The physlQ Heart Rhythm Module is intended for use by a physician or other qualified medical professionals for the calculation of heart rate and heart rate variability and the detection of atrial fibrillation using ambulatory ECG data. The physlQ Heart Rhythm Module supports receiving and analyzing single-lead ECG signals recorded in a compatible format from FDA-cleared ECG biosensor devices using "wet" electrode technology when assessment of rhythm is desired. The phys\Q Heart Rhythm Module is for use in subacute clinical settings for remote patient monitoring. The physlQ Heart Rhythm Module is not for use in patients requiring or life-sustaining systems or ECG Alam devices.

Device Description

The physIQ Heart Rhythm Module (Version 1.0) is a computerized all-software callable function library in the Python programming language that is designed for calculating heart rate and heart rate variability and for detecting atrial fibrillation determined by automated analysis of any single electrocardiogram (ECG) channel collected by commercially-available ECG biosensor devices. This Heart Rhythm Module will be integrated by the customer organization into an end-to-end system (biosensor data collection to clinician display) that makes calls into the product, most typically via a Python middleware script. The "middleware" accesses the source ECG data from a customer's data collection system, most likely via its own application programming interface (API), and makes calls to the physIQ Heart Rhythm Module to input ECG for processing into the vital sign outputs of the product. These outputs are returned to the middleware, which may insert these results into a downstream monitoring system for clinical use.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting studies for the physIQ Heart Rhythm Module (Version 1.0), based on the provided FDA 510(k) document:

phyIQ Heart Rhythm Module (Version 1.0) Acceptance Criteria and Performance

1. Table of Acceptance Criteria and Reported Device Performance

The provided document states that "Performance testing following guidelines of ANS/AAMI EC572012: Testing and Reporting Performance Results of Cardiac Rhythm and ST segment Measurement Algorithms has been applied to each of the algorithms. The performance testing results for all algorithms were compared to physIQ's defined acceptance criteria for performance testing. All algorithms met their corresponding acceptance criteria."

However, the specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for each algorithm (Heartbeat Detector, Heart Rate, Heart Rate Variability, and Atrial Fibrillation Detector) are not explicitly detailed in the provided text. Similarly, the exact reported performance metrics (e.g., the achieved sensitivity/specificity values) are also not provided in a summarized table within this document. The document only confirms that "All algorithms met acceptance criteria."

Therefore, an exact table with numerical acceptance criteria and reported performance cannot be generated from the given text.

2. Sample Size Used for the Test Set and Data Provenance

The document states:
"further supportive clinical validation testing of the physIQ Heart Rhythm Module was performed using electrocardiography (ECG) signals captured from ambulatory patients using a wearable single-lead biosensor device which were annotated by medical experts in cardiology."

Sample Size for Test Set: Not explicitly stated. The document only refers to "ambulatory patients" without specifying the number of patients or the duration/amount of ECG data.
Data Provenance: The ECG signals were "captured from ambulatory patients" using two commercially available FDA-cleared patches: HealthPatch (K152139) manufactured by VitalConnect Inc. and BodyGuardian (K121197; K151188) manufactured by Preventice Inc. The country of origin of the data is not specified, but the use of FDA-cleared devices typically implies data collected in regions where such devices are marketed, often the US. The data appears to be retrospective, as it was "captured from ambulatory patients" and then annotated.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not explicitly stated. The document mentions "medical experts in cardiology."
Qualifications of Experts: They were described as "medical experts in cardiology." Specific experience level (e.g., "10 years of experience") is not provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. The document only says the data was "annotated by medical experts in cardiology." It does not specify if multiple experts independently annotated and then reached consensus, or if a single expert provided the ground truth, or if a specific adjudication process (like 2+1 or 3+1) was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or described in the provided text. The testing focused on the standalone performance of the algorithm against expert annotations.
Effect Size of Human Improvement with AI Assistance: Not applicable, as no MRMC study was described.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Standalone Performance: Yes, a standalone performance evaluation was conducted. The document states: "this testing did not use any patch-generated vitals, but instead compared physIQ Heart Rhythm Module outputs to annotations by cardiology experts using ECG captured from two commercially-available patches..." This indicates the algorithm's output was directly compared to the expert-derived ground truth without human intervention in the device's output.

7. Type of Ground Truth Used

Type of Ground Truth: Expert Consensus (or Expert Annotation). The document explicitly states the ECG signals were "annotated by medical experts in cardiology."

8. Sample Size for the Training Set

Sample Size for Training Set: Not mentioned in the provided text. The document focuses on the performance testing and clinical validation rather than the development and training details of the algorithms.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not mentioned in the provided text. As with the training set size, the document does not delve into the methodology for establishing ground truth for any training data used for the algorithms.

Summary

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August 10, 2018

physIQ Inc. George Hides Vice President, Regulatory and Clinical Affairs 300 E. 5th Avenue, Suite 105 Naperville, Illinois 60563

Re: K180234

Trade/Device Name: physIO Heart Rhythm Module (Version 1.0) Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: July 13, 2018 Received: July 17, 2018

Dear George Hides:

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. 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

M.A. Wilhelm

for Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K180234

Device Name

physIO Heart Rhythm Module (Version 1.0)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Notification K180234

GENERAL INFORMATION

Applicant:

physIQlnc. 300 E. 5th Avenue Suite 105 Naperville IL 60563 USA Phone: (800) 561-7902

Contact Person:

George Allen Hides Vice President, Regulatory and Clinical Affairs physIQ Inc. 300 E. 5th Avenue Suite 105 Naperville IL 60563 USA Email: george.hides@physiq.com Phone: (312) 654-1010

Trade/Proprietary Name:

physIQ Heart Rhythm Module (Version 1.0)

Generic/Common Name:

Electrocardiograph

Classification:

Class II, 21 CFR§870.2340 (Electrocardiograph)

Product Code:

DbS

Predicate Device"

Monebo Automated ECG Analysis and Interpretation Software Library, Version 3.0 (K062282) Monebo Technologies Inc.

Indications for Use:

The physIQ Heart Rhythm Module (Version 1.0) is intended for use by a physician or other qualified medical professionals for the calculation of heart rate variability and the detection of atrial fibrillation using ambulatory ECG data. The physIQ Heart Rhythm Module supports receiving and analyzing single-lead ECG signals recorded in a compatible format from

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FDA-cleared ECG biosensor devices using "wet" electrode technology when assessment of rhythm is desired. The physIQ Heart Rhythm Module is for use in subacute clinical and non-clinical settings for remote patient monitoring. The physIQ Heart Rhythm Module is not for use in patients requiring life-supporting or life-sustaining systems or ECG Alarm devices.

Product Description:

Performance Testing:

physIQ's Heart Rhythm Module (Version 1.0) contains a collection of algorithms intended to be applied to ECG data collected by commercially-available ECG biosensor devices in an ambulatory setting. The collection consists of Heartbeat Detector, and Heart Rate, Heart Rate Variability and Atrial Fibrillation Detector algorithms. Performance testing following guidelines of ANS/AAMI EC572012: Testing and Reporting Performance Results of Cardiac Rhythm and ST segment Measurement Algorithms has been applied to each of the algorithms. The performance testing results for all algorithms were compared to physIQ's defined acceptance criteria for performance testing. All algorithms met their corresponding acceptance criteria.

In addition, further supportive clinical validation testing of the physIQ Heart Rhythm Module was performed using electrocardiography (ECG) signals captured from ambulatory patients using a wearable single-lead biosensor device which were annotated by medical experts in cardiology. This testing did not use any patch-generated vitals, but instead compared physIQ Heart Rhythm Module outputs to annotations by cardiology experts using ECG captured from two commerciallyavailable patches: HealthPatch (K152139) manufactured by VitalConnect Inc. and BodyGuardian (K121197; K151188) manufactured by Preventice Inc. All algorithms met acceptance criteria.

Substantial Equivalence:

The intended use and indications for use for the physIQ Heart Rhythm Module (Version 1.0) are the same as the predicate device, the Monebo Automated ECG Analysis and Interpretation Software Library Version 3.0 (K062282). Patient populations and monitoring environments for the physlQ Heart Rhythm Module are similar to the predicate device. Performance testing on the physIQ Heart Rhythm Module demonstrates comparable performance to the predicate device using international standard ANSI/AAMI EC57:2012. Any differences in the technological characteristics between the physIQ Heart Rhythm Module and the predicate device do not raise any new issues of safety or effectiveness. Therefore, the physlQ Heart Rhythm Module is substantially equivalent to the predicate device.

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DeviceFunctionality	Monebo Automated ECG Analysisand Interpretation SoftwareLibraryVersion 3.0	physIQ Heart Rhythm Module(Version 1.0)
Manufacturer	Monebo Technologies Inc.	physIQ Inc.
510(k) Number	K062282	K180234
Classification	Class II, 21 CFR §870.2340	Class II, 21 CFR §870.2340
Product Code	DPS	DPS
Indications forUse	The Automatic Analysis andInterpretation Software Library isintended for use by qualified medicalprofessionals for the assessment ofarrhythmias using historicambulatory ECG data. The productsupports downloading and analyzingdata recorded incompatible formatsfrom any device used for thearrhythmia diagnostics such asHolter, Event Monitor, 12 leadambulatory or resting ECG devices,or other similar devices whenassessment of the rhythm isnecessary. The Automatic Analysisand Interpretation Software Librarycan also be electronically interfaced,and perform analysis with datatransferred from other computerbased ECG systems, such as an ECGmanagement system. The AutomaticAnalysis and Interpretation SoftwareLibrary provides ECG signalprocessing and analysis on a beat bybeat basis, QRS and VentricularEctopic Beat detection, QRS featureextraction, interval measurement,heart rate measurement, and rhythmanalysis for up to sixteen (16) leadsof captured data. The library is notfor use in life supporting orsustaining systems or ECGmonitoring and Alarm devices. Theproduct can be integrated intocomputerized ECG monitoringdevices. In this case the medicaldevice manufacturer will identify theindication for use depending on theapplication of their device.	The physIQ Heart Rhythm Moduleis intended for use by a physician orother qualified medicalprofessionals for the calculation ofheart rate and heart rate variabilityand the detection of atrialfibrillation using ambulatory ECGdata. The physIQ Heart RhythmModule supports receiving andanalyzing single-lead ECG signalsrecorded in a compatible formatfrom FDA-cleared ECG biosensordevices using "wet" electrodetechnology when assessment ofrhythm is desired. The physIQHeart Rhythm Module is for use insubacute clinical and non-clinicalsettings for remote patientmonitoring. The physIQ HeartRhythm Module is not for use inpatients requiring life-supporting orlife-sustaining systems or ECGAlarm devices.
Level ofConcern	Moderate	Moderate
Components	Software only	Software only
DeviceFunctionality	Monebo Automated ECG Analysisand Interpretation SoftwareLibraryVersion 3.0	physIQ Heart Rhythm Module(Version 1.0)
Interface	Callable application programminginterface (API)	Callable application programminginterface (API)
Display	No primary display	No primary display
QRS detection	YES	YES
Heart rate non-paced adult	YES	YES
Heart ratevariability	YES (deterministic based on R-to-Rinterval derived from QRS detectionwhich may be analyzed usingspectral and time-domainapproaches)	YES (deterministic based on R-to-Rinterval derived from QRSdetection which is analyzed using atime-domain approach)
Atrialfibrillationdetection	YES (classification)	YES (classification)
ECGmorphologicalanalysis	YES (including PR and QT intervals,and QRS duration	NO (other than QRS location andbeat-to-beat analyses, no ECGmorphological analyses areperformed)
Arrhythmiaclassifications(other thanatrialfibrillation)	YES (normal sinus rhythm,ventricular tachycardia, bradycardia,tachycardia, AV block, BBB,ventricular bigeminy, ventriculartrigeminy, AIVR, pause, ventricularflutter)	NO
Patientpopulations	Adult	Adult
Clinical setting	Subacute (non-life-supporting or life-threatening systems required)	Subacute (non-life-supporting orlife-threatening systems required)
Alarm / Trigger	NO	NO

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Conclusion:

The physIQ Heart Rhythm Module (Version 1.0) has the same intended use and patient population and similar technological characteristics as those of the predicate device, the Monebo Automated ECG Analysis and Interpretation Software Library. Any differences in technological characteristics have been analyzed and addressed through performance testing which demonstrated that the physIQ Heart Rhythm Module meets it intended use and that any differences between the physIQ Heart Rhythm Module and the predicate device do not raise any new issues of safety or effectiveness. As such, the physIQ Heart Rhythm Module is substantially equivalent to the predicate device.

Summary:

Based on the information provided and the testing conducted, the physIQ Heart Rhythm Module (Version 1.0) is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).