(222 days)
Unknown
The document describes "automated analysis" but does not explicitly mention AI or ML, nor does it provide details about training or test sets typically associated with ML models.
No.
The device is intended for the calculation of heart rate variability, detection of atrial fibrillation, and determination of respiration rate, which are diagnostic and monitoring functions, not therapeutic.
Yes
The "Intended Use / Indications for Use" section states that the device is intended for "the detection of atrial fibrillation and determination of respiration rate." Detecting a condition like atrial fibrillation and determining a physiological parameter like respiration rate are diagnostic functions.
Yes
The device description explicitly states that the physIQ Heart Rhythm and Respiration Module is a "computerized all-software callable function library". It processes data from external, commercially-available ECG biosensor devices but is itself only software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
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 the diagnosis, treatment, or prevention of disease.
- Device Function: The physIQ Heart Rhythm and Respiration Module analyzes ambulatory ECG and triaxial accelerometer data. This data is collected from the patient's body using external sensors ("wet" electrode technology and triaxial accelerometers), not from specimens taken from the body.
- Intended Use: The intended use is for the calculation of heart rate variability, detection of atrial fibrillation, and determination of respiration rate using this external sensor data. This is a form of physiological monitoring and analysis, not the analysis of biological specimens.
Therefore, the device falls under the category of a medical device that analyzes physiological signals collected externally, rather than an In Vitro Diagnostic device that analyzes biological specimens.
N/A
Intended Use / 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 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 codes
DPS
Device 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 physIQ 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.
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
Intended for use by a physician or other qualified medical professionals. For use in adult patients in subacute clinical and nonclinical 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
GENERAL INFORMATION
Applicant:
- physIQ Inc. 300 E. 5th Avenue Suite 105 Naperville IL 60563 USA Phone: (800) 561-7902
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: george.hides@physiq.com Phone: (312) 654-1010
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
4
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
5
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
Functionality | physIQ Heart Rhythm
Module
(Version 1.0) | HealthPatchMD/
VitalPatch | physIQ Heart Rhythm
and Respiration Module
(Version 2.0) |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison | 510(k)
Predicate Device | 510(k)
Predicate Device | 510(k)
New Device |
| Manufacturer | physIQ Inc. | Vital Connect, Inc. | physIQ Inc. |
| 510(k) Number | K180234 | K152139 | TBD |
| Classification | Class II,
21 CFR §870.2340 | Class II,
21 CFR §870.2910,
§870.1025 | Class II,
21 CFR §870.2340 |
| Product Code | DPS | DRG, DSI, MHX | DPS |
| 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
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 | The Vital Connect
Platform is a wireless
remote monitoring
system intended for use
by healthcare
professionals for
continuous collection of
physiological data in
home and healthcare
settings. This can include
heart rate,
electrocardiography
(ECG), heart rate
variability, R-R interval,
respiratory rate, skin
temperature, activity
(including step count),
and posture (body
position relative to gravity
including fall). Data are
transmitted wirelessly
from the Vital Connect
Sensor for storage and
analysis. The Vital
Connect Platform can
include the ability to
notify healthcare
professionals when | 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
and 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 |
| Device
Functionality | physIQ Heart Rhythm
Module
(Version 1.0) | HealthPatchMD/
VitalPatch | physIQ Heart Rhythm
and Respiration Module
(Version 2.0) |
| Device
Functionality | not for use in patients
requiring life-supporting
or life-sustaining systems
or ECG Alarm devices. | physiological data fall
outside selected
parameters.
The device is intended for
use on general care
patients who are 18 years
of age or older as a
general patient monitor,
to provide physiological
information. The data
from the Vital Connect
Platform are intended for
use by healthcare
professionals as an aid to
diagnosis and treatment.
The device is not intended
for use on critical care
patients. | and Respiration Module is
for use in adult patients in
subacute clinical and non-
clinical 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. |
| Level of
Concern | Moderate | Moderate | Moderate |
| Components | Software only | Wireless data collection
system comprising sensor
hardware and
computational firmware
that computes vital signs;
Relay Software Module
SDK that runs on Android
and iPhone; and an
optional Secure Server
sub-system. | Software only |
| Interface | Callable application
programming interface
(API) | Wireless offloading to
smartphone via Relay
Software Module. | Callable application
programming interface
(API) |
| Display | No primary display | The encrypted wireless
data provided by the
Sensor may be
downloaded from the
relay device for storage,
or integrated into a Third-
Party Relay Application
via the APIs of the Relay
Software Library | No primary display |
| QRS detection | YES | YES | YES |
| Device
Functionality | physIQ Heart Rhythm
Module
(Version 1.0) | HealthPatchMD/
VitalPatch | physIQ Heart Rhythm
and Respiration Module
(Version 2.0) |
| Heart rate
non-paced
adult | YES | YES | YES |
| Heart rate
variability | YES (deterministic based
on R-to-R interval derived
from QRS detection) | YES | YES (deterministic based
on R-to-R interval derived
from QRS detection) |
| Atrial
fibrillation
detection | YES | NO | YES |
| Respiration
rate | NO | YES | YES |
| ECG
morphological
analysis | NO (other than QRS
location and beat-to-beat
analyses, no ECG
morphological analyses
are performed) | NO | NO (other than QRS
location and beat-to-beat
analyses, no ECG
morphological analyses
are performed) |
| Arrhythmia
classifications
(other than
atrial
fibrillation) | NO | NO | NO |
| Patient
populations | Adult | Adult | Adult |
| Clinical setting | Subacute (non-life-
supporting or life-
threatening systems
required) | Not intended for critical
care patients. | Subacute (non-life-
supporting or life-
threatening systems
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.