(262 days)
Not Found
Yes
The device description explicitly states that the device "learns the correlation between multiple vital signs during the patient's daily activity and builds an individualized biometric signature which is dynamically updated based on incoming data." This learning and dynamic updating based on data are core characteristics of machine learning.
No
The device is intended to provide additional information for routine patient monitoring and is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes. Its purpose is informational and adjunct, not therapeutic.
No
The "Intended Use / Indications for Use" section explicitly states, "The BI is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes."
Yes
The device description explicitly states that the Biovitals Analytics Engine consists of an algorithm, cloud-based database, and web APIs and dashboard, all of which are software components. While it uses data from external sensors, the device itself is described solely as software.
Based on the provided information, the Biovitals Analytic Engine (BA Engine) 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, tissue) to obtain information for diagnostic or monitoring purposes.
- BA Engine's Function: The BA Engine analyzes continuous biometric data (heart rate, respiratory rate, activity) from already cleared sensors that are measuring these vital signs in vivo (within the living body). It does not process specimens taken from the body.
- Intended Use: The intended use explicitly states that the BA Engine is an "adjunct to and is not intended to replace vital signs monitoring" and that the Biovitals Index (BI) is "not intended for making clinical decisions regarding patient treatment or for diagnostic purposes." This further reinforces that it's not performing a diagnostic test on a biological sample.
The BA Engine is a software engine that processes physiological data collected by other devices, providing an index for retrospective review by a practitioner. This falls outside the scope of an IVD.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this device.
Intended Use / Indications for Use
The Biovitals Analytic Engine (BA Engine) is intended to be used with continuous biometric data from already cleared sensors measuring heart rate, respiratory rate, and activity in ambulatory patients being monitored in a healthcare facility or at home, during periods of minimal activity. The device learns the correlation between multiple vital signs during the patient's daily activity and builds an individualized biometric signature which is dynamically updated based on incoming data. The device computes a time series Biovitals Index (BI), which reflects changes in the patient's measured vital signs from their measured baseline, which is derived from the individualized biometric signature of the patient.
The BA Engine is a cloud-based software engine, intended to be an adjunct to and is not intended to replace vital signs monitoring. The BI is intended for daily intermittent, retrospective review by a qualified practitioner. The BA Engine is intended to provide additional information for use during routine patient monitoring. The BI is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes.
The device is intended for an adult population.
Product codes (comma separated list FDA assigned to the subject device)
PLB
Device Description
Biovitals Analytics Engine consists of:
- An automated proprietary algorithm to analyze data and generate Biovitals Index.
- A cloud-based database to store the input, intermedium output and the final output
- A web application programming interface (API) which handle the continuous physiology data.
- A web application programming interface (API) query the databases and get output.
- A web dashboard to render the BA Engine output in a continuous graph format, which can help intended users to monitor a patient's Biovitals Index.
Biovitals Analytics Engine works in the following sequence:
- Accept input data via secure API;
- Analyze the input data using Biovitals Analytics Engine proprietary algorithm, which generate Biovitals Index:
- Personal physiology signature data base initialization (at the early stage on the algorithm when the engine learns the patients and builds the personal baseline)
- Biovitals Index calculation
- Biovitals Analytics engine generates the Biovitals Index which is a time series scalar value from 0 to 1.
- The output of BA Engine is stored in a cloud-based database.
- The output API queries the databases and gets the output, and the output shall be reviewed by the qualified practitioner via a dashboard.
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 population
Intended User / Care Setting
qualified practitioner / healthcare facility or at home
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)
Clinical testing was performed with the BA Engine to evaluate the performance of the Biovitals Index. The testing was performed on a total of 50 subjects presenting at an Emergency Department, who were deemed appropriate for home monitoring, and compared the performance of the BI against a panel of three physicians evaluating the changes in the relationship among the patients' vital sign parameters. The testing showed that the BI was correlated to the changes in relationship among vital sign parameters, with a lower bound of the 95% confidence interval of the positive percent agreement (PPA) greater than 0.7.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
lower bound of the 95% confidence interval of the positive percent agreement (PPA) greater than 0.7
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
PhysIQ PPA Engine - K142512
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
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August 15, 2019
Biofourmis Singapore Pte. Ltd % Rakesh Lal Consultant Rakesh Lal 7 Courtyard Pl Lexington, Massachusetts 02420
Re: K183282
Trade/Device Name: Biovitals Analytics Engine Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: PLB Dated: July 18, 2019 Received: July 19, 2019
Dear Rakesh Lal:
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 medical devices and radiation-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,
Stephen Browning Acting Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183282
Device Name Biovitals Analytics Engine
Indications for Use (Describe)
The Biovitals Analytic Engine (BA Engine) is intended to be used with continuous biometric data from already cleared sensors measuring heart rate, respiratory rate, and activity in ambulatory patients being monitored in a healthcare facility or at home, during periods of minimal activity. The device learns the correlation between multiple vital signs during the patient's daily activity and builds an individualized biometric signature which is dynamically updated based on incoming data. The device computes a time series Biovitals Index (BI), which reflects changes in the patient's measured vital signs from their measured baseline, which is derived from the individualized biometric signature of the patient.
The BA Engine is a cloud-based software engine, intended to be an adjunct to and is not intended to replace vital signs monitoring. The BI is intended for daily intermittent, retrospective review by a qualified practitioner. The BA Engine is intended to provide additional information for use during routine patient monitoring. The BL is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes.
The device is intended for an adult population.
| 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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Premarket Notification 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Applicant Information:
| Date Prepared: | July 16, 2019 |
|---|---|
| Name: | Biofourmis Singapore Pte. Ltd. |
| Address: | Vision Exchange, #07-15 |
| 2 Venture Drive | |
| Singapore 608526 | |
| Contact Person: | Rakesh M. Lal, Consultant |
| rakesh.m.lal@gmail.com | |
| Phone: | (817) 734-8303 |
Device Information:
| Trade Name: | Biovitals Analytics Engine |
|---|---|
| Common Names: | BA Engine |
| Classification Name(s): | Cardiovascular |
| Product Code/ Regulation: | PLB/21 CFR 870.2300 |
| Classification: | Class II |
Predicate Device:
- PhysIQ PPA Engine - K142512
Device Description:
Biovitals Analytics Engine consists of:
- An automated proprietary algorithm to analyze data and generate Biovitals Index. ●
- A cloud-based database to store the input, intermedium output and the final output ●
- A web application programming interface (API) which handle the continuous physiology data.
- A web application programming interface (API) query the databases and get output.
- A web dashboard to render the BA Engine output in a continuous graph format, which can ● help intended users to monitor a patient's Biovitals Index.
Biovitals Analytics Engine works in the following sequence:
- Accept input data via secure API;
- Analyze the input data using Biovitals Analytics Engine proprietary algorithm, which ● generate Biovitals Index:
4
- Personal physiology signature data base initialization (at the early stage on the о algorithm when the engine learns the patients and builds the personal baseline)
- Biovitals Index calculation o
- Biovitals Analytics engine generates the Biovitals Index which is a time series scalar value from 0 to 1.
- The output of BA Engine is stored in a cloud-based database.
- The output API queries the databases and gets the output, and the output shall be reviewed by the qualified practitioner via a dashboard.
Interpretation of Biovitals Index:
The BA Engine computes a time series Biovitals Index (BI), which reflects changes in the patient's measured vital signs from their measured baseline, which is derived from the individualized biometric signature of the patient. The BI is displayed in 30-minute segments and ranges from 0 to 1. The BI is intended for daily intermittent, retrospective review by a qualified practitioner.
A BI closer to 0 indicates that the relationships among the patient's vital signs are similar to the baseline. A BI value closer to 1 indicates that the relationships among the patient's vital signs are different from the baseline is initially established using data from the first 24 hours and updated periodically as new data is received. The initial baseline comprises 3 to 13 hours of data and the updated baseline usually comprises the last 9 to 45 hours of data with low change in the relationship among the vital signs, depending on the monitoring duration.
To aid in understanding the magnitude of changes in the relationship among the patient's vital signs as compared to the baseline, the BI is divided into three categories. A BI less than or equal to 0.3 indicates that there has been little or no change in the relationship among the patient's vital signs as compared to baseline. A BI value greater than 0.3 and less than or equal to 0.7 reflects moderate change, and a BI value greater than 0.7 reflects significant change in the relationship among the patient's vital signs as compared to baseline.
The expected within-subject variability for each of the three ranges of the BI are shown in the table below.
| BI Category | Expected within-subject variability |
|---|---|
| Low (BI ≤ 0.3) | 0.11 |
| Moderate (0.3 0.7) | 0.17 |
The expected within-subject variability was computed using data from a clinical study involving 50 emergency department patients that were deemed appropriate for home monitoring.
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Indications for Use:
The Biovitals Analytic Engine (BA Engine) is intended to be used with continuous biometric data from already cleared sensors measuring heart rate, respiratory rate, and activity in ambulatory patients being monitored in a healthcare facility or at home, during periods of minimal activity. The device learns the correlation between multiple vital signs during the patient's daily activity and builds an individualized biometric signature which is dynamically updated based on incoming data. The device computes a time series Biovitals Index (BI), which reflects changes in the patient's measured vital signs from their measured baseline, which is derived from the individualized biometric signature of the patient.
The BA Engine is a cloud-based software engine, intended to be an adjunct to and is not intended to replace vital signs monitoring. The BI is intended for daily intermittent, retrospective review by a qualified practitioner. The BA Engine is intended to provide additional information for use during routine patient monitoring. The BI is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes.
The device is intended for an adult population.
Summary Comparison to Predicate:
The following tables provide a summary of substantial equivalence between the subject device and the cited predicate. The subject device has the same intended use and substantially equivalent characteristics that do not raise different questions of safety or effectiveness.
Comparison to Predicate Device:
The following table provides a comparison of the detection features of Biovitals Analytics Engine and the predicate device:
| Features | Biofourmis
Biovitals Analytics
Engine | PhysIQ
PPA Engine
(K142512) | Comparison |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Characteristics | | | |
| Classification | Class II, 21 CFR 870.2300 | Class II, 21 CFR 870.2300 | Equivalent |
| Product Code | PLB | PLB | Equivalent |
| Intended Use | Patient Monitor (without
alarms) | Patient Monitor (without
alarms) | Equivalent |
| Indications for
Use | The Biovitals Analytic
Engine (BA Engine) is
intended to be used with
continuous biometric data
from already cleared
sensors measuring heart | The Personalized
Physiology Engine (PPA
Engine) is intended to be
used with data from
already cleared sensors
measuring physiological | Equivalent – both devices
are intended to provide an
index to a physician based
a patient's on vital signs,
to provide additional
information during routine |
| Features | Biofourmis | PhysIQ | Comparison |
| | Biovitals Analytics
Engine | PPA Engine
(K142512) | |
| | rate, respiratory rate, and
activity in ambulatory
patients being monitored
in a healthcare facility or
at home, during periods of
minimal activity. The
device learns the
correlation between
multiple vital signs during
the patient's daily activity
and builds an
individualized biometric
signature which is
dynamically updated
based on incoming data.
The device computes a
time series Biovitals Index
(BI), which reflects
changes in the patient's
measured vital signs from
their measured baseline,
which is derived from the
individualized biometric
signature of the patient. | parameters, including
heart rate, respiratory rate,
and activity in ambulatory
patients being monitored
in a healthcare facility or
at home. The device
provides a time series
Multivariate Change Index
(MCI) which indicates
whether the relationships
among the patient's
monitored vital signs
change from those
measured at baseline,
which has been derived
from measurements
previously obtained during
routine activities of daily
living. The MCI is based
on an integrated
computation evaluating
changes in the parameters
and their relationships to
each other. | patient monitoring.
Neither device is intended
to replace vital signs
monitoring, nor is either
device intended to provide
a diagnosis to the
physician. |
| | The BA Engine is a cloud-
based software engine,
intended to be an adjunct
to and is not intended to
replace vital signs
monitoring. The BI is
intended for daily
intermittent, retrospective
review by a qualified
practitioner. The BA
Engine is intended to
provide additional
information for use during
routine patient monitoring.
The BI is not intended for
making clinical decisions
regarding patient treatment
or for diagnostic purposes.
The device is intended for
an adult population. | The PPA Engine is an
adjunct to and is not
intended to replace vital
signs monitoring. The
MCI is intended for daily
intermittent, retrospective
review by a qualified
practitioner. The PPA
Engine is intended to
provide additional
information for use during
routine patient monitoring.
The MCI is not intended
for making clinical
decisions regarding patient
treatment or for diagnostic
purposes. | |
| Features | Biofourmis
Biovitals Analytics
Engine | PhysIQ
PPA Engine
(K142512) | Comparison |
| Patient
Population &
Environment | Ambulatory Non-
pediatric | Ambulatory Non-
pediatric | Equivalent |
| Technological Characteristics | | | |
| Components | Cloud-based Software
only | Software only | Equivalent - the only
differences arise with
regard to the specific
implementation (software
architecture, programming
languages, etc.). These
minor differences do not
raise new questions of
safety and effectiveness. |
| Index
Produced | Non-linear combination of
vital parameters | Non-linear combination of
vital parameters | Equivalent - while the
specific combination of
the index may be different,
the general approach,
meaning of the index and
use of baseline
information are the same. |
| Index Meaning | Index represents how
different the relationships
among the patient's vital
signs are with respect to
normality.
A BI less than or equal to
0.3 indicates that there has
been little or no change in
the relationship among the
patient's vital signs as
compared to baseline. A
BI value greater than 0.3
and less than or equal to
0.7 reflects moderate
change, and a BI value
greater than 0.7 reflects
significant change in the
relationship among the
patient's vital signs as
compared to baseline. | Index represents how
different the relationships
among the patient's vital
signs are with respect to
normality.
An MCI value closer to
zero (0) indicates that the
monitored relationships
among the vital signs are
similar to the learned
baseline. An MCI value
closer to one (1) indicates
that the patient's
monitored relationships
among the vital signs are
likely to be different from
the learned baseline. | Equivalent - the devices
have a different
interpretation of the index
specific to its software
implementation, but the
interpretation is
conceptually similar, and
this difference does not
raise new questions of
safety and effectiveness. |
| Index
Algorithm
Normality | Normality is defined as the
patient's own baseline.
The baseline is initially
established using data
from the first 24 hours and | Normality is defined as the
patient's own baseline | Equivalent - the subject
device's baseline is
periodically updated but
still reflects the same
relationship among vital |
| Features | Biofourmis
Biovitals Analytics
Engine | PhysIQ
PPA Engine
(K142512) | Comparison |
| | updated periodically as
new data is received. | | signs as initially
established in the first 24
hours. This difference does
not raise new questions of
safety and effectiveness. |
| Index Display | Single numeric value of
latest index | Single numeric value of
latest index | Equivalent - specific
differences in the user
interface do not raise
different questions of
safety and effectiveness. |
| | Trend graphs | Trend graphs
Table | |
| Vital Signs
Data Source | FDA cleared Patient
Monitors and Clinical
Information Systems | Clinical Information
Systems | Equivalent - the subject
device enables use of data
captured directly from
FDA cleared patient
monitors. The predicate
device also uses data from
FDA cleared devices but
obtains the data through
integration with Clinical
Information Systems.
Since the actual sensor
data is the same, this
difference does not raise
new questions of safety
and effectiveness. |
| Alarm System | No | No | Equivalent |
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7
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Summary of Performance Testing
Tests have been performed in compliance with the appropriate recognized consensus standards. Testing described in this 510(k) consisted of verification of all design input requirements and product specifications. No residual anomalies appeared during verification and software validation tests. General usability tests, analyzing the users' ability to login, upload, review and download were performed and met all requirements. All software validation testing was completed successfully and met all requirements.
Summary of Clinical Testing
Clinical testing was performed with the BA Engine to evaluate the performance of the Biovitals Index. The testing was performed on a total of 50 subjects presenting at an Emergency Department,
K183282
9
who were deemed appropriate for home monitoring, and compared the performance of the BI against a panel of three physicians evaluating the changes in the relationship among the patients' vital sign parameters. The testing showed that the BI was correlated to the changes in relationship among vital sign parameters, with a lower bound of the 95% confidence interval of the positive percent agreement (PPA) greater than 0.7.
Software
Biofourmis followed IEC 62304:2015 and the FDA Guidance Document, "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" (January, 2002) with respect to software development and validation. The Biofourmis software is classified as a "moderate level of concern" per the FDA guidance document.
Verification and validation testing were completed in compliance with the following standards and guidance documents:
- AAMI ANSI IEC 62304:2015, Medical device software Software life cycle processes ●
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff" ● (January 2002)
- IEC 62366-1 Edition 1.0 2015-02 Medical devices Application of usability engineering . to medical devices
Conclusion
Based upon the intended use, product technical information, clinical and non-clinical testing and standards compliance provided in this premarket notification, Biovitals Analytics Engine has been shown to be substantially equivalent to the legally-marketed predicate.