physiQ Heart Rhythm Module

K180234 · Physiq, Inc. · DPS · Aug 10, 2018 · Cardiovascular

Device Facts

• Record ID: K180234
• Device Name: physiQ Heart Rhythm Module
• Applicant: Physiq, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Aug 10, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The physIQ 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 physIQ 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 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.

Device Story

Computerized software library (Python) for automated analysis of single-lead ECG signals; integrates into customer-developed end-to-end remote monitoring systems via API. Inputs: single-lead ECG data from FDA-cleared biosensors. Processing: heartbeat detection, heart rate calculation, heart rate variability (time-domain), and atrial fibrillation classification. Outputs: vital sign data returned to middleware for downstream clinical monitoring systems. Used in subacute clinical/non-clinical settings; operated by physicians or qualified medical professionals. Benefits: enables remote rhythm assessment and AFib detection to support clinical decision-making.

Clinical Evidence

Bench testing performed per ANSI/AAMI EC57:2012 for heartbeat, heart rate, heart rate variability, and AFib detection algorithms. Supportive clinical validation conducted using ECG signals from ambulatory patients captured via wearable single-lead biosensors (HealthPatch, BodyGuardian). Signals were annotated by cardiology experts; device outputs compared against expert annotations. All algorithms met defined acceptance criteria.

Technological Characteristics

Software-only callable function library (Python). Performs QRS detection, heart rate, heart rate variability (time-domain), and AFib classification. No morphological analysis. Integrates via API into customer systems. Moderate level of concern. Complies with ANSI/AAMI EC57:2012.

Indications for Use

Indicated for adult patients in subacute clinical and non-clinical settings requiring remote monitoring of heart rate, heart rate variability, and atrial fibrillation detection via single-lead ambulatory ECG. Not for use in life-sustaining systems or ECG alarm devices.

Regulatory Classification

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.

Predicate Devices

• Monebo Automated ECG Analysis and Interpretation Software Library, Version 3.0 (K062282)

Reference Devices

• HealthPatch (K152139)
• BodyGuardian (K121197; K151188)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

#### 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)

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.

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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{3}------------------------------------------------

# 510(k) Notification K180234

#### GENERAL INFORMATION

#### Applicant:

physIQlnc. 300 E. 5th Avenue Suite 105 Naperville IL 60563 USA Phone: [phone]

#### Contact Person:

George Allen Hides Vice President, Regulatory and Clinical Affairs physIQ Inc. 300 E. 5th Avenue Suite 105 Naperville IL 60563 USA Email: [e-mail] Phone: [phone]

#### 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

{4}------------------------------------------------

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:

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.

# 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.

{5}------------------------------------------------

| Device<br>Functionality | Monebo Automated ECG Analysis<br>and Interpretation Software<br>Library<br>Version 3.0 | physIQ Heart Rhythm Module<br>(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 for<br>Use | The Automatic Analysis and<br>Interpretation Software Library is<br>intended for use by qualified medical<br>professionals for the assessment of<br>arrhythmias using historic<br>ambulatory ECG data. The product<br>supports downloading and analyzing<br>data recorded incompatible formats<br>from any device used for the<br>arrhythmia diagnostics such as<br>Holter, Event Monitor, 12 lead<br>ambulatory or resting ECG devices,<br>or other similar devices when<br>assessment of the rhythm is<br>necessary. The Automatic Analysis<br>and Interpretation Software Library<br>can also be electronically interfaced,<br>and perform analysis with data<br>transferred from other computer<br>based ECG systems, such as an ECG<br>management system. The Automatic<br>Analysis and Interpretation Software<br>Library provides ECG signal<br>processing and analysis on a beat by<br>beat basis, QRS and Ventricular<br>Ectopic Beat detection, QRS feature<br>extraction, interval measurement,<br>heart rate measurement, and rhythm<br>analysis for up to sixteen (16) leads<br>of captured data. The library is not<br>for use in life supporting or<br>sustaining systems or ECG<br>monitoring and Alarm devices. The<br>product can be integrated into<br>computerized ECG monitoring<br>devices. In this case the medical<br>device manufacturer will identify the<br>indication for use depending on the<br>application of their device. | The physIQ Heart Rhythm Module<br>is intended for use by a physician or<br>other qualified medical<br>professionals for the calculation of<br>heart rate and heart rate variability<br>and the detection of atrial<br>fibrillation using ambulatory ECG<br>data. The physIQ Heart Rhythm<br>Module supports receiving and<br>analyzing single-lead ECG signals<br>recorded in a compatible format<br>from FDA-cleared ECG biosensor<br>devices using "wet" electrode<br>technology when assessment of<br>rhythm is desired. The physIQ<br>Heart Rhythm Module is for use in<br>subacute clinical and non-clinical<br>settings for remote patient<br>monitoring. The physIQ Heart<br>Rhythm Module is not for use in<br>patients requiring life-supporting or<br>life-sustaining systems or ECG<br>Alarm devices. |
| Level of<br>Concern | Moderate | Moderate |
| Components | Software only | Software only |
| Device<br>Functionality | Monebo Automated ECG Analysis<br>and Interpretation Software<br>Library<br>Version 3.0 | physIQ Heart Rhythm Module<br>(Version 1.0) |
| Interface | Callable application programming<br>interface (API) | Callable application programming<br>interface (API) |
| Display | No primary display | No primary display |
| QRS detection | YES | YES |
| Heart rate non-<br>paced adult | YES | YES |
| Heart rate<br>variability | YES (deterministic based on R-to-R<br>interval derived from QRS detection<br>which may be analyzed using<br>spectral and time-domain<br>approaches) | YES (deterministic based on R-to-R<br>interval derived from QRS<br>detection which is analyzed using a<br>time-domain approach) |
| Atrial<br>fibrillation<br>detection | YES (classification) | YES (classification) |
| ECG<br>morphological<br>analysis | YES (including PR and QT intervals,<br>and QRS duration | NO (other than QRS location and<br>beat-to-beat analyses, no ECG<br>morphological analyses are<br>performed) |
| Arrhythmia<br>classifications<br>(other than<br>atrial<br>fibrillation) | YES (normal sinus rhythm,<br>ventricular tachycardia, bradycardia,<br>tachycardia, AV block, BBB,<br>ventricular bigeminy, ventricular<br>trigeminy, AIVR, pause, ventricular<br>flutter) | NO |
| Patient<br>populations | Adult | Adult |
| Clinical setting | Subacute (non-life-supporting or life-<br>threatening systems required) | Subacute (non-life-supporting or<br>life-threatening systems required) |
| Alarm / Trigger | NO | NO |

{6}------------------------------------------------

# 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.