The Physiotrace™Smart is a telemetry device intended for physiological monitoring of men and women above 18 years of age at home, workplace, exercise facilities and alternate care settings. The Physiotrace™ Smart records single lead ECG data for up to 60 minutes during resting and exercise activities; and transmits it to a server for review by healthcare team. The Physiotrace™ Smart is indicated for use as a general patient monitor to provide physiological information as part of an occupational welfare monitoring system, for general research and performance measurement purposes, or where prescribed by a healthcare professional.

The Physiotrace™ Smart is not indicated for use on critical care patients. The Physiotrace™ Smart is not indicated for diagnosis of cardiac conditions.

Device Description

The Physiotrace™ Smart has a wearable design that can be wrapped and fastened around the torso. The device uses dry ECG electrodes and embeds an ECG acquisition unit with a Bluetooth Low Energy transmitter. A mobile application controls the data acquisition, displays the status of the device, heart rate and optionally the ECG waveform during a recording session. The mobile App also stores the ECG and the exercise session information and relays it to a cloud server for permanent storage and review by healthcare staff. The Physiotrace™ Smart is designed to be used without electrolytic gels and without adhesives that necessitate skin preparation.

AI/ML Overview

The Physiotrace™ Smart device is a wearable ECG monitor. The provided text outlines its acceptance criteria and the studies conducted to demonstrate its performance and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device and meeting recognized standards, rather than providing specific quantitative acceptance criteria for ECG performance parameters in a table format. However, based on the text, we can infer some key performance aspects and how "acceptance" was determined:

Acceptance Criteria Category	Specific Criteria/Standard Adherence	Reported Device Performance
General Safety	Compliance with recognized standards for Medical device safety.	Confirmed device meets performance requirements of recognized standards for Medical device safety.
Biocompatibility	Compliance with recognized standards for biocompatibility.	Confirmed device meets performance requirements for biocompatibility. Materials passed biocompatibility tests.
Electromagnetic Compatibility	Compliance with recognized standards for Electromagnetic Compatibility.	Confirmed device meets performance requirements for Electromagnetic Compatibility.
Home Use	Compliance with recognized standards for home use.	Confirmed device meets performance requirements for home use.
ECG Performance	Compliance with recognized standard 60601-2-47.	Met standard 60601-2-47.
Electrode Performance	As per FDA's electrode guidance document.	Tested as per FDA's electrode guidance document and found comparable to the predicate device during a clinical study.
Clinical Safety & Effectiveness	Safety and effectiveness during exercise scenario (up to 60 minutes).	Clinical study showed the 60-minute recording session was safe and effective. Device performance and safety/effectiveness found equivalent or better than the predicate.
Cleaning Validation	Validation of cleaning procedures.	Materials passed cleaning validation tests.

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

Sample Size: The document does not explicitly state the sample size (number of participants) used for the clinical study. It mentions "a clinical study was performed," implying a test set was used.
Data Provenance: The document does not specify the country of origin. The study was described as a "clinical study performed during the exercise scenario." It is presented as a prospective study given it was an evaluation of the device in use.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical study. It mentions the data is transmitted to "a server for review by healthcare team," implying professional review, but specifics are lacking.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication methods like 2+1, 3+1, etc., for the test set interpretation in the clinical study.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The device is an ECG monitor, not an AI-powered diagnostic tool, and the focus is on the accuracy of physiological data acquisition and transmission.

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

The document implies a form of "standalone" assessment in that the device acquires and transmits data for "review by healthcare team." While the device itself doesn't perform diagnosis, its ability to accurately record ECG data for up to 60 minutes was evaluated. The performance comparisons against standards (e.g., 60601-2-47) are a form of standalone performance assessment for the device's signal acquisition capabilities.

7. Type of Ground Truth Used:

For the clinical study, the ground truth for device performance (safety and effectiveness) would likely be based on:

Clinical observation and assessment: To determine safety and effectiveness during exercise.
Comparison against reference standards/predicate device: The document states "device performance and safety and effectiveness was found to be equivalent or better than the predicate device," suggesting direct comparison.
Compliance with recognized physiological monitoring standards: As mentioned for ECG performance (e.g., 60601-2-47).

8. Sample Size for the Training Set:

The document does not mention a training set, as this is typically relevant for machine learning or AI-based devices. The Physiotrace™ Smart appears to be a physiological data acquisition and transmission device, not one that relies on a trained algorithm for its primary function.

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

Not applicable, as no training set is mentioned for this device.

Summary

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

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 23, 2017

NimbleHeart, Inc. Sonal Tambe Chief Executive Officer 1300 White Oaks Rd., Suite #201 Campbell, California 95008

Re: K171244

Trade/Device Name: Physiotrace™ Smart Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II Product Code: DRX, MWI, MHX Dated: July 15, 2017 Received: July 17, 2017

Dear Sonal Tambe:

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Jessica E. Paulsen -S

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

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

510(k) Number (if known) K171244

Device Name

Physiotrace™ Smart

Indications for Use (Describe)

The Physiotrace™ Smart is not indicated for use on critical care patients. The Physiotrace™ Smart is not indicated for diagnosis of cardiac conditions.

Contra-Indications

The Physiotrace™ Smart is contra-indicated for surgical procedures.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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 PRAStaff(@fda.hhs.gov

"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 FDA 3881 (8/14)

Page 1of 1

Publishing Services (301) 443-6740 EF

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

K171244 510(k) Summary

Preparation Date

August 17, 2017

Identification of Product and Classification

Proprietary Name:	Physiotrace Smart
Common Name:	ECG Monitor
Classification Name:	Monitor, Physiological, Patient(Without Arrhythmia Detection Or Alarm)
Regulation Description:	Cardiac monitor (including cardiotachometer and rate alarm).
Classification Panel:	Cardiovascular
Device Class:	II
Product Code:	DRX, MWI
CFR Section:	870.2360, 870.2300
Predicate Device:	BioHarness 3.0 by Zephyr Technology Corporation K113045

Device Description

Indications of Use

The Physiotrace™ Smart is a telemetry device intended for physiological monitoring of men and women above 18 years of age at home, workplace, exercise facilities and alternate care settings. The Physiotrace™ Smart records single lead ECG data for up to 60 minutes during resting and exercise activities; and transmits it to a server for review by healthcare team. The Physiotrace™ Smart is indicated for use as a general patient monitor to provide physiological information as part of an occupational welfare monitoring system, for general research and performance measurement purposes, or where prescribed by a healthcare professional.

The Physiotrace™ Smart is not indicated for use on critical care patients. The Physiotrace™ Smart is not indicated for diagnosis of cardiac conditions.

Contra-Indications

The Physiotrace™ Smart is contra-indicated for surgical procedures.

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

K171244 510(k) Summary

Indications of use comparison
Parameter	Physiotrace Device	Predicate Device
FDA 510(k)	K171244	K113045
Number
Applicant	NimbleHeart, Inc.	Zephyr Technology Corp.
Device Name	Physiotrace Smart	BioHarness 3.0

Classification	870.2360, 870.2300	870.2360, 870.1025
Regulation
Product Code	DRX, MWI	DRX, MHX
Intendedpopulation andlocations	The Physiotrace Smart is a telemetry deviceintended for physiological monitoring ofmen and women above 18 years of age athome, workplace, exercise facilities andalternate care settings.	The BioHarness 3.0 is a physiologicalmonitoring telemetry device intendedfor monitoring of adults in the homeworkplace and alternate care settings.
Indicated usescenario	The Physiotrace Smart records single leadECG data for up to 60 minutes during restingand exercise activities; and transmits it to aserver for review by healthcare team.	The BioHarness 3.0 collects andtransmits measurements capturedduring both sedentary as well asrigorous activity for Heart Rate,Posture and Activity. Breathing ratevalues are accurately transmitted onlyduring sedentary periods.
Indications for use	The Physiotrace™ Smart is indicated foruse as a general patient monitor toprovide physiological information as partof an occupational welfare monitoringsystem, for general research andperformance measurement purposes, orwhere prescribed by a healthcareprofessional. Physiotrace Smart is notindicated for use on critical care patients.The Physiotrace™ Smart is not indicated fordiagnosis of cardiac conditions.	The BioHarness 3.0 is indicated foruse as a general patient monitor toprovide physiological information aspart of an occupational welfaremonitoring system, for generalresearch and performancemeasurement purposes, or whereprescribed by a healthcareprofessional.
Product Design	The device has a wearable and reusabledesign that can be wrapped and fastenedaround the torso. The device uses dry ECGelectrodes and embeds an ECG acquisitionunit with a Bluetooth Low Energytransmitter. A mobile application controls thedata acquisition, displays the status of thedevice, heart rate and optionally the ECGwaveform during a recording session. Themobile App also stores the ECG and theexercise session information and relays it to acloud server for permanent storage andreview by healthcare staff.	The device consists of a chest strapand an electronics module that attachesto the strap. The device stores andtransmits vital sign data includingECG, heart rate, respiration rate, bodyorientation and activity. TheBioHarness 3.0 provides a facility todetect and transmit single lead ECGsignals to be received by Bluetooth/USB qualified ECG instruments.

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

K171244 510(k) Summary

Technological characteristics comparison
Parameter	NimbleHeart Physiotrace	Predicate Device
ECG Electrodes	Gold plated brass electrodes	Silver fabric electrodes
Lead off detection	Lead off detection feature for Right andLeft electrodes	Single indication called of Strap on/off
Performance comparison
ECG Performancestandards met	60601-2-47	EC38
Bluetooth radioversion	BT 4.0 (Max Tx power 4 dBm)	BT 2.1 + EDR (Max Tx power 10dBm)

Safety and Effectiveness

The Physiotrace testing has confirmed this device meets it's the performance requirements of recognized standards for Medical device safety, biocompatibility, Electromagnetic Compatibility and for home use. A clinical study was performed during the exercise scenario as per the intended use. The device performance and safety and effectiveness was found to be equivalent or better than the predicate device.

Substantial Equivalence

The NimbleHeart Inc., Physiotrace Smart is a Class II device that is substantially equivalent to the designated predicate device.

The indications of use scenario where Physiotrace is slightly different is that the recording session time is preprogrammed with a default of 60 minutes for a prescribed exercise session. The mobile App logs out and stops data recording when the session ends. This feature reduces the risk posed by off label use of the device in critical care scenarios. The 60 minutes recording session was shown to be safe and effective during the clinical study.

The technological differences are mainly the electrode design including the materials used. The electrode performance has been tested as per the FDA's electrode guidance document. It was also validated during a clinical study and found comparable to that of the predicate device. All the materials have passed biocompatibility and cleaning validation tests.

Therefore, Physiotrace Smart is as safe and effective as the predicate device and can therefore be found to be substantially equivalent.

Regulation Number and Section

§ 870.2360 Electrocardiograph electrode.

(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.

Indications for Use

Indications for Use (Describe)

Contra-Indications

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

K171244 510(k) Summary

Preparation Date

Company Information

Identification of Product and Classification

Device Description

Indications of Use

Contra-Indications

K171244 510(k) Summary

K171244 510(k) Summary

Safety and Effectiveness

Substantial Equivalence

§ 870.2360 Electrocardiograph electrode.