K Number
K210543
Device Name
IM007
Manufacturer
Date Cleared
2021-11-03

(252 days)

Product Code
Regulation Number
870.1425
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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 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 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.
More Information

Yes
The document explicitly states that the algorithm is "based on Machine Learning technology."

No.

The device IM007 is a software medical device intended for the analysis of ECG signals from Insertable Cardiac Monitor (ICM) devices to assess arrhythmias. It provides diagnostic information to healthcare professionals but does not directly deliver therapy or perform any therapeutic function on the patient.

Yes
The device is intended for the "assessment of arrhythmias" and provides "ECG signal processing and analysis, to detect asystole, bradycardia, atrial tachycardia or atrial fibrillation, ventricular tachycardia, normal rhythm and artifact," which are all diagnostic functions. It also explicitly states that it confirms the "presence or absence of arrhythmias" and provides "additional data to healthcare professionals to support the analysis of abnormal episodes." Although it states that "IM007 interpretation results are not intended to be the sole means of diagnosis," it is still clearly designed to aid in the diagnostic process.

Yes

The device description explicitly states "IM007 is a software medical device" and details its components as an algorithm and a communication interface, with no mention of accompanying hardware.

Based on the provided information, IM007 is not an In Vitro Diagnostic (IVD) device. Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. The tests are performed outside of the body (in vitro).

  • IM007's Function: IM007 analyzes ECG data recorded by an Insertable Cardiac Monitor (ICM). This data represents electrical activity of the heart, which is a physiological signal, not a biological sample taken from the body. The analysis is performed on this recorded signal, not on a biological specimen.

  • Intended Use: The intended use clearly states it's for the "assessment of arrhythmias in Insertable Cardiac Monitor (ICM) ECG data." This reinforces that it's analyzing a physiological signal, not a biological sample.

Therefore, while IM007 is a medical device that performs analysis, its function and the type of data it processes (ECG signals) do not align with the definition of an In Vitro Diagnostic device.

No
The input document does not contain any explicit statements indicating that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

DQK, DPS

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 files. The API consists of 2 messaging queues (an input and an output).

IM007 works as follows:

  1. IM007 receives input data (an ECG file and device parameters) from the remote monitoring platform using the input queue.
  2. 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.
  3. IM007 sends a response to the Remote Monitoring Platform using the output queue.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Yes (Machine Learning)

Input Imaging Modality

ECG data from Insertable Cardiac Monitor (ICM) devices

Anatomical Site

Not Found

Indicated Patient Age Range

Adults (over 18)

Intended User / Care Setting

Qualified healthcare professionals for the assessment of arrhythmias in Insertable Cardiac Monitor (ICM) ECG data.
The device is intended to be electronically interfaced with other computer systems (remote monitoring platform).

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing was conducted to assess algorithm performance and to verify that IM007 performs as intended. 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K170568

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K163460

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

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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)

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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 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 NameIM007 Insertable Cardiac Monitor ECG Analysis System
Common NameICM ECG Analysis System
Classification21 CFR 870.1425, Programmable diagnostic computer, Class II
21 CFR 870.2340, Electrocardiograph, Class II
Product CodeDQK, 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 | 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 DevicePredicate DeviceReference DeviceComparison to Predicate Device
Patient
populationAdults (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.

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Table 3 Comparison between Subject, Reference & Predicate Devices rhythm analysis outputs
Subject Device
Output classificationReference Device
Reveal LINQPredicate DeviceComparison 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
rateBrady
(bradyarrhythmia)
The patient's heart rate
falls to a rate that is
lower than the
programmable brady
threshold.Sinus bradycardia
(