SENSACARE MODEL SAA-102 ARM TYPE DIGITAL BLOOD PRESSURE MONITOR

{0}------------------------------------------------ K070086151 7 (1 - # 510K Summary MAY 1 0 2007 #### 1. DATE PREPARED June 20, 2006 #### 2. SPONSOR INFORMATION SensaCare Ltd. Chris Chan Room 1312, Sterling Centre, 11 Cheung Yue Street, Kowloon, HongKong Tel : 852-3571-8332 Fax :852-3571-8363 Email : chris@sensacare.com #### 3. DEVICE NAME # Proprietary Name : SensaCare SAA-102 Arm Type Digital Blood Pressure Monitor Common/Usual Name : Blood Pressure Monitor ## Classification Name : Non-invasive Blood Pressure Measurement System 21CFR 870.1130, DXN #### 4. DEVICE DESCRIPTION AND INTENDED USE The SensaCare SAA-102 Arm Type Digital Blood Pressure Monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. {1}------------------------------------------------ #### 5. PREDICATED DEVICE It is substantially equivalent to the following device : A&D UA-779PC FDA 510K, K993888, issued on December 20, 1999 ### 6. TECHNOLOGICAL CHARACTERISTECS SAA-102 uses an inflated cuff which is wrapped around the upper arm. The cuff is inflated automatically by the air pump. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by a preset mechanical valve at a constant and The pressure of the cuff is completely released automatically at the end w the measurement. At the same time, the measurements are displayed on the LCD display for one minute. After one minute without operation, SAA-102 turns off automatically. SAA-102 measures blood pressure and pulse rate even when an irregular heartbeat occurs. # 7. SUMMARY INCLUDING CONCLUSION DRAWN FROM CLINICAL TESTS When compared to the predicate device, SAA-102 does not incorporate any significant changes in the intended use, method of operation, material or design that could affect safety and effectiveness. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing the wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the bird symbol. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 TUV America, Inc. c/o Mr. Stefan Preiss 1175 Old Highway 8 NW, Suite 104 New Brighton, MN 55112 MAY 1 0 2007 Re: K070086 Trade/Device Name: MedilogAR4 and MedilogAR12 Digital Holter Recorders Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II Product Code: DSH Dated: March 22, 2007 Received: March 26, 2007 Dear Mr. Preiss: 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 (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. 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 {3}------------------------------------------------ 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 continue 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 (240) 276-4008. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Blymmermonfr Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: Indications For Use: The SensaCare SAA-102 Arm Type Digital Blood Pressure Monitor is a hand held battery operated arm type blood pressure monitor which is intended for use by adults (age 18 or older) for measuring the systolic and diastolic blood pressure and pulse rate. The measurement is by the oscillometric method wherein a cuff is placed on the limb and the pressure in the cuff is increased until the blood flow in the artery is interrupted and then the pressure in the cuff is slowly reduced. The measurement result is shown on a LCD panel in the monitor. The measuring ranges are (1) systolic pressure : 30 to 280 mmHg (2) diastolic pressure : 20 to 255 mmHg (3) heart rate : 20 to 255 times/minutes. Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) B. Hummerston (Division Sign-Off Division of Cardlovascular Devices 510(k) Number Page 2-2 Page 1 of KO7008615