(252 days)
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.
IM007 is a software medical device for the analysis of ECG signals from Insertable Cardiac Monitor (ICM) devices and confirms the presence or absence of arrhythmias. When it is interfaced with a compatible remote monitoring platform, IM007 provides additional data to healthcare professionals to support the analysis of abnormal episodes detected by ICM devices.
IM007 receives as input an ECG data signal via the Implicity remote monitoring platform, then processes the signal with a proprietary algorithm designed to detect arrhythmias and generates as output the result of the analysis to a remote monitoring platform.
IM007 comprises:
- . An algorithm (the Algorithm) that analyzes ECG files in order to detect cardiac rhythm abnormalities.
- A communication interface to external applications with the Algorithm and processing of ECG files. The API consists of 2 messaging queues (an input and an output).
IM007 works as follows:
- . IM007 receives input data (an ECG file and device parameters) from the remote monitoring platform using the input queue.
- . The file is processed by the Algorithm which delineates zones with abnormal waveforms (ECG signals not defined as normal sinus rhythm). The output format is a sequence of waveform labels/start time/end time.
- . IM007 sends a response to the Remote Monitoring Platform using the output queue.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Important Note: The provided text is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device. It typically does not contain detailed descriptions of clinical studies, raw data, or specific statistical results as would be found in a full clinical trial report or scientific publication. Therefore, some information requested might be incomplete or inferred from the high-level descriptions.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with numerical targets. Instead, it refers to "specifications" and "intended use" being met by the device. The reported device performance is described as meeting these specifications and operating as intended. The "Non-clinical Performance" section states: "The results of the testing demonstrate that IM007 performs to its specifications and meets its intended use, which is substantially equivalent to that of the predicate device."
However, we can infer the types of performance criteria from the device's function: detecting specific arrhythmias. The comparison tables (Table 3) list the output classifications, implying that accurate detection of these events is the core performance metric.
| Acceptance Criteria Category (Inferred) | Reported Device Performance |
|---|---|
| Arrhythmia Detection Accuracy | - Device performs to its specifications. |
| (for Asystole, Bradycardia, AT/AF, VT) | - Meets its intended use. |
| Normal Rhythm Detection Accuracy | - Substantially equivalent to the predicate device. |
| Artifact Detection | - Performs as intended. |
| Functional Performance | - Processes and analyzes ECGs (proprietary algorithms). |
| - Receives and sends data via API/messaging queues. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: The document simply states "ECG databases from the ANSI/AAMI EC57:2012 standard as well as Implicity proprietary databases." It does not specify the exact number of ECGs or patients in the test set.
- Data Provenance:
- Country of Origin: Not specified in the text.
- Retrospective or Prospective: Not specified, but generally, tests against established databases (like ANSI/AAMI EC57:2012) are retrospective in nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number or qualifications of experts used to establish ground truth for the test sets. It mentions "qualified healthcare professionals" and "physicians and clinicians" in the context of the device's intended use and advisory nature, but not for the ground truth creation within the non-clinical performance study.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for establishing ground truth classifications within the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was a MRMC study done? No, the document does not mention any MRMC comparative effectiveness study involving human readers with and without AI assistance. The non-clinical performance section describes algorithm-only testing ("algorithm performance") against databases.
- Effect size of human improvement with AI vs. without AI: Not applicable, as no MRMC study was described.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Yes. The "Non-clinical Performance" section explicitly states that "Algorithm performance testing was assessed using ECG databases from the ANSI/AAMI EC57:2012 standard as well as Implicity proprietary databases." This indicates testing of the algorithm itself, without human intervention during the assessment, to ensure it "performs to its specifications and meets its intended use."
7. Type of Ground Truth Used
The type of ground truth used is implied to be expert consensus or established annotations from standard databases. The reference to "ECG databases from the ANSI/AAMI EC57:2012 standard" suggests a comparison to pre-annotated data, often derived from expert review. For the "Implicity proprietary databases," it would likely also involve expert adjudication, but this is not explicitly detailed.
8. Sample Size for the Training Set
The document does not provide the sample size used for the training set. It only mentions that the algorithm is "based on Machine Learning technology" and was tested on "ECG databases from the ANSI/AAMI EC57:2012 standard as well as Implicity proprietary databases." It's common for these databases to serve dual purposes (training and testing, with appropriate splitting), but specific numbers are not given for either.
9. How the Ground Truth for the Training Set Was Established
The document does not specify how the ground truth for the training set was established. Given the mention of "Machine Learning technology" and "ECG databases from the ANSI/AAMI EC57:2012 standard," it is highly probable that the training data and its ground truth were derived from:
- Expert Consensus: Cardiologists or electrophysiologists reviewed and annotated ECG waveforms.
- Established Annotations: Standard, publicly or privately curated databases often come pre-annotated by clinical experts.
However, the specific methods for ground truth establishment for the training set are not detailed in this 510(k) summary.
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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.
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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
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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)
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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 INC185 ALEWIFE BROOK PARKWAY - SUITE 210CAMBRIDGE, MA 02138USAPhone: +33 6 76 731 731 |
|---|---|
| Contact Person | David PerlmutterHead of R&DIMPLICITY INC185 ALEWIFE BROOK PARKWAY - SUITE 210CAMBRIDGE, MA 02138USAregulatory@implicity.comPhone: +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 |
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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 | Comparisonto Predicate | |
|---|---|---|---|---|
| Device Name | IM007 | CardioLogs ECGAnalysis Platform | Reveal LINQ InsertableCardiac Monitor, ModelLNQ11 | |
| Manufacturer | IMPLICITY INC | CARDIOLOGSTECHNOLOGIES | MEDTRONIC INC | |
| 510(k) # | K210543 | K170568 | K163460 | |
| RegulationNumber | 21 CFR 870.142521 CFR 870.2340 | 21 CFR 870.142521 CFR 870.2340 | 21 CFR 870.1025 | Same |
| Class | II | II | II | Same |
| Device Class /Name | Programmablediagnostic computer,Electrocardiograph | Programmablediagnosticcomputer,Electrocardiograph | Detector and Alarm,Arrhythmia | Same |
| Product Code | DQK, DPS | DQK, DPS | DSI | Same |
| Level ofConcern | Major | Moderate | Major | Same |
| Table 2 Comparison between Subject, Predicate and Reference Devices indication for use | ||||
| Subject Device | Predicate Device | ReferenceDevice | Comparison toPredicate Device | |
| Indicationfor Use | IM007 is intended foruse by qualifiedhealthcareprofessionals for theassessment ofarrhythmias inInsertable CardiacMonitor (ICM) ECGdata. | The CardioLogs ECGAnalysis Platform isintended for use byqualified healthcareprofessionals for theassessment ofarrhythmias using ECGdata. | The Reveal LINQICM is aninsertableautomaticallyactivated andpatient-activatedmonitoringsystem thatrecordssubcutaneousECG.It is indicated inthe followingcases:patients withclinicalsyndromes orsituations atincreased risk of | The Indication for Usefor the Subject Deviceis focused on a subsetof ECG data whichspecifically isgenerated from ICMdevices. Thealgorithm has beendeveloped for usewith all ECGgenerating cardiacmonitors. Validationof Implicity's firstgeneration system isfocused on ICMoutputs.The safety andperformance of ECGinterpretation of ICMdevices is comparableto that of the broaderarray of ECG systems. |
| Subject Device | Predicate Device | ReferenceDevice | Comparison toPredicate Device | |
| IM007 supportsdownloading andanalyzing datarecorded incompatible formatsfrom ICMs.This version of theIM007 only supportsECG data fromMedtronic ICMs. | The product supportsdownloading andanalyzing datarecorded in compatibleformats from anydevice used for thearrhythmia diagnosticssuch as Holter, eventrecorder, 12 leadambulatory ECGdevices, or othersimilar devices whenassessment of therhythm is necessary. | cardiacarrhythmias● patients whoexperiencetransientsymptoms suchas dizziness,palpitation,syncope, andchest pain thatmay suggest acardiacarrhythmia. | The Subject Devicetakes ECG data onlyfrom ICMs, and as inthe Predicate, use isrestricted tocompatible formats. | |
| IM007 is intended tobe electronicallyinterfaced with othercomputer systems(remote monitoringplatform) that supplythe ECG data toIM007 and receivethe output of IM007(analysis) for viewingby the healthcareprofessionals. | The Cardiologs ECGAnalysis Platform canalso be electronicallyinterfaced and performanalysis with datatransferred from othercomputer-based ECGsystems, such as anECG managementsystem.The product can beintegrated intocomputerized ECGmonitoring devices. | The device hasnot been testedspecifically forpediatric use. | Same | |
| Table 2 Comparison between Subject, Predicate and Reference Devices indication for use | ||||
| Subject Device | Predicate Device | ReferenceDevice | Comparison toPredicate Device | |
| IM007 provides ECGsignal processing andanalysis, to detectasystole, bradycardia,atrial tachycardia oratrial fibrillation,ventriculartachycardia, normalrhythm and artifact. | The Cardiologs ECGAnalysis Platformprovides ECG signalprocessing andanalysis, QRS andVentricular EctopicBeat detection, QRSfeature extraction,interval measurement,heart ratemeasurement, andrhythmanalysis. | The Subject Deviceuses equivalent signalprocessing andanalysis methodologyas the Predicate.The Subject Deviceoperates as asoftware moduleelectronicallyinterfaced to anothercomputer systemthat handles ECGdata, which is alsoone of the modes ofoperation of thePredicate. | ||
| IM007 is not for usein life supporting orsustaining systems orECG monitor andAlarm devices. | The Cardiologs ECGAnalysis Platform is notfor use in lifesupporting orsustaining systems orECG monitor andAlarm devices. | Same | ||
| Table 2 Comparison between Subject, Predicate and Reference Devices indication for use | ||||
| Subject Device | Predicate Device | ReferenceDevice | Comparison toPredicate Device | |
| IM007 interpretationresults are notintended to be thesole means ofdiagnosis. It is offeredto physicians andclinicians on anadvisory basis only inconjunction with thephysician'sknowledge of ECGpatterns, patientbackground, clinicalhistory, symptoms,and other diagnosticinformation. | CardioLogs ECGAnalysis Platforminterpretation resultsare not intended to bethe sole means ofdiagnosis. It is offeredto physicians andclinicians on anadvisory basis only inconjunction with thephysician's knowledgeof ECG patterns,patient background, | Same |
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The following Table 2 compares the Indication for Use of the Subject Device to the Predicate and the Reference Devices.
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Table 2 Comparison between Subject, Predicate and Reference Devices indication for use
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| Table 2 Comparison between Subject, Predicate and Reference Devices indication for use | ||||
|---|---|---|---|---|
| Subject Device | Predicate Device | Reference Device | Comparison to Predicate Device | |
| Patientpopulation | Adults (over 18) inthe following cases:- patients with clinicalsyndromes orsituations atincreased risk ofcardiac arrhythmias- patients whosymptoms such asdizziness, palpitation,syncope, and chestpain that may suggesta cardiac arrhythmia.The device has notbeen testedspecifically forpediatric use. | Adults (over 18). | - patients withclinicalsyndromes orsituations atincreased risk ofcardiacarrhythmias- patients whoexperiencetransientsymptoms suchas dizziness,palpitation,syncope, andchest pain thatmay suggest acardiacarrhythmiaThe device hasnot been testedspecifically forpediatric use. | Same.The Subject Devicehas also the sametarget population ofthe Reference Device,which is a subset ofthe target populationof the PredicateDevice. |
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.
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| Table 3 Comparison between Subject, Reference & Predicate Devices rhythm analysis outputs | ||||
|---|---|---|---|---|
| Subject DeviceOutput classification | Reference DeviceReveal LINQ | Predicate Device | Comparison withPredicate Device | |
| Asystole (Ventricularpause)Absence of ventricularcontraction for aduration equal orsuperior to the asystoleprogrammable duration. | Pause (asystole)No ventricular eventsare sensed for aprogrammable periodof time. | Ventricular pauseNo ventricularcomplex during atleast three seconds. | Same (except for theprogrammableduration) | |
| BradycardiaSlow ventricular rate.Lower than theprogrammable bradyrate | Brady(bradyarrhythmia)The patient's heart ratefalls to a rate that islower than theprogrammable bradythreshold. | Sinus bradycardia(< 50 /min)Sinus rhythm withunusual orabnormal slow rate. | Same | |
| AT/AF (AtrialTachycardia / AtrialFibrillation)At least one of thefollowing:- Atrial tachycardia(ectopic)- Atrial flutter- Atrial fibrillation | AF only or AT/AF(atrial fibrillation onlyor atrialtachyarrhythmia/atrialfibrillation)The patient has anatrial tachyarrhythmiaor atrial fibrillation. Theclinician can alsochoose to record atrialfibrillation only. TheReveal LINQ devicedetects an episode ofconducted AT or AF byanalyzing theirregularity ofventricular rhythmusing an automaticalgorithm. | AF - AtrialfibrillationAF - Atrialfibrillation or flutter(uncertain)Atrial flutterAtrial tachycardia orflutterAF - Atrialfibrillation, flutteror atrial tachycardiaAtrial tachycardia,ectopicAT - Atrialtachycardia - | SameAll classifications areregrouped under onebecause of theclinical significanceand the fact that it isoften impossible todistinguish withcertainty byhealthcareprofessional. | |
| Table 3 Comparison between Subject, Reference & Predicate Devices rhythm analysis outputs | ||||
| Subject DeviceOutput classification | Reference DeviceReveal LINQ | Predicate Device | Comparison withPredicate Device | |
| short run(s) | ||||
| VT VentricularTachycardiaAt least one of thefollowing:-Tachycardia thatoriginates in a ventricle.Sometimes life-threatening.NSVT - Non-sustainedventricular tachycardia | Tachy (ventriculartachyarrhythmia)The patient's heart rateincreases to a rate thatis higher than theprogrammable tachyrate (interval)threshold for theprogrammable tachyduration or higher than231 bpm (intervalslower than 260 ms) for30 of the last 40 beats. | VT - VentriculartachycardiaWide-QRStachycardia thatoriginates in aventricle.Sometimes life-threatening.NSVT - Non-sustainedventriculartachycardiaRun of ≥ 4consecutiveprematureventricularcomplexes with aheart rate ≥ 100/min. | SameAll classifications areregrouped under onebecause of theclinical significanceand the fact that it isoften impossible todistinguish withcertainty byhealthcareprofessional,with the exception ofusing theprogrammable tachyrate. | |
| Normal RhythmThe ECG does notpresent any significantabnormality. | N/A (Normal rhythm isabsence of abnormalclassification).Normal rhythm isdetected by the devicebut not transmittedthrough remotemonitoring. | Normal rhythm isabsence ofabnormalclassification. | Same | |
| UnspecifiedabnormalityAn abnormality isdetected in the signal,but the abnormality is | N/A | N/A | This label is specificto IM007This output promptsthe healthcare | |
| Table 3 Comparison between Subject, Reference & Predicate Devices rhythm analysis outputs | ||||
| Subject DeviceOutput classification | Reference DeviceReveal LINQ | Predicate Device | Comparison withPredicate Device | |
| not classified as one ofthe other abnormalitylabels by the algorithm. | professional toreview the ECG | |||
| ArtifactPresence of a non-cardiac noise, whichdistorts the signal andprevents proper medicalinterpretation of thespecified portion. | N/A | X - Pure noiseTracing with onlynoise and no ECGdata | Same |
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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 DeviceIM007 | Predicate DeviceCardioLogs ECGAnalysis Platform | Comparison toPredicateDevice |
| Heart ratedetermination fornon-paced adult | Yes | Yes | Same |
| QRS detection | YesThis is not an output of theSubject Device but iscalculated as an intermediatevalue prior to generating theoutput. | Yes | Same |
| Non-pacedarrhythmiainterpretation foradult patients | Yes | Yes | Same |
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| Table 4 Comparison between Subject and Predicate Devices features | |||
|---|---|---|---|
| Feature | Subject DeviceIM007 | Predicate DeviceCardioLogs ECGAnalysis Platform | Comparison toPredicateDevice |
| User interface toview ECG data withtools | NoIM007 does not include a userinterface for viewing ECG data,as the viewing of ECG databelongs to the "client"application. | YesThe user should onlyuse CardioLogs' userinterface to viewECG data analysis. | not necessaryfor the intendeduse |
| Database to storethe results | NoResults are stored in the"client application". | Yes | Not necessaryfor the intendeduse |
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 | Reference Device | Comparison toPredicate Device |
| The IM007 consists of aserver-side service, thatprovides tools toprocess and analyzeECGs through variousalgorithms.IM007 receives requestfrom client application,performs arrhythmiaanalysis on ECG datato client applicationwith the output fromthe algorithm to be | The CardioLogs ECGAnalysis Platformconsists of server-side,application Platform asa Service (PaaS) cloud-based system, and aclient-side applicationwebsite.The server-side,application PaaScomponent collects,stores, performsarrhythmia analysis onECG uploads, andtransfers data to andfrom the client-sideapplication. | The Reveal LINQ ICM isdesigned toautomatically record theoccurrence of anarrhythmia in a patient,continuously senses thepatient's subcutaneousECG, and analyses thetiming of ventricularevents to detectpossible episodes ofarrhythmia.The Reveal LINQ ICMadds three rules to | IM007 and PredicateDevice havesubstantially equivalentfundamental scientifictechnology.Both consist of:- An algorithm based onMachine Learningtechnology.- An API to access to thealgorithm (cloud-basedservice system).Subject device has noclient-side application |
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| Table 5 Comparison between Subject, Reference, and Predicate Devices technology | |||
|---|---|---|---|
| Subject Device | Predicate Device | Reference Device | Comparison toPredicate Device |
| stored on the clientapplication.The automatedproprietary ECGalgorithm providessupportive informationfor ECG diagnosis. Thealgorithm can beaccessed by connectingto the IM007'sApplicationProgramming Interface. | The client-sideapplication allows theusers to review ECG,edit the analysis resultsproduced by the server-side application PaaScomponent.The users may uploadECG to the ECG AnalysisPlatform via the API(REST web service) fromany computerequipment, or, in thespecific cases where theuser's hardware isalready connected tothe CardioLogs'ApplicationProgramming Interface(API), the ECG isautomatically sent toCardioLogs' servers. | reduce false positivedetections listed below:1-Atrial Algorithms –Adaptive P-sense rule2-Dual Sense Bradyrejection rule3-Dual Sense Asystolerejection rule. | website but is designedto be interfaced with aremote monitoringplatform which has aclient-side webinterface. |
ട Device Description
IM007 is a software medical device for the analysis of ECG signals from Insertable Cardiac Monitor (ICM) devices and confirms the presence or absence of arrhythmias. When it is interfaced with a compatible remote monitoring platform, IM007 provides additional data to healthcare professionals to support the analysis of abnormal episodes detected by ICM devices.
IM007 receives as input an ECG data signal via the Implicity remote monitoring platform, then processes the signal with a proprietary algorithm designed to detect arrhythmias and generates as output the result of the analysis to a remote monitoring platform.
IM007 comprises:
- . An algorithm (the Algorithm) that analyzes ECG files in order to detect cardiac rhythm abnormalities.
- A communication interface to external applications with the Algorithm and processing of ECG
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files. The API consists of 2 messaging queues (an input and an output).
IM007 works as follows:
- . IM007 receives input data (an ECG file and device parameters) from the remote monitoring platform using the input queue.
- . The file is processed by the Algorithm which delineates zones with abnormal waveforms (ECG signals not defined as normal sinus rhythm). The output format is a sequence of waveform labels/start time/end time.
- . IM007 sends a response to the Remote Monitoring Platform using the output queue.
Intended Use 6
The predicate and subject device have the same intended use. Both devices are intended for use by qualified healthcare professionals for the assessment of arrhythmias in ECG data. The Indication for Use for the Subject Device is focused on a subset of ECG data which specifically is generated from compatible ICM devices.
The indication for use of IM007 is as follows:
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 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.
Technological Characteristics 7
IM007 and Predicate Device have substantially equivalent fundamental scientific technology. Both consist of:
- An algorithm based on Machine Learning technology.
- An API to access to the algorithm (cloud-based service system)
The subject device has no client-side application website but is designed to be interfaced with a compatible remote monitoring platform which has a client-side web interface.
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Non-clinical Performance 8
Non-clinical testing was conducted to assess algorithm performance and to verify that IM007 performs as intended. Algorithm performance testing was assessed using ECG databases from the ANSI/AAMI EC57:2012 standard as well as Implicity proprietary databases. The results of the testing demonstrate that IM007 performs to its specifications and meets its intended use, which is substantially equivalent to that of the predicate device.
ത Conclusion
The results of non-clinical testing demonstrate that IM007 meets its intended use which is equivalent to that of the predicate device. Testing also ensured that IM007 performs as intended and does not raise different questions of safety or effectiveness as compared to the predicate device.
§ 870.1425 Programmable diagnostic computer.
(a)
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.(b)
Classification. Class II (performance standards).