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.

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 operated via a single button to initiate blood pressure measurements. Data is transmitted automatically. The device is used by patients in a home environment.

AI/ML Overview

The provided text is a 510(k) summary for the Tel-O-Graph non-invasive blood pressure measurement system. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard ISO 81060-2:2013)	Reported Device Performance (Tel-O-Graph)
Section 2.2.3.1 (Mean difference and standard deviation of differences)	Clinical validation demonstrated "appropriate measurement accuracy" according to ISO 81060-2:2013. Specific numerical values for mean difference and standard deviation of differences are not explicitly provided in this summary.
Section 2.2.3.2 (Standard deviation of differences)	Clinical validation demonstrated "appropriate measurement accuracy" according to ISO 81060-2:2013. Specific numerical value for standard deviation of differences is not explicitly provided in this summary.
Pressure accuracy (technical specification)	±3 mmHg
Pulse rate accuracy (technical specification)	±2% or ±3 bpm (whichever is greater)
Electrical safety	Compliance with IEC 60601-1:2012
Essential performance of automatic cycling NIBP	Compliance with IEC 80601-2-30:2009
Electromagnetic compatibility	Compliance with IEC 60601-1-2:2014
Biocompatibility (blood pressure cuff)	Compliance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010. All tests passed successfully; no relevant cytotoxic effect, sensitizing property, or skin irritation detected.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the clinical validation study (test set). It only mentions that the study was conducted in accordance with ISO 81060-2:2013.
The country of origin for the data is not specified, but the manufacturer (IEM GmbH) is located in Germany. The study is assumed to be prospective as it's a clinical validation study for a new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document refers to the ISO 81060-2:2013 standard for clinical validation of automated measurement type sphygmomanometers. This standard typically requires measurements by trained observers, but the number of experts/observers and their specific qualifications are not detailed in this 510(k) summary.

4. Adjudication Method for the Test Set

The document states that 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." This method involves simultaneous or sequential measurements by a trained observer (ground truth) and the device. However, the specific adjudication method (e.g., 2+1, 3+1 for resolving discrepancies) for the reference measurements or device vs. reference measurements is not explicitly described in this summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool where human readers would collaborate with AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance assessment was conducted for the Tel-O-Graph. The clinical validation, electrical safety, essential performance, EMC, and biocompatibility testing all assess the device's inherent performance without human intervention in the measurement process (other than operating the device as intended).

7. The Type of Ground Truth Used

For the clinical validation of blood pressure measurement accuracy, the ground truth would be established by trained human observers using a reference sphygmomanometer, as dictated by the ISO 81060-2:2013 standard. For other tests like electrical safety, EMC, and biocompatibility, the ground truth is defined by the requirements of the respective international standards.

8. The Sample Size for the Training Set

The document does not mention any training set for the device. Blood pressure monitors like the Tel-O-Graph are typically designed using established engineering principles and algorithms, then extensively tested, rather than being "trained" in the machine learning sense.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned or implied for this type of device, this question is not applicable.

Summary

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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). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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

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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 data measured is automatically transmitted.

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)

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Tel-O-Graph

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

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.

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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 measurementrange	30 to 290Systolic: 60 – 290Diastolic: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(operation, transport and storage)	15 to 93	%
Battery capacity	c. 500	measurements
Transmission time	c. 5	min
Data connection(depending on variant)	Bluetooth orMobile communication network
Data transmission(depending on variant)	Class 1 Bluetoothor GPRS Class 12

Table 5A: Summary of technical data

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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 data measured is automatically transmitted.

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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(predicate)	Tel-O-Graph(candidate)	Comparison of equivalence /differences
510(k) Number	K041313	K173895	same
Manufacturer	IEM GmbH	IEM GmbH	same
Classification	Class II	Class II	same
Classification Name	870.1130 Noninvasive bloodpressure measurementsystem.	870.1130 Noninvasive bloodpressure measurementsystem.	same
Product Code	DXN	DXN	same
Indications forUse	The Stabil-O-Graph isintended to be used byadults at home to monitorBlood Pressure (systolic anddiastolic) and pulse rate fromthe upper arm with armcircumference ranging from9.4 inches to 16.5 inches (24cm to 42 cm)	The Tel-O-Graph is intendedfor the home measurementof blood pressure and pulseon the upper arm in adults.The blood pressure monitoris suitable for individuals withan arm circumference of 20-55 cm (7.9-21.7 in) whenused with the correspondingmonitor cuff size.The data measured isautomatically transmitted.	Equivalent
Variants	Stabil-O-Graph mobil	Tel-O-Graph BT / GSM	Equivalent, difference only indata transmission
Principle ofoperation/measurement	Oscillometric	Oscillometric	Same
Measurementrange	Systolic: 70 - 260 mmHgDiastolic:45 - 180 mmHgPulse: 40-240 bpm	Systolic: 60 - 290 mmHgDiastolic:30 - 195 mmHgPulse: 30-240 bpm	Equivalent
Accuracy BPmeasurement	$\pm$ 3 mmHg	$\pm$ 3 mmHg	Equivalent
Memory	50 blood pressuremeasurements	350 blood pressuremeasurements	EquivalentTel-O-Graph automaticallytransmits the measured data.Memory is only backup in case oftransmission problems
User interaction	2 buttons: "START/STOP"and "MENU"	1 button
Dimension andweight	Casing dimensions:125 x 131 x 51 mm ,Weight. approx. 270 gincluding batteries	Casing dimensions:152 x 110 x 57mm,Weight: approx. 325 gexcluding batteries	Equivalent:Differences in design of housingare not affecting safety orperformance.
Materials	Casing: ABSDisplay: LCD	Casing: ABSDisplay: LCD	Equivalent
	Stabil-O-Graph(predicate)	Tel-O-Graph(candidate)	Comparison of equivalence / differences
Accessories:cuffs	Material:Polyester Textile sheathBladder: TPUTube: PVCCuffs in 2 different sizes24-32cm32-38cm	Material:Polyester Textile sheathBladder: TPUTube: PVCCuffs in 4 different sizes:20-24cm24-32cm32-38cm38-55cm	EquivalentSame materials usedThe additional cuff sizes do not affect the safety of the device;clinical validation covers all cuff sizes
Power supply	2 alkaline 1.5 V batteries(AA)	4 alkaline 1.5 V batteries(AA)	EquivalentBoth are battery operated devices.
Biocompatibility	Compliance withISO 10993-1	Compliance withISO 10993-1	EquivalentTesting updated according to current standards
Environmentalconditions	Operating conditions: +10°Cto +40°C)Storage environment:-20°C to 50°C15% to 95%rH	Operating conditions:+5°C to +40°CStorage environment:-25 °C to 70 °C15% to 93% rH	Equivalent
Datatransmission	Infrared, Bluetooth	Bluetooth, GSM	Equivalent:All are open digital technologies for data transmission; Infrared is considered as not being state-of-the-art any more

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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 AsthmaMonitor AM3 GSM(reference)	Tel-O-Graph GSM(candidate)	Comparison
	K133722	K173895
Transmission	Serial (RS232), USB,Bluetooth, GSM	Bluetooth, GSM	Equivalent in termsof BT and GSMtransmission. Serialand USB are notwireless.
EMC testing	Done with wholedevice	Done with wholedevice (Tel-O-GraphGSM)	Equivalent

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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 andtransmitted	Result ofmeasurement(always with dateand time)	Result ofmeasurementtogether with dateand time	Equivalent
GSM Interface	Sierra WirelessWISMO288GSM module	Cinterion ESH 6GSM module	EquivalentBoth modules usetechniques toguarantee theintegrity of thetransferred data.
GSM reception	No critical datatransmittedData stored innonvolatile memory	No critical datatransmittedStorage of up to 350measurements	EquivalentTransmission nottime critical
Time point ofGSM data transfer	Off-line	After measurement	EquivalentDeviceperformance notaffected throughGSM 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.

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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.

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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.

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).