Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI/ML components or algorithms. The performance studies focus on standard accuracy and safety testing, not AI/ML model validation.

Therapeutic

No.
The device is intended for the measurement of blood pressure and pulse, which is a diagnostic function, not a therapeutic one.

Diagnostic

Yes
The device is intended for the home measurement of blood pressure and pulse, which are diagnostic indicators of health. Accurate measurement of these parameters supports the diagnosis and monitoring of conditions such as hypertension.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "table-top device for upper arm blood pressure measurements" and employs the "oscillometric principle" using a "pressurized cuff," indicating it is a hardware device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Tel-O-Graph is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
Tel-O-Graph Function: The Tel-O-Graph measures blood pressure and pulse directly on the upper arm using the oscillometric principle. This is a non-invasive measurement taken on the body, not a test performed on a specimen taken from the body.
Intended Use: The intended use clearly states "home measurement of blood pressure and pulse on the upper arm." This aligns with a physiological measurement device, not an IVD.

Therefore, the Tel-O-Graph is a physiological monitoring device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

DXN

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper arm

Indicated Patient Age Range

adults

Intended User / Care Setting

Home environment

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

The clinical validation of the measurement accuracy demonstrated appropriate measurement accuracy of the Tel-O-Graph according to ISO 81060-2:2013.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Pressure accuracy: ±3 mmHg
Pulse rate accuracy: ±2% or ±3 bpm (whichever is greater)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K041313 Stabil-O-Graph

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K133722

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

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

1

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 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)
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

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Office of Chief Information Officer

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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."

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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

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.

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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 measurement
range	30 to 290
Systolic: 60 – 290
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
(operation, transport and storage)	15 to 93	%
Battery capacity	c. 500	measurements
Transmission time	c. 5	min
Data connection
(depending on variant)	Bluetooth or
Mobile communication network
Data transmission
(depending on variant)	Class 1 Bluetooth
or 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 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
(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 blood
pressure measurement
system. | 870.1130 Noninvasive blood
pressure measurement
system. | same |
| Product Code | DXN | DXN | same |
| Indications for
Use | The Stabil-O-Graph is
intended to be used by
adults at home to monitor
Blood Pressure (systolic and
diastolic) and pulse rate from
the upper arm with arm
circumference ranging from
9.4 inches to 16.5 inches (24
cm to 42 cm) | 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.

Weight. approx. 270 g
including batteries | Casing dimensions:
152 x 110 x 57mm,

Cuffs in 2 different sizes
24-32cm
32-38cm | Material:
Polyester Textile sheath
Bladder: TPU
Tube: PVC

Cuffs in 4 different sizes:
20-24cm
24-32cm
32-38cm
38-55cm | Equivalent
Same materials used

Storage environment:
-20°C to 50°C
15% to 95%rH | Operating conditions:
+5°C to +40°C

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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 Asthma
Monitor AM3 GSM
(reference) | Tel-O-Graph GSM
(candidate) | Comparison |
|--------------|-----------------------------------------------------|------------------------------------------------|----------------------------------------------------------------------------------------------|
| | K133722 | K173895 | |
| Transmission | Serial (RS232), USB,
Bluetooth, GSM | Bluetooth, GSM | Equivalent in terms
of BT and GSM
transmission. Serial
and USB are not
wireless. |
| EMC testing | Done with whole
device | Done with whole
device (Tel-O-Graph
GSM) | 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 and
transmitted | Result of
measurement
(always with date
and time) | Result of
measurement
together with date
and time | Equivalent |
|------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| GSM Interface | Sierra Wireless
WISMO288
GSM module | Cinterion ESH 6
GSM module | Equivalent
Both modules use
techniques to
guarantee the
integrity of the
transferred data. |
| GSM reception | No critical data
transmitted
Data stored in
nonvolatile memory | No critical data
transmitted
Storage of up to 350
measurements | Equivalent
Transmission not
time critical |
| Time point of
GSM data transfer | Off-line | After measurement | Equivalent
Device
performance not
affected through
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.

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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.