ERKA. PERFECT-ANEROID

{0}------------------------------------------------ ERKA. Kallmeyer Medizintechnik GmbH & Co. KG Perfect-Aneroid 510(k) Submission K103637 ## Section 5 = 510(k) summary JUN - 8 2011 1/2 (as described in CFR 807.92 Content and format of a 510(k) summary chapter (a), (1) to (6)) | (1) | | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted by: | ERKA. Kallmeyer Medizintechnik GmbH & Co. KG<br>Im Farchet 15<br>83646 Bad Tölz<br>Germany<br>Tel.: +49 (0)8041 / 8009-0<br>Fax: +49 (0)8041 / 8009-39 | | Contact: | Jan Weiss, Quality Manager | | Date prepared: | 24 November 2010 | | (2) | | | Name of Device: | ERKA. Perfect-Aneroid sphygmomanometer | | Common Name: | Blood Pressure Sphygmomanometer | | Classification Name: | Blood Pressure Cuff; DXQ; 870.1120 | | (3) | | | Predicate Device: | RUDOLF RIESTER PRECISA N Blood Pressure<br>Sphygmomanometer<br>510(k) Document Control No.: K972379 | ### (4) Description of the device: The ERKA. Perfect-Aneroid Sphygmomanometer is an established manual noninvasive blood pressure measurement device that facilitates the auscultatory measuring method of Riva Rocci / Korotkoff. The ERKA. Perfect-Aneroid Sphyqmomanometer is designed to non-invasively measure the systolic and diastolic blood pressure of adult and paediatric, but not neonatal patients together with a common stethoscope. The ERKA. Perfect-Aneroid Sphygmomanometer contains the following components: - the manometer consisting of the main body, gauge, valve, bulb and spoon and - the cuff consisting of cover, bladder and tubing. The ERKA. Perfect-Aneroid comes in two model types: As Model ERKA. Perfect-Aneroid 48, with a 48mm scale diameter scale and as ERKA. Perfect-Aneroid 56, with a 56mm scale diameter. Both types differ solely in the size of the scale. The larger scale allows an easier reading, e.g. for users with reduced eyesight. The smaller 48mm device realizes a weight advantage while ensuring equal precision and functionalitv. The ERKA. Perfect-Aneroid gauge works with a traditional gear driven pointer movement that is triggered by pressure induction on a sealed membrane. The {1}------------------------------------------------ ERKA. Kallmeyer Medizintechnik GmbH & Co. KG Perfect-Aneroid 510(k) Submission manometer features a brass chrome plated housing and a membrane protecting 2tube technology. The mechanics function in exactly the same way in both diameter sizes. The device comes with a polyurethane coated wipeable cuff. The duo-tubing is made of latex-free silicone and the inflatable bladder in the cuff is made of polyurethane material. The cuffs meet the required biocompatibility standards and are substantially equivalent to the cuffs marketed under 510(k) clearance K071885 and K001333. The cuffs may be obtained in the following sizes: - Pediatric: Limb circumference 14 cm 21.5 cm - Small adult: Limb circumference 20.5 cm 28 cm - Adult: Limb circumference 27 cm 35 cm - Large Adult: Limb circumference 34 cm 43 cm - Thigh: Limb circumference 42 cm 54 cm 54 cm ' ### (5) ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ Intended Use statement: The ERKA. Perfect-Aneroid sphygmomanometer is intended for the non-invasive blood pressure measurement of adult and paediatric, but not neonatal patients. The device is not designed, sold or intended for use except as indicated. Restrictions: The ERKA. Perfect-Aneroid sphygmomanometer is only to be used with ERKA. cuffs. Cuff size recommendations must be complied with in order to ensure blood pressure accuracy and safety, ### (6) ## Predicate Device Comparison Table | | ERKA. Perfect-Aneroid<br>(48/56 mm scale diameter) | Riester precisa N<br>(63 mm scale diameter) | |-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | General | | | | Scientific concept | non-invasive, non-automated blood<br>pressure measurement by means of<br>auscultation of the Korotkoff and<br>Riva Rocci sounds | non-invasive, non-automated blood<br>pressure measurement by means<br>of auscultation of the Korotkoff and<br>Riva Rocci sounds | | Intended Use | non-invasive blood pressure<br>measurement of adult and paediatric,<br>but not neonatal patients | non-invasive blood pressure<br>measurement of adult and paediatric<br>patients | | Pressure<br>measurement | aneroid principle | aneroid principle | | Pressure induction | manually by pump bulb | manually by pump bulb | | Technical<br>characteristics | | | | Design of Device | manometer including gauge and valve, cuff including inflatable bladder and tubing | manometer including gauge and valve, cuff including inflatable bladder and tubing | | Pointer movement | gear driven | gear driven | | Measurement range | 0-300 mmHg | 0-300 mmHg | | Measurement accuracy | +/- 3 mmHg | +/- 3 mmHg | | Dimensions | ERKA. dimensions as per datasheet. Dimensions of predicate device slightly different, however this does not have influence on performance | | | Scale diameter | 48mm or 56mm diameter, (technological solution remains exactly the same) | 63mm | | Scale graduation | 2mmHg | 2mmHg | | Tubing | membrane protecting 2-tube concept | membrane protecting 2-tube concept | | Tube material | silicone, latex-free | unknown | | Valve | Precision air release valve | Precision air release valve | | Cuff incl. bladder | PU coated wipeable, latex-free material | Various cotton and nylon cuffs | | Cuff size | various | various | | Material grades of housing and body | Partly different material grades used. Difference does not affect performance. | | | Inflation method | manually by means of pump bulb | manually by means of pump bulb | | Bulb material | latex-free, medical grade PVC | not known | | Patient labeling | | | | Device identification | individual, traceable device number | individual, traceable device number | | Instructions for Use2 | as per Guidance on Medical Device Patient Labeling, IFU included in package | as per Guidance on Medical Device Patient Labeling, IFU included in package | | Packaging container labeling | label on outer container identifies model, article no., manufacturer, serial no. and content | label on outer container identifies model, article no., manufacturer, serial no. and content | | Device labeling | gauge clearly identifies measuring range, unit, device no.; manufacturer, model, symbol for IFU; cuff clearly identifies size, range, latex-free information, artery marking, manufacturer, cuff positioning | gauge clearly identifies measuring range, unit, device no.; manufacturer, model, symbol for IFU; cuff clearly identifies size, range, artery marking, manufacturer, cuff positioning | | Indications for Use | The ERKA. Perfect-Aneroid sphygmomanometer is intended for the non-invasive blood pressure measurement of adult and paediatric, but not neonatal patients. The device is not designed, sold or intended for use except as indicated. | Precisa-N is a sphygmomanometer and is intended to measure the blood pressure (self-measurement)3 | {2}------------------------------------------------ ERKA. Kallmeyer Medizintechnik GmbH & Co. KG Perfect-Aneroid 510(k) Submission . . . . . 73 - 3 The RIESTER statement is shorter, however signifies fundamentally the same meaning. As required by European and FDA regulations ERKA. determined the Indications for Use in greater detail. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ² The IFUs of the ERKA. devices and the predicate device may be found in Appendix B {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized bird or eagle with three curved lines representing its wings or feathers. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 ERKA. Kallmeyer Medizintechnik GmbH & Co. KG c/o Mr. Alexander Schapovalov TUV SUD America, Inc. 1775 Old Highway 8 New Brighton, MN 55112-1891 JUN - 8 2011 Re: K103637 > Trade/Device Names: ERKA. Perfect-Aneroid Sphygmomanometer and Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: DXO Dated: May 18, 2011 Received: May 20, 2011 Dear Mr. Schapovalov: 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. Alexander Schapovalov 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 (OS) 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 s Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K103637 # Section 4 - Indications for use statement | 510(k) Number: | Unknown | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | ERKA. Perfect-Aneroid sphygmomanometer | | Indications for Use: | The ERKA. Perfect-Aneroid sphygmomanometer is<br>intended for the non-invasive blood pressure<br>measurement of adult and paediatric, but not neonatal<br>patients. The device is not designed, sold or intended for<br>use except as indicated. | Prescription Use Over-The-Counter Use yes Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________ ר 103637