Who is the manufacturer of BB-613WP?

Biobeat Technologies , Ltd. filed the 510(k) submission for BB-613WP (K190792).

What is the FDA product code for BB-613WP?

DQA. It is classified under 21 CFR 870.2700 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for BB-613WP?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like BB-613WP?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BB-613WP

Q: What are the predicate devices for BB-613WP?

BB-613 (K181006); Mini-Medic (K113165); BPro BP Ambulatory Blood Pressure Monitoring System (K173028); Caretaker4 Physiological Monitor (K163255).

K190792 · Biobeat Technologies , Ltd. · DQA · Aug 22, 2019 · Cardiovascular

Device Facts

Record ID	K190792
Device Name	BB-613WP
Applicant	Biobeat Technologies , Ltd.
Product Code	DQA · Cardiovascular
Decision Date	Aug 22, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2700
Device Class	Class 2

Intended 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 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 Story

Wrist-worn or adhesive patch device; utilizes LED light source (red/IR) and photodiode sensor to capture photoplethysmography (PPG) signals. Transforms optical pulse data into SpO2, pulse rate, and blood pressure change estimates via Pulse Wave Transit Time (PWTT) algorithm. Requires initial calibration against an oscillometric blood pressure monitor. Used for spot-checking by adult patients or healthcare providers in clinical/home environments. Data transmitted via Bluetooth to a mobile application for display. Enables non-invasive monitoring of vital signs; assists in tracking blood pressure trends to support clinical decision-making.

Clinical Evidence

Clinical validation performed per ISO 81060-2:2013. Animal study (swine model) conducted to evaluate blood pressure detection efficacy against gold standard. Results demonstrated BB-613WP accurately displayed blood pressure changes. No safety events reported during studies. Bench testing included software validation, EMC (IEC 60601-1-2:2014), and biocompatibility (ISO 10993).

Technological Characteristics

Materials: Polycarbonate, photodiode window, silicone, biocompatible adhesive. Sensing: Optical reflectance (4 LEDs: red 650nm, IR 880nm). Connectivity: Bluetooth. Form factor: Watch or adhesive patch. Power: Battery-operated. Software: Controls device, analyzes PPG signals, calculates SpO2/HR/BP. Non-sterile.

Indications for Use

Indicated for adult patients in hospitals, clinics, long-term care, and home settings for spot-checking functional oxygen saturation (%SpO2), pulse rate, and tracking changes in blood pressure via PWTT.

Regulatory Classification

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.

Predicate Devices

BB-613 (K181006)
Mini-Medic (K113165)
BPro BP Ambulatory Blood Pressure Monitoring System (K173028)
Caretaker4 Physiological Monitor (K163255)

Related Devices

K241066 — BB-613-BPM · Biobeat Technologies , Ltd. · Jan 14, 2025
K161530 — Bluetooth blood pressure monitor · Shenzhen Kingyield Technology Co., Ltd. · Mar 31, 2017
K250415 — G0 Blood Pressure Monitoring System (G0) · Aktiia SA · Jul 2, 2025
K222658 — Accurate 24 Non-invasive blood pressure monitor · Accurate Meditech, Inc. · Jun 21, 2023
K222010 — Biobeat Platform-2 and BB-613WP Patch · Biobeat Technologies , Ltd. · Dec 30, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below. 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. {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, 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 {2}------------------------------------------------ 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 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. 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 to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection 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 Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@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}------------------------------------------------ ### 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: 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. {4}------------------------------------------------ ## 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 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. # 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 {5}------------------------------------------------ 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 Device BB-613WP | Primary Predicate Device | Secondary Predicate Device | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | BB-613 (K181006) | Mini-Medic (K113165) | | Indications | 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-613 Watch Oximeter is a small, wrist- worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. It is intended for spot- checking of adult patients in hospitals, clinics, long- term care, and home use. | The mini-Medic™ system is comprised of a minimum of one Forehead Sensor Unit and one Handheld Display Unit and is intended for use on patients who are eighteen (18) years and over. The mini-Medic™ system is indicated as a single or multi-parameter vital signs monitor for SpO2 and pulse rate via an integrated SpO2 forehead sensor, and/or heart rate from ECG electrodes, and forehead skin surface temperature from an infrared temperature sensor. Pulse wave transit time (PWTT) is obtained utilizing pulse measurements from | | Device | Subject Device BB-613WP | Primary Predicate Device BB-613 (K181006) | Secondary Predicate Device Mini-Medic (K113165) | | | The BB-613WP is intended for spot- checking of adult patients in hospitals, clinics, long-term care, and home use. | | the integrated SpO2 forehead sensor and ECG electrodes placed on the upper chest. Pulse wave transit time (PWTT) is used to track changes in blood pressure. Skin temperature is used as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature for hyperthermia and hypothermia conditions. Patient data may be entered on the Handheld Display Unit. The mini-Medic™ system provides vital parameter alarms and a patient composite/summary alarm. Patient information and system commands are transmitted using wireless radio communications between the Forehead Sensor Unit and the Handheld Display Unit. Stored patient data may be output, printed, downloaded and saved via a dedicated mini-Medic™ PC Software application. Typical locations for the use of the mini-Medic™ system are: pre-hospital (i.e., at the point of injury or trauma scene), hospital, healthcare facility, emergency medical application, and during | | Device | Subject Device BB-613WP | Primary Predicate Device BB-613 | Secondary Predicate Device Mini-Medic | | | | (K181006) | (K113165) monitor is intended to be used by trained healthcare providers in military and civilian roles including doctors, nurses, combat medics, combat lifesavers, EMT's, and paramedics. | | Use Population | Adults | Adults | Adults | | Use Environment | Hospitals, clinics, long- term care, and home use | Hospitals, clinics, long- term care, and home use | Pre-hospital (i.e., at the point of injury or trauma scene), hospital, healthcare facility, emergency medical application, and during ground or air transport. | | Monitoring | Spot-checking | Spot-checking | Spot-checking | | Principle of Operation | Pulse reflectance technology, Four LED (red + IR) and photo diode absorbs reflected light. Tracking changes of blood pressure is done by pulse wave transit time (PWTT) which is obtained utilizing pulse measurements from the integrated skin attached SpO2 sensor | Pulse reflectance technology, Four LED (red + IR) and photo diode absorbs reflected light | Integrated SpO2 forehead sensor, and/or heart rate from ECG electrodes, and forehead skin surface temperature from an infrared temperature sensor and pulse wave transit time (PWTT) to track changes in blood pressure | | Measurement site | Wrist area and skin | Wrist area and skin | Forehead sensor and handheld display unit | | Measurement type | Spot | Spot | Spot | | Emitted light peak wavelength | 880nm (IR), 650nm (Red) | 880nm (IR), 650nm (Red) | Unknown | | Measurement Range SpO2 | 40% to 99% | 40% to 99% | Unknown | | Arms SpO2 | ±2% | ±2% | Unknown | | Device | Subject Device BB-613WP | Primary Predicate Device | Secondary Predicate Device | | | | BB-613 (K181006) | Mini-Medic (K113165) | | Measurement Range, HR | 40 to 250 bpm | 40 to 250 bpm | Unknown | | Arms, HR | ±3% | ±3% | Unknown | | Measurement Range, BP | 0 mmHg - 299 mmHg | NA | Unknown | | Accuracy blood pressure | ±5 mmHg | NA | ±3 mmHg | | Contact material | Polycarbonate, photodiode window, silicone, adhesive patch | Polycarbonate, photodiode window, silicone | Unknown | | Application Method | User wears the device as a watch and powers it on or the device is attached to the skin using biocompatible adhesive patch | User wears the device as a watch and powers it on | Multiple chest, ECG electrode and pulse oximetry measured from the forehead | | Sterility | Supplied and used non- sterile | Supplied and used non- sterile | Supplied and used non- sterile | | Data display | LCD on device or handheld display unit (e.g. mobile phone) | LCD on device | Handheld display | | Data storage | No but can transmit the data to handheld device | No | Transmit the data to handheld device | # Summary of Comparison to Predicate Devices: {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ ## 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.