(176 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description of the device's operation and performance studies focuses on traditional signal processing and clinical validation methods.
No
Explanation: The device is intended for remote monitoring and data collection, which is used as an aid to diagnosis and treatment, but it does not directly administer therapy or provide therapeutic effects itself.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the "data from the Biobeat Platform-2 are intended for use by healthcare professionals as an aid to diagnosis and treatment." This directly indicates its role in the diagnostic process.
No
The device description explicitly states that the Biobeat Platform-2 includes a "sensor device that is attached to the patient's chest" and describes its hardware components (LEDs, thermistors, sensor array, photo-diode). This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Biobeat Platform-2 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens, including blood, urine, and tissue, taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the living body (in vitro).
- Biobeat Platform-2 Function: The Biobeat Platform-2 is a noninvasive device that collects physiological data directly from the patient's body (in vivo) through sensors attached to the chest. It measures parameters like SpO2, pulse rate, blood pressure, respiration rate, hemodynamic parameters, and body temperature.
- Intended Use: The intended use is for healthcare professionals to collect physiological data for spot checks and tracking changes in patients. While this data is used as an "aid to diagnosis and treatment," the device itself is not performing laboratory testing on specimens.
The Biobeat Platform-2 falls under the category of physiological monitoring devices or patient monitoring systems, which are distinct from IVDs.
N/A
Intended Use / Indications for Use
The Biobeat Platform-2 is a wireless non-invasive remote monitoring 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), hemodynamic parameters (stroke volume, cardiac output), and body temperature.
The Biobeat Platform-2 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-2 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-2 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)
DQA, DXN, DRG, BZQ, FLL, DXG
Device Description
The Biobeat Platform-2 includes a sensor device that is attached to the patient'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 device. The LEDs transmit light into the subject's skin and part of this light is reflected from the tissue and detected by a photo-diode. This allows measurement of arterial oxygenation, pulse rate, change in blood pressure, stroke volume, cardiac output, 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-patch attached to the skin
Indicated Patient Age Range
Adults
Intended User / Care Setting
healthcare professionals for spot check collection of physiological data in home and healthcare settings. Intended to be used in 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)
Clinical Validation Data:
Ambulatory congestive heart failure patients arriving for right heart catheterization as part of their clinical assessment were recruited. The non-invasive Biobeat devices were simultaneously attached to their chests and frequent monitoring started in parallel to a SGC inserted through the Internal Jugular vein. Comparison was performed retrospectively, after completion of the measurement phase.
Results:
90 patients (19-89yo, 53 males) were recruited, 80 were included in the final analysis comparing the PPG device and Fick, 77 were included in the final analysis comparing TD with Fick, and 82 were included in the final analysis comparing PPG with TD. The mean values of the CO measured using the indirect Fick method, the PPG device, and using the thermodilution (TD) were compared. Bland-Altman analysis showed that the PPG had LOA to the Fick method and TD within 30%.
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 contains 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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
December 30, 2022
BioBeat Technologies Ltd. % John Smith Partner Hogan Lovells U.S. LLP 555 Thirteenth Street NW Washington, District of Columbia 20004
Re: K222010
Trade/Device Name: Biobeat Platform-2 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, DXN, DRG, BZQ, FLL, DXG Dated: July 7, 2022 Received: July 7, 2022
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (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 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.
Robert T. Kazmierski -S
for LCDR Stephen Browning 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
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-2
Indications for Use (Describe)
The Biobeat Platform-2 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), hemodynamic parameters (stroke voltput), and body temperature.
The Biobeat Platform-2 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-2 is intended for spot-checking changes of adult patients in hospitals, clinics, long-term care, and at home. The data from the Biobeat Platform-2 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) 区 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 toreview instructions, search existing data sources, gather and maintain the data needed and review theollection 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 ServicesFood and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) StaffPRAStaff(@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
K222010
510(k) SUMMARY
Biobeat Technologies Ltd.'s Biobeat Platform-2
Submitter:
Biobeat Technologies Ltd. 26 Maqshimim Street Petah Tikva Israel 4934835
Phone: +972 3 933 3022 Facsimile: +972 77 460 1636
Contact Person: Johanan May
Date Prepared: December 29, 2022
Name of Device: Biobeat Platform-2
Common or Usual Name: Cardiopulmonary monitor
Classification Name/Product Code:
- 868.2375 Breathing frequency monitor, BZQ ●
- 870.1130 Noninvasive blood pressure measurement system, DXN ●
- 870.1435 Computer, Diagnostic, Pre-Programmed, Single-Function, 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 Platform, BB-613WP Patch (K212153) (Primary Predicate) EV1000 Clinical Platform™ NI with the ClearSight™ Finger Cuffs or ClearSight™ System (K182245) (Additional Predicate)
System Description
The Biobeat Platform-2 includes a sensor device that is attached to the patient'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 device. The LEDs transmit light into the subject's skin and part of this light is reflected from the tissue and detected by a photo-diode. This allows measurement of arterial oxygenation, pulse rate, change in blood pressure, stroke volume, cardiac output, 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-2 is a wireless non-invasive remote monitoring 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), hemodynamic parameters (stroke volume, cardiac output), and body temperature.
The Biobeat Platform-2 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-2 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-2 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.
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 predicate devices into one device. Specifically, the subject device uses identical technology (i.e., the same sensor units and algorithms) for measuring SpO2, pulse rate, blood pressure, respiratory rate (RRp), and temperature compared to the primary predicate (Biobeat Platform: K212153), which is an earlier iteration of the subject device also manufactured by Biobeat. Both devices are adhesive unit-based devices intended to be attached to the chest to collect the data. In addition to the primary predicate device, a new algorithm, derived from the existing photoplethysmogram, was added for measuring stroke volume and cardiac output. This measurement capability is equivalent to the methodology used by the additional predicate, ClearSight™ System (K182245), to measure the same parameters.
There have been no physical modifications to the BB-613WP Patch itself or to the Biobeat Platform-2 as compared to the version cleared in K212153.
The subject device is supplied and used non-sterile, just like the predicate devices. The subject device uses software to control the device and analyze and display the results. The new software elements have been documented and validated per FDA guidance. The subject device contains electronics that present an electrical hazard and EMC risks. As the electronic components are identical to the primary predicate, repeated safety testing was not needed.
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 testing establishes equivalent performance as compared to the predicate devices.
5
| Device (K
| number) | Subject Device | Primary Predicate Device | Predicate Device |
|---|---|---|---|
| Biobeat Platform-2 / BB- | |||
| 613WP Patch | Biobeat Platform / BB- | ||
| 613WP Patch | |||
| (K212153) | ClearSight System | ||
| (K182245) | |||
| Indications for | |||
| use | The Biobeat Platform-2 is a | ||
| wireless noninvasive remote | |||
| monitoring 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), hemodynamic | |||
| parameters (stroke volume, cardiac | |||
| output), and body temperature. |
The Biobeat Platform-2 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-2 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-2 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. | The Biobeat Platform / BB-613WP
Patch is a wireless noninvasive
remote monitoring system
intended for use by healthcare
professionals for 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, 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 home use.
The data from 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. | The EV1000 Clinical Platform
NI and the ClearSight™ Finger
Cuffs are indicated for patients
over 18 years of age in which
the balance between cardiac
function, fluid status, and
vascular resistance needs
continuous or intermittent
assessment. The EV1000
Clinical Platform may be used
for the monitoring of
hemodynamic parameters in
conjunction with a
perioperative goal directed
therapy protocol. In addition,
the non-invasive system is
indicated or use in patients
with co- morbidities for which
hemodynamic optimization is
desired and invasive
measurements are difficult.
The EV1000 Clinical Platform
and the ClearSight™ Finger
Cuffs noninvasively measures
blood pressure and associated
hemodynamic parameters. |
| Use Population | Adults | Adults | Adults |
| Use
Environment | Hospitals, clinics, long-term care,
and home use | Hospitals, clinics, long-term care,
and home use | Hospitals and other
appropriate clinical
environments. |
| Monitoring | Spot-checking | Spot-checking | Intermittent and continuous |
| K
number) | Subject Device
Biobeat Platform-2 / BB-
613WP Patch | Primary PredicateDevice
Biobeat Platform / BB-613WP
Patch
(K212153) | Predicate Device
ClearSight System
(K182245) |
| Principle of
Operation | Pulse reflectance technology, four
LED (red + IR) and photo diode
absorbs reflectedlight.
Tracking changes of blood pressure is
done by pulse wave transit time
(PWTT) which is obtained utilizing
pulse measurements from the
integrated skin attachedSpO2 sensor.
RRp measured by analyzing cyclic
variations in the
photoplethysmogramdue to
respiration.
Body temperaturemeasured
with thermistors. | Pulse reflectance technology, four
LED (red + IR) and photo diode
absorbs reflectedlight.
Tracking changes of blood pressure is
done by pulse wave transit time
(PWTT) which is obtained utilizing
pulse measurements from the
integrated skin attachedSpO2 sensor.
RRp measured by analyzing cyclic
variations in the
photoplethysmogramdue to
respiration.
Body temperaturemeasured with
thermistors. | 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) in adults and
pediatrics.
RRp measured by
analyzing cyclic
variations in the
photoplethysmogramdue
to respiration |
| Outputs | Oxygen Saturation(SpO2)
Pulse Rate (PR)
Blood Pressure (BP),
Respiration Rate (RRp),
Body Temperature
Hemodynamic parameters
including:
Cardiac Output (CO),
Stroke Volume (SV) | Oxygen Saturation(SpO2)
Pulse Rate (PR)
Blood Pressure (BP),
Respiration Rate (RRp),
Body Temperature | Pulse Rate (PR)
Blood Pressure
(Systolic, Diastolic, and
Mean Arterial Pressure)
Hemodynamic
parameters including:
Cardiac Output (CO),
Stroke Volume (SV)
Cardiac Index (CI)
Stroke Volume Index,
Systemic Vascular
Resistance (SVR),
Systemic Vascular
Resistance Index,
Stroke Volume
Variation. |
| Measurement
site | Chest-patch attached to the skin | Chest-patch attached to the skin | Finger |
| Body
attachment
method | Adhesive patch | Adhesive patch | Clamp pressure from
finger cuff |
| Measurement
type | Spot | Spot | Continuous or intermittent |
Table 7.1: Comparison of Intended Use
6
| able 7.2: Comparison of Technological Characteristics: | |||
|---|---|---|---|
| K | |||
| number) | Subject Device | ||
| Biobeat Platform-2 / BB- | |||
| 613WP Patch | Primary PredicateDevice | ||
| Biobeat Platform / BB-613WP | |||
| Patch | |||
| (K212153) | Predicate Device | ||
| ClearSight System | |||
| (K182245) | |||
| Emitted light | |||
| peak | |||
| wavelength | 880nm (IR), 650nm | ||
| (Red) | 880nm (IR), 650nm | ||
| (Red) | N/A | ||
| Measurement | |||
| Range SpO2 | 40% to 100% | 40% to 100% | N/A |
| Arms, SpO2 | ±2% | ±2% | N/A |
| Measurement | |||
| Range, | |||
| PR/HR | 40 to 250 bpm | 40 to 250 bpm | 0 to 220 bpm |
| Arms, PR/HR | ±3% | ±3% | Not specified |
| Measurement | |||
| Range, BP | 0 mmHg - 299 mmHg | 0 mmHg - 299 mmHg | 0 mmHg - 300 mmHg |
| Accuracy | |||
| blood | |||
| pressure | ±5 mmHg | ±5 mmHg | 1% of full scale |
| (max 3 mmHg) | |||
| Measurement | |||
| Range, CO | 1.5-13 L/min | N/A | 1.0 to 20.0 L/min |
| Accuracy, CO | ±30% | N/A | Bias ≤ ± 0.6 L/min or ≤ |
| 10% | |||
| (Whichever is greater). | |||
| Precision (1σ) ≤ ± 20% | |||
| over the range of | |||
| Cardiac Output from 2 to | |||
| 20 L/min | |||
| Single use | Yes | Yes | No |
| Wireless BLE | Yes | Yes | Yes |
| Operation | |||
| time | 120 hours | 120 hours | N/A |
| Contact | |||
| material | Polycarbonate, photodiode window, | ||
| silicone, adhesive unit | Polycarbonate, photodiode window, | ||
| silicone, adhesive unit | Unknown | ||
| Application | |||
| Method | The device is attached to the chest | ||
| skin using a biocompatible adhesive | |||
| unit | The device is attached to the chest | ||
| skin using a biocompatible adhesive | |||
| unit | User attaches the device | ||
| to the finger | |||
| Sterility | Supplied and used non- sterile | Supplied and used non- sterile | Supplied and used non- |
| sterile | |||
| Data display | Handheld display unit(e.g. tablet) | Handheld display unit(e.g. tablet) | Display unit |
| K | |||
| number) | Subject Device | ||
| Biobeat Platform-2 / BB- | |||
| 613WP Patch | Primary Predicate Device | ||
| Biobeat Platform / BB-613WP | |||
| Patch | |||
| (K212153) | Predicate Device | ||
| ClearSight System | |||
| (K182245) | |||
| Data storage | Yes, but can transmit the data to a | ||
| handheld device for storage and | |||
| analysis | Yes, but can transmit the data to a | ||
| handheld device for storage and | |||
| analysis | Yes |
7
8
9
Performance Data
The Biobeat Platform-2 uses the same hardware as the cleared BB-613WP Patch but features some software changes, including measurements of stroke volume and cardiac output. The device contains the same sensor unit and uses the same algorithm to compute SpO2 and pulse rate and to compute and track changes in blood pressure. Therefore, these signals' evaluation testing, which was submitted in K212153, remains applicable to the subject device. Additional testing was conducted on the updated product features, including:
- . Clinical validation of stroke volume and cardiac output
- Software validation per FDA guidance, General Principles of SoftwareValidation; Final Guidance for Industry and FDA Staff (January 11, 2002)
Clinical Validation Data
Ambulatory congestive heart failure patients arriving for right heart catheterization as part of their clinical assessment were recruited. The non-invasive Biobeat devices were simultaneously attached to their chests and frequent monitoring started in parallel to a SGC inserted through the Internal Jugular vein. Comparison was performed retrospectively, after completion of the measurement phase.
Results
90 patients (19-89yo, 53 males) were recruited, 80 were included in the final analysis comparing the PPG device and Fick, 77 were included in the final analysis comparing TD with Fick, and 82 were included in the final analysis comparing PPG with TD. The mean values of the CO measured using the indirect Fick method, the PPG device, and using the thermodilution (TD) were compared. Bland-Altman analysis showed that the PPG had LOA to the Fick method and TD within 30%.
Conclusions
The Biobeat Platform-2 is as safe and effective as its predicate devices. Specifically, the subject device has the same intended use as the predicate devices and combines the indications for use and technological characteristics of the predicates into one device. The minor technological differences between the Biobeat Platform-2 and its predicate devices, namely adding algorithms to the cloud to provide stroke volume and cardiac output measurements, raise no new issues of safety or effectiveness. Performance data demonstrate that the Biobeat Platform-2 is as safe and effective as the predicates. Thus, the Biobeat Platform-2 is substantially equivalent.