Tel-O-Graph

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 16, 2019 I.E.M. Industrielle Entwicklung and Medizintechnik Hella Witt Regulatory Affairs Vertriebsgesellschaft mbH Cockerillstrabe 69 Stolberg, 52222 DE Re: K173895 Trade/Device Name: Tel-O-Graph Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 12, 2019 Received: April 17, 2019 Dear Hella Witt: 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). 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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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. for Matthew Hillebrenner Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number K173895 Device Name Tel-O-Graph Indications for Use (Describe) The Tel-O-Graph is intended for the home measurement of blood pressure and pulse on the upper arm in adults. The blood pressure monitor is suitable for individuals with an arm circumference of 20-55 cm (7.9-21.7 in) when used with the corresponding monitor cuff size. The data measured is automatically transmitted. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | 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." {3}------------------------------------------------ # Tel-O-Graph Section 05: 510(k) Summary ## Section 05: 510(k) Summary ### Submission Sponsor and Correspondent IEM GmbH Cockerillstraße 69 52222 Stolberg Germany Phone: +49 2402 9500 75 +49 2402 9500 11 Fax: Contact: Hella Witt FDA Establishment Registration # 9617476 Date prepared: 10 April 2019 #### Device identification | Trade Name | Tel-O-Graph | |----------------------------|-----------------------------------------------| | Common name: | Self Blood Pressure Monitor | | Classification Regulation: | CFR 870.1130 | | Classification Name | Noninvasive blood pressure measurement system | | Product Code: | DXN | | Device Class: | Class II | | Classification Panel: | Cardiovascular | ### Legally Marketed Predicate Device K041313 Stabil-O-Graph #### Device Description The Tel-O-Graph is a table-top device for upper arm blood pressure measurements. The device employs the oscillometric principle for the non-invasive determination of the blood pressure from pressure signals obtained from the pressurized cuff placed around the upper arm. The device is Image /page/3/Picture/22 description: The image shows a logo with the letters "IEM" in a stylized design. The "I" and "M" are in a bold, sans-serif font and appear to be solid gray. The "E" is white and partially overlays a gray sphere, creating a three-dimensional effect. The sphere is positioned between the "I" and "M", adding depth to the logo. {4}------------------------------------------------ # Tel-O-Graph # Section 05: 510(k) Summary Image /page/4/Picture/4 description: The image shows a logo for IEM. The logo features a gray sphere with a white "E" partially covering it. To the left of the sphere is a bold, dark gray "I", and to the right is a bold, dark gray "M". There is a slight shadow underneath the sphere and the letters. operated via a single button to initiate blood pressure measurements. Data is transmitted automatically. The device is used by patients in a home environment. ### Summary of technical data: | Specification | Value | Unit | |----------------------------------------------------------------|-------------------------------------------------------|--------------| | Measuring method | Oscillometric | | | Blood pressure measurement<br>range | 30 to 290<br>Systolic: 60 – 290<br>Diastolic:30 – 195 | mmHg | | Pulse measurement range | 30 to 240 | 1/min | | Pressure accuracy | ±3 | mmHg | | Pulse rate accuracy | ±2% or ±3 bpm (whichever is greater) | 1/min | | Memory | 350 | measurements | | Power supply | 6V (4x AA, 1.5V, alkaline) | | | Dimensions (L x W x H) | 152x 110 x 57 | mm | | Weight (excluding batteries) | 325 | g | | Material housing | ABS (acrylonitrile-butadiene-styrene) | | | Material cuff | Polyester | | | Expected service BP monitor | 5 | years | | Expected service life of the cuff | 6 | months | | Operating temperature | +5 to +40 | °C | | Ambient pressure | 700 to 1060 | hPa | | Transport and storage temperature | -25 to +70 | °C | | Humidity, not condensing<br>(operation, transport and storage) | 15 to 93 | % | | Battery capacity | c. 500 | measurements | | Transmission time | c. 5 | min | | Data connection<br>(depending on variant) | Bluetooth or<br>Mobile communication network | | | Data transmission<br>(depending on variant) | Class 1 Bluetooth<br>or GPRS Class 12 | | Table 5A: Summary of technical data {5}------------------------------------------------ # Tel-O-Graph Section 05: 510(k) Summary Image /page/5/Picture/4 description: The image shows a logo with the letters 'I', 'E', and 'M'. The 'E' is stylized and partially overlaps a shaded sphere. The letters 'I' and 'M' are positioned on either side of the sphere, with a subtle shadow effect beneath them, giving the logo a three-dimensional appearance. ### Accessories Blood pressure cuffs are available in four cuff sizes: | Cuff size | Arm circumference in cm/inch | |-----------|------------------------------| | S | 20 – 24 cm /7.9 – 9.5 in | | M | 24 – 32 cm / 9.5 – 12.6 in | | L | 32 – 38 cm/ 12.6 – 15.0 in | | XL | 38 – 55 cm / 15.0 – 21.7 in | Table 5B: Accessories #### Indications for Use: The Tel-O-Graph is intended for the home measurement of blood pressure and pulse on the upper arm in adults. The blood pressure monitor is suitable for individuals with an arm circumference of 20-55 cm (7.9-21.7 in) when used with the corresponding monitor cuff size. The data measured is automatically transmitted. {6}------------------------------------------------ # Tel-O-Graph # Section 05: 510(k) Summary Image /page/6/Picture/4 description: The image shows a logo with the letters 'I' and 'M' in a bold, sans-serif font. To the upper left of the letters is a gray sphere with a white shape on it that resembles the letter 'E'. The sphere casts a shadow to the right, adding a sense of depth to the logo. ## Device Comparison Summary | | Stabil-O-Graph<br>(predicate) | Tel-O-Graph<br>(candidate) | Comparison of equivalence /<br>differences | |-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K041313 | K173895 | same | | Manufacturer | IEM GmbH | IEM GmbH | same | | Classification | Class II | Class II | same | | Classification Name | 870.1130 Noninvasive blood<br>pressure measurement<br>system. | 870.1130 Noninvasive blood<br>pressure measurement<br>system. | same | | Product Code | DXN | DXN | same | | Indications for<br>Use | The Stabil-O-Graph is<br>intended to be used by<br>adults at home to monitor<br>Blood Pressure (systolic and<br>diastolic) and pulse rate from<br>the upper arm with arm<br>circumference ranging from<br>9.4 inches to 16.5 inches (24<br>cm to 42 cm) | The Tel-O-Graph is intended<br>for the home measurement<br>of blood pressure and pulse<br>on the upper arm in adults.<br>The blood pressure monitor<br>is suitable for individuals with<br>an arm circumference of 20-<br>55 cm (7.9-21.7 in) when<br>used with the corresponding<br>monitor cuff size.<br><br>The data measured is<br>automatically transmitted. | Equivalent | | Variants | Stabil-O-Graph mobil | Tel-O-Graph BT / GSM | Equivalent, difference only in<br>data transmission | | Principle of<br>operation/<br>measurement | Oscillometric | Oscillometric | Same | | Measurement<br>range | Systolic: 70 - 260 mmHg<br>Diastolic:45 - 180 mmHg<br>Pulse: 40-240 bpm | Systolic: 60 - 290 mmHg<br>Diastolic:30 - 195 mmHg<br>Pulse: 30-240 bpm | Equivalent | | Accuracy BP<br>measurement | $\pm$ 3 mmHg | $\pm$ 3 mmHg | Equivalent | | Memory | 50 blood pressure<br>measurements | 350 blood pressure<br>measurements | Equivalent<br>Tel-O-Graph automatically<br>transmits the measured data.<br>Memory is only backup in case of<br>transmission problems | | User interaction | 2 buttons: "START/STOP"<br>and "MENU" | 1 button | | | Dimension and<br>weight | Casing dimensions:<br>125 x 131 x 51 mm ,<br><br>Weight. approx. 270 g<br>including batteries | Casing dimensions:<br>152 x 110 x 57mm,<br><br>Weight: approx. 325 g<br>excluding batteries | Equivalent:<br>Differences in design of housing<br>are not affecting safety or<br>performance. | | Materials | Casing: ABS<br>Display: LCD | Casing: ABS<br>Display: LCD | Equivalent | | | Stabil-O-Graph<br>(predicate) | Tel-O-Graph<br>(candidate) | Comparison of equivalence / differences | | Accessories:<br>cuffs | Material:<br>Polyester Textile sheath<br>Bladder: TPU<br>Tube: PVC<br><br>Cuffs in 2 different sizes<br>24-32cm<br>32-38cm | Material:<br>Polyester Textile sheath<br>Bladder: TPU<br>Tube: PVC<br><br>Cuffs in 4 different sizes:<br>20-24cm<br>24-32cm<br>32-38cm<br>38-55cm | Equivalent<br>Same materials used<br><br>The additional cuff sizes do not affect the safety of the device;<br>clinical validation covers all cuff sizes | | Power supply | 2 alkaline 1.5 V batteries<br>(AA) | 4 alkaline 1.5 V batteries<br>(AA) | Equivalent<br>Both are battery operated devices. | | Biocompatibility | Compliance with<br>ISO 10993-1 | Compliance with<br>ISO 10993-1 | Equivalent<br>Testing updated according to current standards | | Environmental<br>conditions | Operating conditions: +10°C<br>to +40°C)<br><br>Storage environment:<br>-20°C to 50°C<br>15% to 95%rH | Operating conditions:<br>+5°C to +40°C<br><br>Storage environment:<br>-25 °C to 70 °C<br>15% to 93% rH | Equivalent | | Data<br>transmission | Infrared, Bluetooth | Bluetooth, GSM | Equivalent:<br>All are open digital technologies for data transmission; Infrared is considered as not being state-of-the-art any more | {7}------------------------------------------------ # Tel-O-Graph Image /page/7/Picture/3 description: The image shows the text "Section 05: 510(k) Summary". The text is in a bold, sans-serif font and is left-aligned. The text is likely a section heading in a document. Image /page/7/Picture/4 description: The image shows a logo with the letters 'I', 'E', and 'M'. The 'E' is white and appears to be wrapped around a gray sphere. The letters 'I' and 'M' are in a dark gray color and are positioned to the left and right of the sphere, respectively. The logo has a simple and modern design. Table 5C: Device technical comparison with predicate device Data transmission via mobile-network communication (Tel-O-Graph GSM) is considered equivalent to data transmission with the FDA cleared AM3 GSM (K13722). | | Spirometer Asthma<br>Monitor AM3 GSM<br>(reference) | Tel-O-Graph GSM<br>(candidate) | Comparison | |--------------|-----------------------------------------------------|------------------------------------------------|----------------------------------------------------------------------------------------------| | | K133722 | K173895 | | | Transmission | Serial (RS232), USB,<br>Bluetooth, GSM | Bluetooth, GSM | Equivalent in terms<br>of BT and GSM<br>transmission. Serial<br>and USB are not<br>wireless. | | EMC testing | Done with whole<br>device | Done with whole<br>device (Tel-O-Graph<br>GSM) | Equivalent | {8}------------------------------------------------ # Tel-O-Graph ## Section 05: 510(k) Summary Image /page/8/Picture/4 description: The image shows a logo with the letters 'I', 'E', and 'M'. The letter 'I' is positioned to the left of a sphere, while the letter 'M' is to the right. The letter 'E' is integrated into the sphere, creating a three-dimensional effect. The logo has a simple and modern design. | Data stored and<br>transmitted | Result of<br>measurement<br>(always with date<br>and time) | Result of<br>measurement<br>together with date<br>and time | Equivalent | |------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | GSM Interface | Sierra Wireless<br>WISMO288<br>GSM module | Cinterion ESH 6<br>GSM module | Equivalent<br>Both modules use<br>techniques to<br>guarantee the<br>integrity of the<br>transferred data. | | GSM reception | No critical data<br>transmitted<br>Data stored in<br>nonvolatile memory | No critical data<br>transmitted<br>Storage of up to 350<br>measurements | Equivalent<br>Transmission not<br>time critical | | Time point of<br>GSM data transfer | Off-line | After measurement | Equivalent<br>Device<br>performance not<br>affected through<br>GSM function | ## Substantial Equivalence Discussion IEM considers the Tel-O-Graph and its accessories as substantially equivalent to the predicate device Stabil-O-Graph. The validation of two additional cuff sizes permits the use of the device in patients with arm circumferences of 20-55 cm. The intended use and user group are the same. The Tel-O-Graph has an advanced method for data transmission as compared to the predicate device. Wireless data transmission was expanded to enable data transmission via the mobile network (variant Tel-O-Graph GSM). The GSM transmission is equivalent to the data transmission of the FDA cleared device Asthma Monitor AM3 GSM (K133722). The differences between the Tel-O-Graph and the predicate device do not concern the operating principle and fundamental scientific technology. The device under application is as safe and effective as the predicate device, hence the Tel-O-Graph and the predicate device are substantially equivalent. {9}------------------------------------------------ # Tel-O-Graph ## Section 05: 510(k) Summary Image /page/9/Picture/4 description: The image shows a logo with the letters "IEM" next to a sphere. The letter "I" is to the left of the sphere, and the letters "E" and "M" are to the right. The letter "E" is partially superimposed on the sphere. The sphere is shaded to give it a three-dimensional appearance. There is a shadow under the sphere and the letters. ## Nonclinical and clinical testing Electrical safety and performance testing of the Tel-O-Graph was conducted by an external test laboratory to demonstrate conformance with recognized standards. Bench testing confirmed compliance with: - . IEC 60601-1: 2012 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance; - IEC 80601-2-30: 2009 Medical electrical equipment Part 2-30: Particular requirements . for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment (see exhibit 17G) The Tel-O-Graph meets the stated requirements for overall design, performance, biocompatibility, electrical safety and electromagnetic compatibility. - IEC 60601-1-2: 2014 Medical electrical equipment; Part 1: 2. General requirements for . basic safety and essential performance - Collateral standard: Electromagnetic disturbances - requirements and tests [Recognition Number 19-08] The device passed all testing in accordance with the applicable voluntary international standards. Biocompatibility testing focused on the blood pressure cuff (textile sheath and tube), as other materials, i.e. the ABS plastic of the casing, have a sufficient long history of use in this configuration. Based on risk analysis and in compliance with ISO 10993-1, IEM conducted Biocompatibility testing in accordance with the following voluntary standards: - . ISO 10993-1: 2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process [Recognition Number 2-220], - . ISO 10993-5: 2009, Biological Evaluation of Medical Devices – Part 5: Tests for in-vitro cytotoxicity [Recognition Number 2-245], - . ISO 10993-10: 2010, Biological Evaluation of Medical Devices – Part 10: Tests for irritation and skin sensitization [Recognition Number 2-174]. All tests were passed successfully. No relevant cytotoxic effect, sensitizing property or skin irritation was detected. Clinical performance testing of the Tel-O-Graph covers the Tel-O-Graph monitor and its accessories. The accuracy of blood pressure measurements was tested in accordance with the same arm sequential method described in section 5.2.4.2 of ISO 81060-2: 2013 - Non-invasive sphygmomanometers -- Part 2: Clinical validation of automated measurement type. {10}------------------------------------------------ # Tel-O-Graph Section 05: 510(k) Summary Image /page/10/Picture/4 description: The image shows a logo with the letters 'I', 'E', and 'M'. The 'I' and 'M' are in a bold, sans-serif font and are positioned next to each other. Above the 'I' and slightly overlapping it is a shaded sphere with the letter 'E' cut out of it. The overall design is simple and modern. The clinical validation of the measurement accuracy demonstrated appropriate measurement accuracy of the Tel-O-Graph according to ISO 81060-2:2013. ## Conclusion From Risk Assessment and from non-clinical and clinical device testing IEM concludes that the Tel-O-Graph device performs as well and is as save and effective as the predicate device. Performance testing confirms that product specifications are met in accordance with the technological characteristics and the intended use.