The physIQ Heart Rhythm and Respiration Module (Version 2.0) is intended for use by a physician or other qualified medical professionals for the calculation of heart rate variability, the detection of atrial fibrillation and determination of respiration rate using ambulatory ECG and triaxial accelerometer data. The physIQ Heart Rhythm and Respiration Module supports receiving and analyzing single-lead ECG signals recorded in a compatible format from FDA-cleared ECG biosensor devices using "wet" electrode technology and triaxial accelerometers when assessment of rhythm and respiration rate is desired. The physIQ Heart Rhythm and Respiration Module is for use in adult patients in subacute clinical and nonclinical settings for remote patient monitoring. The physIQ Heart Rhythm and Respiration Module is not for use in patients requiring life-supporting or life-sustaining systems or as ECG or respiration alarm devices.

Device Description

The physIQ Heart Rhythm and Respiration Module (Version 2.0) 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 and determining respiration rate determined by automated analysis of any single electrocardiogram (ECG) channel collected by commercially-available ECG biosensor devices with triaxial accelerometers. The physIQ Heart Rhythm and Respiration 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 and triaxial accelerometer data from a customer's data collection system, most likely via its own application programming interface (API), and makes calls to the phys/Q Heart Rhythm and Respiration Module to input ECG and triaxial accelerometer data 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

The physIQ Heart Rhythm and Respiration Module (Version 2.0) was assessed for its performance in calculating heart rate variability, detecting atrial fibrillation, and determining respiration rate. The study followed guidelines of ANSI/AAMI EC57-2012 for heart rate variability and atrial fibrillation, while respiration rate was evaluated using internal acceptance criteria and comparison to a predicate device due to a lack of FDA-recognized consensus standards.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature	Acceptance Criteria	Reported Device Performance
Heart Rate Variability	(Not specified, but tested per ANSI/AAMI EC57-2012)	Not explicitly provided in the summary, but stated to meet standards.
Atrial Fibrillation Detection	(Not specified, but tested per ANSI/AAMI EC57-2012)	Not explicitly provided in the summary, but stated to meet standards.
Respiration Rate Algorithm Performance	Met internal acceptance criteria	Met internal acceptance criteria
Respiration Rate Algorithm Comparison	Performed comparably to the predicate device (Vital Connect HealthPatch)	Performed comparably to the predicate device (Vital Connect HealthPatch)

2. Sample Size for Test Set and Data Provenance:

The document does not explicitly state the sample size for the test set used for the respiration rate algorithm or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "performance validation was performed using clinical and bench testing."

For heart rate variability and atrial fibrillation, performance testing followed ANSI/AAMI EC57-2012 guidelines in a previous submission (K180234), but the specific sample size and provenance for that previous test are not detailed in this document.

3. Number of Experts and Qualifications for Ground Truth:

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set.

4. Adjudication Method:

The document does not specify the adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

The document does not mention if an MRMC comparative effectiveness study was done or the effect size of human readers' improvement with AI vs. without AI assistance. The device is a "computerized all-software callable function library" and its output is intended for use by medical professionals, suggesting it's an assistive tool, but a comparative effectiveness study with human readers is not detailed.

6. Standalone Performance:

Yes, a standalone (algorithm only without human-in-the-loop performance) study was conducted. The "Performance Testing" section states that the device contains "a collection of algorithms intended to be applied to ECG data." The validation was performed on these algorithms, and the results were compared to acceptance criteria.

7. Type of Ground Truth Used:

The type of ground truth used is not explicitly stated. However, for heart rate variability and atrial fibrillation, the reference to ANSI/AAMI EC57-2012 suggests established standards and potentially expert consensus or validated physiological measurements for ground truth. For respiration rate, it was compared to "internal acceptance criteria" and a "predicate device," implying a form of reference standard or clinical gold standard might have been used for the internal criteria.

8. Sample Size for Training Set:

The document does not provide the sample size used for the training set.

9. How Ground Truth for Training Set Was Established:

The document does not provide information on how the ground truth for the training set was established.

Summary

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July 10, 2019

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

Re: K183322

Trade/Device Name: physIQ Heart Rhythm and Respiratory Module Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: June 6, 2019 Received: June 10, 2019

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

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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 (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 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,

for Nicole Goodsell External Heart Rhythm and Rate Team Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183322

Device Name

physIQ Heart Rhythm and Respiration Module (Version 2.0)

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) Summary

GENERAL INFORMATION

Applicant:

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

Date Prepared:

June 6, 2019

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 and Respiration Module (Version 2.0)

Generic/Common Name:

Electrocardiograph

Classification: Class II, 21 CFR§870.2340 (Electrocardiograph)

Product Code: DbS

Predicate Device"

physIQ Heart Rhythm Module, Version 1.0 (K180234) physIQ Inc. HealthPatchMD/VitalPatch (K152139) Vital Connect, Inc.

Indications for Use:

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technology and triaxial accelerometers when assessment of rhythm and respiration rate is desired. The physIQ Heart Rhythm and Respiration Module is for use in adult patients in subacute clinical and nonclinical settings for remote patient monitoring. The physIQ Heart Rhythm and Respiration Module is not for use in patients requiring life-supporting or life-sustaining systems or as ECG or respiration alarm devices.

Product Description:

Performance Testing:

The physIQ Heart Rhythm and Respiration Module (Version 2.0) contains a collection of algorithms intended to be applied to ECG data collected by commercially-available ECG biosensor devices with triaxial accelerometers in an ambulatory setting. The collection consists of Heartbeat Detector, Heart Rate Variability, Atrial Fibrillation and Respiration Rate algorithms. Performance testing following guidelines of ANSI/AAMI EC572012: Testing and Reporting Performance Results of Cardiac Rhythm and ST segment Measurement Algorithms was applied to heart rate variability, and atrial fibrillation algorithms in a previous Traditional 510(k) submission for the physIQ Heart Rhythm Module (K180234). There are no FDA-recognized consensus standards to assess the performance of respiration rate algorithms. In this submission, performance validation was performed using clinical and bench testing and results for the respiration rate algorithm were compared to internal acceptance criteria as well as to the predicate device, the Vital Connect HealthPatch (K152139). The respiration rate algorithm met its corresponding acceptance criteria and performed comparably to the predicate device.

Substantial Equivalence:

The physIQ Heart Rhythm and Respiration Module (Version 2.0) has the same intended use to the predicate devices, the physlQ Heart Rhythm Module and Vital Connect's VitalPatch (in its computational aspect). The physIQ Heart Rhythm Module calculates heart rate variability and detects atrial fibrillation from a single-lead ECG. The Vital Connect VitalPatch calculates heart rate variability, and determines respiration rate from a single-lead ECG plus triaxial accelerometry. The patient population for both the physIQ Heart Rhythm and Respiration Module and the predicate devices includes subacute adults who do not require life-supporting or life-sustaining systems or device alarms. Of note, the intended uses of the physIQ Heart Rhythm and Respiration Module and the predicate devices are to supplement standard of care and not to replace or substitute for routine vital signs monitoring. Both the physlQ Heart Rhythm and Respiration Module and the physlQ Heart Rhythm Module predicate have similar safety and technological characteristics as both are all software medical devices and require input of time-series ECG from commercially available devices in a format acceptable for signal processing and algorithm function. Likewise, the physlQ Heart Rhythm and Respiration Module and the VitalPatch (in its

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computational aspect) similarly require input of time-series ECG and triaxial accelerometer data. Any differences in technological characteristics have been analyzed and addressed through performance validation testing and hazard analysis. Performance testing demonstrates that the physlQ Heart Rhythm and Respiration Module meets its intended use and any differences in technological characteristics between the physIQ Heart Rhythm and Respiration Module and the predicate devices are adequately addressed. Therefore, the physlQ Heart Rhythm and Respiration Module is substantially equivalent to the predicate devices.

DeviceFunctionality	physIQ Heart RhythmModule(Version 1.0)	HealthPatchMD/VitalPatch	physIQ Heart Rhythmand Respiration Module(Version 2.0)
Comparison	510(k)Predicate Device	510(k)Predicate Device	510(k)New Device
Manufacturer	physIQ Inc.	Vital Connect, Inc.	physIQ Inc.
510(k) Number	K180234	K152139	TBD
Classification	Class II,21 CFR §870.2340	Class II,21 CFR §870.2910,§870.1025	Class II,21 CFR §870.2340
Product Code	DPS	DRG, DSI, MHX	DPS
Indications forUse	The physIQ Heart RhythmModule (Version 1.0) isintended for use by aphysician or otherqualified medicalprofessionals for thecalculation of heart rateand heart rate variabilityand the detection of atrialfibrillation usingambulatory ECG data. ThephysIQ Heart RhythmModule supportsreceiving and analyzingsingle-lead ECG signalsrecorded in a compatibleformat from FDA-clearedECG biosensor devicesusing "wet" electrodetechnology whenassessment of rhythm isdesired. The physIQ HeartRhythm Module is for usein subacute clinical andnon-clinical settings forremote patientmonitoring. The physIQHeart Rhythm Module is	The Vital ConnectPlatform is a wirelessremote monitoringsystem intended for useby healthcareprofessionals forcontinuous collection ofphysiological data inhome and healthcaresettings. This can includeheart rate,electrocardiography(ECG), heart ratevariability, R-R interval,respiratory rate, skintemperature, activity(including step count),and posture (bodyposition relative to gravityincluding fall). Data aretransmitted wirelesslyfrom the Vital ConnectSensor for storage andanalysis. The VitalConnect Platform caninclude the ability tonotify healthcareprofessionals when	The physIQ Heart Rhythmand Respiration Module(Version 2.0) is intendedfor use by a physician orother qualified medicalprofessionals for thecalculation of heart rateand heart rate variability,the detection of atrialfibrillation anddetermination ofrespiration rate usingambulatory ECG andtriaxial accelerometerdata. The physIQ HeartRhythm and RespirationModule supportsreceiving and analyzingsingle-lead ECG signalsrecorded in a compatibleformat from FDA-clearedECG biosensor devicesusing "wet" electrodetechnology and triaxialaccelerometers whenassessment of rhythm andrespiration rate is desired.The physIQ Heart Rhythm
DeviceFunctionality	physIQ Heart RhythmModule(Version 1.0)	HealthPatchMD/VitalPatch	physIQ Heart Rhythmand Respiration Module(Version 2.0)
DeviceFunctionality	not for use in patientsrequiring life-supportingor life-sustaining systemsor ECG Alarm devices.	physiological data falloutside selectedparameters.The device is intended foruse on general carepatients who are 18 yearsof age or older as ageneral patient monitor,to provide physiologicalinformation. The datafrom the Vital ConnectPlatform are intended foruse by healthcareprofessionals as an aid todiagnosis and treatment.The device is not intendedfor use on critical carepatients.	and Respiration Module isfor use in adult patients insubacute clinical and non-clinical settings forremote patientmonitoring. The physIQHeart Rhythm andRespiration Module is notfor use in patientsrequiring life-supportingor life-sustaining systemsor as ECG or respirationalarm devices.
Level ofConcern	Moderate	Moderate	Moderate
Components	Software only	Wireless data collectionsystem comprising sensorhardware andcomputational firmwarethat computes vital signs;Relay Software ModuleSDK that runs on Androidand iPhone; and anoptional Secure Serversub-system.	Software only
Interface	Callable applicationprogramming interface(API)	Wireless offloading tosmartphone via RelaySoftware Module.	Callable applicationprogramming interface(API)
Display	No primary display	The encrypted wirelessdata provided by theSensor may bedownloaded from therelay device for storage,or integrated into a Third-Party Relay Applicationvia the APIs of the RelaySoftware Library	No primary display
QRS detection	YES	YES	YES
DeviceFunctionality	physIQ Heart RhythmModule(Version 1.0)	HealthPatchMD/VitalPatch	physIQ Heart Rhythmand Respiration Module(Version 2.0)
Heart ratenon-pacedadult	YES	YES	YES
Heart ratevariability	YES (deterministic basedon R-to-R interval derivedfrom QRS detection)	YES	YES (deterministic basedon R-to-R interval derivedfrom QRS detection)
Atrialfibrillationdetection	YES	NO	YES
Respirationrate	NO	YES	YES
ECGmorphologicalanalysis	NO (other than QRSlocation and beat-to-beatanalyses, no ECGmorphological analysesare performed)	NO	NO (other than QRSlocation and beat-to-beatanalyses, no ECGmorphological analysesare performed)
Arrhythmiaclassifications(other thanatrialfibrillation)	NO	NO	NO
Patientpopulations	Adult	Adult	Adult
Clinical setting	Subacute (non-life-supporting or life-threatening systemsrequired)	Not intended for criticalcare patients.	Subacute (non-life-supporting or life-threatening systemsrequired)
Alarm / Trigger	NO	NO	NO

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Conclusion:

The physIQ Heart Rhythm and Respiration Module has the same intended use and patient population and similar technological characteristics as those of the predicate devices, the physIQ Heart Rhythm Module and the HealthPatch/VitalPatch. Differences in technological characteristics have been analyzed and addressed through performance validation testing which demonstrated that the physlQ Heart Rhythm and Respiration Module meets it intended use and that any differences between the physlQ Heart Rhythm and Respiration Module and the predicate devices dare adequately addressed. Therefore, the physIQ Heart Rhythm and Respiration Module is substantially equivalent to the predicate devices.

Summary:

Based on the information provided and the testing conducted, the physIQ Heart Rhythm and Respiration Module is substantially equivalent to the predicate devices.

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).