(249 days)
Not Found
Yes
The predicate device, K181823 (KardiAI), is known to incorporate AI/ML for ECG analysis. While the summary doesn't explicitly state AI/ML for the subject device, the functional description of ECG rhythm analysis and classification, combined with the predicate device's technology, strongly suggests the use of AI/ML.
No.
The device is a software library that processes ECG signals to provide heart rate and rhythm analysis. It is described as being "integrated into other device software" and provides diagnostic information, but it does not directly apply any therapy to a patient. The output is for "clinical decision making," and users are explicitly told "not make changes to their medication without consulting a physician."
Yes
The device is described as classifying a 30-second ECG spot check recording as normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, unreadable, or inconclusive, and clearly states its purpose is for "ECG rhythm analysis" and extraction of "beats from an ECG signal to provide a heart rate reading and ECG rhythm analysis." It also states "All interpretations must be reviewed by a medical professional for clinical decision making." This indicates the device provides information for diagnosis.
Yes
The device is described as a "Software Library" and an "object library," which are collections of code. It is intended to be integrated into other device software and accepts a digital ECG stream as input. There is no mention of accompanying hardware developed or provided by the submitter.
Based on the provided information, the B-Secur HeartKey Software Library is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- HeartKey's function: The HeartKey Software Library processes and analyzes ECG signals, which are electrical signals from the heart, not samples taken from the body. It performs signal processing and rhythm analysis based on these electrical signals.
- Intended Use: The intended use clearly states it's for assessing single lead ECG spot checks from adult patients and providing heart rate and ECG rhythm analysis. This is a physiological measurement and analysis, not a diagnostic test performed on a biological sample.
While the software is intended for use in medical devices and provides information relevant to a medical condition (heart rhythm), its function is based on analyzing electrical signals from the body, not on testing biological samples. Therefore, it falls outside the scope of an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" is explicitly marked "Not Found".
Intended Use / Indications for Use
The B-Secur HeartKey Software Library is intended to be used by medical device manufacturers in medical devices to assess a single lead ECG spot checks from adult patients. The product allows the processing and extraction of beats from an ECG signal to provide a heart rate reading and ECG rhythm analysis. The library will classify a 30 second ECG spot check recording as normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia, unreadable or inconclusive.
The library is intended to be integrated into other device software. All interpretations must be reviewed by a medical professional for clinical decision making, and the user of the device should not make changes to their medication without consulting a physician. The library is not intended for use in life supporting or sustaining systems, or cardiac alarm systems.
Product codes (comma separated list FDA assigned to the subject device)
DOK, DPS
Device Description
The B-Secur HeartKey Software Library is an "object library". An object library is a collection of callable functions that have been compiled into native machine code of the computer on which they will execute. The HeartKey Software Library includes a basic application for viewing and analyzing electrocardiogram (ECG) data. The source code for the library is not available and cannot be modified by the end user.
The B-Secur HeartKey Software Library provides ECG signal processing and QRS detection for a single lead ECG 30s spot check. System input lead is configurable based on the application, but the typical application is arrhythmia screening from a Lead I stainless steel dry electrode device capable of carrying out periodic spot checks. The software library is designed to accept a digital ECG stream and produce several metrics.
Features:
- Signal filtering: The removal of noise from the input ECG
- QRS detection: Identification of QRS complexes
- Heart rate: Report calculated heart rate (40 bpm - 200 bpm) from the input ECG
- RR interval: Report of time between QRS complexes
- Signal Quality: Analysis and output of the quality of incoming signal
- Arrhythmia analysis: Normal Sinus Rhythm, Bradycardia, Tachycardia, Atrial Fibrillation, Inconclusive, Unreadable
All features are accessed via an application programming interface (API).
The device is only intended to analyze ECG from:
- (1) "wet" lead I-or II electrodes, or
- (2) lead I handheld stainless-steel dry electrodes from devices intended for automated ECG analysis.
B-Secur will compile the HeartKey library for the ECG device manufacturer. An object library will be created and delivered to the device manufacturer, who can then integrate it into their product for their ECG analysis.
It is the responsibility of the device manufacturer to integrate HeartKey correctly and to obtain the necessary regulatory approval/clearance for the final device integrating the HeartKey. It is also the responsibility of the device manufacturer to ensure their ECG device has the correct regulatory approvals and meets the required standards for their intended use; any regulatory clearance and tests that HeartKey has does not apply to an ECG device integrating HeartKey, and these processes and tests should be repeated at the system level.
Principle of Operation:
It is intended that the library is integrated into other device software. An application software program is written that calls some or all of the available functions within the software library. The application which forms the device software could be written to run on a PC, server or embedded microcontroller. All features are accessed via a documented application programming interface (API).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults (over 18)
Intended User / Care Setting
Home or healthcare environment. All interpretations must be reviewed by a medical professional for clinical decision making, and the user of the device should not make changes to their medication without consulting a physician.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was conducted to assess algorithm performance and to verify that the HeartKey® Software Library performs as intended including Heart Rate Validation, Tachycardia and Bradycardia Validation, Atrial Fibrillation Validation and Arrhythmia Detection Validation assessed using ECG databases from the ANSI/AAMI EC57:2012 standard as well as B-Secur proprietary databases. The results of the testing demonstrate that the HeartKey® Software Library 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.
K181823 – AliveCor, Inc. - KardiAI
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.
Not Found
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
§ 870.2340 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 contains 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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
December 7, 2020
B-Secur Ltd. % Paul Dryden Consultant B-Secur Ltd. c/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K200884
Trade/Device Name: B-Secur HeartKey Software Library Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, DPS Dated: October 30, 2020 Received: November 2, 2020
Dear Paul Dryden:
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
1
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 medical devices and radiation-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 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)
K200884
Device Name
B-Secur HeartKev Software Librarv
Indications for Use (Describe)
The B-Secur HeartKey Software Library is intended to be used by medical device manufacturers in medical devices to assess a single lead ECG spot checks from adult patients. The product allows the processing and extraction of beats from an ECG signal to provide a heart rate reading and ECG rhythm analysis. The library will classify a 30 second ECG spot check recording as normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia, unreadable or inconclusive.
The library is intended to be integrated into other device software. All interpretations must be reviewed by a medical professional for clinical decision making, and the user of the device should not make changes to their medication without consulting a physician.
The library is not intended for use in life supporting or sustaining systems, or cardiac alarm systems.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
XX Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (6/20)
3
| Page 1 of 7 | |
|---|---|
| Date Prepared: | 7-Dec-20 |
| Sponsor: | |
| B-Secur Ltd | |
| 20 Queens Road | |
| Belfast BT3 9DT United Kingdom | |
| Tel - + 44 2890 737800 | |
| Sponsor Contact: | David Brown, Head of Operations |
| Submission Correspondent: | Paul Dryden |
| ProMedic, LLC | |
| Proprietary or Trade Name: | HeartKey Software Library |
| Common/Usual Name: | Electrocardiograph |
| Classification Name: | |
| Product Classification: | |
| Regulation: | |
| Class: | Programmable diagnostic computer |
| DQK | |
| 21CFR 870.1425 | |
| Class II | |
| Classification Name: | |
| Product Classification: | |
| Regulation: | |
| Class: | Electrocardiograph |
| DPS | |
| 21CFR 870.2340 | |
| Class II | |
| Predicate Device: | K181823 – AliveCor, Inc. - KardiAI |
Device Description:
The B-Secur HeartKey Software Library is an "object library". An object library is a collection of callable functions that have been compiled into native machine code of the computer on which they will execute. The HeartKey Software Library includes a basic application for viewing and analyzing electrocardiogram (ECG) data. The source code for the library is not available and cannot be modified by the end user.
The B-Secur HeartKey Software Library provides ECG signal processing and QRS detection for a single lead ECG 30s spot check. System input lead is configurable based on the application, but the typical application is arrhythmia screening from a Lead I stainless steel dry electrode device capable of carrying out periodic spot checks.
The software library is designed to accept a digital ECG stream and produce several metrics.
| Feature | Description |
|---|---|
| Signal filtering | The removal of noise from the input ECG |
| QRS detection | Identification of QRS complexes |
| Heart rate | Report calculated heart rate (40 bpm - 200 bpm) |
| from the input ECG | |
| RR interval | Report of time between QRS complexes |
4
| Feature | Description |
|---|---|
| Signal Quality | Analysis and output of the quality of incoming signal |
| Arrhythmia analysis | Normal Sinus Rhythm |
| Bradycardia | |
| Tachycardia | |
| Atrial Fibrillation | |
| Inconclusive | |
| Unreadable |
510(k) Summary Page 2 of 7
All features are accessed via an application programming interface (API).
The device is only intended to analyze ECG from:
- (1) "wet" lead I-or II electrodes, or
- (2) lead I handheld stainless-steel dry electrodes from devices intended for automated ECG analysis.
B-Secur will compile the HeartKey library for the ECG device manufacturer. An object library will be created and delivered to the device manufacturer, who can then integrate it into their product for their ECG analysis.
It is the responsibility of the device manufacturer to integrate HeartKey correctly and to obtain the necessary regulatory approval/clearance for the final device integrating the HeartKey. It is also the responsibility of the device manufacturer to ensure their ECG device has the correct regulatory approvals and meets the required standards for their intended use; any regulatory clearance and tests that HeartKey has does not apply to an ECG device integrating HeartKey, and these processes and tests should be repeated at the system level.
Principle of Operation:
It is intended that the library is integrated into other device software. An application software program is written that calls some or all of the available functions within the software library. The application which forms the device software could be written to run on a PC, server or embedded microcontroller. All features are accessed via a documented application programming interface (API).
Indications for Use:
The B-Secur HeartKey Software Library is intended to be used by medical device manufacturers in medical devices to assess a single lead ECG spot checks from adult patients. The product allows the processing and extraction of beats from an ECG signal to provide a heart rate reading and ECG rhythm analysis. The library will classify a 30 second ECG spot check recording as normal sinus rhythm, atrial fibrillation, bradycardia, unreadable or inconclusive.
The library is intended to be integrated into other device software. All interpretations must be reviewed by a medical professional for clinical decision making, and the user of the device should not make changes to their medication without consulting a physician.
The library is not intended for use in life supporting or sustaining systems, or cardiac alarm systems.
5
Patient Population:
Adults (over 18)
Environments of use:
Home or healthcare environment
We present the proposed device vs. the predicate in Table 1.
As part of the comparison we will present and discuss the:
- Indications for Use ●
- Technology and Principle of Operation
- . Performance and Specifications
Table 1 is a comparison - Subject Device vs. the Predicate, K181823 - AliveCor, Inc. - KardiAI. Note that the comparison to the predicate is based upon available technical specifications vs. comparative testing.
6
K200884 510(k) Summary Page 4 of 7
| Table 1 - Comparison - Subject vs. Predicate | |
|---|---|
| ---------------------------------------------- | -- |
| Predicate - KardiAI | Subject device - HeartKey® Software Library | Comparison | |
|---|---|---|---|
| K# | K181823 | K200884 | - |
| Product Code | DQK and DPS | DQK and DPS | Same |
| CFR | 870.1425 / 870.2340 | 870.1425 / 870.2340 | Same |
| Classification | Programmable Diagnostic Computer | Programmable Diagnostic Computer | Same |
| Indications for Use | KardiaAI is a software analysis library intended | The B-Secur HeartKey Software Library is intended | Similar |
| to assess ambulatory electrocardiogram (ECG) | |||
| rhythms from adult subjects. The device supports | |||
| analyzing data recorded in compatible formats from | |||
| any ambulatory ECG devices such as event recorders, | |||
| or other similar devices. The library is intended to be | |||
| integrated into other device software. | to be used by medical device manufacturers in | ||
| medical devices to assess a single lead ECG spot | |||
| checks from adult patients. The product allows the | |||
| processing and extraction of beats from an ECG | |||
| signal to provide a heart rate reading and ECG | |||
| rhythm analysis. The library will classify a 30 second | |||
| ECG spot check recording as normal sinus rhythm, | |||
| atrial fibrillation, bradycardia, and tachycardia, | |||
| unreadable or inconclusive. | The predicate device may be | ||
| implemented in a device with | |||
| OTC and/or prescriptive use. | |||
| The medical device | |||
| manufacturer integrating the | |||
| library, or select features of | |||
| the library, into an ECG | |||
| monitoring device will | |||
| determine the type of use | |||
| for their specific application. | |||
| The library is not intended for use in life | |||
| supporting, or sustaining systems, or ECG | |||
| monitors, or cardiac alarm, or OTC use only | |||
| devices. | The library is intended to be integrated into other | ||
| device software. All interpretations must be | |||
| reviewed by a medical professional for clinical | |||
| decision making, and the user of the device should | |||
| not make changes to their medication without | |||
| consulting a physician. | |||
| KardiaAI provides the following capabilities: | |||
| • ECG noise filtering, | |||
| • heart rate measurement from ECGs, | |||
| • detection of noisy ECGs, and | |||
| • ECG rhythm analysis for detecting the presence of | |||
| normal sinus rhythm, atrial fibrillation, bradycardia, | |||
| and tachycardia (when prescribed or used under the | |||
| care of a physician). | |||
| The library is not intended for use in life supporting | |||
| or sustaining systems, or cardiac alarm systems. | |||
| Target Population | Adults (over 18) | Adults (over 18) | Same |
| Components | Software only | Software only | Same |
7
K200884 510(k) Summary Page 5 of 7
| Predicate - KardiAI | Subject device - HeartKey® Software Library | Comparison | |
|---|---|---|---|
| Software Functional | |||
| Comparisons | An interface that provides tools to process and | ||
| analyze ECGs through various algorithms |
The automated proprietary ECG algorithms
provide supportive information for ECG
diagnosis.
The library can be accessed by directly connecting to
the KardiaAI's Application Programming Interface | An interface that provides tools to process and
analyze ECGs through various algorithms.
An application software library can be written to
invoke some or all of the functions in an object
library.
The library can be accessed by directly calling the
HeartKey Application Programming Interface. | Similar
An object library is a
collection of callable functions
that have been compiled into
native machine code of the
computer on which they will
execute. It is intended that an
application software program
is written that calls some or all
of the available functions
within the library. |
| Parameters measured | ECG Signal Processing
Beat Detection
Heart Rate determination for non-paced adults
Arrhythmia determination for adults including Atrial
Fibrillation, Tachycardia and Bradycardia | ECG Signal Processing
Beat Detection
Heart Rate determination for non-paced adults
Arrhythmia determination for adults including Atrial
Fibrillation, Tachycardia and Bradycardia | Same |
| Performance Testing | Algorithm performance testing was assessed using
ECG databases from ANSI/AAMI EC57:2012 and
other proprietary datasets | Algorithm performance testing was assessed using
ECG databases from ANSI/AAMI EC57:2012 and
other proprietary datasets | Same |
| Biocompatibility | No patient contact materials | No patient contact materials | Same |
8
Substantial Equivalence Discussion
The HeartKey® Software Library has the same general intended use and similar indications, technological characteristics, and principles of operation as the predicate AliveCor KardiaAI, K181823.
Intended Use/ Indications for Use
The indications for use for the B-Secur HeartKey® Software Library and the predicate AliveCor KardiaAI, K181823 both are software libraries which are intended to be integrated into medical devices. Both devices allow for the processing and extraction of beats from an ECG signal, providing an accurate heart rate measurement, in either an ambulatory or non-ambulatory environment.
Both the proposed and the predicate allow for ECG rhythm analysis in order to detect Sinus Rhythm, Atrial Fibrillation, Tachycardia and Bradycardia. The indications for use are similar.
Environment of Use and Target Population
The HeartKey® Software Library is intended for prescriptive and for adults over 18. The predicate KardiaAI library has the same environment of use and population.
Both the HeartKey® Software Library and the KardiaAI library are intended for home use.
Technological Characteristics and Principles of Operation
The HeartKey® Software Library is an "object library" - a collection of callable functions that have been compiled to native machine code of the computer on which they will execute. The HeartKev® Software Library is intended to be implemented into medical devices by medical device manufacturers. The HeartKey® library has the same intended use and users as the predicate.
The HeartKey® Software Library provides the medical devices it is intended to be used in, with real time ECG signal processing and beat extraction in order to provide a heart rate reading and arrhythmia analysis to the device user. The predicate KardiaAI (K181823) software analysis library assesses ambulatory electrocardiogram (ECG) rhythms from adult subjects. The HeartKey® Software Library and KardiaAI are based on the following technological characteristics:
- Process ECG signals ●
- . Detect peaks in ECG signals
- o Output heart rate measurements to the user
- Rhythm analysis to detect Sinus Rhythm, Atrial Fibrillation, Bradycardia and Tachycardia
The HeartKey® Software Library and the predicate are substantially equivalent in relation to their technological characteristics.
Non-clinical Testing
Non-clinical testing was conducted to assess algorithm performance and to verify that the HeartKey® Software Library performs as intended including Heart Rate Validation, Tachycardia and Bradycardia Validation, Atrial Fibrillation Validation and Arrhythmia Detection Validation assessed using ECG databases from the ANSI/AAMI EC57:2012 standard as well as B-Secur
9
proprietary databases. The results of the testing demonstrate that the HeartKey® Software Library performs to its specifications and meets its intended use, which is substantially equivalent to that of the predicate device.
Differences and Substantial Equivalence Conclusion
The results of nonclinical testing demonstrate that the HeartKey® Software Library meets its intended use which is equivalent to that of the predicate device. Testing also ensured that differences in technological characteristics perform as intended and do not raise different questions of safety or effectiveness.