(117 days)
No
The summary describes a device for recording and transmitting ECG data for review, but there is no mention of AI or ML being used for analysis or interpretation of the data.
No.
The device is a physiological monitor that records and transmits ECG data; it is not described as providing any form of therapy or treatment.
No
The "Intended Use" explicitly states, "The Physiotrace™ Smart is not indicated for diagnosis of cardiac conditions." While it records physiological data for review, its purpose is monitoring, not diagnosis.
No
The device description explicitly states it has a "wearable design," "dry ECG electrodes," and embeds an "ECG acquisition unit with a Bluetooth Low Energy transmitter," indicating it includes hardware components beyond just software.
Based on the provided information, the Physiotrace™ Smart is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Physiotrace™ Smart Function: The Physiotrace™ Smart is a telemetry device that records and transmits physiological data (single lead ECG) from the body surface. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for physiological monitoring and provides information as part of an occupational welfare monitoring system, for general research and performance measurement, or where prescribed by a healthcare professional. It explicitly states it is not indicated for diagnosis of cardiac conditions.
Therefore, the Physiotrace™ Smart falls under the category of a physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
DRX, MWI, MHX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
torso
Indicated Patient Age Range
men and women above 18 years of age
Intended User / Care Setting
at home, workplace, exercise facilities and alternate care settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
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FORM FDA 3881 (8/14)
Page 1of 1
Publishing Services (301) 443-6740 EF
3
K171244 510(k) Summary
Preparation Date
August 17, 2017
Company Information
Sonal Tambe NimbleHeart, Inc. 1300 White Oaks Rd.. #201 Campbell CA 95008 USA 408 475 7630 regulatory@nimbleheart.com
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
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.
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 | |
| Intended | |||
| population and | |||
| locations | 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 BioHarness 3.0 is a physiological | ||
| monitoring telemetry device intended | |||
| for monitoring of adults in the home | |||
| workplace and alternate care settings. | |||
| Indicated use | |||
| scenario | 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 BioHarness 3.0 collects and | ||
| transmits measurements captured | |||
| during both sedentary as well as | |||
| rigorous activity for Heart Rate, | |||
| Posture and Activity. Breathing rate | |||
| values are accurately transmitted only | |||
| during sedentary periods. | |||
| Indications for use | 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. Physiotrace Smart is not | |||
| indicated for use on critical care patients. | |||
| The Physiotrace™ Smart is not indicated for | |||
| diagnosis of cardiac conditions. | The BioHarness 3.0 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. | |||
| Product Design | The device has a wearable and reusable | ||
| 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 device consists of a chest strap | ||
| and an electronics module that attaches | |||
| to the strap. The device stores and | |||
| transmits vital sign data including | |||
| ECG, heart rate, respiration rate, body | |||
| orientation and activity. The | |||
| BioHarness 3.0 provides a facility to | |||
| detect and transmit single lead ECG | |||
| signals 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 and | |||
| Left electrodes | Single indication called of Strap on/ | |||
| off | ||||
| Performance comparison | ||||
| ECG Performance | ||||
| standards met | 60601-2-47 | EC38 | ||
| Bluetooth radio | ||||
| version | BT 4.0 (Max Tx power 4 dBm) | BT 2.1 + EDR (Max Tx power 10 | ||
| dBm) |
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.