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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly list "acceptance criteria" in a separate table with specific numerical targets for each parameter. However, it states the device aims for equivalent performance to its predicate devices and provides accuracy statements for certain physiological parameters. For the new parameters (Stroke Volume (SV) and Cardiac Output (CO)), the acceptance criterion is implicitly demonstrated by the Bland-Altman analysis showing acceptable Limits of Agreement (LOA) against a reference method.

Here's an attempt to structure the information into a table, inferring the acceptance criteria from the performance data and comparisons to predicate devices:

Table of Acceptance Criteria and Reported Device Performance

Parameter / Metric	Acceptance Criteria (Implicitly from Predicate Comparison or Performance Data)	Reported Device Performance	Study that Proves Device Meets Acceptance Criteria
Functional Oxygen Saturation (%SpO2)	Accuracy (Arms): ±2%	Not explicitly re-tested for Biobeat Platform-2, relied on K212153.	K212153 (Primary Predicate Device study data)
Pulse Rate (PR/HR)	Accuracy (Arms): ±3%	Not explicitly re-tested for Biobeat Platform-2, relied on K212153.	K212153 (Primary Predicate Device study data)
Blood Pressure (BP)	Accuracy: ±5 mmHg	Not explicitly re-tested for Biobeat Platform-2, relied on K212153.	K212153 (Primary Predicate Device study data)
Respiration Rate (RRp)	No specific accuracy stated, but "measured by analyzing cyclic variations in the photoplethysmogram due to respiration."	Not explicitly re-tested for Biobeat Platform-2, relied on K212153.	K212153 (Primary Predicate Device study data)
Body Temperature	No specific accuracy stated.	Not explicitly re-tested for Biobeat Platform-2, relied on K212153.	K212153 (Primary Predicate Device study data)
Cardiac Output (CO)	Bland-Altman LOA to reference method (Fick, TD) within 30%.	Bland-Altman analysis showed LOA to the Fick method and TD within 30%.	Clinical Validation Data (90 patients, 80/77/82 included in final analysis)
Stroke Volume (SV)	Implicitly covered by Cardiac Output (CO) validation, as it's a hemodynamic parameter measured through the same new algorithm.	Implicitly covered by CO validation.	Clinical Validation Data (90 patients, 80/77/82 included in final analysis)
Software Validation	Per FDA guidance, General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 11, 2002)	"The new software elements have been documented and validated per FDA guidance."	Software validation per FDA guidance

Study Details for New Features (Stroke Volume & Cardiac Output)

1. Sample sizes used for the test set and the data provenance:
* Sample Size:
* 90 patients recruited.
* 80 patients included in the final analysis comparing PPG device and Fick method.
* 77 patients included in the final analysis comparing TD with Fick method.
* 82 patients included in the final analysis comparing PPG with TD.
* Data Provenance:
* Country of Origin: Not explicitly stated, but the company address is in Petah Tikva, Israel. Based on the Clinical Validation Data section, it seems to be from a clinical site where patients underwent right heart catheterization.
* Retrospective or Prospective: The study states, "Comparison was performed retrospectively, after completion of the measurement phase." However, subjects were "recruited" and "simultaneously attached" to devices, which suggests prospective data collection followed by retrospective analysis. The description indicates a prospective collection design for the "test set."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* This information is not provided in the text. The ground truth was established by objective medical methods (indirect Fick method and thermodilution), not subjective expert assessment.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* None. The ground truth was established by objective reference measurements (Fick method and thermodilution, and a comparison between PPG and TD), not by human expert adjudication of images or data.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* No. This was not an MRMC study. The study focused on the accuracy of the device's measurements against established clinical reference methods, not on human reader performance with or without AI assistance. The device output is physiological data for healthcare professionals to aid diagnosis and treatment, not an AI interpretation for a human reader to validate.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Yes. The clinical validation data presents the performance of the Biobeat device's algorithm (PPG device) in measuring cardiac output and comparing it to the reference methods (Fick and Thermodilution). This is a standalone algorithm performance evaluation.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Objective Clinical Reference Standards:
* Indirect Fick method
* Thermodilution (TD)
* These are considered "gold standard" or highly accurate methods for measuring cardiac output in a clinical setting.

7. The sample size for the training set:
* This information is not provided in the text. The document describes clinical validation for the test set, but not the training of the algorithms. It only states that a "new algorithm, derived from the existing photoplethysmogram, was added for measuring stroke volume and cardiac output."

8. How the ground truth for the training set was established:
* This information is not provided in the text. Given the new algorithm for SV/CO was "derived from the existing photoplethysmogram," it's possible it was developed using internal data and/or existing physiological models. The document focuses on the validation of this algorithm.

Summary

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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.

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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

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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)

K222010

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 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."

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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

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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.

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.

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Device (Knumber)	Subject Device	Primary Predicate Device	Predicate Device
	Biobeat Platform-2 / BB-613WP Patch	Biobeat Platform / BB-613WP Patch(K212153)	ClearSight System(K182245)
Indications foruse	The Biobeat Platform-2 is awireless noninvasive remotemonitoring system intended for useby healthcare professionals for spotcheck collection of physiologicaldata in home and healthcaresettings. This can include,functional oxygen saturation ofarterial hemoglobin (%SpO2), pulserate, blood pressure, respirationrate (RRp), hemodynamicparameters (stroke volume, cardiacoutput), and body temperature.The Biobeat Platform-2 trackschanges in blood pressure basedon Pulse Wave Transit Time(PWTT) which is obtained utilizingpulse measurements from theintegrated SpO2 sensor, following acalibration process using an FDA-cleared oscillometric blood pressuremonitor.The Biobeat Platform-2 is intendedfor spot-checking and trackingchanges of adult patients inhospitals, clinics, long-term care,and at home. The data from theBiobeat Platform-2 are intended foruse by healthcare professionals asan aid to diagnosis and treatment.The device is not intended for useon critical care patients.	The Biobeat Platform / BB-613WPPatch is a wireless noninvasiveremote monitoring systemintended for use by healthcareprofessionals for collection ofphysiological data in home andhealthcare settings. This caninclude, functional oxygensaturation of arterial hemoglobin(%SpO2), pulse rate, bloodpressure, respiration rate, andbody temperature.The Biobeat Platform trackschanges in blood pressurebased on Pulse Wave TransitTime (PWTT) which is obtainedutilizing pulse measurementsfrom the integrated SpO2sensor, following a calibrationprocess using an FDA-clearedoscillometric blood pressuremonitor.The Biobeat Platform isintended for spot- checkingand tracking changes of adultpatients in hospitals, clinics,long-term care, and home use.The data from the BiobeatPlatform are intended for useby healthcare professionals asan aid to diagnosis andtreatment. The device is notintended for use on criticalcare patients.	The EV1000 Clinical PlatformNI and the ClearSight™ FingerCuffs are indicated for patientsover 18 years of age in whichthe balance between cardiacfunction, fluid status, andvascular resistance needscontinuous or intermittentassessment. The EV1000Clinical Platform may be usedfor the monitoring ofhemodynamic parameters inconjunction with aperioperative goal directedtherapy protocol. In addition,the non-invasive system isindicated or use in patientswith co- morbidities for whichhemodynamic optimization isdesired and invasivemeasurements are difficult.The EV1000 Clinical Platformand the ClearSight™ FingerCuffs noninvasively measuresblood pressure and associatedhemodynamic parameters.
Use Population	Adults	Adults	Adults
UseEnvironment	Hospitals, clinics, long-term care,and home use	Hospitals, clinics, long-term care,and home use	Hospitals and otherappropriate clinicalenvironments.
Monitoring	Spot-checking	Spot-checking	Intermittent and continuous
Knumber)	Subject DeviceBiobeat Platform-2 / BB-613WP Patch	Primary PredicateDeviceBiobeat Platform / BB-613WPPatch(K212153)	Predicate DeviceClearSight System(K182245)
Principle ofOperation	Pulse reflectance technology, fourLED (red + IR) and photo diodeabsorbs reflectedlight.Tracking changes of blood pressure isdone by pulse wave transit time(PWTT) which is obtained utilizingpulse measurements from theintegrated skin attachedSpO2 sensor.RRp measured by analyzing cyclicvariations in thephotoplethysmogramdue torespiration.Body temperaturemeasuredwith thermistors.	Pulse reflectance technology, fourLED (red + IR) and photo diodeabsorbs reflectedlight.Tracking changes of blood pressure isdone by pulse wave transit time(PWTT) which is obtained utilizingpulse measurements from theintegrated skin attachedSpO2 sensor.RRp measured by analyzing cyclicvariations in thephotoplethysmogramdue torespiration.Body temperaturemeasured withthermistors.	Finger SpO2 sensormeasurement offunctional oxygensaturation of arterialhemoglobin (SpO2),pulse rate (PR),calculation of PerfusionIndex (Pi) and optionalPleth Variability Index(PVi) in adults andpediatrics.RRp measured byanalyzing cyclicvariations in thephotoplethysmogramdueto respiration
Outputs	Oxygen Saturation(SpO2)Pulse Rate (PR)Blood Pressure (BP),Respiration Rate (RRp),Body TemperatureHemodynamic parametersincluding: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, andMean Arterial Pressure)Hemodynamicparameters including:Cardiac Output (CO),Stroke Volume (SV)Cardiac Index (CI)Stroke Volume Index,Systemic VascularResistance (SVR),Systemic VascularResistance Index,Stroke VolumeVariation.
Measurementsite	Chest-patch attached to the skin	Chest-patch attached to the skin	Finger
Bodyattachmentmethod	Adhesive patch	Adhesive patch	Clamp pressure fromfinger cuff
Measurementtype	Spot	Spot	Continuous or intermittent

Table 7.1: Comparison of Intended Use

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		able 7.2: Comparison of Technological Characteristics:

Knumber)	Subject DeviceBiobeat Platform-2 / BB-613WP Patch	Primary PredicateDeviceBiobeat Platform / BB-613WPPatch(K212153)	Predicate DeviceClearSight System(K182245)
Emitted lightpeakwavelength	880nm (IR), 650nm(Red)	880nm (IR), 650nm(Red)	N/A
MeasurementRange SpO2	40% to 100%	40% to 100%	N/A
Arms, SpO2	±2%	±2%	N/A
MeasurementRange,PR/HR	40 to 250 bpm	40 to 250 bpm	0 to 220 bpm
Arms, PR/HR	±3%	±3%	Not specified
MeasurementRange, BP	0 mmHg - 299 mmHg	0 mmHg - 299 mmHg	0 mmHg - 300 mmHg
Accuracybloodpressure	±5 mmHg	±5 mmHg	1% of full scale(max 3 mmHg)
MeasurementRange, 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 ofCardiac Output from 2 to20 L/min
Single use	Yes	Yes	No
Wireless BLE	Yes	Yes	Yes
Operationtime	120 hours	120 hours	N/A
Contactmaterial	Polycarbonate, photodiode window,silicone, adhesive unit	Polycarbonate, photodiode window,silicone, adhesive unit	Unknown
ApplicationMethod	The device is attached to the chestskin using a biocompatible adhesiveunit	The device is attached to the chestskin using a biocompatible adhesiveunit	User attaches the deviceto 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
Knumber)	Subject DeviceBiobeat Platform-2 / BB-613WP Patch	Primary Predicate DeviceBiobeat Platform / BB-613WPPatch(K212153)	Predicate DeviceClearSight System(K182245)
Data storage	Yes, but can transmit the data to ahandheld device for storage andanalysis	Yes, but can transmit the data to ahandheld device for storage andanalysis	Yes

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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.

Regulation Number and Section

§ 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).