MULTIFUNCTION KEITO K5

{0}------------------------------------------------ JAN 1 8 2000 K981/083 Multifunction K5 Bumedco International Inc. 510(k) Premarket Notification Appendix VIII. 510(k) Summary of Safety and Effectiveness Data Page 1 of 2 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA ### I. General Information | A. | Submitted By: | Bumedco International Inc. | |----|----------------------|------------------------------------------------| | | | 725 Timber Lane | | | | Shoreview, MN 55126 | | | Tel: | (612) 787-0625 | | | Fax: | (612) 765-0186 | | | Contact Person: | Darrold L. Glanville | | B. | Device Trade Name: | Multifunction K5 | | | Common Name: | Blood Pressure Monitoring System | | | Classification Name: | Non-invasive Blood-Pressure Measurement System | | C. | Predicate Device: | Omron Portable Wrist Blood Pressure Kit, | | | | Model HEM-608 | #### D. Device Description: The Multifunction KEITO K5 (K5) is designed to provide the user with measurements of blood pressure, height, and weight, as well as to calculate the Body Mass Index (BMI) and pulse rate. The user is prompted to select a measurement cycle, step onto the K5 platform, and wait momentarily while the measurements and calculations are performed. After the measurements have been taken, the K5 provides the user with the results. Vita-Stat Model 8000-C To operate the K5 the user inserts a coin into the coin slot, and steps onto the platform. The user has the option of selecting a partial measuring cycle or a complete cycle. In a partial cycle, weight and height measurements are taken and Body Mass Index calculations are performed in the partial cycle. In a complete cycle, weight, height, blood pressure, and pulse measurements are taken. Body Mass Index is calculated and the W.H.O. blood pressure recommendations are provided. The K5 prints out a ticket containing the results {1}------------------------------------------------ of the measurements and the recommended ranges for both BMI and blood pressure. - E. Indications for Use: The Multifunction KEITO K5 is intended to measure height, weight, and blood pressure and to calculate pulse rate. - F. Technological Comparison: The Multifunction KEITO K5, Vita-Stat Model 8000-C and the Omron Portable Wrist Blood Pressure Monitor have the same type of measurement method as well as provide systolic, diastolic, and pulse measurements. ## II. Testing The pressure system was tested by Physikalisch-Technische Bundesanstalt, to verify the accuracy of the pressure system as compared to a manual sphygmomanometer in accordance with the German's regulations for clinical testing of blood pressure systems (BGBI.IS. 759,771 and 1667). The results were evaluated in accordance with the acceptance requirements of the regulation (BGBI.IS.759,771 and 1667) and found to be acceptable. Additional testing was conducted to determine the correct user height compensation for the K5. The procedure involved testing multiple users of different heights, ages and sex with a manual sphygmomanometer and the K5. The results were computed using statistical methodologies. Based on the results, a formula was developed to compensate for user height during wrist cuff blood pressure measurements. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 1 8 2000 Darrold Glanville President Bumedco International, Inc. 725 Timber Lane Shoreview, Minnesota 55126 K984083 Re: Trade Name: Multifunction Keito K5, Non-Invasive Blood Pressure System Regulatory Class: II (two) Product Code: DXN Dated: November 5, 1999 November 8, 1999 Received: Dear Mr. Glanville: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such Existing major regulations affecting your device additional controls. can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ ## Page 2 - Mr. Darrold Glanville This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Soff. Sore R. Samperlee Celia M. Witten, Ph.D., Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # INDICATIONS FOR USE STATEMENT 510(k) Number (if known): Device Name: Multifunction KEITO K5 Bumedco International Inc. Sponsor Name: # Indications for Use The Multifunction KEITO K5 is intended to be used by adults in order to measure height, weight, systolic and diastolic blood pressures, and to calculate pulse rate. Beue Q. Bamperski (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number 1< 984083 ## Do Not Write Below This Line - Continue on Another Page if Needed Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use