Who is the manufacturer of IM007?

Implicity, Inc. filed the 510(k) submission for IM007 (K210543).

What is the FDA product code for IM007?

DQK. It is classified under 21 CFR 870.1425 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for IM007?

510(k) clearance (submission type: Traditional).

Does IM007 use AI or machine learning?

Yes. IM007 (K210543) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like IM007?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like IM007 get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

IM007

Q: What are the predicate devices for IM007?

CardioLogs ECG Analysis Platform (K170568).

K210543 · Implicity, Inc. · DQK · Nov 3, 2021 · Cardiovascular

Device Facts

Record ID	K210543
Device Name	IM007
Applicant	Implicity, Inc.
Product Code	DQK · Cardiovascular
Decision Date	Nov 3, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1425
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Asystole	—	—	—	—	—	—	—
Bradycardia	—	—	—	—	—	—	—
Atrial Tachycardia / Atrial Fibrillation	—	—	—	—	—	—	—
Ventricular Tachycardia	—	—	—	—	—	—	—
Normal Rhythm	—	—	—	—	—	—	—
Artifact	—	—	—	—	—	—	—

Indications for Use

IM007 is intended for use by qualified healthcare professionals for the assessment of arrhythmias in Insertable Cardiac Monitor (ICM) ECG data. IM007 supports downloading and analyzing data recorded in compatible formats from ICMs. This version of the IM007 only supports ECG data from Medtronic ICMs. IM007 is intended to be electronically interfaced with other computer systems (remote monitoring platform) that supply the ECG data to IM007, and receive the output of IM007 (analysis) for viewing by the healthcare professionals. IM007 provides ECG signal processing and analysis, to detect asystole, bradycardia, atrial tachycardia or atrial fibrillation, ventricular tachycardia, normal rhythm and artifact. IM007 is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. IM007 interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

Device Story

IM007 is a cloud-based software medical device (SaMD) that analyzes ECG signals from Medtronic Insertable Cardiac Monitors (ICMs). It functions as a server-side service accessed via an API by remote monitoring platforms. The device receives ECG files and parameters, processes them using a proprietary machine learning algorithm to detect arrhythmias (asystole, bradycardia, AT/AF, VT, normal rhythm, or artifact), and returns labeled waveform segments with timestamps to the remote platform. It is operated by healthcare professionals who review the advisory analysis alongside clinical history to aid in diagnosis. It does not provide a user interface or storage, relying on the integrated remote monitoring platform for these functions. It benefits patients by providing automated, supportive analysis of long-term cardiac monitoring data.

Clinical Evidence

Bench testing only. Algorithm performance was validated using ECG databases compliant with ANSI/AAMI EC57:2012 and proprietary Implicity databases. Results confirmed the device meets specifications and performs equivalently to the predicate device.

Technological Characteristics

Cloud-based server-side service; API-based communication (messaging queues); Machine Learning-based arrhythmia detection algorithm; interfaces with remote monitoring platforms; no client-side software or hardware; software-only device.

Indications for Use

Indicated for adults (over 18) with clinical syndromes or situations at increased risk of cardiac arrhythmias, or experiencing transient symptoms (dizziness, palpitation, syncope, chest pain) suggesting arrhythmia. Not tested for pediatric use.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

CardioLogs ECG Analysis Platform (K170568)

Reference Devices

Reveal LINQ Insertable Cardiac Monitor (K163460)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 3, 2021 Implicity, Inc. % Mark Johnson Regulatory Consultant MJ Medtech Consulting Services LLC 24125 Butteville Rd. NE Aurora, Oregon 97002 Re: K210543 Trade/Device Name: IM007 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DPS Dated: October 1, 2021 Received: October 4, 2021 Dear Mark Johnson: 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. {1}------------------------------------------------ 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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K210543 Device Name IM007 ## Indications for Use (Describe) IM007 is intended for use by qualified healthcare professionals for the assessment of arrhythmias in Insertable Cardiac Monitor (ICM) ECG data. IM007 supports downloading and analyzing data recorded in compatible formats from ICMs. This version of the IM007 only supports ECG data from Medtronic ICMs. IM007 is intended to be electronically interfaced with other computer systems (remote monitoring platform) that supply the ECG data to IM007, and receive the output of IM007 (analysis) for viewing by the healthcare professionals. IM007 provides ECG signal processing and analysis, to detect asystole, bradycardia, atrial tachycardia or atrial fibrillation, ventricular tachycardia, normal rhythm and artifact. IM007 is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. IM007 interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information. Type of Use (Select *one* or *both*, as applicable)X 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}------------------------------------------------ # 510(k) Summary This summary of 510(k) substantial equivalence information is submitted in accordance with the requirements of 21 CFR 807.92 #### General Information 1 | Applicant | IMPLICITY INC 185 ALEWIFE BROOK PARKWAY - SUITE 210 CAMBRIDGE, MA 02138 USA Phone: +33 6 76 731 731 | |----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | David Perlmutter Head of R&D IMPLICITY INC 185 ALEWIFE BROOK PARKWAY - SUITE 210 CAMBRIDGE, MA 02138 USA regulatory@implicity.com Phone: +33 6 76 731 731 | Assisted by Mark Johnson Regulatory consultant to Implicity Inc MJ Medtech Consulting Services LLC 3332 Rockwood circle Billings, Montana 59102 +1 (503) 575-5886 #### 2 Date prepared: November 2, 2021 #### Device Information 3 | Trade Name | IM007 Insertable Cardiac Monitor ECG Analysis System | |----------------|-------------------------------------------------------------| | Common Name | ICM ECG Analysis System | | Classification | 21 CFR 870.1425, Programmable diagnostic computer, Class II | | | 21 CFR 870.2340, Electrocardiograph, Class II | | Product Code | DQK, DPS | {4}------------------------------------------------ #### Predicate Device 4 The predicate and reference devices for IM007 Insertable Cardiac Monitor ECG Analysis System are: Predicate Device CARDIOLOGS, Inc., CardioLogs ECG Analysis Platform, K170568 Reference Device MEDTRONIC, Inc., Reveal LINQ Insertable Cardiac Monitor, K163460 Table 1 provides device information for the subject device Implicity IM007 and compares it to the predicate and the reference devices listed. | | Subject Device | Predicate Device | Reference Device | Comparison to Predicate | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | IM007 | CardioLogs ECG Analysis Platform | Reveal LINQ Insertable Cardiac Monitor, Model LNQ11 | | | Manufacturer | IMPLICITY INC | CARDIOLOGS TECHNOLOGIES | MEDTRONIC INC | | | 510(k) # | K210543 | K170568 | K163460 | | | Regulation Number | 21 CFR 870.1425 21 CFR 870.2340 | 21 CFR 870.1425 21 CFR 870.2340 | 21 CFR 870.1025 | Same | | Class | II | II | II | Same | | Device Class / Name | Programmable diagnostic computer, Electrocardiograph | Programmable diagnostic computer, Electrocardiograph | Detector and Alarm, Arrhythmia | Same | | Product Code | DQK, DPS | DQK, DPS | DSI | Same | | Level of Concern | Major | Moderate | Major | Same | | Table 2 Comparison between Subject, Predicate and Reference Devices indication for use | | | | | | | Subject Device | Predicate Device | Reference Device | Comparison to Predicate Device | | Indication for Use | IM007 is intended for use by qualified healthcare professionals for the assessment of arrhythmias in Insertable Cardiac Monitor (ICM) ECG data. | The CardioLogs ECG Analysis Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data. | The Reveal LINQ ICM is an insertable automatically activated and patient-activated monitoring system that records subcutaneous ECG. It is indicated in the following cases: patients with clinical syndromes or situations at increased risk of | The Indication for Use for the Subject Device is focused on a subset of ECG data which specifically is generated from ICM devices. The algorithm has been developed for use with all ECG generating cardiac monitors. Validation of Implicity's first generation system is focused on ICM outputs. The safety and performance of ECG interpretation of ICM devices is comparable to that of the broader array of ECG systems. | | Subject Device | Predicate Device | Reference Device | Comparison to Predicate Device | | | IM007 supports downloading and analyzing data recorded in compatible formats from ICMs. This version of the IM007 only supports ECG data from Medtronic ICMs. | The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices when assessment of the rhythm is necessary. | cardiac arrhythmias ● patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia. | The Subject Device takes ECG data only from ICMs, and as in the Predicate, use is restricted to compatible formats. | | | IM007 is intended to be electronically interfaced with other computer systems (remote monitoring platform) that supply the ECG data to IM007 and receive the output of IM007 (analysis) for viewing by the healthcare professionals. | The Cardiologs ECG Analysis Platform can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. The product can be integrated into computerized ECG monitoring devices. | The device has not been tested specifically for pediatric use. | Same | | | Table 2 Comparison between Subject, Predicate and Reference Devices indication for use | | | | | | | Subject Device | Predicate Device | Reference Device | Comparison to Predicate Device | | | IM007 provides ECG signal processing and analysis, to detect asystole, bradycardia, atrial tachycardia or atrial fibrillation, ventricular tachycardia, normal rhythm and artifact. | The Cardiologs ECG Analysis Platform provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis. | | The Subject Device uses equivalent signal processing and analysis methodology as the Predicate. The Subject Device operates as a software module electronically interfaced to another computer system that handles ECG data, which is also one of the modes of operation of the Predicate. | | | IM007 is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. | The Cardiologs ECG Analysis Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. | | Same | | Table 2 Comparison between Subject, Predicate and Reference Devices indication for use | | | | | | | Subject Device | Predicate Device | Reference Device | Comparison to Predicate Device | | | IM007 interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information. | CardioLogs ECG Analysis Platform interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, | | Same | {5}------------------------------------------------ The following Table 2 compares the Indication for Use of the Subject Device to the Predicate and the Reference Devices. {6}------------------------------------------------ ## Table 2 Comparison between Subject, Predicate and Reference Devices indication for use {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ | Table 2 Comparison between Subject, Predicate and Reference Devices indication for use | | | | | |----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device | Predicate Device | Reference Device | Comparison to Predicate Device | | Patient population | Adults (over 18) in the following cases: - patients with clinical syndromes or situations at increased risk of cardiac arrhythmias - patients whosymptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia. The device has not been tested specifically for pediatric use. | Adults (over 18). | - patients with clinical syndromes or situations at increased risk of cardiac arrhythmias - patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia The device has not been tested specifically for pediatric use. | Same. The Subject Device has also the same target population of the Reference Device, which is a subset of the target population of the Predicate Device. | The Subject, Predicate, and Reference devices all provide output classifications in the analysis of ECG signals that are transmitted from compatible Insertable Cardiac Monitor (ICM) devices. Table 3 below compares the output classifications between these devices. {10}------------------------------------------------ | Table 3 Comparison between Subject, Reference & Predicate Devices rhythm analysis outputs | | | | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Subject Device Output classification | Reference Device Reveal LINQ | Predicate Device | Comparison with Predicate Device | | | Asystole (Ventricular pause) Absence of ventricular contraction for a duration equal or superior to the asystole programmable duration. | Pause (asystole) No ventricular events are sensed for a programmable period of time. | Ventricular pause No ventricular complex during at least three seconds. | Same (except for the programmable duration) | | | Bradycardia Slow ventricular rate. Lower than the programmable brady rate | Brady (bradyarrhythmia) The patient's heart rate falls to a rate that is lower than the programmable brady threshold. | Sinus bradycardia (< 50 /min) Sinus rhythm with unusual or abnormal slow rate. | Same | | | AT/AF (Atrial Tachycardia / Atrial Fibrillation) At least one of the following: - Atrial tachycardia (ectopic) - Atrial flutter - Atrial fibrillation | AF only or AT/AF (atrial fibrillation only or atrial tachyarrhythmia/atrial fibrillation) The patient has an atrial tachyarrhythmia or atrial fibrillation. The clinician can also choose to record atrial fibrillation only. The Reveal LINQ device detects an episode of conducted AT or AF by analyzing the irregularity of ventricular rhythm using an automatic algorithm. | AF - Atrial fibrillation AF - Atrial fibrillation or flutter (uncertain) Atrial flutter Atrial tachycardia or flutter AF - Atrial fibrillation, flutter or atrial tachycardia Atrial tachycardia, ectopic AT - Atrial tachycardia - | Same All classifications are regrouped under one because of the clinical significance and the fact that it is often impossible to distinguish with certainty by healthcare professional. | | | Table 3 Comparison between Subject, Reference & Predicate Devices rhythm analysis outputs | | | | | | Subject Device Output classification | Reference Device Reveal LINQ | Predicate Device | Comparison with Predicate Device | | | | | short run(s) | | | | VT Ventricular Tachycardia At least one of the following: -Tachycardia that originates in a ventricle. Sometimes life- threatening. NSVT - Non-sustained ventricular tachycardia | Tachy (ventricular tachyarrhythmia) The patient's heart rate increases to a rate that is higher than the programmable tachy rate (interval) threshold for the programmable tachy duration or higher than 231 bpm (intervals lower than 260 ms) for 30 of the last 40 beats. | VT - Ventricular tachycardia Wide-QRS tachycardia that originates in a ventricle. Sometimes life- threatening. NSVT - Non- sustained ventricular tachycardia Run of ≥ 4 consecutive premature ventricular complexes with a heart rate ≥ 100 /min. | Same All classifications are regrouped under one because of the clinical significance and the fact that it is often impossible to distinguish with certainty by healthcare professional, with the exception of using the programmable tachy rate. | | | Normal Rhythm The ECG does not present any significant abnormality. | N/A (Normal rhythm is absence of abnormal classification). Normal rhythm is detected by the device but not transmitted through remote monitoring. | Normal rhythm is absence of abnormal classification. | Same | | | Unspecified abnormality An abnormality is detected in the signal, but the abnormality is | N/A | N/A | This label is specific to IM007 This output prompts the healthcare | | | Table 3 Comparison between Subject, Reference & Predicate Devices rhythm analysis outputs | | | | | | Subject Device Output classification | Reference Device Reveal LINQ | Predicate Device | Comparison with Predicate Device | | | not classified as one of the other abnormality labels by the algorithm. | | | professional to review the ECG | | | Artifact Presence of a non- cardiac noise, which distorts the signal and prevents proper medical interpretation of the specified portion. | N/A | X - Pure noise Tracing with only noise and no ECG data | Same | | {11}------------------------------------------------ {12}------------------------------------------------ Table 4 provides a comparison of the features of the Subject and Predicate devices. | Table 4 Comparison between Subject and Predicate Devices features | | | | |-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|--------------------------------------| | Feature | Subject Device IM007 | Predicate Device CardioLogs ECG Analysis Platform | Comparison to Predicate Device | | Heart rate determination for non-paced adult | Yes | Yes | Same | | QRS detection | Yes This is not an output of the Subject Device but is calculated as an intermediate value prior to generating the output. | Yes | Same | | Non-paced arrhythmia interpretation for adult patients | Yes | Yes | Same | {13}------------------------------------------------ | Table 4 Comparison between Subject and Predicate Devices features | | | | |-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------| | Feature | Subject Device IM007 | Predicate Device CardioLogs ECG Analysis Platform | Comparison to Predicate Device | | User interface to view ECG data with tools | No IM007 does not include a user interface for viewing ECG data, as the viewing of ECG data belongs to the "client" application. | Yes The user should only use CardioLogs' user interface to view ECG data analysis. | not necessary for the intended use | | Database to store the results | No Results are stored in the "client application". | Yes | Not necessary for the intended use | Table 5 provides a comparison of the technology of the Subject, Predicate, and Reference devices | Table 5 Comparison between Subject, Reference, and Predicate Devices technology | | | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Subject Device | Predicate Device…

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