SERENO ELECTRONIC STETHOSCOPE

{0}------------------------------------------------ K062481 # OCT 16 2006 ## EXHIBIT 2 510(k) Summary Pishon High Tech Co., Ltd 2nd Floor, Moeller building 403-1, Daebang-dong, Dongjak-gu, Seoul, 156-020, Korea Phone: 82-2-826-1750 Fax: 82-2-826-1724 #### July 12, 2006 Contact: Y.Y. Park, Managing Director - l . Identification of the Device: Proprietary-Trade Name: SERENO Electronic Stethoscope Classification Name: Electronic Stethoscope, Product code DQD Common/Usual Name: Electronic Stethoscope - 2. Equivalent legally marketed devices 3M™ Littmann™ Electronic Stethoscope (K003723), JABES Electronic stethoscope (k031446) - 3. Indications for Use (intended use) The SERENO Electronic Stethoscope is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment. - 4. Description of the Device: The SERENO electronic stethoscope is intended for use as a diagnostic aid in patient diagnosis and monitoring. The SERENO electronic stethoscope amplifies sounds up to 20 times bigger than ordinary acoustic stethoscope in a broad frequency range including a range higher than the traditional diaphragm mode. It looks similar to the traditional stethoscope including parts like a probe head, binaural pipes and ear tips. It has four (4) buttons on the top of the chest set (opposite to the probe). Each of the buttons has a function of controlling the modes, volume up/down and power on/off. As an electronic stethoscope, it needs two (2) batteries (AAA type, 1.5V) to operate. The stethoscope has automatic power off function for longer battery life and has a LCD display to show volume level, frequency mode and low battery indicator. With the enclosed audio cable. utilizing a personal computer, the user can store sound signals in the PC and transmit diagnosis data via e-mail. This stethoscope is a stand-alone unit, has no software and operates using an analog audio system with a digital timer for power saving and a digital control for the volume and the filter mode selection. It can be connected to audio input of a sound card in a computer to use the PC software functions. However, the software does not operate nor control the stethoscope in any manner. In fact, the stethoscope's audio output can be connected to any ordinary audio equipment such as a cassette recorder, a hi-fi audio component and portable audio.. - Safety and Effectiveness, comparison to predicate device. The results of bench and user 5. testing indicates that the new device is as safe and effective as the predicate devices. Page 1 of 2 Page 8 of 168 {1}------------------------------------------------ | | Predicate Devices | | New Device | |------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------| | Device name | 3M Littmann Electronic<br>stethoscope,<br>Model 4000(K003723) | JABES electronic<br>stethoscope (K031446) | SERENO electronic<br>stethoscope | | Classification<br>Name | Electronic Stethoscope | Electronic Stethoscope | Electronic Stethoscope | | Applicant | 3M | GS Technology Co., Ltd | Pishon High Tech Co.,<br>Ltd | | Frequency<br>Response Mode | Bell(20-200Hz),<br>Diaphragm(100-500Hz)<br>Extended range:<br>(20-1,000Hz) | Bell(20-500Hz),<br>Diaphragm(200-800Hz)<br>Extended range:<br>(20-1,000Hz) | Bell(20-450Hz),<br>Diaphragm(200-1,200Hz)<br>Extended range:<br>(20-1,500Hz) | | Amplification | Up to 18times<br>amplification | Up to 18times<br>amplification | Up to 20 times<br>amplification | | Display heart rate | Yes | No | No | | Permits data<br>transfer of stored<br>digital signal to<br>IBM-Compatible PC | Yes | No | No | | Volume control | 8 Steps Volume control | 12 Steps Volume control | 12 Steps Volume control | | Energy source | Two(2) AAA alkaline<br>batteries | Two(2) AAA alkaline<br>batteries | Two(2) AAA alkaline<br>batteries | | Manual<br>On/Off button<br>Automatic shut-off<br>by electronics | Yes | Yes | Yes | | Low Battery<br>Indicator | Yes | Yes | Yes | #### Substantial Equivalence Chart 6. ### 7. Conclusion After analyzing bench, electrical safety, EMC, and user testing data, it is the conclusion of Pishon High Tech Co., Ltd., that the SERENO Electronic is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device. Page 2 of 3 Page 9 of 168 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a circular seal or logo. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged around the top half of the circle. Inside the circle is a stylized graphic consisting of three curved, parallel lines that resemble a stylized human figure or symbol. The image is in black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # OCT 16 2006 Pishon High Tech Co., LTD c/o Mr. Daniel Kamm, P.E. Regulatory Engineer PO Box 7007 Deerfield, IL 60015 Re: K062481 Trade Name: Sereno Electronic Stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: August 22, 2006 Received: August 24, 2006 Dear Mr. Kamm: 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 such 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. {3}------------------------------------------------ # Page 2 – Mr. Daniel Kamm Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be determination that your device complies with other requirements of the Act that I DA has made a covernes administered by other Federal agencies. You must comply or any I case in states and result ing, but not limited to: registration and listing (21 CFR Part with an the Ace I requirements, associations practice requirements as set forth in the 807); adoning (21 CFR Part 820); and if applicable, the electronic product quality of Sections (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) I ms leter will and in your of substantial equivalence of your device to a legally premaince notificate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please in Joan the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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, Bfommmar for Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): KOW2481 Device Name: Electronic stethoscope (Model: SERENO) Indications for Use: The SERENO Electronic Stethoscope is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment. 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) Blummenstons 510/kl Nu Page 1 of 1