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 Description

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 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.

AI/ML Overview

The Memtec Corporation's MobileECG 2 BT device underwent testing to demonstrate its substantial equivalence to predicate devices. The study information is extracted from the provided text.

1. Acceptance Criteria and Reported Device Performance

The provided document describes a comparison of technical specifications and indications for use between the subject device (MobileECG 2 BT) and two predicate devices (Preventice BodyGuardian and Memtec Corporation Model 950-12L). The primary acceptance criteria for establishing substantial equivalence were that differences in technological specifications should not raise any new issues of safety or effectiveness. The document concludes 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."

A table comparing the technical specifications of the MobileECG 2 BT with the predicate devices is provided in the source document. Since the reported performance is largely a qualitative statement of "Same" or "Different" with a justification for why the difference does not affect safety or effectiveness, a direct quantitative comparison of acceptance criteria vs. specific reported device performance values for each technical specification is not explicitly detailed in a pass/fail format within this document. The conclusion states all criteria were met to establish substantial equivalence.

Acceptance Criteria Category	Acceptance Criteria (Qualitative)	Reported Device Performance (Qualitative)
Technical Specifications	Differences should not raise new safety or effectiveness concerns.	Number of ECG Channels: Different (MobileECG 2 BT: 1, 2, 3, or 8 Ch vs. Preventice: 1 Ch; Model 950-12L: 1, 2, 3, or 8 Ch). Justification: MobileECG 2 BT is the same when used in the same configuration. No change to safety/effectiveness.Resolution: Same (12bit). Justification: No change to safety/effectiveness.Device Type: Same (Digital). Justification: No change to safety/effectiveness.Power Source: Different (MobileECG 2 BT: 1 "AAA" Alkaline vs. Preventice: 3.7v Li-ion; Model 950-12L: "AA" Alkaline). Justification: Power source does not affect operation. No change to safety/effectiveness.Signal Verification: Same (On Device, or Smartphone). Justification: No change to safety/effectiveness.Common Mode Rejection: Same (100db). Justification: No change to safety/effectiveness.Frequency Response: Not Specified for MobileECG 2 BT, Preventice 0.05-40Hz, Model 950-12L Not Specified. (Discrepancy in table for MobileECG 2 BT, lists "Maximum Storage" instead of Frequency Response). Justification: Not explicitly stated for frequency response, but for "Maximum Storage" listed below it says "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 Storage: MobileECG 2 BT: 64GB (30+ days) vs. Preventice: Not Specified; Model 950-12L: 16GB. Justification: Different- Storage Capacity does not affect operation. No change to safety/effectiveness.Maximum Days for Holter: Same (30 days). Justification: No change to safety/effectiveness.Battery Life: Different (MobileECG 2 BT: 7 days vs. Preventice: 24 Hrs; Model 950-12L: 3 Days). Justification: MobileECG 2 BT battery life exceeds predicates. No change to safety/effectiveness.Enclosure: Same (Molded Plastic). Justification: No change to safety/effectiveness.Operating range: Same (5 °C to +45 °C). Justification: No change to safety/effectiveness.Transport and Storage Range: Same (0 °C to +60 °C). Justification: No change to safety/effectiveness.Relative Humidity: Same (10% - 95% Non-Condensing). Justification: No change to safety/effectiveness.Dimensions: Different (MobileECG 2 BT: 2.55"L X 2.0" W X .5 H vs. Preventice: 2.36"L X 2.25"W X .67"H; Model 950-12L: 3.35"L X 2.4"W X .71"H). Justification: Dimensions does not affect operation. No change to safety/effectiveness.Weight: Different (MobileECG 2 BT: 1.45 oz. vs. Preventice: 1.23 oz.; Model 950-12L: 3.4 oz). Justification: Size does not affect operation. No change to safety/effectiveness.Wireless Transmission: Same (Bluetooth BLE 4.1). Justification: No change to safety/effectiveness.Communication Monitoring: Same (Continuous). Justification: No change to safety/effectiveness.Lead-Off Detection: Same (Yes). Justification: No change to safety/effectiveness.Low Battery Indication: Same (Yes). Justification: No change to safety/effectiveness.Retrieval of Data: Same (30 days). Justification: No change to safety/effectiveness.Holter Mode: Same (Yes). Justification: No change to safety/effectiveness.30 Day Long Term Holter Mode: Same (Yes). Justification: No change to safety/effectiveness.Patient Activated Event Mode: Same (Yes). Justification: No change to safety/effectiveness.Mobile Cardiac Telemetry Mode: Same (Yes). Justification: No change to safety/effectiveness.Electrode Type Used: Same (Snap). Justification: No change to safety/effectiveness.
Indications for Use (IFU)	IFU must be substantially equivalent to predicate devices.	Environment of Use: Same (Office, Clinic, or Outpatient (Home)). Justification: No change to safety/effectiveness.Detects and Stores Cardiac Arrhythmias in Ambulatory Patients: Same (Yes). Justification: No change to safety/effectiveness.Provide Diagnostic Analysis: Same (No). Justification: No change to safety/effectiveness.Use in Clinical and Non-Clinical Settings: Same (Yes). Justification: No change to safety/effectiveness.In-Hospital Monitoring: Same (No). Justification: No change to safety/effectiveness.Collects and Transmits Cardiac Arrhythmias in Ambulatory Patients: Same (Yes). Justification: No change to safety/effectiveness.Use With Age Requirements: Different (MobileECG 2 BT: Infant to Adult vs. Preventice: Adult; Model 950-12L: Infant to Adult). Justification: Different because of its use with an approved FDA Analysis System. No change to safety/effectiveness.Pacemaker Detection: Same (Yes). Justification: No change to safety/effectiveness.

Conclusion: The provided document states that the MobileECG 2 BT's performance testing results demonstrate that the differences in "Technological Specifications" do not raise any new safety or effectiveness issues, and that the "Indications For Use" are substantially equivalent to the predicate devices.

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

The provided document does not specify a separate test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The assessment of substantial equivalence relies on comparison of technical specifications and indications for use against predicate devices validated against recognized FDA standards. The non-clinical tests mentioned are conformance to these standards.

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

The document does not mention the use of experts to establish ground truth for a test set. Substantial equivalence was determined through comparison to predicate devices and conformance to recognized standards.

4. Adjudication Method

The document does not mention any adjudication method as no expert review or human evaluation of a test set is described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

The document does not describe an MRMC comparative effectiveness study, nor does it provide information on human reader improvement with or without AI assistance. The device is a data acquisition system that transmits data to an existing analysis system (TM eCloud ECG Analysis System, K142349).

6. Standalone Performance Study

The document does not describe a standalone (algorithm only without human-in-the-loop performance) study for the MobileECG 2 BT itself in terms of diagnostic accuracy. Instead, it states that "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." The MobileECG 2 BT is primarily a data acquisition device, and its performance is evaluated through its conformity to established medical device standards and comparison of its technical specifications to predicate devices. The TM eCloud ECG Analysis System is a referenced device (K142349), suggesting its own performance would have been established separately.

7. Type of Ground Truth Used

For the MobileECG 2 BT device itself, the ground truth for performance assessment seems to be derived from compliance with FDA-recognized consensus standards (e.g., ANSI/AAMI ES60601-1-2005, IEC 60601-1-2:2014, ANSI/AAMI-IEC 60601-2-47-2012, ANSI/AAMI EC53:1995). The document does not describe a clinical study with pathology or outcomes data specifically for the MobileECG 2 BT's diagnostic performance for arrhythmias, as it functions as a data recorder for an analysis system.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. The MobileECG 2 BT is a hardware device for ECG data acquisition; it does not explicitly describe an AI algorithm or model that would require a training set. The referenced "TM eCloud ECG Analysis System" (K142349) would be the component that uses algorithms and would likely have had its own training set.

9. How the Ground Truth for the Training Set Was Established

As no training set is described for the MobileECG 2 BT, there is no information provided on how its ground truth would have been established.

Summary

{0}------------------------------------------------

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

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K181658

Device Name

MobileECG 2 BT

Indications for Use (Describe) Indications for Use

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

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

Prescription Use (Part 21 CFR 801 Subpart D)	☑
Over-The-Counter Use (21 CFR 801 Subpart C)	☐

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

007 510(K) Summary

510(k) Summary

Date: 11/28/2018

1. General Information

Submitter's Name:	Dennis GarboskiMemtec Corporation68 Stiles Road Unit DSalem, 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

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

{4}------------------------------------------------

007 510(K) Summary

provide Mobile Cardiac Telemetry (MCT). 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.

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

{5}------------------------------------------------

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.

	MemtecCorporationMobileECGSystem	PreventiceBodyGuardian	Memtec CorporationModel 950-12L
TechnicalSpecifications				Comparison Discussion
Number of ECGChannels	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, orSmartphone	Smartphone	On Device	Same: There is no change to the safety or effectiveness of the device.
Common ModeRejection	100db	Not Specified	100db	Same: There is no change to the safety or effectiveness of the device.
FrequencyResponse	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.

{6}------------------------------------------------

007_510(K) Summary

{7}------------------------------------------------

007_510(K) Summary

Low BatteryIndication	Yes	Yes	Yes	Same: There is no change tothe safety or effectiveness ofthe device.
Retrieval of Data	30 days	30 days	30 days	Same: There is no change tothe safety or effectiveness ofthe device.
Holter Mode	Yes	Yes	Yes	Same: There is no change tothe safety or effectiveness ofthe device.
30 Day Long TermHolter Mode	Yes	Yes	Not Applicable	Same: There is no change tothe safety or effectiveness ofthe device.
Patient ActivatedEvent Mode	Yes	Yes	Yes	Same: There is no change tothe safety or effectiveness ofthe device.
Mobile CardiacTelemetry Mode	Yes	Yes	Not Applicable	Same: There is no change tothe safety or effectiveness ofthe device.
Electrode TypeUsed	Snap	Snap	Snap	Same: There is no change tothe safety or effectiveness ofthe device.
Indications For Use
Environment of Use	Office, Clinic, orOutpatient(Home)	Office, Clinic, orOutpatient(Home)	Office, Clinic, orOutpatient (Home)	Same: There is no change tothe safety or effectiveness ofthe device.
Detects and StoresCardiacArrhythmias inAmbulatoryPatients	Yes	Yes	Yes	Same: There is no change tothe safety or effectiveness ofthe device.
Provide DiagnosticAnalysis	No	No	No	Same: There is no change tothe safety or effectiveness ofthe device.
Use in Clinical andNon-ClinicalSettings	Yes	Yes	Yes	Same: There is no change tothe safety or effectiveness ofthe device.
In-HospitalMonitoring	No	No	No	Same: There is no change tothe safety or effectiveness ofthe device.
Collects andTransmits CardiacArrhythmias inAmbulatoryPatients	Yes	Yes	Not Applicable	Same: There is no change tothe safety or effectiveness ofthe device.
Use With AgeRequirements	Infant to Adult	Adult	Infant to Adult	Different - This specification isdifferent because of its usewith an approved FDA AnalysisSystem. There is no change tothe safety or effectiveness ofthe device.
PacemakerDetection	Yes	Yes	Yes	Same: There is no change tothe safety or effectiveness ofthe device.

{8}------------------------------------------------

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)
1. ANSI/AAMI IEC 60601-1-2:2014 (FDA 19-12)
1. 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.

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
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.(b)
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.