MobileECG 2 BT

K181658 · Memtec Corporation · DSI · Mar 26, 2019 · Cardiovascular

Device Facts

• Record ID: K181658
• Device Name: MobileECG 2 BT
• Applicant: Memtec Corporation
• Product Code: DSI · Cardiovascular
• Decision Date: Mar 26, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Configuration 1) Holter Mode: The MobileECG 2 BT is intended to record continuous data for 30+ days for the detection of arrhythmias in ambulatory patients. Such monitoring is frequently used for patient symptoms such as: Palpitations, shortness of breath, chest pain, syncope, evaluating pacemakers, heart rate variability's, and clinical studies. The MobileECG 2 BT device transmits all collected data to a call center for interpretation using the TM eCloud ECG Analysis System at the end of the completed study. Configuration 2) Mobile Cardiac Telement Mode: The MobileECG 2 BT is intended to continuously monitor, transmit, and record data for up to 30 days for patient transient symptoms that may suggest cardiac arrhythmia. The MobileECG 2 BT device continuously transmits data to a call center for interpretation of ECG data using the TM eCloud ECG Analysis System. Configuration 3) Event Mode: The MobileECG 2 BT is intended to monitor and record patient activated data for up to 30 days for patient transient symptoms that may suggest cardiac arrhythmia. The MobileECG 2 BT device transmits all patient event activated data to a call center for interpretation of ECG data using the TM eCloud ECG Analysis System. The MobileECG 2 BT is intended for use in adults and children of any age from birth upwards. The MobileECG 2 BT and the TM eCloud ECG Analysis System interpretation software is not intended as sole means of diagnosis and is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG.

Device Story

MobileECG 2 BT is a 3-in-1 digital ambulatory monitor (Holter, Event, MCT) recording high-resolution ECG data and pacemaker spikes. Device inputs: ECG signals via electrodes. Operation: Data stored on removable Micro SD card or transmitted via Bluetooth (BLE 4.1) to a smartphone app for real-time cellular transmission to a call center. Output: ECG data analyzed by TM eCloud ECG Analysis System. Used in clinic or home settings by patients; monitored by technicians at a call center. Device features LCD for real-time signal verification and lead hook-up confirmation. Healthcare providers use analyzed reports to assist in diagnosing cardiac arrhythmias. Benefits include long-term (30+ days) continuous monitoring for transient symptoms.

Clinical Evidence

Bench testing only. Device performance verified against FDA-recognized standards including ANSI/AAMI ES60601-1, ANSI/AAMI IEC 60601-1-2, and ANSI/AAMI-IEC 60601-2-47. No clinical trial data presented.

Technological Characteristics

Digital ECG monitor; 1, 2, 3, or 8 channels; 12-bit resolution; 250/500/1000 Hz sampling. Powered by single AAA alkaline/lithium battery. Connectivity: Bluetooth BLE 4.1, USB 3.0, Micro SD. Enclosure: Molded plastic. Standards: ANSI/AAMI ES60601-1, ANSI/AAMI IEC 60601-1-2, ANSI/AAMI-IEC 60601-2-47, ANSI/AAMI EC53. Lead-off detection and low battery indication included.

Indications for Use

Indicated for adults and children (birth upwards) with symptoms suggesting cardiac arrhythmia (palpitations, shortness of breath, chest pain, syncope), pacemaker evaluation, heart rate variability assessment, or clinical studies.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• Preventice BodyGuardian DSI (K151188)
• Memtec Corporation Model 950-12L (K102723)

Reference Devices

• TM eCloud ECG Analysis System (K142349)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 26, 2019

Memtec Corporation Dennis Garboski President 68 Stiles Road Unit D Salem, New Hampshire 03079

#### Re: K181658

Trade/Device Name: MobileECG 2 BT Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: DSI, MWJ Dated: February 21, 2019 Received: February 26, 2019

#### Dear Dennis Garboski:

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 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

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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 (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Jessica E. Paulsen -S

for

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 (if known) K181658

Device Name

MobileECG 2 BT

Indications for Use (Describe) Indications for Use

Configuration 1) Holter Mode: The MobileECG 2 BT is intended to record continuous data for 30+ days for the detection of arrhythmias in ambulatory patients. Such monitoring is frequently used for patient symptoms such as: Palpitations, shortness of breath, chest pain, syncope, evaluating pacemakers, heart rate variability's, and clinical studies. The MobileECG 2 BT device transmits all collected data to a call center for interpretation using the TM eCloud ECG Analysis System at the end of the completed study.

Configuration 2) Mobile Cardiac Telement Mode: The MobileECG 2 BT is intended to continuously monitor, transmit, and record data for up to 30 days for patient transient symptoms that may suggest cardiac arrhythmia. The MobileECG 2 BT device continuously transmits data to a call center for interpretation of ECG data using the TM eCloud ECG Analysis System.

Configuration 3) Event Mode: The MobileECG 2 BT is intended to monitor and record patient activated data for up to 30 days for patient transient symptoms that may suggest cardiac arrhythmia. The MobileECG 2 BT device transmits all patient event activated data to a call center for interpretation of ECG data using the TM eCloud ECG Analysis System.

The MobileECG 2 BT is intended for use in adults and children of any age from birth upwards.

The MobileECG 2 BT and the TM eCloud ECG Analysis System interpretation software is not intended as sole means of diagnosis and is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG.

Type of Use (*Select one or both, as applicable*)

| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;">☑</span> |
|----------------------------------------------|-----------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 20px;">☐</span> |

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## 007 510(K) Summary

## 510(k) Summary

#### Date: 11/28/2018

### 1. General Information

| Submitter's Name: | Dennis Garboski<br>Memtec Corporation<br>68 Stiles Road Unit D<br>Salem, NH 03079 |
|------------------------|-----------------------------------------------------------------------------------|
| Telephone: | 603 893-8080 Ext. 204 |
| Contact Person: | Dennis Garboski |
| Trade Name: | MobileECG 2 BT |
| Classification Name: | Detector and Alarm, Arrhythmia |
| Device Classification: | 870.1025 |
| Product Codes: | DSI, MWJ |
| Class: | Class II Device |

## 2. Description of Device

The MEMTEC MobileECG 2 BT digital Monitor provides high resolution recording of patient ECG data and pacemaker spike detection for a period of up to 30 Days. The 3 in 1 Multi - Function BT monitor provides Holter, Event, and MCT ambulatory use. The data is stored on a removable Micro SD Card and no data compression is used. The data can be downloaded by a USB 3.0 cable, BT, or removable Micro SD Card. The BLE 4.1 (Bluetooth) sends patient data to cell phone continuous for 30 days for use as an Event or MCT Monitor. The patient ID/Date/Time is stamped on the recording every 2 minutes preventing the mixing of data with another patients data. The large LCD provides real time patient ECG signals and confirms lead hook-ups. In Holter Mode the unit has selectable sample rates of 250, 500, or 1000 samples per second with resolution of 12bits. The MobileECG 2 BT operates on a single "AAA" alkaline or "AAA" lithium battery.

Configuration 1 (Holter Mode): MobileECG 2 BT is used with the TM eCloud Analysis System (K142349) for Holter monitoring. In Holter usage, data is recorded for the prescribed duration and then uploaded and analyzed after the recording period has ended. The TM eCloud algorithm suite is used to analyze and interpret the ECG data.

Configuration 2 (MCT Mode): MobileECG 2 BT is combined with a special purpose cell phone and Android APP to store and transmit real-time ECG to the TM eCloud Analysis System (K142349) to

> K181658 Page 1 of 6

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# 007 510(K) Summary

provide Mobile Cardiac Telemetry (MCT). The TM eCloud algorithm suite is used to analyze and interpret the ECG data.

Configuration 3 (Event Mode): MobileECG 2 BT is combined with a special purpose cell phone and Android APP to store and transmit real-time ECG on patient activated events to the TM eCloud Analysis System (K142349). The TM eCloud algorithm suite is used to analyze and interpret the ECG data.

## 3. Indications for Use

Configuration 1) Holter Mode: The MobileECG 2 BT is intended to record continuous data for 30+ davs for the detection of arrhythmias in ambulatory patients. Such monitoring is frequently used for patient symptoms such as: Palpitations, shortness of breath, chest pain, syncope, evaluating pacemakers, heart rate variability's, and clinical studies. The MobileECG 2 BT device transmits all collected data to a call center for interpretation using the TM eCloud ECG Analysis System at the end of the completed study.

Configuration 2) Mobile Cardiac Telemetry Mode: The MobileECG 2 BT is intended to continuously monitor, transmit, and record data for up to 30 days for patient symptoms that may suggest cardiac arrhythmia. The MobileECG 2 BT device continuously transmits data to a call center for interpretation of ECG data using the TM eCloud ECG Analysis System.

Configuration 3) Event Mode: The MobileECG 2 BT is intended to monitor and record patient activated data for up to 30 days for patient transient symptoms that may suggest cardiac arrhythmia. The MobileECG 2 BT device transmits all patient event activated data to a call center for interpretation of ECG data using the TM eCloud ECG Analysis System.

The MobileECG 2 BT is intended for use in adults and children of any age from birth upwards.

The MobileEGG 2 BT and the TM eCloud ECG Analysis System interpretation software is not intended as sole means of diagnosis and is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG.

#### 4. Alarms

Alarms: Automatically processed by TM eCloud ECG Analysis System (K142349) after cellular transmission. All urgent events (Tier 1) and non urgent events (Tier 2) are verified by monitor center technicians within one hour maximum after being received.

#### 5. Predicated Device

The legally marketed predicated devices to which equivalence is being claimed is: Preventice BodyGuardian DSI K151188 Memtec Corporation Model 950-12L MWJ K102723

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## 007_510(K) Summary

## 6. Reference Device

TM eCloud ECG Analysis System (K142349) Product Codes: DQK, KRE, MLO, DPS, DXH, OUG

#### 7. Predicated Device Comparison

The following table compares the "Technical Specifications" and "Indications for Use" of the predicated devices to the MobileECG 2 BT.

| | Memtec<br>Corporation<br>MobileECG<br>System | Preventice<br>BodyGuardian | Memtec Corporation<br>Model 950-12L | | | | | | |
|-----------------------------|----------------------------------------------|----------------------------|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-------------|------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Technical<br>Specifications | | | | Comparison Discussion | | | | | |
| Number of ECG<br>Channels | 1, 2, 3, or 8 Ch | 1 Ch | 1, 2, 3, or 8 Ch | Different - MobileECG 2 BT is the same when used in the same configuration. There is no change to the safety or effectiveness of the device. | | | | | |
| Resolution | 12bit | 12bit | 12bit | Same: There is no change to the safety or effectiveness of the device. | | | | | |
| Device Type | Digital | Digital | Digital | Same: There is no change to the safety or effectiveness of the device. | | | | | |
| Power Source | 1 "AAA" Alkaline | 3.7v Li-ion | "AA" Alkaline | Different- Power source does not affect the operation of any of the devices. There is no change to the safety or effectiveness of the device. | | | | | |
| Signal Verification | On Device, or<br>Smartphone | Smartphone | On Device | Same: There is no change to the safety or effectiveness of the device. | | | | | |
| Common Mode<br>Rejection | 100db | Not Specified | 100db | Same: There is no change to the safety or effectiveness of the device. | | | | | |
| Frequency<br>Response | Maximum Storage | 0.05 - 40Hz | 64GB (30+ days) | Not Specified | Not Specified | 0.05 - 40Hz | 16GB | Same: There is no change to the safety or effectiveness of the device. | Different- Storage Capacity does not affect the operation of any of the devices. There is no change to the safety or effectiveness of the device. |
| Maximum Days for Holter | 30 days | 30 days | 7 days | Same: There is no change to the safety or effectiveness of the device. | | | | | |
| Battery Life | 7 days | 24 Hrs. | 3 Days | Different- MobileECG 2 BT battery life exceeds the BodyGuardian and the Model 950-12L. There is no change to the safety or effectiveness of the device. | | | | | |
| Enclosure | Molded Plastic | Molded Plastic | Molded Plastic | Same: There is no change to the safety or effectiveness of the device. | | | | | |
| Operating range | 5 °C to +45 °C | 5 °C to +45 °C | 5 °C to +45 °C | Same: There is no change to the safety or effectiveness of the device. | | | | | |
| Transport and Storage Range | 0 °C to +60 °C | 0 °C to +60 °C | 0 °C to +60 °C | Same: There is no change to the safety or effectiveness of the device. | | | | | |
| Relative Humidity | 10% - 95% Non-Condensing | 10% - 95% Non-Condensing | 10% - 95% Non-Condensing | Same: There is no change to the safety or effectiveness of the device. | | | | | |
| Dimensions | 2.55"L X 2.0" W X .5 H | 2.36"L X 2.25"W X .67"H | 3.35"L X 2.4"W X .71"H | Different- Dimensions does not affect the operation of any of the devices. There is no change to the safety or effectiveness of the device. | | | | | |
| Weight | 1.45 oz. | 1.23 oz. | 3.4 oz | Different- Size does not affect the operation of any of the devices. There is no change to the safety or effectiveness of the device. | | | | | |
| Wireless Transmission | Bluetooth BLE 4.1 | Bluetooth | Not Applicable | Same: There is no change to the safety or effectiveness of the device. | | | | | |
| Communication Monitoring | Continuous | Continuous | Not Applicable | Same: There is no change to the safety or effectiveness of the device. | | | | | |
| Lead-Off Detection | Yes | Yes | Not Applicable | Same: There is no change to the safety or effectiveness of the device. | | | | | |

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# 007_510(K) Summary

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# 007_510(K) Summary

| Low Battery<br>Indication | Yes | Yes | Yes | Same: There is no change to<br>the safety or effectiveness of<br>the device. |
|-------------------------------------------------------------------------------|--------------------------------------------|--------------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Retrieval of Data | 30 days | 30 days | 30 days | Same: There is no change to<br>the safety or effectiveness of<br>the device. |
| Holter Mode | Yes | Yes | Yes | Same: There is no change to<br>the safety or effectiveness of<br>the device. |
| 30 Day Long Term<br>Holter Mode | Yes | Yes | Not Applicable | Same: There is no change to<br>the safety or effectiveness of<br>the device. |
| Patient Activated<br>Event Mode | Yes | Yes | Yes | Same: There is no change to<br>the safety or effectiveness of<br>the device. |
| Mobile Cardiac<br>Telemetry Mode | Yes | Yes | Not Applicable | Same: There is no change to<br>the safety or effectiveness of<br>the device. |
| Electrode Type<br>Used | Snap | Snap | Snap | Same: There is no change to<br>the safety or effectiveness of<br>the device. |
| Indications For Use | | | | |
| Environment of Use | Office, Clinic, or<br>Outpatient<br>(Home) | Office, Clinic, or<br>Outpatient<br>(Home) | Office, Clinic, or<br>Outpatient (Home) | Same: There is no change to<br>the safety or effectiveness of<br>the device. |
| Detects and Stores<br>Cardiac<br>Arrhythmias in<br>Ambulatory<br>Patients | Yes | Yes | Yes | Same: There is no change to<br>the safety or effectiveness of<br>the device. |
| Provide Diagnostic<br>Analysis | No | No | No | Same: There is no change to<br>the safety or effectiveness of<br>the device. |
| Use in Clinical and<br>Non-Clinical<br>Settings | Yes | Yes | Yes | Same: There is no change to<br>the safety or effectiveness of<br>the device. |
| In-Hospital<br>Monitoring | No | No | No | Same: There is no change to<br>the safety or effectiveness of<br>the device. |
| Collects and<br>Transmits Cardiac<br>Arrhythmias in<br>Ambulatory<br>Patients | Yes | Yes | Not Applicable | Same: There is no change to<br>the safety or effectiveness of<br>the device. |
| Use With Age<br>Requirements | Infant to Adult | Adult | Infant to Adult | Different - This specification is<br>different because of its use<br>with an approved FDA Analysis<br>System. There is no change to<br>the safety or effectiveness of<br>the device. |
| Pacemaker<br>Detection | Yes | Yes | Yes | Same: There is no change to<br>the safety or effectiveness of<br>the device. |

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# 007 510(K) Summary

Conclusion: The MobileECG 2 BT performance testing results demonstrate that the differences in the above "Technological Specifications" between the devices do not raise any new issues of safety or effectiveness, demonstrating that the subject device is as safe and as effective as the predicated devices. And after comparing the "Indications For Use" between the predicated devices to the MobileECG 2 BT, Memtec concludes that the MobileECG 2 BT is substantially equivalent to the predicated devices.

## 8. Non-clinical Tests Used in Determination of Substantial Equivalence

The MobileECG 2 BT was tested and conforms to the predicated devices using the following FDA recognized standards:

#### MobileECG 2 BT

- 1. ANSI/AAMI ES60601-1-2005 (R)2012 AND A1-2012- C1-2009 (R)2012 AND A2:2010/(R)2012 (FDA 19-4)
- 2. ANSI/AAMI IEC 60601-1-2:2014 (FDA 19-12)
- 3. ANSI/AAMI-IEC 60601-2-47-2012(R)2016 (FDA 3-127)

#### Leadwires

- 1) ANSI/AAMI EC53:1995(R)2008 (FDA 3-129)
#### 9. Conclusions from Nonclinical Testing

After comparing predicated devices to Memtec's MobileECG 2 BT results show that with the intended use, the MobileECG 2 BT with the TM eCloud ECG Analysis System® is equivalent in safety and effectiveness. Therefore, Memtec supports a claim of substantial equivalence for the MobileECG 2 BT to the Predicated Devices.