The BB-613 WP is a wrist-worn or skin attached device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO₂) and pulse rate.

The BB-613WP can also track changes in blood pressure based on Pulse Wave Transit Time (PWTT) which is obtained utilizing pulse measurements from the integrated SpO2 sensor, following a calibration process using oscillometric blood pressure monitor.

The BB-613WP is intended for spot-checking of adult patients in hospitals, clinics, long-term care, and home use.

Device Description

The BB-613WP consists of a light source (LEDs) and sensor array on the backside of the device. The device is available in two versions, a watch version and an adhesive patch version. 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. The integrated display is used to display the blood saturation, pulse rate results and changes in blood pressure following calibration. These results are displayed on the LCD screen for the watch version and/or displayed on a mobile application installed on the user's phone. The display also shows symbols that show if there was no signal as well as well as battery status.

AI/ML Overview

I am unable to provide a detailed table of acceptance criteria and reported device performance for blood pressure measurement, as the provided text doesn't contain a specific table or detailed numerical results for blood pressure accuracy from the clinical studies. The text only states that the device "achieved the requirements of the ISO 81060-2:2013 and accurately displayed blood pressure" and lists an accuracy of "±5 mmHg" in the comparison table, but doesn't specify if this is a mean absolute difference (MAD) or part of a defined acceptance criteria.

However, I can extract the available information from the provided text for other aspects of your request.

Analysis of Acceptance Criteria and Study Details for BioBeat Technologies Ltd.'s BB-613 WP (K190792)

Based on the provided 510(k) summary, the BB-613 WP is a wrist-worn or skin-attached device that measures and displays functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, and tracks changes in blood pressure based on Pulse Wave Transit Time (PWTT).

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Stated or Implied)	Reported Device Performance	Notes
SpO2 Accuracy	±2% (Implied by comparison to predicate K181006)	Not explicitly stated for BB-6613WP, but claimed to be derived from K181006 performance as the algorithm is the same. K181006 SpO2 accuracy: ±2%.	The text states: "The device contains the same sensor unit and uses the same algorithm to compute SpO2 and pulse rate. Therefore, the SpO2 and pulse rate testing submitted in K181006 remains applicable to both models of the subject device."
Heart Rate (HR) Accuracy	±3% (Implied by comparison to predicate K181006)	Not explicitly stated for BB-6613WP, but claimed to be derived from K181006 performance as the algorithm is the same. K181006 HR accuracy: ±3%.	Same as SpO2, performance is based on the predicate device due to identical sensor and algorithm.
Blood Pressure (BP) Accuracy (tracking changes)	"achieved the requirements of the ISO 81060-2:2013" and "accurately displayed blood pressure." (Specific numerical criteria of this ISO standard are not provided in the document, but typically involve mean difference and standard deviation). A comparison table lists "±5 mmHg" for accuracy.	"achieved the requirements of the ISO 81060-2:2013 and accurately displayed blood pressure." The comparative table lists "±5 mmHg" for accuracy of blood pressure. Specific statistical results (e.g., mean difference, standard deviation per ISO 81060-2:2013) are not detailed in this summary.	The ±5 mmHg value in the comparison table is likely the criterion they aimed to meet as per the ISO standard, rather than a specific reported result from the study. The phrasing in the performance data section confirms compliance with the standard without providing exact numerical results.
Software Validation	Compliance with FDA guidance	Performed
EMC Testing	Compliance with IEC 60601-1-2:2014	Performed	EMC testing unique to activated Bluetooth feature was also performed.
Biocompatibility	Cytotoxicity, sensitization, and irritation per ISO 10993	Performed
Safety Events	Absence of safety events during studies (Implied)	"during the studies, there were no safety events, showing the BB-613WP to be a safe device for use."

2. Sample Size Used for the Test Set and Data Provenance

SpO2 and Pulse Rate: The summary states that the SpO2 and pulse rate testing submitted for the predicate device (BB-613, K181006) remains applicable. Therefore, the sample size and data provenance for these parameters would be from the K181006 submission, which is not detailed in the provided document.
Blood Pressure (PWTT):
- Clinical Tests: Conducted per ISO 80601-2:2013. The sample size for this clinical validation is not explicitly stated in the provided document.
- Animal Tests: An animal model study was performed in a swine model to evaluate the efficacy of the BB-613WP to detect blood pressure. The specific number of animals is not stated.
- Data Provenance (Clinical): The document does not specify the country of origin of the clinical data nor whether it was retrospective or prospective. It just states "Clinical validations of blood pressure per ISO 80601-2:2013 were performed."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

SpO2 and Pulse Rate: Ground truth related to the predicate device, not detailed here.
Blood Pressure (PWTT):
- Clinical Tests: Not explicitly stated how the ground truth was established beyond referencing "reference devices" and compliance with ISO 81060-2:2013. The ISO standard itself outlines requirements for comparing a non-invasive blood pressure monitor to a reference measurement (often invasive arterial pressure or another validated non-invasive device). It doesn't mention expert consensus for establishing ground truth directly but relies on established measurement methods.
- Animal Tests: Gold standard device was used for systolic and diastolic blood pressure measurements. No mention of human experts for ground truth establishment.

4. Adjudication Method (for the test set)

SpO2, Pulse Rate, Blood Pressure: No adjudication method is described in the provided text for any of the performance studies.

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 described for this device. This device is a measurement device, not an AI-assisted diagnostic imaging tool that would typically involve human readers.

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

Yes, for the blood pressure measurement, the clinical validation and animal tests assess the standalone performance of the device's algorithm in measuring or tracking blood pressure changes against a reference standard. The device "accurately displayed blood pressure" and results were compared between "reference devices" and the BB-613WP.

7. The type of ground truth used

SpO2 and Pulse Rate: Not explicitly stated for BB-613WP, relies on predicate. Typically, oximetry ground truth in clinical studies involves arterial blood gas analysis for SpO2.
Blood Pressure (PWTT):
- Clinical Tests: Comparison to "reference devices" as per ISO 81060-2:2013. This typically involves validated oscillometric blood pressure monitors or, less commonly for this type of device, invasive arterial pressure. The method for establishing ground truth is not explicitly stated as expert consensus, pathology, or outcomes data, but rather a comparison to established measurement techniques outlined in the ISO standard.
- Animal Tests: Comparison to a "gold standard device" for systolic and diastolic blood pressure measurement.

8. The sample size for the training set

The document does not provide any information regarding a training set size. This suggests that the blood pressure algorithm might have been developed and internally validated using data not specified in this public summary, or the algorithm development process was not detailed as part of this 510(k) submission. For SpO2 and HR, the algorithms are reused from a previous device.

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

As no information on a training set or its sample size is provided, there is no information on how ground truth for a training set was established.

Summary

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August 22, 2019

BioBeat Technologies Ltd. % Yarmela Pavlovic Partner Hogan Lovells US LPP 3 Embarcadero Center, Suite 1500 San Francisco, California 94111

Re: K190792

Trade/Device Name: BB-613 WP Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DOA, DRG Dated: July 19, 2019 Received: July 19, 2019

Dear Yarmela Pavlovic:

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,

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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510(k) Number (if known)

K190792

Device Name

BB-613 WP

Indications for Use (Describe)

The BB-613 WP is a wrist-worn or skin attached device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate.

The BB-613WP is intended for spot-checking of adult patients in hospitals, clinics, long-term care, and home use.

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)

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K190792

510(k) SUMMARY

Biobeat Technologies Ltd.'s BB-613 WP

Submitter:

Biobeat Technologies Ltd. 26 Magshimim Street Petah Tikva Israel 44425

Phone: +972 3 933 3022 Facsimile: +972 77 460 1636 Contact Person: Johanan May

Date Prepared: August 19, 2019

Name of Device: BB-613 WP

Common or Usual Name: Oximeter, non-invasive blood pressure measurement system

Classification Name: 21 C.F.R. 870.2700 Oximeter, 870.1130 Noninvasive blood pressure measurement system

Regulatory Class: Class II Product Code: DQA, DXN, DRG

Primary Predicate Devices: K181006 BB-613

Secondary Predicate Devices:

K113165 Mini-Medic K173028 BPro BP Ambulatory Blood Pressure Monitoring System K163255 Caretaker4 Physiological Monitor

Device Description:

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Intended Use / Indications for Use:

The BB-613WP is a wrist-worn or skin attached device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO₂) and pulse rate.

The BB-613WP is intended for spot-checking of adult patients in hospitals, clinics, long-term care, and home use.

Summary of Technological Characteristics:

The watch model of the subject device and the predicate device are identical in regards to physical components and differ only in regards to software (the addition of the blood pressure algorithm and Bluetooth connectivity, which is discussed below).

The subject patch model uses the same sensor unit and SpO2 and pulse rate algorithms as the predicate. The primary difference, beyond calculation of blood pressure parameters and Bluetooth connectivity, between the subject and predicate devices is the inclusion of the adhesive patch form factor. The adhesive patch model primarily differs from the predicate BB613 in regards to method used to attach the device to the patient and the user interface. Specifically, the predicate attaches to the patient with a watch band whereas the subject device additionally uses an adhesive patch. Differences in attachment method do not raise new types of questions and the effectiveness of the adhesive patch to maintain good contact with the patient over its intended use life has been demonstrated.

The user interface has also been modified. Both devices perform a spot check only after the user presses a button to begin measurement, although the design location of the button differs. The predicate device contains an integrated LCD screen used to display the results of the measurement. In the subject device, the user installs an app on their smart phone that allows the device to wirelessly transmit the results to the smartphone. However, aside for the addition of date and time, the same information is displayed to the user. The subject device also differs from the predicate in that information is transmitted wirelessly through Bluetooth. While the predicate BB613 physically contains the Bluetooth array, this feature was not activated. The BB-613WP and the Mini-Medic (K113165) predicate device both use Bluetooth components to transmit the data to a handheld device.

Both the subject and the predicate devices have the same contact classification and duration, permanent contact device with intact skin. All devices are supplied and used non-sterile. All devices use software to control the device and analyze and display the results. The new software elements have been documented and validated per FDA guidance. All devices contain electronics that present electrical hazard and EMC risks. As the electronic components are identical to the predicate, repeated safety testing was needed. EMC testing unique to the activated Bluetooth feature of the device were performed. In sum, although there are minor differences in the

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technological characteristics, these differences do not raise difference questions and the provided testing establishes equivalent performance as compared to the predicates.

The primary difference between the subject and primary predicate devices is the inclusion of blood pressure measurement via PWTT. However, the same underlying principle of PWTT is found in BPro BP Ambulatory Blood Pressure Monitoring System (K173028) as well as Mini-Medic (K113165), although the details of how PWTT is measured slightly differs between the devices.

Specifically, the subject device determines the PWTT optically, while the reference device measures PWTT via ECG or tonometry. Differences in measurement method do not raise different questions of safety or efficacy as both are measuring the same underlying physical phenomenon. Further, Caretaker4 Physiological Monitor K163255) also measures blood pressure optically, although they measure rise time of the pulse wave as an indirect measure of PWTT, while the subject device measures it directly. Ultimately, the critical question for all of these devices is whether the device produces as accurate measurement of change in blood pressure based on PWTT. The company has performed pre-clinical and clinical testing to validate the measured change in blood pressure per ISO 80601-2-61:2011.

Device	Subject DeviceBB-613WP	Primary PredicateDevice	Secondary PredicateDevice
		BB-613(K181006)	Mini-Medic(K113165)
Indications	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 SpO2sensor, following acalibration processusing oscillometricblood pressure monitor.	The BB-613 WatchOximeter is a small, wrist-worn device indicated foruse in measuring anddisplaying functionaloxygen saturation ofarterial hemoglobin(%SpO2) and pulse rate.It is intended for spot-checking of adult patientsin hospitals, clinics, long-term care, and home use.	The mini-Medic™ system iscomprised of a minimum ofone Forehead Sensor Unitand one Handheld DisplayUnit and is intended for useon patients who areeighteen (18) years andover.The mini-Medic™ system isindicated as a single ormulti-parameter vital signsmonitor for SpO2 and pulserate via an integrated SpO2forehead sensor, and/orheart rate from ECGelectrodes, and foreheadskin surface temperaturefrom an infraredtemperature sensor.Pulse wave transit time(PWTT) is obtained utilizingpulse measurements from
Device	Subject DeviceBB-613WP	Primary PredicateDeviceBB-613(K181006)	Secondary PredicateDeviceMini-Medic(K113165)
	The BB-613WP isintended for spot-checking of adultpatients in hospitals,clinics, long-term care,and home use.		the integrated SpO2forehead sensor and ECGelectrodes placed on theupper chest. Pulse wavetransit time (PWTT) is usedto track changes in bloodpressure.Skin temperature is used asan adjunct to other clinicaldiagnostic procedures in thediagnosis, quantifying, andscreening of relative skinsurface temperature forhyperthermia andhypothermia conditions.Patient data may be enteredon the Handheld DisplayUnit.The mini-Medic™ systemprovides vital parameteralarms and a patientcomposite/summary alarm.Patient information andsystem commands aretransmitted using wirelessradio communicationsbetween the ForeheadSensor Unit and theHandheld Display Unit.Stored patient data may beoutput, printed, downloadedand saved via a dedicatedmini-Medic™ PC Softwareapplication. Typicallocations for the use of themini-Medic™ system are:pre-hospital (i.e., at thepoint of injury or traumascene), hospital, healthcarefacility, emergency medicalapplication, and during
Device	Subject DeviceBB-613WP	Primary PredicateDeviceBB-613	Secondary PredicateDeviceMini-Medic
		(K181006)	(K113165)monitor is intended to beused by trained healthcareproviders in military andcivilian roles includingdoctors, nurses, combatmedics, combat lifesavers,EMT's, and paramedics.
Use Population	Adults	Adults	Adults
Use Environment	Hospitals, clinics, long-term care, and homeuse	Hospitals, clinics, long-term care, and home use	Pre-hospital (i.e., at thepoint of injury or traumascene), hospital, healthcarefacility, emergency medicalapplication, and duringground or air transport.
Monitoring	Spot-checking	Spot-checking	Spot-checking
Principle ofOperation	Pulse reflectancetechnology,Four LED (red + IR)and photo diodeabsorbs reflected light.Tracking changes ofblood pressure is doneby pulse wave transittime (PWTT) which isobtained utilizing pulsemeasurements from theintegrated skinattached SpO2 sensor	Pulse reflectancetechnology,Four LED (red + IR) andphoto diode absorbsreflected light	Integrated SpO2 foreheadsensor, and/or heart ratefrom ECG electrodes, andforehead skin surfacetemperature from aninfrared temperature sensorand pulse wave transit time(PWTT) to track changes inblood pressure
Measurementsite	Wrist area and skin	Wrist area and skin	Forehead sensor andhandheld display unit
Measurementtype	Spot	Spot	Spot
Emitted lightpeak wavelength	880nm (IR), 650nm(Red)	880nm (IR), 650nm (Red)	Unknown
MeasurementRange SpO2	40% to 99%	40% to 99%	Unknown
Arms SpO2	±2%	±2%	Unknown
Device	Subject DeviceBB-613WP	Primary PredicateDevice	Secondary PredicateDevice
		BB-613(K181006)	Mini-Medic(K113165)
MeasurementRange, HR	40 to 250 bpm	40 to 250 bpm	Unknown
Arms, HR	±3%	±3%	Unknown
MeasurementRange, BP	0 mmHg - 299 mmHg	NA	Unknown
Accuracy bloodpressure	±5 mmHg	NA	±3 mmHg
Contact material	Polycarbonate,photodiode window,silicone, adhesivepatch	Polycarbonate,photodiode window,silicone	Unknown
ApplicationMethod	User wears the deviceas a watch and powersit on or the device isattached to the skinusing biocompatibleadhesive patch	User wears the device asa watch and powers it on	Multiple chest, ECGelectrode and pulseoximetry measured from theforehead
Sterility	Supplied and used non-sterile	Supplied and used non-sterile	Supplied and used non-sterile
Data display	LCD on device orhandheld display unit(e.g. mobile phone)	LCD on device	Handheld display
Data storage	Nobut can transmit thedata to handhelddevice	No	Transmit the data tohandheld device

Summary of Comparison to Predicate Devices:

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Performance Data:

Performance Data - Bench Tests

The watch model of the BB-613WP uses the same hardware as the cleared BB-613 aside for software changes. The device contains the same sensor unit and uses the same algorithm to compute SpO2 and pulse rate. Therefore, the SpO2 and pulse rate testing submitted in K181006 remains applicable to both models of the subject device.

The following bench tests were performed:

Software validation per FDA quidance
· EMC testing per IEC 60601-1-2:2014
· Cytotoxicity, sensitization and irritation per ISO 10993

Performance Data - Animal Tests

In order to demonstrate substantial equivalence to the reference device, an animal study that evaluate the efficacy of the BB-613WP to detect blood pressure an animal model study was performed.

The study results present the reliability of a photoplethysmograph device (BB-613WP, BioBeat Ltd.) and comparing it to the gold standard device including systolic and diastolic blood pressure which were measured in a swine model.

Performance Data - Clinical Tests

Clinical validations of blood pressure per ISO 80601-2:2013 were performed.

When comparing BP measurements of reference devices to the BB-613WP device, it was showed that the BB-613WP achieved the requirements of the ISO 81060-2:2013 and accurately displayed blood pressure. In terms of safety, during the studies, there were no safety events, showing the BB-613WP to be a safe device for use.

Conclusions

The BB-613WP is as safe and effective as the predicate devices. The BB-613 WP has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended diagnostic use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the BB-613WP and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the BB-613WP is as safe and effective. Thus, the BB-613WP 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).