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.

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.

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.

AI/ML Overview

The provided 510(k) summary for the TeleEMG, LLC CloudEKG details non-clinical performance testing but does not include any clinical trial data or a study providing acceptance criteria and performance against those criteria. The document explicitly states: "No clinical testing was conducted to support this submission."

Therefore, I cannot provide the requested information regarding acceptance criteria derived from clinical studies, human reader improvement with AI, or standalone algorithm performance, as these are not present in the provided text.

However, I can extract information related to the non-clinical performance testing and the product's specifications as a comparison to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

As no clinical acceptance criteria or direct performance metrics against such criteria are reported in a comparative study for the CloudEKG, this table summarizes the technical specifications compared to the predicate device, which implicitly serve as performance benchmarks for substantial equivalence. The "Acceptance Criteria" column reflects the predicate device's performance, as the CloudEKG is deemed substantially equivalent based on meeting similar technical specifications.

Parameter	Predicate Device (Corscience BT3/6, BT12) "Acceptance Criteria"	CloudEKG Reported Performance
Intended Use	Cardiac monitoring and diagnosis by medically trained persons. Not for critical patients or intracardiac use. Valid only with other clinical findings. Infants < 10 kg.	Cardiac monitoring and diagnosis by healthcare professionals. Not for critical patients or intracardiac use. Valid only with other clinical findings. Infants < 10 kg.
Compatible ECG electrodes	Bio-compatible and CE-approved ECG electrodes	Any ECG electrodes legally marketed in the U.S.
ECG data processing software	Heart rate and QRS axis calculation. No ECG interpretation.	Heart rate and QRS axis calculation. No ECG interpretation for Poly-Spectrum.net software.
Input dynamic range	+/- 5 mV	+/- 10 mV
Frequency response bandwidth	0.05-150 Hz / according to EC11 and IEC 60601-2-51	0.05-150 Hz
Resolution	24 bit A/D converter (15 bit transmitted); 2.58 µV/bit	24 bit A/D converter
Leads	3/6 or 12	3/6 or 12
CMRR	>94 dB	100 dB
Pacemaker detection	Yes	Yes
Current consumption (Operation)	148 mA (BT12)	Not more than 140 mA
Current consumption (Stand-by)	37 mA (BT12)	Not more than 40 mA
Battery type	2 × 1.5V alkaline or 2 × 1.2V rechargeable	2 Batteries of AA type
Input impedance	20 MΩ	≥ 20 MΩ
DC offset correction	± 190 mA	± (300 ± 30) mV
ECG storage capacity	5 min/12 channel when transmission is interrupted	No
Temperature range (Operation)	0-50°C	10-35°C
Temperature range (Storage)	-20-70°C	5-40°C
Display	LCD	No
Weight	260 g incl. batteries and cable; 154 g without batteries	Electronic unit: 200 g incl. batteries
Electronic unit Dimension	61 × 106 × 23 mm	140 × 70 × 24 mm
A to D sampling rate	500 samples/sec	User-defined, 250, 500 and 1000 Hz
Data transmission	Wireless (Bluetooth)	Bluetooth radio channel
Degree of protection against water	IPX3	IPX0
Classification	BF	BF
Defibrillation protection	Patient cable includes protection circuit.	Electronic unit conforms to IEC 60601-1. Patient cable includes defibrillation protection circuit.

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

Not applicable. The submission explicitly states, "No clinical testing was conducted to support this submission." Performance evaluation was limited to hardware and software tests and validations against industry standards.

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

Not applicable. No clinical testing, and therefore no expert-established ground truth, was used for a test set.

4. Adjudication Method for the Test Set

Not applicable. No clinical testing was performed, so no adjudication method was used for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The CloudEKG is a hardware device for acquiring and transmitting EKG signals, not an AI-based interpretation system. No MRMC study was conducted, and no AI is mentioned for enhancing human reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The CloudEKG is a hardware device, and its software focuses on signal processing and display, not standalone diagnostic interpretation. The document explicitly states: "No ECG interpretation for Poly-Spectrum.net software."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable for clinical ground truth. For non-clinical performance, the "ground truth" was defined by industry standards (e.g., IEC 60601 series for medical electrical equipment and electrocardiographs) and functional specifications verified through hardware and software tests.

8. The sample size for the training set

Not applicable for clinical data. The device's software performs signal processing and display, not interpretation based on a trained model.

9. How the ground truth for the training set was established

Not applicable for clinical data. The device does not utilize a training set in the context of machine learning for diagnostic interpretation. Its "ground truth" for non-clinical testing was based on compliance with established engineering and safety standards.

Summary

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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

. 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.

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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)

How the Device Functions

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

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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.

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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

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

The deterial

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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.

6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE

Parameter	CloudEKG	Predicate DeviceCorscience BT3/6, BT12
Intended use	The CloudEKG device is a 12standard leads battery operated unitintended for recording andtransmitting standardelectrocardiogram signals for cardiacmonitoring and diagnosis byhealthcare professionals.Recorded signals are processed by thedevice and transmitted to a PC orhand-held monitoring devicewirelessly using Bluetoothtechnology.The transmitted signals are displayedon the monitoring device to allow fortheir review, analysis, saving, andprinting by healthcare professionals.CloudEKG can be used in adults andinfants weighing less than 22 lbs (10Kg) but is not appropriate for use tomonitor critical patients or performintracardiac recordings.All measurements obtained with theCloudEKG device should take intoaccount the patient's clinical	The BT3/6 (3/6-lead) and BT12 (12-lead), hereafter referred to as the"BT devices", are battery powereddevices capable of acquiring andtransmitting a standardelectrocardiogram (EKG) to be appliedby medically trained persons for thepurpose of cardiac monitoring anddiagnosis performed by medicalprofessionals. The collected data is notinterpreted by the BT device as this isdone by the monitoring deviceoperated by medical professionals. Thecollected data is processed by the BTdevice and then transmitted via astandard wireless link to a monitoringdevice, such as a PC or hand-helddevice for display, review, printing,saving and post event processing bymedical professionals. Use of the BTdevices is not restricted to adultpopulation, but is also intended forinfants weighing less than 10 kg (22lbs.).Measurements taken by the BT devicesare only significant if considered inconnection with other clinical findings
Parameter	CloudEKG	Predicate DeviceCorscience BT3/6, BT12
	symptoms and findings to beconsidered valid and no treatment bydrugs or other therapies should beinitiated based solely on themeasurements obtained with thedevice.	No therapy or drugs can beadministered based solely on ECG dataderived from the BT devices. BTdevices are not intended for monitoringcritical patients and are not intendedfor intracardiac use.
Compatible ECGelectrodes	Any ECG electrodes legally marketedin the U.S.	Only use bio-compatible and CE-approved ECG electrodes with theECG measuring unit
ECG data processingsoftware	Heart rate and QRS axis calculation.No ECG interpretation for Poly-Spectrum.net software	Heart rate and QRS axis calculation.No ECG interpretation for VM300software
Input dynamic range	+/- 10 mV	+/- 5 mV
Frequency responsebandwidth	0.05-150 Hz	0.05-150 Hz / according to EC11 andIEC 60601-2-51
Resolution	24 bit A/D converter	24 bit A/D converter (15 bittransmitted)2.58 $μ$ V/bit
Leads	3/6 or 12	3/6 or 12
CMRR	100 dB	>94 dB
Pacemaker detection	Yes	Yes
Current consumption	Operation: Not more than 140 mAStand-by: Not more than 40 mA	For BT12:Operation (incl. transmission): 148 mAStand-by: 37 mA
Battery type	2 Batteries of AA type	2 × 1.5V alkaline or2 × 1.2V rechargeable
Input impedance	$≥$ 20 MΩ	20 MΩ
DC offset correction	$±$ (300 $±$ 30) mV	$±$ 190 mA
ECG storage capacity	No	5 min/12 channel when transmission isinterrupted
Temperature range	Operation: 10-35°CStorage: 5-40°C	Operation: 0-50°CStorage: -20-70°C
Display	No	LCD
Weight	Electronic unit: 200 g incl. batteries	260 g incl. batteries and cable154 g without batteries, incl. cable
Electronic unitDimension in mm	140 × 70 × 24	61 × 106 × 23
A to D sampling rate	User-defined, 250, 500 and 1000 Hz	500 samples/sec
Data transmission	Bluetooth radio channel	Wireless (Bluetooth in their productBrochure)
Degree of protectionagainst penetration ofwater	IPX0	IPX3
Classification	BF	BF
Defibrillationprotection	The electronic unit conforms to IEC60601-1 standard requirements ofdefibrillator impulse protection	Device itself is not defibrillation proof,but ECG patient cable supplied withdevice by manufacturer has
Parameter	CloudEKG	Predicate DeviceCorscience BT3/6, BT12
	Patient cable includes defibrillationprotection circuit.	defibrillation protection circuit. Note in manual that guarantee of defibrillationprotection can be given only incombination with original cable.

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

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K130878

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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.

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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

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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

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Indications for Use

510(k) Number (K130878):

Device Name: CloudEKG

Indications for Use:

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.

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

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).