DM-3000 DIGITAL BLOOD PRESSURE MONITOR

{0}------------------------------------------------ K061086 AUG 1 0 2006 ## SAFETY & EFFECTIVENESS DATA SUMMARY Submitters Name, Address & Phone Number: Nihon Seimitsu Sokki., Co., Ltd. (Nissei) 2508-13, Nakago,Komochi-Mura Kitagunma-Gun, Gunma-Ken 377-0293,Japan +81-0279-20-2311 Submission Correspondent: Lyle Howard Corporation 106 East 5th Avenue Mount Dora, FL 32757 USA Attention: Lynette Howard 908-788-4580 Classification Name: Common / Usual Name: Proprietary Name: Noninvasive Blood Pressure Monitor Blood Pressure Monitor Model DM-3000 Digital Blood Pressure Monitor Establishment Registration Number: 9610827 Classification: Class II, Reg. # 870.1130, DXN, Cardiovascular Devices Panel Performance Standard: Section 898 and 1010 of the Federal Food, Drug and Cosmetic Act ### Substantial Equivalence: The legally marketed device to which substantial will demonstrated is the Nissei Model DM-3000 Digital Blood Pressure Monitor. This device was cleared for marking under 510(k) No.K993890, SE decision December 3, 1999. The subject device is essentially an updating of the predicate device. As can be seen in Appendix P, many of the features and performance specifications are identical. Note particularly that both systems contain a built-in air pump for automatic cuff inflation, have the same measurement accuracy for both blood pressure and pulse rate. {1}------------------------------------------------ The principal differences are that the bar LCD to demonstrate mercury-column-like pressure flow is added to the new DM-3000 besides the segmental LCD to display pressure in a digital value as the predicate device and that optional function was added to switch the instrument to a pressure gauge with which inflation and deflation of the cuff is done automatically but the determination of blood pressure is made by a physician using a stethoscope. The setting of preset pressure and, for manual measurement, the setting of deflation rate, which the predicate device did not have, is also added to the subject device. Because the difference between the subject device and the predicate device represent functional improvements that have been evaluated though both bench testing and clinical evaluation, it is clear that these changes raise no new questions with respect to either safety or effectiveness. # Testing conducted or standards applied to assure safety and effectiveness includes but is not limited to: Clinical Performance and Accuracy: ANSI/AAMI Standard SP10-1992, Electronic or Automated Sphygmomanometers. Electromagnetic Compatibility: IEC 60601-2, 2001 with test procedures according to IEC 61000-4-2, 2001; IEC 61000-4-3, 2001, IEC 61004-4, 2001 with Amendment 1, 2000 and Amendment 2, 2001; IEC 61004-6, 2001; IEC61004-4-8, 2001; IEC 61000-4-11, 2001. Electromagnetic Interference: IEC 60601-1-2, 2001. #### Description of the new device: The Model DM-3000 Digital Blood Pressure Monitor is an automatic sphygmomanometer intended for measurement of systolic and diastolic blood pressures and pulse rate in adult patients under the supervision of a physician. Blood pressure is measured in the brachial artery using an arm cuff of the appropriate size. The unit includes air pumps for automatic cuff inflation, electric valves, button controls, circuitry to detect and process minute pressure oscillations, a bar LCD to display mercury-column-like pressure flow and a segment LCD to display blood pressure and pulse rate as a digital value and operation indications such as inflation, measurement error and battery error. Measurement can be made either automatically, where entire operation including inflation and deflation of the cuff and determination of blood pressures and pulse rate is automatically done, or {2}------------------------------------------------ K06:036 . : : manually, where only inflation and deflation of the cuff are automatically done but determination of the blood pressures is done by a physician using a stethoscope. The unit saves the last reading in its memory circuit. The system is powered by the AC adaptor or the rechargeable nickel battery. : : , {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 0 2006 LDR Spine USA % Mr. James W. Burrows Director of Clinical Marketing 4030 West Braker Lane, Suite 360 Austin, Texas 78759 Re: K061017 Trade Name: Easyspine® System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH Dated: July 19, 2006 Received: July 20, 2006 Dear Mr. Burrows: 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. 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); 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. {4}------------------------------------------------ ### Page 2 - Ms. Elizabeth A. Rosenfeld 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 contact 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, Bfummma for Bram D. Zuckerman, M.D. Director, Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Appendix C Revision 6 July 2006 510(K) Number: K061086 Model DM-3000 Digital Blood Pressure Monitor Device Name : Indications For Use : The DM-3000 system is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adolescents (age 12 to 21 years) adult patients, i.e., age 21 and above and is intended to be operated by physicians or under supervision of a physician. Prescription Use______________________________________________________________________________________________________________________________________________________________ Over-The Counter Use _________________________________________________________________________________________________________________________________________________________ AND / OR (21 CFR 807 Subpart C) (Per 21 CFR 801.109 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Bhumlama evices