TONOPORT VI

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be part of a single, continuous line. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 14, 2017 PAR Medizintechnik GmbH & Co. KG Thomas Fischer Sachsendamm 6 10829 Berlin Germany Re: K170966 Trade/Device Name: TONOPORT VI Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 12, 2017 Received: May 15, 2017 Dear Thomas Fischer: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, 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 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 limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device {1}------------------------------------------------ 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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, M.A. Hillebrenner for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Statement of Indications for Use 4 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K170966 Device Name TONOPORT VI # Indications for Use (Describe) The TONOPORT VI is a small-size, lightweight, portable, non-invasive blood pressure (NIBP) monitor for ambulatory measurement of the blood pressure by the oscillometric method. The cuff is borne on the upper arm and an electrical pump in the device generates the pressure in the cuff. The TONOPRT VI is powered by two AA size batteries (alkaline or rechargeable NiMH batteries). The device records up to 400 blood pressurements at predefined intervals. In order to assess the measurements, the stored data can be transmitted via a RS-232. USB 1.1 or USB 2.0 interface to a PC for further evaluation or archiving purposes by analysis software. TONOPORT VI is intended to be used for measuring the systolic, diastolic, mean arterial blood pressure and the heart rate of human beings. The intended paient populations are adults and children (but not neonates) with a circumference of the upper arm in the range of 17 to 42 cm. TONOPORT VI is a prescription device in health care medicine and is intended for use following consultation and instruction by a physician (family doctor, specialist or hospital). It can be used, if the physical condition of the patient allows an automatic, non-invasive blood pressurement. Preparation and application of the TONOPORT VI is done by medically trained staff. The patient does not operate with the TONOPORT VI by himself. TONOPORT VI is not intended to be used in intensive care medicine or for alarming of life-threatening conditions. A measurement with TONOPORT VI can be combined with other measurements and medical examinations at the patient that a diagnosis about the patient's health condition depends not alone from the measurement of the TONOPORT VI. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (8/14) {3}------------------------------------------------ Special 510(k) TONOPORT VI ### 5 510(k) Summary | Table 2: Submitter information | | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | PAR Medizintechnik GmbH & Co. KG<br>Sachsendamm 6<br>10829 Berlin<br>Germany | | Contact person: | Mr. Thomas Fischer<br>Research and development department<br>PAR Medizintechnik GmbH & Co. KG<br>E-mail: info@par-berlin.com<br>Phone: +49 30 235070 10<br>Fax: +49 30 2138542 | | Date: | March 29th, 2017 | # Table 3: Device information | Table 3: Device information | | | | |-----------------------------|---------------------------|-------------------------------------------------------------------------------------------------------|------------| | Device: | Trade name: | TONOPORT VI | | | | Common name: | Non-Invasive Blood-Pressure Monitor | | | | Classification name: | Non-invasive blood pressure measurement<br>system<br>(21 CFR 870.1130, Product Code DXN,<br>Class II) | | | | Legally marked<br>device: | Device name: | TONOPORT V | | | | 510(k) number: | K012647 | ### Device Description 5.1 # Table 4: Device description | Device functions: | The TONOPORT VI measures the blood pressure non-invasively and<br>provides the systolic, diastolic, mean arterial blood pressure and the<br>heart rate of human beings. The cuff is borne on the upper arm of the<br>patient and an electrical pump in the device generates the pressure in<br>the cuff. The TONOPRT VI is powered by two AA size batteries<br>(alkaline or rechargeable NiMH batteries). The device records up to<br>400 blood pressure measurements at predefined intervals. In order to<br>assess the measurements, the stored data can be transmitted via a RS-<br>232, USB 1.1 or USB 2.0 interface to a PC for further evaluation or<br>archiving purposes by analysis software. It is intended to get used by<br>physicians (primary care physician, specialists and hospitals). | |-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {4}------------------------------------------------ | PAR Medizintechnik<br>GmbH & Co. KG | | Special 510(k) TONOPORT VI | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | Basic scientific<br>concept: | The blood pressure is measured by the oscillometric method. The<br>criteria for this method are the pressure pulsations superimposed<br>with every systole on the air pressure in the cuff. In order to measure<br>the blood pressure, a blood pressure cuff wrapped around the upper<br>arm needs to be inflated and subsequently deflated. | | | Device design: | The TONOPORT VI is a small-sized, light weighted and portable<br>NIBP monitor with an easy to read display. | | | Used materials: | Polycarbonate (PC) and acrylonitrile butadiene styrene (ABS) for the<br>case and plastic foil for the labels of the device. Tested biocompatible<br>materials (Nylon and PVC) are used for the cuffs. | | | Physical<br>properties: | Size: width: 73.0 mm / height: 27.0 mm / depth: 108.0 mm | | | | Weight: under 190 g, incl. batteries | | | | Connectors: cuff, USB and RS-232 connector | | # 5.2 Indications for Use The TONOPORT VI is a small-size, lightweight, portable, non-invasive blood pressure (NIBP) monitor for ambulatory measurement of the blood pressure by the oscillometric method. The cuff is borne on the upper arm and an electrical pump in the device generates the pressure in the cuff. The TONOPRT VI is powered by two AA size batteries (alkaline or rechargeable NiMH batteries). The device records up to 400 blood pressure measurements at predefined intervals. In order to assess the measurements, the stored data can be transmitted via a RS-232, USB 1.1 or USB 2.0 interface to a PC for further evaluation or archiving purposes by analysis software. TONOPORT VI is intended to be used for measuring the systolic, diastolic, mean arterial blood pressure and the heart rate of human beings. The intended patient populations are adults and children (but not neonates) with a circumference of the upper arm in the range of 17 to 42 cm. TONOPORT VI is a prescription device in health care medicine and is intended for use following consultation and instruction by a physician (family doctor, specialist or hospital). It can be used, if the physical condition of the patient allows an automatic, noninvasive blood pressure measurement. Preparation and application of the TONOPORT VI is done by medically trained staff. The patient does not operate with the TONOPORT VI {5}------------------------------------------------ by himself. TONOPORT VI is not intended to be used in intensive care medicine or for alarming of life-threatening conditions. A measurement with TONOPORT VI can be combined with other measurements and medical examinations at the patient that a diagnosis about the patient's health condition depends not alone from the measurement of the TONOPORT VI. {6}------------------------------------------------ AR Medizintechni GmbH & Co. KG oecial 510(k) TONOPORT # Comparison of the TONOPORT VI and the predicate dev 5.3 The TONOPORT VI is substantially equivalent and employs the same functional technology as the predicate device TONOPORT # Table 5: Device compariso | Characteristic | Subject device<br>TONOPORT VI | Primary predicate device<br>TONOPORT V (510(k) -No.: K012647) | Explanation of the<br>differences | | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product code | DXN | DXN | Identical | | | Classification<br>number | 21 CFR 870.1130 | 21 CFR 870.1130 | Identical | | | Common name | Non-Invasive Blood-Pressure Monitor | Non-Invasive Blood-Pressure Monitor | Identical | | | Class | Class II | Class II | Identical | | | Intended use | The TONOPORT VI measures and stores<br>the blood pressure data (systolic pressure,<br>diastolic pressure and heart rate) at human<br>beings. The blood pressure can be<br>measured several times at the physician or<br>up to 400 times during a long-term<br>monitoring with one set of fully charged<br>batteries. Medically trained staff has to<br>apply the device and the physician has to<br>analyze the results. The patient does not<br>operate with the TONOPORT VI by<br>himself. The stored data can be<br>transmitted to a PC based application via<br>serial interface for analysis and<br>evaluation. | The TONOPORT V measures and stores<br>the blood pressure data (systolic pressure,<br>diastolic pressure and heart rate) at human<br>beings. The blood pressure can be<br>measured several times at the physician or<br>up to 200 times during a long-term<br>monitoring with one set of fully charged<br>batteries. Medically trained staff has to<br>apply the device and the physician has to<br>analyze the results. The patient does not<br>operate with the device by himself. The<br>stored data can be printed directly on a<br>printer and/or transmitted to a PC-based<br>application via serial interface for analysis<br>and evaluation. | Equivalent<br>The storage capacity is<br>increased and the<br>transmission interfaces are<br>state of the art for the<br>clearance times. These<br>changes are documented<br>and do not influence the<br>indications for use. | | | PAR Medizintechnik<br>GmbH & Co. KG | Special 510(k) TONOPORT VI | | | | | Characteristic | Subject device<br>TONOPORT VI | Primary predicate device<br>TONOPORT V (510(k) -No.: K012647) | Explanation of the<br>differences | | | Indications for use | Target population:<br>Adults and children, but <b>not</b> neonates<br>Anatomical site:<br>Upper arm (see section 0)<br>Where used:<br>In hospital and at home (following consultation and instruction by a physician) | Target population:<br>Adults and children, but <b>not</b> neonates<br>Anatomical site:<br>Upper arm<br>Where used:<br>In hospital and at home (following consultation and instruction by a physician) | Identical | | | Design | New and good looking ergonomic design<br>of the case and the user interface | Functional design of the case and the user<br>interface | Equivalent<br>The changes of the case<br>ergonomics and the user<br>interface that enhance the<br>operator's and patient's<br>convenience are<br>documented and are <b>not</b><br>relevant for the<br>indications for use. | | | PAR Medizintechnik<br>GmbH & Co. KG | | Special 510(k) TONOPORT VI | | | | Characteristic | Subject device<br>TONOPORT VI | Primary predicate device<br>TONOPORT V (510(k) -No.: K012647) | Explanation of the<br>differences | | | Display | 27.0 mm x 58.0 mm<br>(width to height)<br>Image: [display] | 30.0 mm x 10.5 mm<br>(width to height)<br>Image: [display] | Equivalent<br>The change of the<br>ergonomics of the user<br>interface into a clear and<br>easy to read display that<br>increases the safety of the<br>device and enhance the<br>convenience are<br>documented. | | | Dimensions and<br>weight | Smaller with lower weight compared to<br>TONOPORT V | Small size and low weight | Equivalent<br>The changes in<br>dimensional specifications<br>are documented, do not<br>affect the indications for<br>use and enhance the<br>operator's and patient's<br>convenience. | | | Width | 73.0 mm | 80.0 mm | Identical | | | Height | 27.0 mm | 27.0 mm | | | | Depth | 108.0 mm | 100.0 mm | | | | Weight | Approximately 190 g with batteries | Approximately 199 g with batteries | | | | Communication | Measurement settings of the device and<br>the read out of the stored data can be done<br>via serial interface | Measurement settings of the device and<br>the read out of the stored data can be done<br>via serial interface | Identical | | | Event marking | By pressing the START STOP Button | By pressing the START STOP Button | Identical | | | Energy source | Powered by two AA size batteries<br>(alkaline or NiMH batteries). | Powered by two AA size batteries<br>(alkaline or NiMH batteries). | Identical | | | GmbH & Co. KG | Characteristic | Subject device<br>TONOPORT VI | Primary predicate device<br>TONOPORT V (510(k) -No.: K012647) | Explanation of the<br>differences | | | Storage capacity | Up to 400 measurements | Up to 200 measurements | Equivalent<br>The evaluation of user needs showed that more<br>storage capacity is need.<br>The change is documented<br>and do not influence the<br>indications for use. | | | Measuring method | Oscillometric measuring method during<br>deflation of the cuff | Oscillometric measuring method during<br>deflation of the cuff | Identical | | | Measuring range | 60 to 260 mmHg<br>40 to 220 mmHg<br>35 to 240 min-1<br>systolic pressure<br>diastolic pressure<br>pulse rate (HR) | 60 to 260 mmHg<br>40 to 220 mmHg<br>35 to 240 min-1<br>systolic pressure<br>diastolic pressure<br>pulse rate (HR) | Identical | | | Max cuff pressure | 300 mmHg | 300 mmHg | Identical | | | Materials | PC and ABS for the case and plastic foil<br>for the labels of the device. Biocompatible<br>materials are used for the applied parts<br>(cuff). | PC for the case and plastic foil for the<br>labels of the device. Biocompatible<br>materials are used for the applied parts<br>(cuff). | Equivalent<br>The change of the material<br>formulation to increase<br>the durability of the<br>device is documented. The<br>changed materials are not<br>in contact with the body<br>of the patient. | 5-4 {7}------------------------------------------------ ecial 510(k) TONOPORT VI - Doc.-Rev. E from June 14th, 201 K170966 Page 5 of 9 {8}------------------------------------------------ {9}------------------------------------------------ AR Medizintechni Special 510(k) TONOPORT VI {10}------------------------------------------------ AR Medizintechnil GmbH & Co. KG pecial 510(k) TONOPORT VR | | Characteristic | Subject device<br>TONOPORT VI | | Primary predicate device<br>TONOPORT V (510(k) -No.: K012647) | | Explanation of the<br>differences | |----------------------------------------------------------------|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-----------------------------------------------------------------------------------------------| | Environmental<br>conditions<br>for<br>Operation | Temperature | +5 to +40 °C | | +10 to +40 °C | Temperature | Equivalent | | | Humidity | 15 to 93 % | Atmospheric pressure | 30 to 75 % | Humidity | The environmental<br>conditions are changed | | | Atmospheric pressure | 700 to 1060 hPa | | 700 to 1060 hPa | Atmospheric pressure | according to the | | Environmental<br>conditions<br>for<br>transport and<br>storage | Temperature | -25 to +70 °C | | -20 to +70 °C | Temperature | requirements of the | | | Humidity | 10 to 93 % | | 10 to 90 % | Humidity | standards IEC 80601-2-30<br>and 60601-1-11. These | | | Atmospheric pressure | 500 to 1060 hPa | | 500 to 1060 hPa | Atmospheric pressure | changes do not affect the<br>indications for use. | | Safety | Increased safety | An additional pressure sensor and a<br>pressure release valve are added.<br><br>Two controllers (main and supervisor<br>controller) that monitor each other and the<br>safety related components are used. | | Standard safety<br><br>One pressure sensor and one valve for the<br>deflation of the cuff are used.<br>One controller (main controller) is used. | | Equivalent<br><br>The improvement of the<br>safety properties of the<br>device is documented. | | Sterilization | Not applicable | Not applicable | | Not applicable | | Identical | | Expiration date | Not applicable | Not applicable | | Not applicable | | Identical | {11}------------------------------------------------ ### Summary of performance testing 5.4 | Characteristic | Standard/Test/FDA Guidance | Result | |-----------------------------------------------------------------------------------------------------|-------------------------------------------------|----------------------| | Safety (electrical,<br>mechanical, chemical,<br>thermal and radiation) and<br>essential performance | IEC 60601-1<br>IEC 60601-1-11<br>IEC 80601-2-30 | Pass<br>Pass<br>Pass | | Usability | IEC 60601-1-6 | Pass | | Software | IEC 62304 | Pass | | Risk Management | | | | Risk analysis | ISO 14971 | Pass | # Table 6: Performance testing to demonstrate equivalence The TONOPORT VI complies with the voluntary and mandatory standards. The following quality assurance measures were applied to the development of the TONOPORT VI to ensure that design inputs, safety requirements, new features, preexisting requirements were met and re-tested: - Requirements specification review - o Software and hardware testing - Safety testing - Environmental testing - Final verification and validation - o Compliance with performance standards An assessment of clinical data to show safety and performance of the device was not made, because the TONOPORT VI uses identical algorithms for the blood pressure measurement like the predicate device TONOPORT V. Consequently the form FDA-3674 'Certification of compliance with requirements of ClinicalTrails.gov data bank' is not completed and submitted. ### 5.5 Conclusion The TONOPORT VI is substantially equivalent to the TONOPORT V with respect to the indications for use and the basic scientific concept.