DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143

{0}------------------------------------------------ K092683 P1/4 SEP 2 5 2009 # Attachment 2 # 510k summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Section 807.92. The assigned 510(k) number is: ## A. General Information on submitter 1. Submitter's Name: 2. Address: SHANGHAI LITTLE DOCTOR ELECTRONIC CO., LTD. NO. 8, TONGXING ROAD. ECONOMIC AND TECHNOLOGICAL DEVELOPMENT DISTRICT, NANTONG CITY, JIANGSU PROVINCE, 226007, CHINA 3. Telephone: 4. Contact Person: 5. Date Prepared: 6. Registration Number: 7. Owner Number of Registration: ## B. General information of modified device 1. Name: 2. Trade Name: 3. Common Name: 4. Classification Name: 5. Product Code : 6. Class: II 7. Regulation Number: 08/15/2009 3005907323 9086965 Digital wrist BP monitor Digital wrist blood pressure monitor, model LD 1143 Electronic Sphygmomanometer 0086-513-8598 6718 Mr. Janusun Wang System, measurement, blood pressure, non-invasive DXN 870.1130 {1}------------------------------------------------ K092683 p2/4 ### C. Identification of FDA Cleared Devices(predicate) 1. Name: Digital wrist blood pressure monitor, model LD 8 2. K Number: K070825 3. Date Cleared: May 25, 2007 #### D. Description of the Device The Digital Wrist Blood Pressure Monitor, Model LD1143, is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual adult by using a non-invasive technique in which an inflatable wrist cuff is wrapped around the wrist. The method to define systolic and diastolic pressure is. similar to the auscultatory method but uses an electronic semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and to calculate pulse rate, which is a well-known technique in the market called the "oscillometric method". The device can analyze the signals promptly and display the results. The modified device has two new auxiliary features called WHO indication and date and time display. . #### E. Intended Use Statement LD1143 Fully Automatic Wrist Blood Pressure Monitor is intended for use by medical professionals in hospital or by patients for self monitoring at home to monitor and display diastolic, systolic blood pressure and pulse rate of adult, with the cuff around the wrist, which is same as predicate device. #### F. Comparisons to the predicate The modified device has the same intended use and identical fundamental scientific principle called oscillometric BP measurement method. It is identical in safety and effectiveness of the intended use to the 510(k) cleared device model L.D8. The modifications to our original 510(k) cleared device include dimensional specifications and adding new auxiliary features of WHO and date and time indication. The software codes of the modified device remains unchanged. The fundamental scientific technology of the modified device remains the same as that of the 510(k) cleared device. The modifications that were made are: 1. Appearance - 2. WHO blood pressure classification indication - 3. Change into 90 sets of memory recalls from 30 - 4. Date and time display {2}------------------------------------------------ K092683 p3/4 5. Packaging and wording in instruction manual Please find the following tabulated comparisons supporting that the modified device is substantially equivalent to the predicate device with FDA 510K# K070825 Technological Characteristics Comparisons table | Intended use | identical | |------------------------------------------|----------------| | Fundamental scientific principle | Identical | | Target population | Identical | | Use at home or in hospital | Identical | | Safety and effectiveness | Identical | | Over the counter | Identical | | Performance specifications | Identical | | Stirility | Not applicable | | Biocompatibility | Identical | | Mechanical safety | Identical | | Electrical safety | Identical | | Standards met | Identical | | Energy used or delivered | Identical | | Environmental specifications | Identical | | Ergonomics of the patient-user interface | Identical | | Software | Similar | | Packaging or labeling | Similar | | Dimensional specification | Similar | ### G. Discussion of Similarities and Differences The modified device is identical to the predicate in functionality and performance ,with the only differences being the additional features, such as WHO indication, date and time display and an increased measurement recall capacity to 90 sets of measurement. The modifications to our original 510(k) cleared device include the dimensional specifications, packaging and labeling and subprogram of software for WHO indication and date and time display. The blood pressure measurement algorithm and its software codes of the modified devices remains unchanged. The fundamental scientific technology of the {3}------------------------------------------------ K092683 P4/4 modified device remains the same as that of the 510(k) cleared device. These differences have no impact on safety or effectiveness of the device. ## H. Performance testing The subjects have been tested and found otherwise to comply with the following standards: * IEC/EN 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance *IEC/EN/ANSI 60601-1-2, Medical Electrical Equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and Test * ISO 10993-1, Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing * ANSI/AAMI SP10-2002. Manual. Electronic or Automated Sphygmomanometers The following testing was conducted: a. General Functions Test b. Reliability Test - Operation Conditions - c. Reliability Test Drop Testing - d. Reliability Test Storage - e. Reliability Test Vibration Testing f. EMC Testing g. IEC 60601-1 Safety Testing None of the testing demonstrated any design characteristics that violated the requirement of the Reviewer Guidance or resulted in any safety hazards #### I. Conclusions: The LD1143 Digital Wrist Blood Pressure Monitor is as safe and effective as the predicate device in terms of intended use in blood pressure measurement, based on electrical, mechanical an environmental testing results, and SP-10 standard requirements. FDA Good Manufacturing Practices requirements were also met. Therefore, our modified device is as safe and effective as the predicate device. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized depiction of a bird, possibly an eagle, with its wings spread, symbolizing protection and care. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002 Shaghai Little Doctor Electronic Co., Ltd. c/o Mr. Janusun Wang Regulatory Affairs Representative Medical Device Division No. 8. Tongxing Road Nantong, Jiangsu 226007 CHINA SEP 2 5 2009 Re: K092683 > Trade/Device Name: Little Doctor Digital Wrist BP Monitor LD 1143 Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: August 19, 2009 Received: September 1, 2009 Dear Mr. Wang: 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 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. {5}------------------------------------------------ #### Page 2 - Mr. Janusun Wang 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/ResourcesforYou/Industry/default.htm. Sincerely yours, D.M.P. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Attachment 1 # Indications for use 510(k) Number (if known) : Device Name: Littledoctor Digital Wrist BP Monitor LD 1143 # Indications for Use: The subject is intended to be used for measuring blood pressure(systolic and diastolic pressure) and pulse rate, for adult, by oscillometric method, upon the upper arm and at home or in hospital. Prescription Use Over-The-Counter Use AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of GDF Device Evaluation (ODE) السعيده (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number Page 1 of 1 4--1