FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO

{0}------------------------------------------------ #### KD-7902BTJ, KD-7963NJ and KD-7971J Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files # 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92. #### 1.0 submitter's information Name: Address: Andon Health Co., Ltd. Phone number: Fax number: Contact: Date of Application: No 3, Jinping Street Ya An Road, Nankai District, Tianjin, P.R. China 86-22-6052 6161 86-22-6052 6162 Liu Yi 06/20/2011 #### 2.0 Device information Device name (1) KD-7902BTJ Fully Automatic Electronic Blood Pressure Monitor (2) KD-7963NJ Fully Automatic Electronic Blood Pressure Monitor (3) KD-7971J Fully Automatic Electronic Blood Pressure Monitor (4) KD-7966 Fully Automatic Electronic Blood Pressure Monitor #### 3.0 Classification Production code: DXN- Noninvasive blood pressure measurement system. Regulation number: 870.1130 Classification: ll Panel: Cardiovascular #### 4.0 Predicate device information | 1. Manufacturer: | Andon Health Co., Ltd. | |------------------|--------------------------------------------------------------| | Device: | KD-7971 Fully Automatic Electronic Blood Pressure<br>Monitor | #### ર- I {1}------------------------------------------------ KD-7902BTJ, KD-7963NJ and KD-7971J Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files | | 510(k) number: | K093452 | |---|----------------|--------------------------------------------------------------| | | Manufacturer: | Andon Health Co., Ltd. | | 2 | Device: | KD-7964 Fully Automatic Electronic Blood Pressure<br>Monitor | | | 510(k) number: | K102906 | #### 5.0 Device description KD-7902BTJ, KD-7963NJ, KD-7971J and KD-7966 Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and are non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 14cm-25cm. It is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers: The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. If any irregular heartbeat is detected, it can also be shown on the LCD. More over, it also calculates the average of the last three measurements. #### 6.0 Intended use KD-7902BTJ, KD-7963NJ, KD-7971J and KD-7966 Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and are non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 14cm-25cm. The intended use and the indication for use of KD-7902BTJ, KD-7963NJ, KD-7971J and KD-7966, as described in the labeling are the same as their predicated device KD-7971. {2}------------------------------------------------ 3/4 ### 7.0 Summary comparing technological characteristics with predicate device | Technological Characteristics | Comparison result | |-------------------------------|-------------------| | Design principle | Identical | | Appearance | Similar | | Patients contact Materials | Identical | | Performance | Similar | | Biocompatibility | Identical | | Mechanical safety | Identical | | Energy source | Identical | | Standards met | Identical | | Electrical safety | Identical | | EMC | Identical | | Function | Similar | #### 8.0 Discussion of non-clinical and clinical test performed #### Non-clinical Tests have been done as follows: a. Electromagnetic compatibility evaluation according to IEC 60601-1-2; - b. Electrical safety test according test to IEC 60601-1 ; - c. Safety and performance characteristics of the test according to SP10 None of the test demonstrates that KD-7902BTJ, KD-7963NJ, KD-7971J and KD-7966 bring new questions of safety and effectiveness. #### Clinical Test Concerning the Compliance of ANSI/AAMI SP10 From the technical point of view, the subject device KD-7902BTJ, KD-7963NJ, KD-7971J and KD-7966 are identical to their predicate device KD-7971. The difference between the subject devices and their predicate device do not affect the clinical accuracy in terms of blood pressure detection. The clinical test report of KD-7971(K093452) is applicable to our subject device. {3}------------------------------------------------ 4/4 #### 9.0 Performance summary KD-7902BTJ, KD-7963NJ, KD-7971J and KD-7966 Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards: - IEC 60601-1. Medical Electrical Equipment Part 1: General . Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995. - EN 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, 2007. - AAMI SP10:2002, Manual, electronic or automated sphygmomanometers. - AAMI / ANSI SP10:2002/A1:2003 -- Amendment 1 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers. - AAMI / ANSI SP10:2002/A2:2006 --, Amendment 2 to ANSI/AAMI � SP10:2002 Manual, electronic, or automated sphygmomanometers. #### Comparison to the predicate device and the conclusion 10.0 Our device KD-7902BTJ, KD-7963NJ, KD-7971J and KD-7966 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-7971 whose 510(k) number is K093452. KD-7902BTJ, KD-7963NJ, KD-7971J and KD-7966 are very similar with their predicate device in the intended use, the design principle, the material, the performance and the applicable standards. The main modification for the four new subject device is the appearance; except that, KD-7902BTJ, KD-7963NJ and KD-7971J use the JNC hypertension classification while their predicate devices KD-7971 and KD-7964 use the WHO hypertension classification. However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness to the new devices. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002 DEC - 9 2011 Andon Health Co., Ltd. c/o Ms. M. Elizabeth Bierman Morgan, Lewis & Bockius LLP 1111 Pennsylvania Avenue, NW Washington, DC 20004 K111830 Re: RT11030 Trade/Device Name: Fully Automatic Electronic Blood Pressure Monitor with models: KD-7902BTJ, KD-7963NJ, KD-7971J and KD-7966 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (Two) Product Code: DXN Dated: November 14, 2011 Received: November 15, 2011 Dear Ms. Bierman: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave ro roved your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the energours) to regardy the Medical Device Amendments, or to connered pror co may 2011/03/2017 accordance with the provisions of the Federal Food, Drug, de rices mat have been roomstilled require approval of a premarket approval application (PMA). and Cosmetic Fere, market the device, subject to the general controls provisions of the Act. The r ou may, merelory mans of the Act include requirements for annual registration, listing of general controls provinciting 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), 11 your device is classified (600 a00 10) is existing major regulations affecting your device can be it may be subject to adultional controllations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {5}------------------------------------------------ Page 2 - Ms. M. Elizabeth Bierman 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); medical device reporting (reporting of medical device-related 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/ReportaProblem/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, Bran D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation . Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## Statement of Indications for Use K111830 510(k) Number : KD-7902BTJ, KD-7963NJ, KD-7971J and KD-7966 Device name: Fully Automatic Electronic Blood Pressure Monitor #### Indications for use: . KD-7902BTJ, KD-7963NJ, KD-7971J and KD-7966 Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and are non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 14cm-25cm. · Prescription use Part 21 CFR 801 Subpart D) Over-The-Counter Use YES AND/OR (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH &ffice of Device Evaluation (ODE) (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number R 111830 Page 1 of 4-1