HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-

{0}------------------------------------------------ ู้ " K/0/892 # 510(k) Summary of Safety and Effectiveness AUG 27 2010 In accordance with the requirements of the Safe Medical Device Act, HEINE Optotechnik GmbH & Co. KG herewith submits a Summary of Safety and Effectiveness. | Submitter Information: | HEINE Optotechnik GmbH & Co. KG<br>Kientalstr. 7<br>82211 Herrsching<br>Germany<br>Registration Number:<br>1000379039<br>Owner/Operator Number: 9003020 | |---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Official Correspondent: | Mrs. Claudia Schwieger<br>Head of Quality Management<br>HEINE Optotechnik GmbH & Co. KG<br>Phone: +49 8152 383 40 | | US Agent (Contact): | Benoit st. Jean<br>HEINE USA, Itd.<br>10 Innovation Way<br>Dover, NH 03820 USA<br>Phone: +1 603 7427217<br>E-mail: Bstjean@heine-na.com | | Date Prepared: | July 02, 2010 | | Device(s) Identification:<br>Device Trade Name:<br>Common Name: | HEINE Gamma G7®; G5®; GP®; GST®; XXL LF®<br>Non-Automated Sphygmomanometers | | Classification of the device:<br>Device Classification Name:<br>Product Code:<br>Device Classification No.:<br>Panel:<br>Regulatory Status: | Blood Pressure Cuff<br>DXQ<br>Part 870.1120<br>Cardiovascular<br>Class II | {1}------------------------------------------------ Predicate devices: | 1. | | |--------------------|------------------------------| | Device Trade Name: | Riester Precisa N | | Applicant: | RUDOLF RIESTER GMBH & CO. KG | | 510(k) No.: | K972379 | | 2. | | | Device Trade Name: | Riester Risan | | Applicant: | RUDOLF RIESTER GMBH & CO. KG | | 510(k) No.: | K002954 | | 3. | | | Device Trade Name: | Riester Big Ben | | Applicant: | RUDOLF RIESTER GMBH & CO. KG | | 510(k) No.: | K972301 | | 4. | | | Device Trade Name: | Riester Sanaphon | | Applicant: | RUDOLF RIESTER GMBH & CO. KG | | 510(k) No.: | K972378 | The HEINE GAMMA aneroid sphygmomanometers are considered substantial equivalent to the Riester Precisa N (K972379), Riester Risan (K002954), Riester Big Ben (K972301), and Riester Sanaphon (K972378). There is no significant difference in intended use or technology. ### Device Description: The HEINE Gamma aneroid sphygmomanometers are non-invasive blood-pressure measurement devices to measure systolic and diastolic blood pressure in adults and pediatric patients. The HEINE Gamma sphygmomanometers consist of a large insufflation bulb, a gauge with a large diameter scale, a valve, and a single tube cuff with Velcro fastener. The HEINE Gamma sphygmomanometers come in five models; G5, G7, GP, GST, and XXL LF. The models comprise either a push-button valve or a spin valve. The HEINE Gamma GST comprises an integrated stethoscope for self measurement. The HEINE Gamma XXL LF is a wall-, desk-, or rail-mounted devices and is available with a wheeled stand. HEINE Gamma G5, G7, GP, and XXL LF will be available in five cuff sizes; child small, child, adult small, adult, and thigh. The HEINE Gamma GST comes with an adult cuff. The HEINE Gamma aneroid sphygmomanometers are intended for use in a wide variety of settings. This includes hospital departments, medical practices, and nursing homes, as well as home health care. {2}------------------------------------------------ #### Intended Use: The HEINE Gamma Sphygmomanometers are used for non-automated blood pressure measurement by professional and lay users. The devices are non-sterile and are intended as multi-patient reusable devices. The HEINE Gamma Sphygmomanometers are available in infant through adult sizes. #### Summary of Non-Clinical Performance Testing: Bench Testing was conducted to demonstrate Safety and Effectiveness by conformance to the ANSI/AAMI SP9-1994 standard for non-automated Sphygmomanometers, as referenced in the FDA Guidance Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance Version 1. #### Conclusion: HEINE Optotechnik believes that the HEINE Gamma aneroid sphygmomanometers are substantially equivalent to the currently legally marketed devices. They do not introduce new indications for use, have the same technological characteristics and do not introduce new potential hazards or safety risks. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The text is in all capital letters and is evenly spaced around the circle. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002 Heine Optotechnik,GmbH & Co., Kg c/o Mr. Thomas Weber PROSYSTEM AG Beim Strohhause 27 Hamburg, GERMANY 20097 AUG 27 2010 Re: K101892 Trade/Device Name: Heine GAMMA® Sphygmomanometers Regulatory Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: II (two) Product Code: 74 DXQ Dated: July 5, 2010 Received: July 7, 2010 Dear Mr. Weber: 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. {4}------------------------------------------------ #### Page 2 - Mr. Thomas Weber 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/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, W. Mad. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K101892 HEINE GAMMA® Sphygmomanometers ## Indications for Use 510(k) number (if known): Device Name: Indications For Use: HEINE GAMMA aneroid sphygmomanometers are exclusively designed for measuring blood pressure at the upper arm or thigh on healthy skin. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use x (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) W.W.B. (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number Page 1 of *_*_