The Biobeat BB-613-BPM is a noninvasive blood pressure monitor which provides a notification to the user every 15 minutes over a 24 hour period for user- initiated measurements. It includes a device and a platform (BPM) for use in adults by healthcare professionals, for collection of pulse rate and tracking changes in blood pressure based on Pulse Wave Transit Time (PWTT) in hospitals, clinics, long-term care and at home. The BB-613-BPM tracks changes in blood pressure and requires callbration using an FDA-cleared oscillometric blood pressure monitor. The data from the Biobeat BB-613-BPM can be accessed through the Biobeat platform for review by a healthcare professional or can be downloaded as a report. The device is not intended to be used on critical care patients.

Device Description

The Biobeat BB-613-BPM 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 is designed to measure systolic and diastolic blood pressure and pulse rate, in adults, using a noninvasive technique using a light source (LEDs), and sensor array on the backside of the device. Identical to the method cleared in K190792 and in K222010, 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 pulse rate, and noninvasive blood pressure. The device is a pre-programmed 24-hour blood pressure monitor (BPM), prompting the use to take measurements at fixed intervals every 15 minutes. In addition, the data is transmitted to a mobile application via Bluetooth and then uploaded to the cloud, accessed through the Biobeat platform for review by a healthcare professional. In addition, the data could be downloaded as a report. The device does not contain any alarms. The device is intended to be used by healthcare professionals and patients in clinical and patient's environments.

AI/ML Overview

The provided text is a 510(k) summary for the Biobeat BB-613-BPM. It outlines the device, its indications for use, technological characteristics, and a comparison to predicate devices, ultimately concluding substantial equivalence. However, it does not contain specific details about acceptance criteria, the study design (e.g., sample size, data provenance, expert qualifications, adjudication methods), or performance data results that would be typically found in a clinical study report.

The document explicitly states: "The Biobeat BB-613-BPM uses the same hardware as the cleared Biobeat Platform-2 and the BB-613WP Patch but features some software changes. The device contains the same sensor unit and uses the same algorithm to compute pulse rate and blood pressure. Therefore, these signals' evaluation testing, which was submitted in K222010 and K190792, remains applicable to the subject device. Additional testing was conducted on the updated product features, including: . Software validation per FDA guidance..."

This indicates that the primary focus of the new submission (K241066) was on software validation for the new feature (24-hour, patient-initiated measurements with notifications), rather than extensive new clinical performance studies for blood pressure or pulse rate accuracy, as those were already established for the predicate devices utilizing the same sensor unit and algorithm.

Therefore, many of the requested details about a study proving the device meets acceptance criteria are not present in the provided text. I will answer based on the information that is available.

Here's an attempt to answer your questions based only on the provided text, flagging where information is missing:

1. A table of acceptance criteria and the reported device performance

The document provides a comparison table of technological characteristics, including measurement ranges and accuracies, which can be interpreted as performance specifications inherited from the predicates and serving as acceptance criteria.

Characteristic	Acceptance Criteria (from Predicates)	Reported Performance (for Subject Device)
Pulse Rate (PR) Range	40 to 250 bpm	Not explicitly re-stated, implied to be same due to identical hardware/algorithm
PR Accuracy (Arms, PR)	±3%	Not explicitly re-stated, implied to be same due to identical hardware/algorithm
Blood Pressure (BP) Range	SBP: 60 - 220 mmHg, DBP: 40 - 110 mmHg	Not explicitly re-stated, implied to be same due to identical hardware/algorithm
BP Accuracy	±5 mmHg	Not explicitly re-stated, implied to be same due to identical hardware/algorithm

Note: The document states, "The device contains the same sensor unit and uses the same algorithm to compute pulse rate and blood pressure. Therefore, these signals' evaluation testing, which was submitted in K222010 and K190792, remains applicable to the subject device." This implies that the BB-613-BPM is expected to meet the same accuracy standards as its predicates for PR and BP. The primary new "performance data" mentioned is "Software validation per FDA guidance."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in this document. The document refers to prior testing for pulse rate and blood pressure (from K222010 and K190792) and software validation.
Data Provenance: Not specified.
Retrospective/Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable or not provided. The ground truth for blood pressure and pulse rate measurements in medical devices like this is typically established using established reference methods (e.g., intra-arterial measurements, or a validated oscillometric device for calibration as mentioned in the Indications for Use). Expert readers are typically not used to establish ground truth for physiological measurements like BP or PR.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable or not provided, as this is not a study involving human reader interpretation or adjudication.

5. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document. This type of study is relevant for AI systems that aid human interpretation (e.g., radiology AI), which is not the primary function described for this blood pressure measurement system's new feature.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document implies that standalone performance for pulse rate and blood pressure was established and deemed acceptable in prior submissions (K222010 and K190792) because the subject device uses the "same sensor unit and uses the same algorithm to compute pulse rate and blood pressure." The new submission focuses on software changes related to the 24-hour monitoring feature and notifications, rather than core measurement algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For blood pressure and pulse rate measurements: The Indications for Use state, "The BB-613-BPM tracks changes in blood pressure and requires calibration using an FDA-cleared oscillometric blood pressure monitor." This strongly suggests that an FDA-cleared oscillometric blood pressure monitor serves as the ground truth or reference method for calibration and presumably for performance validation in the previous submissions.

8. The sample size for the training set

Not specified. This document only pertains to a 510(k) submission, not a full scientific publication detailing model development.

9. How the ground truth for the training set was established

Not specified. As noted above, the ground truth for physiological measurements typically involves comparison to a gold standard or reference method. However, details of the training set (if any specific to this submission's new features beyond the core algorithm) are not provided. The phrase "pre-programmed" suggests the algorithms are fixed, not adaptively learning from ongoing data.

Summary

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January 14, 2025

BioBeat Technologies Ltd. % John Smith Partner Hogan Lovells US LLP 555 13th St. NW Washington, District of Columbia 20003

Re: K241066

Trade/Device Name: BB-613-BPM Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 18, 2024 Received: April 18, 2024

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K241066

Device Name BB-613-BPM

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K241066

510(k) SUMMARY

Biobeat Technologies Ltd.'s Biobeat BB-613-BPM

Submitter:

Biobeat Technologies Ltd. 22 Efal Street Petah Tikva lsrael 4951122

Phone: +972 3 933 3022 Facsimile: +972 77 460 1636

Contact Person: Johanan May

Date Prepared: January 14, 2025

Name of Device: Biobeat BB-613-BPM

Common or Usual Name: Noninvasive Blood Pressure Measurement System

Classification Name/Product Code:

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 .

Requlatory Class: Class II

Predicate Devices

BB-613 WP (K190792) Biobeat Platform-2 (K222010)

System Description

In addition, the data is transmitted to a mobile application via Bluetooth and then uploaded to the cloud, accessed through the Biobeat platform for review by a healthcare professional. In addition, the data could be downloaded as a report. The device does not contain any alarms. The device is intended to be used by healthcare professionals and patients in clinical and patient's environments.

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Indications for Use

The Biobeat BB-613-BPM is a noninvasive blood pressure monitor which provides a notification to the user every 15 minutes over a 24 hour period for user- initiated measurements. It includes a device and a platform (BPM) for use in adults by healthcare professionals, for collection of pulse rate and tracking changes in blood pressure based on Pulse Wave Transit Time (PWTT) in hospitals, clinics, long-term care and at home. The BB-613-BPM tracks changes in blood pressure and requires calibration using an FDAcleared oscillometric blood pressure monitor. The data from the Biobeat BB-613-BPM can be accessed through the Biobeat platform for review by a healthcare professional or can be downloaded as a report. The device is not intended to be used on critical care patients.

Summary of Technological Characteristics

The subject and predicate devices are all intended to measure and display blood pressure. The subject device uses identical technology (i.e., the same sensor units and algorithms) for measuring pulse rate and blood pressure compared to the predicate devices cleared in K190792 (BB-613 WP - wrist and patch devices) and K222010 (Biobeat Platform-2), also manufactured by Biobeat. Both these predicates and the subject devices are skin attached devices intended to collect the data. In addition to the predicate devices, an updated software was added for the 24-hour measuring of blood pressure.

There have been no physical modifications to the BB-613-BPM Patch itself as compared to the versions cleared in K190792 and K222010.

The subject device is supplied and used non-sterile, just like the predicate devices. The subject device uses software to control the device 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 predicate devices cleared in K190792 and K222010, repeated EMC or 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 DeviceBiobeat BB-613-BPM Patch	Predicate DeviceBiobeatPlatform-2(K222010)	Predicate DeviceBB-613 WP(K190792)
Indications foruse	The Biobeat BB-613-BPM is a noninvasive24-hour blood pressuremonitor which providesa notification to the userevery 15 minutes over a24 hour period for user-initiated measurements.It includes a device anda platform (BPM) for usein adults by healthcareprofessionals, forcollection of pulse rateand tracking changes inblood pressure basedon Pulse Wave TransitTime (PWTT) inhospitals, clinics, long-term care and at home.The BB-613-BPM trackschanges in bloodpressure and requirescalibration using anFDA-clearedoscillometric bloodpressure monitor. Thedata from the BiobeatBB-613-BPM can beaccessed through theBiobeat platform forreview by a healthcareprofessional or can bedownloaded as a report.The device is notintended to be used oncritical care patients.	The Biobeat Platform-2is a wirelessnoninvasive remotemonitoring systemintended for use byhealthcare professionalsfor spot check collectionof physiological data inhome and healthcaresettings. This caninclude, functionaloxygen saturation ofarterial hemoglobin(%SpO2), pulse rate,blood pressure,respiration rate (RRp),hemodynamicparameters (strokevolume, cardiac output),and body temperature.The Biobeat Platform-2tracks changes in bloodpressure based onPulse Wave TransitTime (PWTT) which isobtained utilizing pulsemeasurements from theintegrated SpO2 sensor,following a calibrationprocess using an FDA-cleared oscillometricblood pressure monitor.The Biobeat Platform-2is intended for spot-checking and trackingchanges of adultpatients in hospitals,clinics, long-term care,and at home. The datafrom the BiobeatPlatform-2 are intendedfor use by healthcareprofessionals as an aidto diagnosis andtreatment. The device isnot intended for use oncritical care patients.	The BB-613 WP is awrist-worn or skinattached deviceindicated for use inmeasuring anddisplaying functionaloxygen saturation ofarterial hemoglobin(%SpO2) and pulserate.The BB-613WP canalso track changes inblood pressure basedon Pulse Wave TransitTime (PWTT) which isobtained utilizing pulsemeasurements from theintegrated SpO2 sensor,following a calibrationprocess usingoscillometric bloodpressure monitor.The BB-613WP isintended for spotchecking of adultpatients in hospitals,clinics, long-term care,and home use.
Use Population	Adults	Adults	Adults
BIOBEAT Technologies LTD.		K241066	Biobeat BB-613-BPM
Device (Knumber)	Subject DeviceBiobeat BB-613-BPM Patch	Predicate DeviceBiobeatPlatform-2(K222010)	Predicate DeviceBB-613 WP(K190792)
UseEnvironment	Hospitals, clinics, long-term care, and home use	Hospitals, clinics, long-term care, and home use	Hospitals, clinics, long-term care, and home use
Monitoring	Spot-checking	Spot-checking	Spot-checking
Device(K number)	Subject DeviceBiobeat BB-613-BPM Patch	Predicate DeviceBiobeatPlatform-2(K222010)	Predicate DeviceBB-613 WP(K190792)
Principle ofOperation	Pulse reflectancetechnology, four LED (red+ IR) and photo diodeabsorbs reflected light.Tracking changes of bloodpressure is done by pulsewave transit time (PWTT)which is obtained utilizingpulse measurements fromthe integrated skinattached SpO2 sensor.	Pulse reflectancetechnology, four LED (red+ IR) and photo diodeabsorbs reflected light.Tracking changes of bloodpressure is done by pulsewave transit time (PWTT)which is obtained utilizingpulse measurements fromthe integrated skinattached SpO2 sensor.RRp measured by	Pulse reflectancetechnology, four LED (red+ IR) and photo diodeabsorbs reflected light.Tracking changes of bloodpressure is done by pulsewave transit time (PWTT)which is obtained utilizingpulse measurements fromthe integrated skinattached SpO2 sensor.
		analyzing cyclic variationsin thephotoplethysmogram dueto respiration.Body temperaturemeasured withthermistors.
Outputs	Pulse Rate (PR)Blood Pressure (BP)	Oxygen Saturation(SpO2)Pulse Rate (PR)Blood Pressure (BP)Respiration Rate (RRp)Body TemperatureHemodynamicparameters including:Cardiac Output (CO)Stroke Volume (SV)	Oxygen Saturation(SpO2)Pulse Rate (PR)Blood Pressure (BP)
Measurementsite	Chest-patch attached tothe skin	Chest-patch attached tothe skin	Wrist watch or Chest-patchattached to the skin
Bodyattachmentmethod	Adhesive patch	Adhesive patch	Wrist watch or Adhesivepatch
Measurementtype	Spot	Spot	Spot
Emitted lightpeakwavelength	880nm (IR), 650nm(Red)	880nm (IR), 650nm(Red)	880nm (IR), 650nm(Red)

Table 7.1: Comparison of Intended Use

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		Table 7.2: Comparison of Technological Characteristics:
Device(K number)	Subject DeviceBiobeat BB-613-BPM Patch	Predicate DeviceBiobeatPlatform-2(K222010)	Predicate DeviceBB-613 WP(K190792)
MeasurementRange,PR/HR	40 to 250 bpm	40 to 250 bpm	40 to 250 bpm
Arms, PR	±3%	±3%	±3%
MeasurementRange, BP	60 - 220 for SBP,40 - 110 for DBP	0 - 299 mmHg	0 – 299 mmHg
Accuracybloodpressure	±5 mmHg	±5 mmHg	±5 mmHg
Single use	Yes	Yes	Skin patch - YesWrist watch - No
Wireless BLE	Yes	Yes	Yes
Operationtime	24 hours	120 hours	120 hours
Contactmaterial	Polycarbonate,photodiode window,silicone, adhesive unit	Polycarbonate,photodiode window,silicone, adhesive unit	Polycarbonate, photodiodewindow, silicone, adhesiveunit for the skin patch
ApplicationMethod	The device is attachedto the chest skin using abiocompatible adhesiveunit	The device is attached tothe chest skin using abiocompatible adhesiveunit	The device is attached tothe chest skin using abiocompatible adhesiveunit or to the wrist using asilicone band
Sterility	Supplied and used non-sterile	Supplied and used non-sterile	Supplied and used non-sterile
Data display	Handheld display unit(e.g., tablet) running theBiobeat software	Handheld display unit(e.g., tablet) running theBiobeat software	Handheld display unit (e.g.tablet) running the Biobeatsoftware
Data storage	Yes, but can transmit thedata to a handhelddevice for storage andanalysis	Yes, but can transmit thedata to a handheld devicefor storage and analysis	Yes, but can transmit thedata to a handheld devicefor storage and analysis

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Performance Data

The Biobeat BB-613-BPM uses the same hardware as the cleared Biobeat Platform-2 and the BB-613WP Patch but features some software changes. The device contains the same sensor unit and uses the same algorithm to compute pulse rate and blood pressure. Therefore, these signals' evaluation testing, which was submitted in K222010 and K190792, remains applicable to the subject device. Additional testing was conducted on the updated product features, including:

. Software validation per FDA guidance, General Principles of SoftwareValidation; Final Guidance for Industry and FDA Staff (January 11, 2002)

Conclusions

The Biobeat BB-613-BPM is as safe and effective as its predicate devices. The minor technological differences between the Biobeat BB-613-BPM and its predicate devices cleared in K190792 and K222010, namely adding notifications to the user to allow for 24-hour, patient initiated measurements, raise no new issues of safety or effectiveness. Performance data demonstrate that the Biobeat BB-613-BPM is as safe and effective as the predicates. Thus, the Biobeat BB-613-BPM is substantially equivalent.

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).