(267 days)
Not Found
Unknown
The description mentions a "proprietary AccurECG algorithm" that uses "advanced signal processing and image-based techniques" and "statistical classification" for automated arrhythmia interpretation. While these techniques could involve AI/ML, the summary does not explicitly state that AI or ML is used. The lack of mention of training/test sets or specific AI/ML terminology makes it impossible to definitively confirm the presence of AI/ML.
No.
The device is described as an analysis system that provides supportive information for ECG analysis and is an adjunct to facilitate healthcare decision-making, rather than directly treating or preventing a disease.
Yes
The "Intended Use / Indications for Use" section states: "The AccurECG Analysis System's automated interpretation results are not intended to be the sole means of diagnosis. The AccurECG Report is an adjunct intended to facilitate health care decision making in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information to arrive at a diagnostic conclusion." This indicates its role in supporting the diagnostic process.
Yes
The device description explicitly states that the system consists of a client-side web interface and a server-side algorithm, and that it "does not interface with data management systems or hardware and is device independent." This indicates it is purely software for analyzing existing ECG data.
Based on the provided information, the AccurECG Analysis System is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The system is intended for the "assessment of a patient's recorded ambulatory ECG data" and provides "analysis results" to "facilitate health care decision making." While it's not the sole means of diagnosis, it provides information derived from a biological signal (ECG) to aid in the diagnostic process.
- Device Description: It analyzes and interprets ECG signals, which are physiological measurements from the patient.
- Predicate Device: The listed predicate device, K212112 (Cardiologs Holter Platform), is also a system for analyzing ambulatory ECG data, and such systems are typically regulated as IVDs.
However, it's important to note:
- The definition of IVD can be nuanced. While the AccurECG system analyzes biological data to aid in diagnosis, it doesn't directly analyze a sample taken from the body (like blood or urine). It analyzes a signal from the body.
- Regulatory classification is ultimately determined by regulatory bodies. While the characteristics strongly suggest it falls under the IVD umbrella, the final classification is made by the relevant regulatory authority (e.g., FDA in the US).
In summary, based on the intended use of analyzing patient physiological data (ECG) to provide information for diagnosis, and the nature of the predicate device, the AccurECG Analysis System strongly aligns with the characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AccurECG Analysis System is intended for use by qualified healthcare professionals in the assessment of a patient's recorded ambulatory ECG data. Analysis results are provided in a standard report for review and printing.
The System provides single-lead analysis on a beat-by-beat basis. Ventricular Ectopic Beat and Supraventricular Ectopic Beat detection, heart rate measurement, and rhythm analysis. The AccurECG Analysis System is compatible with ECG recordings taken with silver/silver chloride (Ag / AgCl) electrodes (wet leads).
The AccurECG Analysis System is not for use in life-supporting or sustaining systems or ECG monitor and alarm devices. The System is not intended to be used with cardiac telemetry monitors.
The AccurECG Analysis System's automated interpretation results are not intended to be the sole means of diagnosis. The AccurECG Report is an adjunct intended to facilitate health care decision making in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information to arrive at a diagnostic conclusion.
The AccurECG Analysis System does not interface with data management systems or hardware and is device independent.
Product codes
DPS, DQK
Device Description
The AccurECG Analysis System ("AccurECG" or the "System") consists of: (1) A client-side web interface which provides tools to upload and review ECG recordings via a web application programming interface (API), and (2) A server-side automated proprietary ECG interpretation support algorithm which measures and analyzes ECGs to provide physicians supportive information for ECG analysis.
AccurECG is intended to analyze recordings performed on adults over the age of 22 and works in the following sequence:
- i. The web interface allows the user to select files and upload to the AccurECG secure database.
- ii. The proprietary AccurECG algorithm analyzes and labels the ECG:
- o Delineation detection of ORS complexes and T waves on the ECG signal through advanced signal processing and image-based techniques.
- · Abnormality labels automated arrhythmia interpretation and statistical classification.
- iii. AccurECG Analysis System displays the resulting analysis and original ECG signal with reviewing tools in the web interface.
- iv. AccurECG Analysis System allows for preliminary comments summarizing the review before generating a report.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ECG recordings
Anatomical Site
Not Found
Indicated Patient Age Range
Adults over the age of 22.
Intended User / Care Setting
Qualified healthcare professionals
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
Not Found
Summary of Performance Studies
Performance tests have been conducted in conformance with the following FDA-recognized consensus standards.
- · AAMI/ANSI EC 57:2012 Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms
- · IEC 60601-2-47:2012 Medical Electrical Equipment, Part 2-47: Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems (Section 201.12.1.101 -Algorithm Testing).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
June 23, 2023
AccurKardia, Inc. % Adrienne Lenz Principle Medical Device Regulation Expert Hyman, Phelps & McNamara, PC 700 Thirteenth Street, N.W., Suite 1200 Washington, District of Columbia 20005-5929
Re: K223013
Trade/Device Name: AccurECG® Analysis System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DQK Dated: May 26, 2023 Received: May 26, 2023
Dear Adrienne Lenz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
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-regulatoryinformation/postmarketing-safety-reporting-combination-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,
Shruti N. Mistry -S
for
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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K223013
Device Name
AccurECG® Analysis System
Indications for Use (Describe)
The AccurECG Analysis System is intended for use by qualified healthcare professionals in the assessment of a patient's recorded ambulatory ECG data. Analysis results are provided in a standard report for review and printing.
The System provides single-lead analysis on a beat-by-beat basis, Ventricular Ectopic Beat detection, heart rate measurement, and rhythm analysis System is compatible with ECG recordings taken with silver/silver chloride (Ag / AgCI) electrodes (wet leads).
The AccurECG Analysis System is not for use in life-supporting or ECG monitor and alarm devices. The System is not intended to be used with cardiac telemetry monitors.
The AccurECG Analysis System's automated interpretation results are not intended to be the sole means of diagnosis. The AccurEGG Report is an adjunct intended to facilitate health care decision with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information to arrive at a diagnostic conclusion.
The AccurECG Analysis System does not interface with data management systems or hardware and is device independent.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D) [ ] Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
SECTION 5 : 510(k) Summary
5.1 Applicant/Submitter
| Company Name | : | AccurKardia, Inc. |
|---|---|---|
| Street Address | : | 101 Avenue of the Americas, FL 8 |
| City | : | New York |
| State | : | New York |
| Zip Code | : | 10013 |
| Phone Number | : | 646-334-5728 |
5.2 Contact Person
| Full Name | : Juan C. Jiménez |
|---|---|
| Phone | : 646-334-5728 |
5.3 Correspondent Information
| Full Name | : Juan C. Jiménez |
|---|---|
| Phone | : 646-334-5728 |
5.4 Date of Preparation
Date of Preparation
: 05/26/2023
5.5 Device Information
| Device Name | AccurECG® Analysis System |
|---|---|
| Model Number | |
| Common Name | ECG Analysis System |
| Regulation | 21 CFR 870.2340, 21 CFR 870.1425 |
| Product Code | DPS;DQK |
| Reviewing Panel/Branch | Cardiovascular |
| Submission Number | K223013 |
4
5.6 Predicate Device(s)
| Table - 5.1 Predicate Device(s) | ||
|---|---|---|
| -- | ---------------------------------- | -- |
| Predicate Type | 510(k) Number | Device Name | Manufacturer | Product Code |
|---|---|---|---|---|
| Primary | K212112 | Cardiologs Holter Platform | Cardiologs Technologies | DPS,DQK |
5.7 Device Description
The AccurECG Analysis System ("AccurECG" or the "System") consists of: (1) A client-side web interface which provides tools to upload and review ECG recordings via a web application programming interface (API), and (2) A server-side automated proprietary ECG interpretation support algorithm which measures and analyzes ECGs to provide physicians supportive information for ECG analysis.
AccurECG is intended to analyze recordings performed on adults over the age of 22 and works in the following sequence:
- i. The web interface allows the user to select files and upload to the AccurECG secure database.
- ii. The proprietary AccurECG algorithm analyzes and labels the ECG:
- o Delineation detection of ORS complexes and T waves on the ECG signal through advanced signal processing and image-based techniques.
- · Abnormality labels automated arrhythmia interpretation and statistical classification.
- iii. AccurECG Analysis System displays the resulting analysis and original ECG signal with reviewing tools in the web interface.
- iv. AccurECG Analysis System allows for preliminary comments summarizing the review before generating a report.
5.8 Intended Use/Indications for Use
The AccurECG Analysis System is intended for use by qualified healthcare professionals in the assessment of a patient's recorded ambulatory ECG data. Analysis results are provided in a standard report for review and printing.
The System provides single-lead analysis on a beat-by-beat basis. Ventricular Ectopic Beat and Supraventricular Ectopic Beat detection, heart rate measurement, and rhythm analysis. The AccurECG Analysis System is compatible with ECG recordings taken with silver/silver chloride (Ag / AgCl) electrodes (wet leads).
The AccurECG Analysis System is not for use in life-supporting or sustaining systems or ECG monitor and alarm devices. The System is not intended to be used with cardiac telemetry monitors.
The AccurECG Analysis System's automated interpretation results are not intended to be the sole means of diagnosis. The AccurECG Report is an adjunct intended to facilitate health care decision making in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information to arrive at a diagnostic conclusion.
The AccurECG Analysis System does not interface with data management systems or hardware and is device independent.
5.9 Comparison of Technological Characteristics with Predicate
The subject device has the same intended use and substantially equivalent technological characteristics that do not raise questions of safety or effectiveness. Table - 5.2 Feature Comparison: AccurECG System to the predicate device illustrates a comparison of detection features between the AccurECG system and the cited predicate.
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| Feature | AccurECG | CardioLogs ECG Analysis Platform |
|---|---|---|
| Heart rate determination for non-paced | ||
| adult | Yes | Yes |
| QRS Detection | Yes | Yes |
| Non-paced arrhythmia interpretation for | ||
| adult patients | Yes | Yes |
| Non-paced ventricular arrhythmia calls | Yes | Yes |
| Intervals measurements | Yes | Yes |
| Ventricular ectopic beat detection | Yes | Yes |
| Patient Population | Adult | Adult & Pediatric |
Table - 5.2 Feature Comparison: AccurECG to the predicate device
Table - 5.3 Comparison of technological characteristics: AccurECG to the predicate device provides a comparison of the technological characteristics of the AccurECG System with the cited predicate.
Table - 5.3 Comparison of technological characteristics: AccurECG System to the predicate device
| | AccurECG
(this submission) | CardioLogs ECG Analysis Platform
(K170568) | Comparison to
predicate device |
|------------------------------|------------------------------------|-----------------------------------------------|-----------------------------------|
| Device Trade
Name | AccurECG® Analysis System | CardioLogs ECG Analysis Platform | N/A |
| Manufacturer | AccurKardia, Inc. | CardioLogs Technologies | N/A |
| 510(K) No. | (this submission) | K212112 | N/A |
| Regulation
Number | 21 CFR 870.2340
21 CFR 870.1425 | 21 CFR 870.2340
21 CFR 870.1425 | Same |
| Product Code | DQK, DPS | DQK, DPS | Same |
| Class | 2 | 2 | Same |
| Device
Class/Name | Electrocardiograph | Electrocardiograph | Same |
| Software Level of
Concern | Major | Moderate | Same |
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| Indications for
Use | The AccurECG Analysis System is | The Cardiologs Platform (Also known
as Cardiologs ECG Analysis Platform) | The predicate device is |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | intended for use by qualified healthcare
professionals
("HCP") in the assessment of a patient's
recorded ambulatory ECG data.
Analysis results are provided in a
standard report for review and printing.
The System provides single-lead analysis
on a beat-by-beat basis, Ventricular
Ectopic Beat and Supraventricular
Ectopic Beat detection, heart rate
measurement, and rhythm analysis. The
AccurECG Analysis System is
compatible with ECG recordings taken
with silver/silver chloride (Ag / AgCl)
electrodes (wet leads).
The AccurECG Analysis System is not
for use in life-supporting or sustaining
systems or ECG monitor and alarm
devices. The System is not intended to
be
used with cardiac telemetry monitors.
The AccurECG Analysis System's
automated interpretation results are not
intended to be the sole means of
diagnosis. The AccurECG Report is an
adjunct intended to facilitate health care
decision making in conjunction with the
physician's knowledge of ECG patterns,
patient background, clinical history,
symptoms, and other diagnostic
information to arrive at a diagnostic
conclusion.
The AccurECG Analysis System does
not interface with data management
systems or hardware and is device
independent. | is intended for use by qualified
healthcare professionals for the
assessment of arrhythmias using ECG
data in the adult and pediatric
population. 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.
The Cardiologs 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 Cardiologs 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 Cardiologs Platform is not for use
in life supporting or sustaining systems
or ECG monitor and Alarm devices.
The product can be integrated into
computerized ECG monitoring devices.
In this case, the medical device
manufacturer will identify the
indication for use depending on the
application of their device.
The product can be integrated into
computerized ECG monitoring devices.
In this case, the medical device
manufacturer will identify the
indication for use depending on the
application of their device.
Cardiologs 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, clinical history, | indicated for pediatric as
well as adult patients. |
| Fundamental
scientific
technology | The AccurECG Analysis System
consists of: | The Cardiologs Holter Platform
consists of: | The AccurECG Analysis
System does not present
any major technological
differences compared to
the
predicate device. |
| | An interface which provides tools to
upload, analyze, review ECG data coded
in Java. | An interface which provides tools to
measure, analyze and review numerous
ECGs coded in java language under the
Angular and D3.js frameworks; | Substantially equivalent:
Both
devices provide a web
interface which provides
tools to upload, analyze,
review ECG data, but are
coded in a different
programming language,
which should not have
any effect on intended us
or performance and does
not introduce new issues
of safety or effectiveness |
| | An automated proprietary ECG
interpretation support
algorithm which measures and analyses
ECGs to provide
supportive information for ECG
diagnosis, written in LabVIEW using
the G Programming language. | An automated proprietary ECG
interpretation support
algorithm which measures and analyzes
ECGs to provide supportive
information for ECG diagnosis, written
in Python language. | Both are accessed throug
an
internet connection and a
web browser, but the
predicate device can also
be accessed through a
direct connection to the
API. This connection
difference should not
have any effect on
intended use or
performance and does no
introduce new issues of
safety or effectiveness. |
| | This application is accessed through an
Internet connection and a web browser
connected to the AccurECG Application
Programming Interface (API). | This application can be accessed
through an Internet
connection and a web browser, or is
directly connected to the Cardiologs'
Application Programming Interface
(API). | |
7
5.10 Summary of Performance Data
Performance tests have been conducted in conformance with the following FDA-recognized consensus standards.
- · AAMI/ANSI EC 57:2012 Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms
- · IEC 60601-2-47:2012 Medical Electrical Equipment, Part 2-47: Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems (Section 201.12.1.101 -Algorithm Testing).
5.11 Software verification and validation
Testing described in this premarket notification consisted of verification of all design input requirements and product specifications. All clinical input requirements were validated against a gold standard. There are 2 residual anomalies appeared during verification and software validation tests. The Anomalies can be found in the APPX 44 PRJ-21-059 v05 Software Anomalies Listing, AccurECG.
Usability of the AccurECG Analysis System was tested throughout development, validating the effectiveness of risk control measures associated with the user interface. AccurKardia conducted usability tests of the AccurECG user interface with Certified Cardiovascular Technicians to evaluate the effectiveness of the design, labeling and risk. The protocols cover the testable technical requirements relevant to the user interface as described in the User Interface Specification.
5.12 Conclusion
Based upon the Intended Use, Indications for Use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, the AccurECG® Analysis System has been shown to be substantially equivalent to the cited predicate.