physIQ Heart Rhythm and Respiratory Module

K183322 · Physiq, Inc. · DPS · Jul 10, 2019 · Cardiovascular

Device Facts

• Record ID: K183322
• Device Name: physIQ Heart Rhythm and Respiratory Module
• Applicant: Physiq, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Jul 10, 2019
• 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 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 Story

Software-only library (Python) for automated analysis of single-lead ECG and triaxial accelerometer data. Integrates into customer-developed end-to-end systems via API/middleware. Inputs: time-series ECG and accelerometer data from FDA-cleared biosensors. Outputs: heart rate, heart rate variability, atrial fibrillation detection, and respiration rate. Used in subacute clinical/nonclinical settings for remote monitoring. Clinicians use outputs to supplement standard of care; not for diagnostic substitution or life-critical monitoring. Benefits: enables remote physiological monitoring without requiring bedside alarm systems.

Clinical Evidence

Bench and clinical performance validation. Respiration rate algorithm performance compared to internal acceptance criteria and VitalPatch (K152139) predicate. Heart rate variability and atrial fibrillation algorithms validated in previous submission (K180234) per ANSI/AAMI EC57:2012. Results confirmed the module meets intended use and performs comparably to the predicate.

Technological Characteristics

Software-only callable function library (Python). Processes single-lead ECG and triaxial accelerometer data. Deterministic algorithms for QRS detection, heart rate variability, atrial fibrillation, and respiration rate. No primary display; integrates via API. Moderate level of concern.

Indications for Use

Indicated for adult patients in subacute clinical and nonclinical settings for remote patient monitoring requiring heart rate variability calculation, atrial fibrillation detection, and respiration rate determination. Not for use in patients requiring life-supporting/sustaining systems or as an alarm device.

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

• physIQ Heart Rhythm Module, Version 1.0 (K180234)
• HealthPatchMD/VitalPatch (K152139)

Submission Summary (Full Text)

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

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.

| Type of Use (Select one or both, as applicable) |
|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> □ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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#### 510(k) Summary

#### GENERAL INFORMATION

## Applicant:

- physIQ Inc. 300 E. 5th Avenue Suite 105 Naperville IL 60563 USA Phone: [phone]
#### 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: [e-mail] Phone: [phone]

### 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:

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

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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:

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.

## 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.

| Device<br>Functionality | physIQ Heart Rhythm<br>Module<br>(Version 1.0) | HealthPatchMD/<br>VitalPatch | physIQ Heart Rhythm<br>and Respiration Module<br>(Version 2.0) |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison | 510(k)<br>Predicate Device | 510(k)<br>Predicate Device | 510(k)<br>New Device |
| Manufacturer | physIQ Inc. | Vital Connect, Inc. | physIQ Inc. |
| 510(k) Number | K180234 | K152139 | TBD |
| Classification | Class II,<br>21 CFR §870.2340 | Class II,<br>21 CFR §870.2910,<br>§870.1025 | Class II,<br>21 CFR §870.2340 |
| Product Code | DPS | DRG, DSI, MHX | DPS |
| Indications for<br>Use | The physIQ Heart Rhythm<br>Module (Version 1.0) is<br>intended for use by a<br>physician or other<br>qualified medical<br>professionals for the<br>calculation of heart rate<br>and heart rate variability<br>and the detection of atrial<br>fibrillation using<br>ambulatory ECG data. The<br>physIQ Heart Rhythm<br>Module supports<br>receiving and analyzing<br>single-lead ECG signals<br>recorded in a compatible<br>format from FDA-cleared<br>ECG biosensor devices<br>using "wet" electrode<br>technology when<br>assessment of rhythm is<br>desired. The physIQ Heart<br>Rhythm Module is for use<br>in subacute clinical and<br>non-clinical settings for<br>remote patient<br>monitoring. The physIQ<br>Heart Rhythm Module is | The Vital Connect<br>Platform is a wireless<br>remote monitoring<br>system intended for use<br>by healthcare<br>professionals for<br>continuous collection of<br>physiological data in<br>home and healthcare<br>settings. This can include<br>heart rate,<br>electrocardiography<br>(ECG), heart rate<br>variability, R-R interval,<br>respiratory rate, skin<br>temperature, activity<br>(including step count),<br>and posture (body<br>position relative to gravity<br>including fall). Data are<br>transmitted wirelessly<br>from the Vital Connect<br>Sensor for storage and<br>analysis. The Vital<br>Connect Platform can<br>include the ability to<br>notify healthcare<br>professionals when | The physIQ Heart Rhythm<br>and Respiration Module<br>(Version 2.0) is intended<br>for use by a physician or<br>other qualified medical<br>professionals for the<br>calculation of heart rate<br>and heart rate variability,<br>the detection of atrial<br>fibrillation and<br>determination of<br>respiration rate using<br>ambulatory ECG and<br>triaxial accelerometer<br>data. The physIQ Heart<br>Rhythm and Respiration<br>Module supports<br>receiving and analyzing<br>single-lead ECG signals<br>recorded in a compatible<br>format from FDA-cleared<br>ECG biosensor devices<br>using "wet" electrode<br>technology and triaxial<br>accelerometers when<br>assessment of rhythm and<br>respiration rate is desired.<br>The physIQ Heart Rhythm |
| Device<br>Functionality | physIQ Heart Rhythm<br>Module<br>(Version 1.0) | HealthPatchMD/<br>VitalPatch | physIQ Heart Rhythm<br>and Respiration Module<br>(Version 2.0) |
| Device<br>Functionality | not for use in patients<br>requiring life-supporting<br>or life-sustaining systems<br>or ECG Alarm devices. | physiological data fall<br>outside selected<br>parameters.<br>The device is intended for<br>use on general care<br>patients who are 18 years<br>of age or older as a<br>general patient monitor,<br>to provide physiological<br>information. The data<br>from the Vital Connect<br>Platform are intended for<br>use by healthcare<br>professionals as an aid to<br>diagnosis and treatment.<br>The device is not intended<br>for use on critical care<br>patients. | and Respiration Module is<br>for use in adult patients in<br>subacute clinical and non-<br>clinical settings for<br>remote patient<br>monitoring. The physIQ<br>Heart Rhythm and<br>Respiration Module is not<br>for use in patients<br>requiring life-supporting<br>or life-sustaining systems<br>or as ECG or respiration<br>alarm devices. |
| Level of<br>Concern | Moderate | Moderate | Moderate |
| Components | Software only | Wireless data collection<br>system comprising sensor<br>hardware and<br>computational firmware<br>that computes vital signs;<br>Relay Software Module<br>SDK that runs on Android<br>and iPhone; and an<br>optional Secure Server<br>sub-system. | Software only |
| Interface | Callable application<br>programming interface<br>(API) | Wireless offloading to<br>smartphone via Relay<br>Software Module. | Callable application<br>programming interface<br>(API) |
| Display | No primary display | The encrypted wireless<br>data provided by the<br>Sensor may be<br>downloaded from the<br>relay device for storage,<br>or integrated into a Third-<br>Party Relay Application<br>via the APIs of the Relay<br>Software Library | No primary display |
| QRS detection | YES | YES | YES |
| Device<br>Functionality | physIQ Heart Rhythm<br>Module<br>(Version 1.0) | HealthPatchMD/<br>VitalPatch | physIQ Heart Rhythm<br>and Respiration Module<br>(Version 2.0) |
| Heart rate<br>non-paced<br>adult | YES | YES | YES |
| Heart rate<br>variability | YES (deterministic based<br>on R-to-R interval derived<br>from QRS detection) | YES | YES (deterministic based<br>on R-to-R interval derived<br>from QRS detection) |
| Atrial<br>fibrillation<br>detection | YES | NO | YES |
| Respiration<br>rate | NO | YES | YES |
| ECG<br>morphological<br>analysis | NO (other than QRS<br>location and beat-to-beat<br>analyses, no ECG<br>morphological analyses<br>are performed) | NO | NO (other than QRS<br>location and beat-to-beat<br>analyses, no ECG<br>morphological analyses<br>are performed) |
| Arrhythmia<br>classifications<br>(other than<br>atrial<br>fibrillation) | NO | NO | NO |
| Patient<br>populations | Adult | Adult | Adult |
| Clinical setting | Subacute (non-life-<br>supporting or life-<br>threatening systems<br>required) | Not intended for critical<br>care patients. | Subacute (non-life-<br>supporting or life-<br>threatening systems<br>required) |
| 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.