This document summarizes a 510(k) submission for two fully automatic electronic blood pressure monitors, models KD-512 and KD-712, manufactured by Andon Health Co., Ltd. The submission provides device descriptions, intended use, comparison to predicate devices including design, technology and performance, and concludes the devices are substantially equivalent to legally marketed predicates. The monitors are intended to non-invasively measure blood pressure and pulse using an inflatable cuff on the upper arm or wrist and were determined to be substantially equivalent to predicate devices.
This document summarizes a 510(k) submission for two fully automatic electronic blood pressure monitors, models KD-512 and KD-712, manufactured by Andon Health Co., Ltd. The submission provides device descriptions, intended use, comparison to predicate devices including design, technology and performance, and concludes the devices are substantially equivalent to legally marketed predicates. The monitors are intended to non-invasively measure blood pressure and pulse using an inflatable cuff on the upper arm or wrist and were determined to be substantially equivalent to predicate devices.
This document summarizes a 510(k) submission for two fully automatic electronic blood pressure monitors, models KD-512 and KD-712, manufactured by Andon Health Co., Ltd. The submission provides device descriptions, intended use, comparison to predicate devices including design, technology and performance, and concludes the devices are substantially equivalent to legally marketed predicates. The monitors are intended to non-invasively measure blood pressure and pulse using an inflatable cuff on the upper arm or wrist and were determined to be substantially equivalent to predicate devices.
This document summarizes a 510(k) submission for two fully automatic electronic blood pressure monitors, models KD-512 and KD-712, manufactured by Andon Health Co., Ltd. The submission provides device descriptions, intended use, comparison to predicate devices including design, technology and performance, and concludes the devices are substantially equivalent to legally marketed predicates. The monitors are intended to non-invasively measure blood pressure and pulse using an inflatable cuff on the upper arm or wrist and were determined to be substantially equivalent to predicate devices.
c0ozT¼ 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 NOV"' ;' 3 201Th.
Name: Andon Health Co., Ltd.
Address: No 3, Jinping Street Ya An Road, Nankai District, Tianjin, P.R. China Phone number: 86-22-6052 6161 Fax number: 86-22-6052 6162 Contact: Liu Yi Date of Application: 09/27/20 10
5- I KD-512 and KD-712 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files
)C IO2P
5.0 Device description
KD-512 Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and is a 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 upper arm. The cuff circumference is limited to 22cm-48cm.
KD-712 Fully Automatic Electronic Blood Pressure Monitor is for use by
medical professionals or at home and is a 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 l4cm-25cm.
It is designed and manufactured according to ANSI/AAMI SP1O--manual,
electronic or automated sphygmanomneters.
The operational principle is based on oscillomnetric and silicon integrate
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-512 Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and is a 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 upper arm. The cuff circumference is limited to 22cm-48cm.
KD-712 Fully Automatic Electronic Blood Pressure Monitor is for use by
medical professionals or at home and is a 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 l4cm-25cm.
The intended use and the indication for use of KD-512, as described in the
5- 2 KD-5l2 and KD-712 Fully Automatic Electronic Blood Pressure Monitor FDA5iO(k) Files iI o)zcr-~a
labeling are the same as their predicated device KD-556. While the intended use and the indication for use of KD-712 is the same as its predicated devices KID-735.
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 EMVC Identical Function Similar
5- 3 KD-5 12 and KD-7 12 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files
8.0 Performance summaryI'
KD-512 and KD-712 Fully Automatic Electronic Blood Pressure Monitor
conforms to the following standards: * lEG 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 SP1O0:2002, Manual, electronic or automated sphygmomanometers. * AAMI I ANSI SP10:2002/A1:2003 --, Amendment 1 to ANSIIAAMI SP1O0:2002 Manual, electronic, or automated sphygmomanometers. * AAMI I ANSI SP10:2002/A2:2006 -- , Amendment 2 to ANSIIAAMI SP1O:2002 Manual, electronic, or automated sphygmomanometers.
9.0 Comparison to the predicate device and the conclusion
Our device KD-512 Fully Automatic Electronic Blood Pressure Monitor is
substantially equivalent to. the Fully Automatic Electronic Blood Pressure Monitor KD-556 whose 510(k) number is K090963. And KD-712 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-738 whose 510(k) number is K092045.
KD-512 is very similar with its predicate device in the intended use, the design principle, the material, the performance and the applicable standards. Only their appearance, the memory time, the display information and the averaging measurement function are different.
KD-712 is very similar with the predicate device KD-738 in the intended use, the design principle, the material, the performance and the applicable standards. Only their appearance, the memory time and the display information are different.
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.
5. 4 DEPARTMENT OF HEALTH & HUMAN SERVICES Publ IcHealth Ser vice
C/O Mr. Liu Yi, President No. 3 Jinping Street Ya'an Road Nankai District, Tianjin 300190 NOV 3 2010h China
Re: K 102930 Trade/Device Name: Fully Automatic Electronic Blood Pressure Monitor, Models: KD-5 12, KD-712 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: Not Dated Received: October 4, 201 0
Dear Mr. Yi:
We have reviewed your Section 5 10(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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind y'ou, 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 Ill (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. Jn 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 Page 2 - Mr. Liui Yi
comply wvith 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 mtanufacturing 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 53 1-542 of the Act); 21 CFR 1000- 1050.
If you desire specific advice for your device on our labeling regulation (21 CER Part 801), please go to http://www~N.fda.gov/AboutFDA/CenitersOffices/CD R.lIC DRI-IOffitces/ucnm 115 809.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 preimarket notification" (2ICFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CER Part 803), please go to http://www.fda. gov/MedicalDevices/Safetv/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) 796-71 00 or at its Internet address hittp://www.fda. pov/MedicalDevices/ResourcesforYou/Industrv/defauilt.htm.
Sincerely yours
Bra DZuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure KD-512 and KD-712 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files
Statement of Indications for Use NOV - 3 2010
510(k) Number: ________
Device name: KD-512 and KD-712 Fully Automatic Electronic Blood
Pressure Monitor
Indications for use:
KD-512 Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and is a 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 upper arm. The cuff circumference is limited to 22cm-48cm.
KD-712 Fully Automatic Electronic Blood Pressure Monitor is for use by
medical professionals or at home and is a 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 l4cm-25cm.
Prescription use ______ AND/OR Over-The-Counter Use YES
Part 21 CFR 801 Subpart 0) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON
ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Oft)g o Division of Cardiovascular DevicesPaeIoI
