(193 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a "computerized all-software callable function library" using standard performance testing guidelines (ANS/AAMI EC57). There is no mention of training or inference on complex models typically associated with AI/ML.
No
The device is described as a module for calculating heart rate and heart rate variability and detecting atrial fibrillation using ECG data. It is intended for monitoring and analysis, not for providing therapy or treatment.
Yes
The device detects atrial fibrillation and calculates heart rate and heart rate variability to aid medical professionals in the assessment of rhythm. These functions are diagnostic in nature, providing information used for clinical decision-making.
Yes
The device description explicitly states that the physIQ Heart Rhythm Module is a "computerized all-software callable function library". It processes data from external, commercially-available ECG biosensor devices and does not include any hardware components of its own.
Based on the provided information, the physIQ Heart Rhythm Module is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- physIQ Heart Rhythm Module Function: The physIQ Heart Rhythm Module analyzes ECG signals collected from a biosensor device attached to the patient's body. It does not analyze specimens taken from the body. Its function is to process physiological signals (electrical activity of the heart) to calculate heart rate, heart rate variability, and detect atrial fibrillation.
- Intended Use: The intended use clearly states it analyzes "ambulatory ECG data" and "single-lead ECG signals recorded in a compatible format from FDA-cleared ECG biosensor devices." This reinforces that it's working with signals from the body, not specimens from the body.
Therefore, the physIQ Heart Rhythm Module falls under the category of a medical device that analyzes physiological signals, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 physIQ 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.
Product codes
DPS
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult
Intended User / Care Setting
Physician or other qualified medical professionals / subacute clinical and non-clinical settings for remote patient monitoring.
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
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 commercially-available patches: HealthPatch (K152139) manufactured by VitalConnect Inc. and BodyGuardian (K121197; K151188) manufactured by Preventice Inc. All algorithms met acceptance criteria.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 commercially-available patches: HealthPatch (K152139) manufactured by VitalConnect Inc. and BodyGuardian (K121197; K151188) manufactured by Preventice Inc. All algorithms met acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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3
510(k) Notification K180234
GENERAL INFORMATION
Applicant:
physIQlnc. 300 E. 5th Avenue Suite 105 Naperville IL 60563 USA Phone: (800) 561-7902
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 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
Functionality | Monebo Automated ECG Analysis
and Interpretation Software
Library
Version 3.0 | physIQ Heart Rhythm Module
(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
Use | The Automatic Analysis and
Interpretation Software Library is
intended for use by qualified medical
professionals for the assessment of
arrhythmias using historic
ambulatory ECG data. The product
supports downloading and analyzing
data recorded incompatible formats
from any device used for the
arrhythmia diagnostics such as
Holter, Event Monitor, 12 lead
ambulatory or resting ECG devices,
or other similar devices when
assessment of the rhythm is
necessary. The Automatic Analysis
and Interpretation Software Library
can also be electronically interfaced,
and perform analysis with data
transferred from other computer
based ECG systems, such as an ECG
management system. The Automatic
Analysis and Interpretation Software
Library provides ECG signal
processing and analysis on a beat by
beat basis, QRS and Ventricular
Ectopic Beat detection, QRS feature
extraction, interval measurement,
heart rate measurement, and rhythm
analysis for up to sixteen (16) leads
of captured data. The library is not
for use in life supporting or
sustaining systems or ECG
monitoring and Alarm devices. The
product can be integrated into
computerized ECG monitoring
devices. In this case the medical
device manufacturer will identify the
indication for use depending on the
application of their device. | 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. |
| Level of
Concern | Moderate | Moderate |
| Components | Software only | Software only |
| Device
Functionality | Monebo Automated ECG Analysis
and Interpretation Software
Library
Version 3.0 | physIQ Heart Rhythm Module
(Version 1.0) |
| Interface | Callable application programming
interface (API) | Callable application programming
interface (API) |
| Display | No primary display | No primary display |
| QRS detection | YES | YES |
| Heart rate non-
paced adult | YES | YES |
| Heart rate
variability | YES (deterministic based on R-to-R
interval derived from QRS detection
which may be analyzed using
spectral and time-domain
approaches) | YES (deterministic based on R-to-R
interval derived from QRS
detection which is analyzed using a
time-domain approach) |
| Atrial
fibrillation
detection | YES (classification) | YES (classification) |
| ECG
morphological
analysis | YES (including PR and QT intervals,
and QRS duration | NO (other than QRS location and
beat-to-beat analyses, no ECG
morphological analyses are
performed) |
| Arrhythmia
classifications
(other than
atrial
fibrillation) | YES (normal sinus rhythm,
ventricular tachycardia, bradycardia,
tachycardia, AV block, BBB,
ventricular bigeminy, ventricular
trigeminy, AIVR, pause, ventricular
flutter) | NO |
| Patient
populations | Adult | Adult |
| Clinical setting | Subacute (non-life-supporting or life-
threatening systems required) | Subacute (non-life-supporting or
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.