Yes | | Materials of Construction | | | | | Materials | Plastic and metal | Plastic and metal | Plastic and metal | 20 {2}------------------------------------------------ #### NONCLINICAL AND CLINICAL TEST 807.92(b) ## Electrical Safety The electrical performance of the DDI Ultrasonic Nebulizer System meets the requirements of the following standards: IEC 60601: 1988 + A1: 1991 + A2: 1996 EN 60601-1:1990 +A1: 1993 + A2: 1995 +A13: 1996 EN 60 601-1-2:2001 ## CONCLUSION ## 807.92(b)(3) The DDI Ultrasonic Nebulizer System and the predicate devices use a micro pore mesh vibrating at ultrasonic frequencies to produce aerosol. All of the performance parameters of the devices are statistically identical, and do not raise any new safety or efficacy. All devices are similar in: - Intended Use . - Materials ● - Design ● - Technological Characteristics . The DDI Ultrasonic Nebulizer System introduces no new questions concerning the safety or effectiveness and is thus 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 features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Public Health Service JUN 18 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Diagnostic Devices Incorporated C/O Mr. E. J. Smith Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114 Re: K090307 Trade/Device Name: DDI Ultrasonic Nebulizer System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: February 5, 2009 Received: March 20, 2009 Dear Mr. Smith: 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. {4}------------------------------------------------ ## Page 2 - Mr. Smith 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 yours, Susan Curre Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, 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: DDI Ultrasonic Nebulizer System Indications for Use: The DDI Ultrasonic Nebulizer System is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used with pediatric and adult patients in the home, hospital, and subacute care settings. Prescription Use ﺳﮯ (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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) L Schultz (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices le 510(k) Number: -04307 Page *_ of _*