CLOUDEKG

{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) - 2. 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<br>Corscience BT3/6, BT12 | |---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | The CloudEKG device is a 12<br>standard leads battery operated unit<br>intended for recording and<br>transmitting standard<br>electrocardiogram signals for cardiac<br>monitoring and diagnosis by<br>healthcare professionals.<br><br>Recorded signals are processed by the<br>device and transmitted to a PC or<br>hand-held monitoring device<br>wirelessly using Bluetooth<br>technology.<br><br>The transmitted signals are displayed<br>on the monitoring device to allow for<br>their review, analysis, saving, and<br>printing by healthcare professionals.<br><br>CloudEKG can be used in adults and<br>infants weighing less than 22 lbs (10<br>Kg) but is not appropriate for use to<br>monitor critical patients or perform<br>intracardiac recordings.<br><br>All measurements obtained with the<br>CloudEKG device should take into<br>account the patient's clinical | The BT3/6 (3/6-lead) and BT12 (12-<br>lead), hereafter referred to as the<br>"BT devices", are battery powered<br>devices capable of acquiring and<br>transmitting a standard<br>electrocardiogram (EKG) to be applied<br>by medically trained persons for the<br>purpose of cardiac monitoring and<br>diagnosis performed by medical<br>professionals. The collected data is not<br>interpreted by the BT device as this is<br>done by the monitoring device<br>operated by medical professionals. The<br>collected data is processed by the BT<br>device and then transmitted via a<br>standard wireless link to a monitoring<br>device, such as a PC or hand-held<br>device for display, review, printing,<br>saving and post event processing by<br>medical professionals. Use of the BT<br>devices is not restricted to adult<br>population, but is also intended for<br>infants weighing less than 10 kg (22<br>lbs.).<br><br>Measurements taken by the BT devices<br>are only significant if considered in<br>connection with other clinical findings | | Parameter | CloudEKG | Predicate Device<br>Corscience BT3/6, BT12 | | | symptoms and findings to be<br>considered valid and no treatment by<br>drugs or other therapies should be<br>initiated based solely on the<br>measurements obtained with the<br>device. | No therapy or drugs can be<br>administered based solely on ECG data<br>derived from the BT devices. BT<br>devices are not intended for monitoring<br>critical patients and are not intended<br>for intracardiac use. | | Compatible ECG<br>electrodes | Any ECG electrodes legally marketed<br>in the U.S. | Only use bio-compatible and CE-<br>approved ECG electrodes with the<br>ECG measuring unit | | ECG data processing<br>software | Heart rate and QRS axis calculation.<br>No ECG interpretation for Poly-<br>Spectrum.net software | Heart rate and QRS axis calculation.<br>No ECG interpretation for VM300<br>software | | Input dynamic range | +/- 10 mV | +/- 5 mV | | Frequency response<br>bandwidth | 0.05-150 Hz | 0.05-150 Hz / according to EC11 and<br>IEC 60601-2-51 | | Resolution | 24 bit A/D converter | 24 bit A/D converter (15 bit<br>transmitted)<br>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 mA<br>Stand-by: Not more than 40 mA | For BT12:<br>Operation (incl. transmission): 148 mA<br>Stand-by: 37 mA | | Battery type | 2 Batteries of AA type | 2 × 1.5V alkaline or<br>2 × 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 is<br>interrupted | | Temperature range | Operation: 10-35°C<br>Storage: 5-40°C | Operation: 0-50°C<br>Storage: -20-70°C | | Display | No | LCD | | Weight | Electronic unit: 200 g incl. batteries | 260 g incl. batteries and cable<br>154 g without batteries, incl. cable | | Electronic unit<br>Dimension 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 product<br>Brochure) | | Degree of protection<br>against penetration of<br>water | IPX0 | IPX3 | | Classification | BF | BF | | Defibrillation<br>protection | The electronic unit conforms to IEC<br>60601-1 standard requirements of<br>defibrillator impulse protection | Device itself is not defibrillation proof,<br>but ECG patient cable supplied with<br>device by manufacturer has | | Parameter | CloudEKG | Predicate Device<br>Corscience BT3/6, BT12 | | | Patient cable includes defibrillation<br>protection circuit. | defibrillation protection circuit. Note in manual that guarantee of defibrillation<br>protection can be given only in<br>combination with original cable. | #### 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. {7}------------------------------------------------ #### 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