(259 days)
Not Found
No
The summary does not mention AI, ML, deep learning, training sets, or any other indicators of AI/ML technology. The device description focuses on sensor technology and data transmission.
No.
The device is described as a monitoring system intended for data collection to "aid to diagnosis and treatment," rather than providing direct therapeutic intervention.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "The Biobeat Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment."
No
The device description explicitly mentions a "BB-613WP Patch sensor" which is a physical device attached to the patient's chest containing LEDs, thermistors, and a sensor array for data collection. This indicates the presence of hardware components beyond just software.
Based on the provided information, the Biobeat Platform is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro - "in glass"). This typically involves blood, urine, tissue, or other bodily fluids.
- The Biobeat Platform measures physiological data directly from the body (in vivo - "in the living"). It uses sensors attached to the skin to measure parameters like SpO2, pulse rate, blood pressure, respiration rate, and body temperature.
The device description clearly states that the sensor is attached to the patient's chest and uses light and thermistors to collect data from the skin and underlying tissue. This is a direct measurement from the living body, not an analysis of a sample taken from the body.
N/A
Intended Use / Indications for Use
The Biobeat Platform is a wireless nonitoring system intended for use by healthcare professionals for spot check collection of physiological data in home and healthcare settings. This can include, functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, blood pressure, respiration rate (RRp), and body temperature.
The Biobeat Platform tracks changes in blood pressure based on Pulse Wave Transit Time (PWTT) which is obtained utilizing pulse measurements from the integrated SpO2 sensor, following a calibration process using an FDA-cleared oscillometric blood pressure monitor.
The Biobeat Platform is intended for spot-checking changes of adult patients in hospitals, clinics, longterm care, and at home. The Biobeat 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.
Product codes (comma separated list FDA assigned to the subject device)
DXN, DQA, DRG, BZQ, DXG, FLL
Device Description
The Biobeat Platform and the BB-613WP Patch sensor include a device that is attached to thepatient's chest to collect physiological data for later review by their healthcare provider. The device consists of a light source (LEDs), thermistors and sensor array on the backside of the LEDs transmit light into the subject's skin and part of this light is reflected from thetissue and detected by a photo-diode. This allows measurement of arterial oxygenation, pulserate, change in blood pressure, and respiration rate. Body temperature is measured by the thermistors. Data is transmitted to a gateway via Bluetooth and then uploaded to the cloud. From the cloud, data is transmitted and presented in a web application for review by a healthcare professional. The device does not contain any alarms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest (for the patch sensor), Wrist area (for predicate device BB-613 Watch Oximeter), Fingertip (for predicate device MightySat Rx)
Indicated Patient Age Range
Adults
Intended User / Care Setting
Healthcare professionals; home and healthcare settings (hospitals, clinics, long-term care, and 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)
The Biobeat Platform and the BB-613WP Patch uses the same hardware as the cleared BB- 613WP but features some software changes, including activation of two thermistors to measure body temperature and an option of an additional gateway device. The device contains the samesensor unit and uses the same algorithm to compute SpO2 and pulse rate and to compute andtrack changes in blood pressure. Therefore, these signals' evaluation testing, which was submitted in K190792, remains applicable to the subject device. Additional testing was conducted on the updated product features, including:
- Respiration rate validation
- Clinical validation of temperature per ISO 80601-2-56:2018
- Software validation per FDA quidance, General Principles of Software ● Validation; Final Guidance for Industry and FDA Staff (January 11, 2002)
- Cybersecurity assessment
- IEC 60601-1-2:2014 (4th Edition) EMC Requirements and tests ●
- IEC 60601-1:2012 (3.1 Edition) General requirements for basic safety ● andessential performance
- ANSI C63.27-2017 Standard for Evaluation of Wireless Coexistence
Clinical validations of respiration rate and body temperature were performed to evaluate the efficacy of the new parameters. It was shown that the Biobeat Platform met the pre-specified efficacy requirements and performed in a manner that was substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 25, 2022
BioBeat Technologies Ltd. % John Smith Partner Hogan Lovells US LLP 555 Thirteenth St., NW Washington, District of Columbia 20004
Re: K212153
Trade/Device Name: Biobeat Platform, BB-613WP Patch Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DQA, DRG, BZQ, DXG, FLL Dated: July 9, 2021 Received: July 9, 2021
Dear John Smith:
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,
LCDR Stephen Browning Assistant Director 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name
Biobeat Platform, BB-613WP Patch
Indications for Use (Describe)
The Biobeat Platform is a wireless nonitoring system intended for use by healthcare professionals for spot check collection of physiological data in home and healthcare settings. This can include, functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, blood pressure, respiration rate (RRp), and body temperature.
The Biobeat Platform tracks changes in blood pressure based on Pulse Wave Transit Time (PWTT) which is obtained utilizing pulse measurements from the integrated SpO2 sensor, following a calibration process using an FDA-cleared oscillometric blood pressure monitor.
The Biobeat Platform is intended for spot-checking changes of adult patients in hospitals, clinics, longterm care, and at home. The Biobeat 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.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response. including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number
3
K212153
510(k) SUMMARY
Biobeat Technologies Ltd.'s BB-613 WP Patch
Submitter:
Biobeat Technologies Ltd. 26 Magshimim Street Petah Tikva lsrael 4934835
Phone: +972 3 933 3022 Facsimile: +972 77 460 1636
Contact Person: Johanan May
Date Prepared:February 14, 2022
Name of Device: Biobeat Platform, BB-613WP Patch
Common or Usual Name: Breathing frequency monitor
Classification Name/Product Code:
- 868.2375 Breathing frequency monitor, BZQ
- 870.1130 Noninvasive blood pressure measurement system, DXN ●
- 870.1435 Single-function, preprogrammed diagnostic computer, DXG ●
- 870.2700 Oximeter, DQA
- 870.2910 Radiofrequency physiological signal transmitter and receiver, DRG ●
- 880.2910 Clinical electronic thermometer, FLL ●
Regulatory Class: Class II
Predicate Devices
Biobeat's BB-613 WP (K190792) (Primary Predicate) Masimo Corporation's MightySat Rx Fingertip Pulse Oximeter (K181956) (SecondaryPredicate) VitalConnect, Inc,'s VitalConnect Platform (K183078) (Secondary Predicate)
System Description
The Biobeat Platform and the BB-613WP Patch sensor include a device that is attached to thepatient's chest to collect physiological data for later review by their healthcare provider. The device consists of a light source (LEDs), thermistors and sensor array on the backside of the LEDs transmit light into the subject's skin and part of this light is reflected from thetissue and detected by a photo-diode. This allows measurement of arterial oxygenation, pulserate, change in blood pressure, and respiration rate. Body temperature is measured by the thermistors. Data is transmitted to a gateway via Bluetooth and then uploaded to the cloud. From the cloud, data is transmitted and presented in a web application for review by a healthcare professional. The device does not contain any alarms.
4
Intended Use / Indications for Use
The Biobeat Platform is a wireless nonitoring system intended for use by healthcare professionals for spot-checking collection of physiological data in home and healthcare settings. This can include, functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, blood pressure, respiration rate (RRp), and body temperature.
The Biobeat Platform tracks changes in blood pressure based on Pulse Wave Transit Time (PWTT) which is obtained utilizing pulse measurements from the integrated SpO2 sensor, following a calibration process using an FDA-cleared oscillometric blood pressure monitor.
The Biobeat Platform is intended for spot-checking and tracking changes of adult patients in hospitals, clinics, long-term care, and at home. The data from the Biobeat Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. The deviceis not intended for use on critical care patients.
Summary of Technological Characteristics
The subject and predicate devices are all intended to measure and display physiological signals. The subject device combines the parameters measured by the three predicates into one device. Specifically, the subject device uses identical technology (i.e., the same sensor unit and algorithms) for measuring SpO2, pulse rate, and blood pressure compared to the primary predicate (BB-613 WP; K190792), which is an earlier iteration of the subject device also manufactured by Biobeat. Both devices are adhesive unitbased devices intended to be attached to the chest to collect the data. As compared to the primary predicate, a new algorithm, derived from the existing photoplethysmogram, was added for measuring respiration rate (RRp). RRp relies upon cyclic variations in the photoplethysmogram due to respiration. This measurement capability is nearly identical to the methodology used by the MightySat Rx predicate (K181956) to measure the same parameter.
In addition, a sensor array (two thermistors) that was inactive in the prior version (K190792) has been activated as part of this submission to allow for the measurement of body temperature. The measurement methodology is nearly identical to another previously-cleareddevice (VitalConnect; K183078), which serves as the third predicate device for this submission.
There have been no physical modifications to the BB-613WP itself as compared to the versioncleared in K190792. A gateway device has been added to the system for transmission of datato the cloud and software to access the data on the cloud has been added.
In sum, although there are minor differences in the technological characteristics, these differences do not raise different questions of safety or effectiveness, and the provided testingestablishes equivalent performance as compared to the predicate devices.
5
| Device (K
number) | Subject Device BB-613WP Patch | Primary Predicate
Device
BB-613 Watch
Oximeter
(K190792) | Predicate Device
MightySat Rx
(K181956) | Predicate Device
VitalConnect
(K183078) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications foruse | The Biobeat Platform is a
wireless noninvasive
remote monitoring system
intended for use by
healthcare professionals
for spot-checking
collection ofphysiological
data in home and
healthcare settings. This
can include, functional
oxygen saturation of
arterial hemoglobin
(%SpO2), pulse rate, blood
pressure, respiration rate
(RRp), and body
temperature.
The Biobeat Platform
tracks changes in blood
pressure based on Pulse
Wave TransitTime (PWTT)
which is obtained utilizing
pulse measurements from
the integrated SpO2
sensor, following a
calibration process using
an FDA-cleared
oscillometric blood
pressure monitor.
The Biobeat Platform is
intended for spot- checking
and tracking changes of
adult patients in hospitals,
clinics, long-term care, and
at home . The data from the
Biobeat | The BB-613 WP is a
wrist-worn or skin
attached device
indicated for use in
measuring and
displaying functional
oxygen saturation of
arterial hemoglobin
(%SpO2) and pulse
rate.
The BB-613WP can also
track changes in blood
pressure based on Pulse
Wave TransitTime (PWTT)
which is
obtained utilizing pulse
measurements from the
integrated SpO2 sensor,
following a calibration
process using oscillometric
blood pressure monitor.
The BB-613WP is
intended for spot-
checking of adult patients
in hospitals, clinics, long-
term care, and home use. | The Masimo MightySat
Rx Fingertip Pulse
Oximeter is intended for
hospitals, hospital-type
facilities, home
environments, and
transport.
The Masimo MightySat
Rx Fingertip Pulse
Oximeter is indicated for
the noninvasive spot
checking of functional
oxygen saturation of
arterial hemoglobin
(SpO2) and pulse rate
(PR) for adult and
pediatric patients
during both no motion
and motion conditions,
and for patients who
are well or poorly
perfused.
The Masimo MightySat
Rx Fingertip Pulse
Oximeter is indicated for
the noninvasive spot
checking of respiration
rate (RRp) for adult
patients. | The VitalConnect
Platform is a wireless
remote monitoring
system intended for
use byhealthcare
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, body
temperature, skin
temperature, activity
(including step count),
and posture (body
position relative to
gravity including fall).
Data are transmitted
wirelessly from the
VitalConnect
Biosensor for storage
and analysis. The
VitalConnect Platform
can include the ability
to notify healthcare
professionals when
physiological data fall
outside selected
parameters.
The device is intended
for use on |
| Device (K
number) | Subject Device BB-
613WP Patch | Primary Predicate
Device
BB-613 Watch
Oximeter
(K190792) | Predicate Device
MightySat Rx
(K181956) | Predicate Device
VitalConnect
(K183078) |
| | Platform are intended for
use by healthcare
professionals as an aidto
diagnosis and treatment.
The device is not intended
for use on critical care
patients. | | | general care patients
who are 18years of age
or older as a general
patient monitor, to
provide physiological
information. The data
from the VitalConnect
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. |
| Use Population | Adults | Adults | Adults and pediatrics | Adults |
| Use
Environment | Hospitals, clinics, long-
term care, and home use | Hospitals, clinics, long-
term care, and home use | Hospitals, hospital-
type facilities, home
environments, and
transport. | Home and healthcare
settings |
| Monitoring | Spot-checking | Spot-checking | Spot-checking | Spot-checking |
Comparison of Intended Use
6
Table 7.2: Comparison of Technological Characteristics:
| Device (K
number) | Subject Device BB-
613WP Patch | Primary PredicateDevice
BB-613 Watch
Oximeter
(K190792) | Predicate Device
MightySat Rx
(K181956) | Predicate Device
VitalConnect
(K183078) |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of
Operation | Pulse reflectance
technology,
Four LED (red + IR) and
photo diode absorbs
reflected light.
Tracking changes of blood
pressure is doneby pulse
wave transit time (PWTT)
which is
obtained utilizing pulse | Pulse reflectance
technology,
Four LED (red + IR) and
photo diode absorbs
reflected light.
Tracking changes of blood
pressure is doneby pulse
wave transit time (PWTT)
which is
obtained utilizing pulse | Finger SpO2 sensor
measurement of
functional oxygen
saturation of arterial
hemoglobin (SpO2),
pulse rate (PR),
calculation of Perfusion
Index (Pi) and optional
Pleth Variability Index
(PVi) | Electrocardiography
and accelerometer |
| Device (K
number) | Subject Device BB-
613WP Patch | Primary PredicateDevice
BB-613 Watch
Oximeter
(K190792) | Predicate Device
MightySat Rx
(K181956) | Predicate Device
VitalConnect
(K183078) |
| | measurements from the
integrated skin attached
SpO2 sensor. | measurements from the
integrated skin attached
SpO2 sensor. | in adults and
pediatrics. | |
| | RRp measured by
analyzing cyclic
variations in the
photoplethysmogram
due to respiration.
Body temperature
measured with
thermistors. | | RRp measured by
analyzing cyclic
variations in the
photoplethysmogram
due to respiration | Body temperature
measured with
thermistors. |
| Outputs | Oxygen Saturation
(SpO2)
Pulse Rate (PR) Blood
Pressure (BP)
Respiration Rate (RRp)
Body Temperature | Oxygen Saturation
(SpO2)
Pulse Rate (PR) Blood
Pressure (BP) | Oxygen Saturation
(SpO2)
Pulse Rate (PR)
Perfusion Index (Pi)
Pleth Variability
Index (PVi)
Respiration rate
(RRp) | ECG Dynamic
Range
Heart Rate (HR)
Respiration Rate
(RRp)
Fall Detection
Step Count
Heart Rate
Variability
Body Temperature |
| Measurement
site | Chest-patch attached to the
skin | Wrist area and attached to
the skin | Fingertip | Chest-patch attached
to the skin |
| Includes
adhesive
sheet | Yes | N/A | N/A | Yes |
| Measurement
type | Spot | Spot | Spot | Spot |
| Emitted light
peak
wavelength | 880nm (IR), 650nm
(Red) | 880nm (IR), 650nm
(Red) | Similar | N/A |
| Measurement
Range SpO2 | 40% to 100% | 40% to 100% | 70% to 100% | N/A |
| Arms, SpO2 | ±2% | ±2% | ±2% | N/A |
| Measurement
Range, PR/HR | 40 to 250 bpm | 40 to 250 bpm | 25 to 240 bpm | 30 to 200 bpm |
| Arms, PR/HR | ±3% | ±3% | ±3 bpm |