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 [Link] 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

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.32
Silver Spring, MD 20993
[Link]
K212153 - John Smith Page 2

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (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
[Link]
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
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 [Link]
mdr-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 ([Link]
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
([Link] 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 ([Link]
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email (DICE@[Link]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Stephen C. Browning -S
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
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K212153 510(k) Summary Page 2of 8

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Device (K Subject Device BB- Primary Predicate Predicate Device Predicate Device
number) 613WP Patch Device MightySat Rx VitalConnect
BB-613 Watch (K181956) (K183078)
Oximeter
(K190792)
Indications foruse The Biobeat Platform isa The BB-613 WP is a The Masimo MightySat The VitalConnect
wireless noninvasive wrist-worn or skin Rx Fingertip Pulse Platform is a wireless
remote monitoring system attached device remote monitoring
Oximeter is intendedfor
intended for use by indicated for use in system intended for
hospitals, hospital-type
healthcare professionals measuring and facilities, home use byhealthcare
for spot-checking displaying functional environments, and professionals for
collection ofphysiological oxygen saturation of transport. continuous collection
data in home and arterial hemoglobin of physiological data in
The Masimo MightySat
healthcare settings. This (%SpO2) and pulse home and healthcare
Rx Fingertip Pulse
can include, functional rate. [Link] can
Oximeter is indicatedfor
oxygen saturation of include heart rate,
the noninvasive spot
arterial hemoglobin electrocardiography
The BB-613WP can also checking of functional
(%SpO2), pulse rate, blood (ECG), heart rate
track changes in blood oxygen saturation of
pressure, respiration rate variability, R-R
pressure based on Pulse arterial hemoglobin
(RRp), and body interval, respiratory
temperature. Wave TransitTime (PWTT) (SpO2) and pulse rate rate, body
which is (PR) for adult and
temperature, skin
obtained utilizing pulse pediatric patients
The Biobeat Platform temperature, activity
measurements from the during both no motion
tracks changes in blood (including step count),
integrated SpO2 sensor, and motion conditions,
pressure based on Pulse and posture (body
following a calibration and for patients who
Wave TransitTime (PWTT) position relative to
which is obtained utilizing process using oscillometric are wellor poorly gravity including fall).
blood pressure monitor. perfused.
pulsemeasurements from
the integrated SpO2 The Masimo MightySat Data are transmitted
sensor, following a The BB-613WP is Rx Fingertip Pulse wirelessly from the
calibration process using intended for spot- Oximeter is indicatedfor VitalConnect
an FDA-cleared checking of adult patients the noninvasive spot Biosensor for storage
oscillometric blood in hospitals, clinics, long- checking of respiration and analysis. The
pressure monitor. term care,and home use. rate (RRp) for adult VitalConnect Platform
patients. can include the ability
The Biobeat Platform is tonotify healthcare
intended for spot- checking professionals when
and tracking changes of physiological data fall
adult patients in hospitals,
outside selected
clinics, long-term care, and
at home . The data from the parameters.
Biobeat
The device is intended
for use on

K212153 510(k) Summary Page 3of 8

366

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Device (K Subject Device BB- Primary Predicate Predicate Device Predicate Device
number) 613WP Patch Device MightySat Rx VitalConnect
BB-613 Watch (K181956) (K183078)
Oximeter
(K190792)
 Platform are intended for   general care patients
use by healthcare who are 18years of age
professionals as an aidto or older as a general
diagnosis and treatment. patient monitor, to
The device is not intended provide physiological
for use on critical care information. The data
patients. 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 Hospitals, clinics, long- Hospitals, clinics, long- Hospitals, hospital- Home and healthcare
Environment term care, and home use term care, and home use type facilities, home settings
environments, and
transport.
Monitoring Spot-checking Spot-checking Spot-checking Spot-checking

7DEOH&RPSDULVRQRI7HFKQRORJLFDO&KDUDFWHULVWLFV

Device (K Subject Device BB- Primary PredicateDevice Predicate Device Predicate Device
number) 613WP Patch BB-613 Watch MightySat Rx VitalConnect
Oximeter (K181956) (K183078)
(K190792)

Principle of Pulse reflectance Pulse reflectance Finger SpO2 sensor Electrocardiography

Operation technology, technology, measurement of and accelerometer
Four LED (red + IR) and Four LED (red + IR) and functional oxygen
photo diode absorbs photo diode absorbs saturation of arterial
reflected light. reflected light. hemoglobin (SpO2),
pulse rate (PR),
Tracking changes of blood Tracking changes of blood
calculation of Perfusion
pressure is doneby pulse pressure is doneby pulse
Index (Pi) and optional
wave transit time (PWTT) wave transit time (PWTT)
Pleth Variability Index
which is which is
(PVi)
obtained utilizing pulse obtained utilizing pulse

K212153 510(k) Summary Page 4of 8

367

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Device (K Subject Device BB- Primary PredicateDevice Predicate Device Predicate Device
number) 613WP Patch BB-613 Watch MightySat Rx VitalConnect
Oximeter (K181956) (K183078)
(K190792)

 measurements from the measurements from the in adults and

integrated skin attached integrated skin attached pediatrics.
SpO2 sensor. SpO2 sensor.

RRp measured by RRp measured by

analyzing cyclic analyzing cyclic
variations in the variations in the
photoplethysmogram photoplethysmogram
due to respiration. due to respiration
Body temperature
Body temperature
measured with
measured with
thermistors.
thermistors.
Outputs Oxygen Saturation Oxygen Saturation Oxygen Saturation ECG Dynamic
(SpO2) (SpO2) (SpO2) Range
Pulse Rate (PR) Blood Pulse Rate (PR) Blood Pulse Rate (PR) Heart Rate (HR)
Pressure (BP) Pressure (BP) Perfusion Index (Pi) Respiration Rate
Pleth Variability (RRp)
Index (PVi) Fall Detection
Respiration Rate (RRp) Respiration rate Step Count
(RRp) Heart Rate
Variability

Body Temperature Body Temperature

Measurement Chest-patch attached to the Wrist area and attached to Fingertip Chest-patch attached
site skin the skin to the skin
Includes Yes N/A N/A Yes
adhesive
sheet
Measurement Spot Spot Spot Spot
type
Emitted light 880nm (IR), 650nm 880nm (IR), 650nm Similar N/A
peak (Red) (Red)
wavelength
Measurement 40% to 100% 40% to 100% 70% to 100% N/A
Range SpO2
Arms, SpO2 ±2% ±2% ±2% N/A

Measurement 40 to 250 bpm 40 to 250 bpm 25 to 240 bpm 30 to 200 bpm

Range, PR/HR
Arms, PR/HR ±3% ±3% ±3 bpm <±5 or 10% bpm,
whichever is greater

K212153 510(k) Summary Page 5of 8

368

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Device (K Subject Device BB- Primary PredicateDevice Predicate Device Predicate Device
number) 613WP Patch BB-613 Watch MightySat Rx VitalConnect
Oximeter (K181956) (K183078)
(K190792)

Measurement 0 mmHg – 299 mmHg 0 mmHg – 299 mmHg N/A N/A

Range, BP
Accuracy ±5 mmHg ±5 mmHg N/A N/A
blood
pressure
Measurement 4 to 40 RPM N/A 4 to 70 RPM 10 to 30 RPM
Range,
Respiration rate

Accuracy ±3 RPM N/A ±3 RPM <±3 RPM

respiration
rate
Measurement 32 ϶C to 42 ϶C N/A N/A 32 ϶C to 42 ϶C
Range, Body
Temperature
Body temperature Yes N/A N/A Yes
iscalculated from
skin temp' and
ambient temp'

Accuracy ±0.3 ϶C N/A N/A ±1.0 ϶C

Temperature
Single use Yes No No Yes

Wireless BLE Yes No Yes Yes

Operation time 120 hours 72 hours Operation time of 120 hours

two AAA alkaline
batteries
Contact Polycarbonate, Polycarbonate, Unknown Hydrocolloid
material photodiode window, photodiode window, adhesive
silicone, adhesive unit silicone
Application The device is attached tothe The device is attached to User attaches the The device is
Method chest skin using a the skin using a wrist band device to the attached to the chest
biocompatible adhesive unit or a biocompatibleadhesive fingertip skin using a
unit biocompatible
adhesive unit
Sterility Supplied and used non- Supplied and used non- Supplied and used Supplied and used
sterile sterile non-sterile non-sterile
Data display Handheld display unit LCD on device or handheld OLED color display Handheld display
(e.g. tablet) display unit screen on device and unit

K212153 510(k) Summary Page 6of 8

369
 

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Device (K Subject Device BB- Primary PredicateDevice Predicate Device Predicate Device
number) 613WP Patch BB-613 Watch MightySat Rx VitalConnect
Oximeter (K181956) (K183078)
(K190792)

   handheld display unit 

(e.g. mobile phone)
Data storage Limited, but can transmitthe Yes Yes, and can transmit No, but can transmit
data for storage and analysis the data tohandheld the data for storage
device and analysis


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