Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard EKG signal acquisition, transmission, display, and basic processing (saving, printing, report generation) using conventional hardware and software. There is no mention of AI/ML algorithms for signal analysis, interpretation, or diagnosis support beyond basic processing and display for healthcare professionals to interpret.

Therapeutic

No.
The device is intended for recording and transmitting EKG signals for cardiac monitoring and diagnosis, not for providing therapy. It explicitly states that "no treatment by drugs or other therapies should be initiated based solely on the measurements obtained with the device."

Diagnostic

Yes

The "Intended Use / Indications for Use" section states that the device is "intended for recording and transmitting standard electrocardiogram signals for cardiac monitoring and diagnosis by healthcare professionals." The "Device Description" also mentions "medical diagnosis support for qualified health care providers."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the delivery set includes an electronic unit, patient cable, batteries, and a Bluetooth adapter, in addition to the software. It also describes the hardware components involved in signal acquisition and transmission (electrodes, cables, amplifier channels, ADC, Bluetooth radio interface). Furthermore, the performance studies section mentions hardware qualification tests. This indicates the device is a combination of hardware and software, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the CloudEKG device is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
CloudEKG's Function: The CloudEKG device records and transmits electrical signals from the heart (electrocardiogram signals) directly from the patient's body. It does not analyze biological specimens.
Intended Use: The intended use is for recording and transmitting EKG signals for cardiac monitoring and diagnosis by healthcare professionals. This involves measuring physiological signals, not analyzing biological samples.

Therefore, the CloudEKG device falls under the category of a medical device that measures physiological parameters, but it is not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The CloudEKG device is a 12 standard leads battery operated unit intended for recording and transmitting standard electrocardiogram signals for cardiac monitoring and diagnosis by healthcare professionals.

Recorded signals are processed by the device and transmitted to a PC or hand-held monitoring device wirelessly using Bluetooth technology.

The transmitted signals are displayed on the monitoring device to allow for their review, analysis, saving. and printing by healthcare professionals.

CloudEKG can be used in adults and infants weighing less than 22 lbs (10 Kg) but is not appropriate for use to monitor critical patients or perform intracardiac recordings.

All measurements obtained with the CloudEKG device should take into account the patient's clinical symptoms and findings to be considered valid and no treatment by drugs or other therapies should be initiated based solely on the measurements obtained with the device.

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

DXH

Device Description

CloudEKG is a compact and mobile digital electrocardiograph system. When in connection wirelessly with a receiving unit, the device can be worn on a patient's body and serves as a stand alone EKG system for the following purposes:

. Acquiring EKG signals
Displaying, processing and storing EKG signals on the receiving unit with the . included POLY-SPECTRUM.NET software
. Cardiac monitoring and medical diagnosis support for qualified health care providers

The CloudEKG device is not intended for monitoring critical patients or for intra-cardiac use but can be used in outpatient clinical or doctor practice areas.

The device can also be operated by a properly trained patient for home monitoring purposes. The acquired EKG signals are transferred to an external receiving unit via a Bluetooth interface. The signals can be displayed, saved, read, printed and processed by a trained health care provider and transmitted remotely for further use.

The delivery set includes an electronic unit, a patient cable, 2 AA batteries, a Bluetooth adapter, software, and a user manual.

Depending on the chosen number of leads/standards for recording electrocardiographic signals, recordings can be made from:

1. Four (4) standard leads (Einthoven and Goldberger)
1. Six (6) standard leads (Wilson setup)

Sensors, button and tab electrodes can be connected to ColudEKG via electrode clips on the ECG cables. With the integrated data transmission technology, EKG data can be transmitted online to a nearby PC or handheld device unit for evaluation.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adults and infants weighing less than 22 lbs (10 Kg)

Intended User / Care Setting

Healthcare professionals in outpatient clinical or doctor practice areas. Can also be operated by a properly trained patient for home monitoring purposes.

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)

Performance evaluation of the features described in the CloudEKG user manual has been successfully completed utilizing hardware and software tests and validations. Hardware qualification is performed using the following industry standards:

. IEC60601-1:1988+A1:1991+A2:1995 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for . safety - Collateral standard: Safety requirements for medical electrical systems

. IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility requirements and tests

◆ IEC 60601-2-25:1993+A1:1999 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

IEC 60601-2-51: 2003 Medical electrical equipment - Part 2-51: Particular requirements . for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

The CloudEKG device software was tested as described in section 16 "Software" following the corresponding FDA software guidelines.

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

Not Found

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.

K082077

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.

Not Found

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

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).

Summary

0

510(k) Summary for the TeleEMG, LLC CloudEKG

(per 21 CFR 807.92 and http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm)

1. SUBMITTER/510(K) HOLDER

TeleEMG, LLC 65 Arlington Road Woburn, MA 01801, USA

Contact Person: Barry V. Ashar, Makromed, Inc. Telephone: (603) 890-3311 Date Prepared: February 24, 2014

2. DEVICE NAME

Proprietary Name: CloudEKG Common/Usual Name: Wireless electrocardiograph Classification Name: Transmitters and receivers, electrocardiograph, telephone Product Code: DXH

3. PREDICATE DEVICES

Corscience BT3/6, BT12, K082077

4. DEVICE DESCRIPTION

Physical Description

CloudEKG is a compact and mobile digital electrocardiograph system. When in connection wirelessly with a receiving unit, the device can be worn on a patient's body and serves as a stand alone EKG system for the following purposes:

. Acquiring EKG signals
Displaying, processing and storing EKG signals on the receiving unit with the . included POLY-SPECTRUM.NET software
. Cardiac monitoring and medical diagnosis support for qualified health care providers

The CloudEKG device is not intended for monitoring critical patients or for intra-cardiac use but can be used in outpatient clinical or doctor practice areas.

1

The device can also be operated by a properly trained patient for home monitoring purposes. The acquired EKG signals are transferred to an external receiving unit via a Bluetooth interface. The signals can be displayed, saved, read, printed and processed by a trained health care provider and transmitted remotely for further use.

The delivery set includes an electronic unit, a patient cable, 2 AA batteries, a Bluetooth adapter, software, and a user manual.

Depending on the chosen number of leads/standards for recording electrocardiographic signals, recordings can be made from:

1. Four (4) standard leads (Einthoven and Goldberger)
1. Six (6) standard leads (Wilson setup)

Sensors, button and tab electrodes can be connected to ColudEKG via electrode clips on the ECG cables. With the integrated data transmission technology, EKG data can be transmitted online to a nearby PC or handheld device unit for evaluation.

How the Device Functions

The device's principle of operation is based on the recording and transmission of electrocardiogram (EKG) signals to a PC or handheld device for the purpose of cardiac monitoring and diagnosis. The functional scheme of the device is represented in figure 5-1.

The ECG signals collected from the patient are transferred to 8 amplifier channels via the electrodes and cables. The amplified signals are then delivered to multi-channel analog-todigital converter (ADC).

The ADC processes the received information and transfers it to PC or handheld device via Bluetooth radio interface. The signals are processed with the POLY-SECTRUM.NET software, displayed and presented in different modes. The data can be stored, or processed to generate exam reports, or printed for qualified health care providers to interpret the result.

The required power supply for all electronic components of recording is provided by 2 AA alkaline batteries or rechargeable batteries.

2

Image /page/2/Figure/1 description: The image shows a block diagram of an ECG system. The system consists of several components, including amplifiers for 10 ECG channels, an ADC, a central processor, a Bluetooth module, and a supply unit. The amplifiers receive input from electrodes labeled FD, LD, CH1 through CH8, R, and N. The central processor is connected to indicators for battery discharge, operation, and Bluetooth operation.

Figure 5-1. Device Functional Scheme

Scientific Concepts that form the Basis for the Device

Electrocardiography (ECG or EKG from the German Elektrokardiogramm) is a noninvasive technique for recording and evaluating electrical activity in the heart. EKG is performed using an instrument called an electrocardiograph, to produce a record called an electrocardiogram generated by the heart muscle cell depolarization during each heartbeat.

The EKG signals can be used to identify if the heart muscle or neural tissues have been damaged and/or to measure the effects of drugs or devices used to regulate the heart, such as a pacemaker.

Significant Physical and Performance Characteristics of the Device, such as Device Design, Material Used, and Physical Properties

The CloudEKG delivery set consists of an electronic unit, a patient cable, 2 AA batteries, a Bluetooth adapter, software and a user manual.

3

Image /page/3/Figure/1 description: The image shows a device labeled as "CloudEKG" with various indicators and buttons. The device features an on/off button, indicators for BT operation, battery discharge, and general operation. It also includes a clamp for electronic unit fixation and a battery compartment. The device's serial number is 03320209, and it is made in Russia.

CloudEKG electronic unit (140 × 70 × 24mm)

Image /page/3/Picture/3 description: In the image, a coiled cable with multiple wires and connectors is displayed against a white background. The cable appears to be composed of numerous individual wires bundled together, with a connector visible at each end. The wires are predominantly gray or white, with occasional colored markings or labels near the connectors, which are light gray.

Patient cable

5. INTENDED USE

The CloudEKG device is a 12 standard leads battery operated unit intended for recording and transmitting standard electrocardiogram signals for cardiac monitoring and diagnosis by healthcare professionals.

Recorded signals are processed by the device and transmitted to a PC or hand-held monitoring device wirelessly using Bluetooth technology.

The deterial

4

The transmitted signals are displayed on the monitoring device to allow for their review, analysis, saving, and printing by healthcare professionals.

CloudEKG can be used in adults and infants weighing less than 22 lbs (10 Kg) but is not appropriate for use to monitor critical patients or perform intracardiac recordings.

All measurements obtained with the CloudEKG device should take into account the patient's clinical symptoms and findings to be considered valid and no treatment by drugs or other therapies should be initiated based solely on the measurements obtained with the device.

6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE

| Parameter | CloudEKG | Predicate Device
Corscience BT3/6, BT12 |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The CloudEKG device is a 12
standard leads battery operated unit
intended for recording and
transmitting standard
electrocardiogram signals for cardiac
monitoring and diagnosis by
healthcare professionals.

Recorded signals are processed by the
device and transmitted to a PC or
hand-held monitoring device
wirelessly using Bluetooth
technology.

The transmitted signals are displayed
on the monitoring device to allow for
their review, analysis, saving, and
printing by healthcare professionals.

CloudEKG can be used in adults and
infants weighing less than 22 lbs (10
Kg) but is not appropriate for use to
monitor critical patients or perform
intracardiac recordings.

All measurements obtained with the
CloudEKG device should take into
account the patient's clinical | The BT3/6 (3/6-lead) and BT12 (12-
lead), hereafter referred to as the
"BT devices", are battery powered
devices capable of acquiring and
transmitting a standard
electrocardiogram (EKG) to be applied
by medically trained persons for the
purpose of cardiac monitoring and
diagnosis performed by medical
professionals. The collected data is not
interpreted by the BT device as this is
done by the monitoring device
operated by medical professionals. The
collected data is processed by the BT
device and then transmitted via a
standard wireless link to a monitoring
device, such as a PC or hand-held
device for display, review, printing,
saving and post event processing by
medical professionals. Use of the BT
devices is not restricted to adult
population, but is also intended for
infants weighing less than 10 kg (22
lbs.).

Table 5-1. Side-by-Side Comparison of the Proposed Device with Cited Predicate Device

5

K130878

·

6

7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

Performance Testing

Performance evaluation of the features described in the CloudEKG user manual has been successfully completed utilizing hardware and software tests and validations. Hardware qualification is performed using the following industry standards:

. IEC60601-1:1988+A1:1991+A2:1995 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for . safety - Collateral standard: Safety requirements for medical electrical systems

. IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility requirements and tests

◆ IEC 60601-2-25:1993+A1:1999 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

IEC 60601-2-51: 2003 Medical electrical equipment - Part 2-51: Particular requirements . for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

The CloudEKG device software was tested as described in section 16 "Software" following the corresponding FDA software guidelines.

Biocompatibility Testing

TeleEMG does not provide electrodes in the delivery set of CloudEKG. Therefore, this testing is not applicable.

CLINICAL TESTING AS BASIS FOR SUBSTANTIAL SUMMARY OF 8. EQUIVALENCE

No clinical testing was conducted to support this submission.

9. SUMMARY OF OTHER INFORMATION

No other information is available.

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10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

Based on the information and supporting documentation provided in the premarket notification, the CloudEKG device is substantially equivalent to the cited predicate device. Testing demonstrates that the CloudEKG device fulfills prospectively defined design and performance specifications.

8

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human figure with three arms or lines extending from the body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the graphic.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 4, 2014

TeleEMG, LLC c/o Barry V. Ashar Makromed, Inc. 88 Stiles Road Salem, New Hampshire 03079 US

K130878 Re:

Trade/Device Name: CloudEKG Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II Product Code: DXH Dated: March 6, 2014 Received: March 7, 2014

Dear Mr. Barry Ashar:

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 than a 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

9

Page 2 - Mr. Barry Ashar

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman -S

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

10

Indications for Use

510(k) Number (K130878):

Device Name: CloudEKG

Indications for Use:

The CloudEKG device is a 12 standard leads battery operated unit intended for recording and transmitting standard electrocardiogram signals for cardiac monitoring and diagnosis by healthcare professionals.

Recorded signals are processed by the device and transmitted to a PC or hand-held monitoring device wirelessly using Bluetooth technology.

The transmitted signals are displayed on the monitoring device to allow for their review, analysis, saving. and printing by healthcare professionals.

CloudEKG can be used in adults and infants weighing less than 22 lbs (10 Kg) but is not appropriate for use to monitor critical patients or perform intracardiac recordings.

All measurements obtained with the CloudEKG device should take into account the patient's clinical symptoms and findings to be considered valid and no treatment by drugs or other therapies should be initiated based solely on the measurements obtained with the device.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of Device Evaluation (ODE)

Bram D. Zuckerman -S 2014.04.04 15:34:32 -04'00'

TeleEMG LLC, Traditional 510(k) CloudEKG