DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400

{0}------------------------------------------------ 1- Submitter Name: K042014 page 1 of 2 ## 510(k) Summary As Required by 21 section 807.92 ( c ) Sein Electronics Co., Ltd - 2- Address: #506, U-chan Factopia, 196 Manan-Gu, Anyang-city, Kyunggi-do, Republic of Korea 3- Phone: (82) 31-421-0389 4- Fax: (82) 31-422-0821 5- Contact Person: Won-Ky Kim 6- Date summary prepared: July 20, 2004 7 - Official Correspondent: Mansour Consulting LLC 8- Address: 1308 Morningside Park Dr. Alpharetta, GA 30022 USA 9- Phone: 770-777-4146 10- Fax: 678-623-3765 11- Contact Person: Jay Mansour, President - - 12- Device Trade or Proprietary Name: Automatic Digital Blood Pressure Monitor (Model SE-9000), Manual Digital Blood Pressure Monitor (Model SE-9200), Full Auto Arm Digital Blood Pressure Monitor (Model SE-9400). - 13- Device Common or usual name: Digital Blood Pressure Monitor - 14- Device Classification Name: Non Invasive blood pressure measuring system - 15- Substantial Equivalency is claimed against the following device: 510K #K032927 Full Auto Arm Digital Blood Pressure Monitor, Model SE-7070, manufactured by Sein Electronics Co., Ltd. #### 16- Description of the Device: Digital Blood Pressure Monitors SE-9000, SE-9200 and SE-9400 are intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using arm cuff and oscillometric method of measurement. There are no contraindications; the subject device may be employed in the care of normotensive, hypertensive, or hypotensive patents. The user interface panels of SE-9200 and SE-9400 have power button, mode button, memory button and liquid crystal display ("LCD") except that SE-9000 has power button, mode/pressure button, memory button, start button. SE-9000, SE-9200 and SE-9400 have memory capacity to store the 140 most recent measurement results. The patient is responsible for applying the cuff, for initiating the measurements sequence by pressuring the "Power" button, and for recording results. The patient cannot alter bleed-down rate. All system functions are preprogrammed. The user is cautioned in the instruction manual against attempting any programming or other modification. No special training beyond basic ability to follow instruction is required. Since the products are designed for home use, detailed instructions on avoidance of practices that adversely affect the accuracy of measurements are included in the instruction manual. PAGE 9 {1}------------------------------------------------ KC042014 page 2 of 2 ### 17- Intended use of the device: (refer to FDA form attached) This device is an over the counter device, and its intended use is to measure systolic and diastolic pressure and pulse rate of adults by the individual, in a home care environment, using arm cuff and oscillometric method of measurement. #### 18- Safety and Effectiveness of the device: This device is safe and effective as the predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below) ## 14- Summary comparing technological characteristics with predicate device: Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Indeed, this device is SUBSTANTIALLY EQUIVALENT to the predicate device. Refer to the explanations/details within the main submission. | FDA file reference number | 510k # K032927 | |--------------------------------------------------|-------------------| | TECHNOLOGICAL CHARACTERISTICS | Comparison result | | Indications for use | Identical | | Target population | Identical | | Design | Similar | | Materials | Identical | | Performance | Identical | | Sterility | Not Applicable | | Biocompatibility | Identical | | Mechanical safety | Identical | | Chemical safety | Not Applicable | | Anatomical sites | Identical | | Human factors | Similar | | Energy used and/or delivered | Identical | | Compatibility with environment and other devices | Identical | | Where used | Identical | | Standards met | Identical | | Electrical safety | Identical | | Thermal safety | Identical | | Radiation safety | Not Applicable | Refer to the submission for more details. PAGE 10 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG - 6 2004 Sein Electronics Co., Ltd. c/o Jay Mansour, MSQA, BE, LA, RAC President Mansour Consulting LLC 1308 Morningside Park Drive Alpharetta, GA 30022 Re: K042014 Trade Name: Blood Pressure Monitor SE-9000, SE-9200 and SE-9400 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: July 20, 2004 Received: July 27, 2004 Dear Mr. Mansour: 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 – Jay Mansour, MSQA, BE, LA, RAC 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 (301) 594-4646. 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 may be obtained from the Division of Small Manufacturers, International and Consumer 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, Neil R.P. Ogden for Bram D. Zuckerman, M.D. 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): KOY2014 Device Name: Blood Pressure Monitor SE-9000, SE-9200 and SE-9400 Indications For Use: This device is an over the counter device, and is indicated for use to measure systolic and diastolic pressure and pulse rate of adults by the individual, in a home care environment, using arm cuff and oscillometric method of measurement. 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) Concurrence of CDRH, Office of Device Evaluation (ODE) Neil R.L. Ogden (Division Sign-Off) for BDZ Division of Cardiovascular Devices 510(k) Number K042014 Page Page 1 of PAGE 2 1