F10

{0}------------------------------------------------ # JUN 2 4 2011 510(k) Submission - F10 ## 510(k) Summary of Safety and Effectiveness This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. ### Submitter Mediana Co., Ltd. Dongwha Medical Instrument Complex, 1650-1, Donghwa-ri, Munmak-eup, Wonju-si, Gangwon-do, Korea Tel) +82-70-7092-9964 Fax) +82-2-542-7447 Company Contact: Amy M.H. Kim Date Summary Prepared: October 26, 2010 #### Device Name | Trade Name: | F10 Fetal Doppler | |----------------------|--------------------------------------------------| | Common Name: | Monitor, Ultrasonic, Fetal | | Classification Name: | Monitor, Ultrasonic, Fetal (21CFR 884.2660, KNG) | | Classification: | Class 2 | #### Predicate Device (Legally Marketed Devices) The predicate devices for Fetal Doppler, Model F10 are: - 0 Edan Instruments, Inc. Ultrasonic Pocket Doppler, Sonotrax cleared by FDA through 510(k) No. K040480 (Decision Date - May. 25. 2004), and - 0 Bistos Co., Ltd. Ultrasonic Pocket Doppler, BT-200 cleared by FDA through 510(k) No. K05219 (Decision Date - Oct. 4. 2005) #### Device Description F10 is a pocket-size fetal Doppler that measures the fetal heat rate and outputs the fetal heart sound through built-in speaker. By measuring fetal heart rate(FHR), you are able to predict fetal well-being. F10 irradiates fetal wave to the abdomen of a pregnant woman to detect the Doppler frequency signal and analyze, and displays the heart rate on LCD screen. The device also provides the heart sound from the heart of fetus {1}------------------------------------------------ #### Indications for Use The F10 Fetal Doppler measures heart rate, which is displayed on a LCD display and provides fetal heart sounds. The fetal heart rate is measured using Doppler ultrasound. #### Comparison with predicate device Mediana Co., Ltd. believes that the F10 Fetal Doppler is substantially equivalent to the Sonotrax of Edan Instruments, Inc. and BT-200 of Bistos Co., Ltd. The F10 Fetal Monitors described in this 510(k) submissions has the same intended use and similar technical characteristics as the Sonotrax of Edan Instruments, Inc., and the BT-200 of Bistos Co., Ltd.. - The similarities are as below; 'Mode of operation', 'System characteristics', 'FHR Monitoring', 'Transducer Type', 'Ultrasound Frequency', 'FHR Detection Method', 'FHR Range', 'Display method', and 'Intended use', etc. - The differences are as below; 'Ultrasound Frequency' - Ultrasound frequency has a little difference. But there is not a difference to basic function. 'Battery type, voltage and life' – Battery type, voltage and life have a little difference. But it has not effect on efficiency, effectiveness and safety. #### Safety, EMC and Performance Data Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All test results were satisfactory. #### Conclusions In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Mediana Co., Ltd. concludes that F10 are safe and effective and substantially equivalent to predicate devices as described herein. Mediana Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA. 12-A1-2 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 Mediana Co., LTD. % Mr. Marc M. Mouser Engineering Leader & FDA Office Coordinator, Program Reviewer Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607 JUN 2 4 2011 Re: KI10630 > Trade Name: F-10 Fetal Doppler Regulation Number: 21 CFR §884.2660 Regulation Name: Fetal Ultrasonic monitor and accessories Regulatory Class: II Product Code: KNG Dated: June 16, 2011 Received: June 16, 2011 Dear Mr. Mouser: 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). and Cosmetic For (110) that be 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. Please be advised that FDA's issuance of a substantial equivalence determination does not mean I hat 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 of any I outstar of and regulations, but not limited to: registration and listing (21 CFR Part with an the s requirements) in medical device reporting (reporting of medical device-related {3}------------------------------------------------ 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/ReportalProblem/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/Resourcesfor You/Industry/default:htm. Sincerely yours, Hubert Lenoir MD Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health. Enclosure {4}------------------------------------------------ ## Indications for Use KI10630 510(k) Number (if known): Device Name: __ F10 Fetal Doppler Indications for Use: The F10 Fetal Doppler measures heart rate, which is displayed on a LCD display and provides fetal heart sounds. The fetal heart rate is measured using Doppler ultrasound. X Prescription Use (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) Helene Kenny rision Sign-Off) ductive, Gastro-Renal, and {5}------------------------------------------------ ## F10 Fetal Doppler ## 510(k) Submission # K110630 Appendix F # Diagnostic Ultrasound Indications For Use Form Fill out one form for each ultrasound system and each transducer. ## 2MHz PW DOPPLER FETAL PROBE – MODEL : F10 Intended use : Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(Specify) | |----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | Ophthalmic | | | | | | | | | | | | Fetal | | | | | N | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative<br>(specify) | | | | | | | | | | | | Intraoperative | | | | | | | | | | | | Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ<br>(specify) | | | | | | | | | | | | Neonatal | | | | | | | | | | | | Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Pheperial | | | | | | | | | | | | Vascular | | | | | | | | | | | | Lapaloscopic | | | | | | | | | | | | Musculo-skeletal<br>Conventional | | | | | | | | | | | | Musculo-skeletal<br>Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N=new indication; P=previously cleared by FDA; E=added under Appendix E Additional Comments : (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation(ODE) Prescription Use(Per 21 CFR 801.109) Division Sign-Off ion of Reproductive. Gastro-Renal, and 510(k) Number