Who is the manufacturer of Biobeat Platform, BB-613WP Patch?

Biobeat Technologies , Ltd. filed the 510(k) submission for Biobeat Platform, BB-613WP Patch (K212153).

What is the FDA product code for Biobeat Platform, BB-613WP Patch?

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

What is the regulatory pathway for Biobeat Platform, BB-613WP Patch?

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

What are the predicate devices for Biobeat Platform, BB-613WP Patch?

Biobeat's BB-613 WP (K190792); Masimo Corporation's MightySat Rx Fingertip Pulse Oximeter (K181956); VitalConnect, Inc,'s VitalConnect Platform (K183078).

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

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.

Biobeat Platform, BB-613WP Patch

K212153 · Biobeat Technologies , Ltd. · DQA · Mar 25, 2022 · Cardiovascular

Device Facts

Record ID	K212153
Device Name	Biobeat Platform, BB-613WP Patch
Applicant	Biobeat Technologies , Ltd.
Product Code	DQA · Cardiovascular
Decision Date	Mar 25, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2700
Device Class	Class 2

Intended Use

The Biobeat Platform is a wireless nonitoring system intended for use by healthcare professionals for spot-checking 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), and body temperature. The Biobeat Platform tracks changes in blood pressure based on Pulse Wave Transit Time (PWTT) which is obtained utilizing pulse measurements from the integrated SpO2 sensor, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. The Biobeat Platform is intended for spot-checking and tracking changes of adult patients in hospitals, clinics, long-term care, and at home. The data from the Biobeat Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients.

Device Story

Chest-worn adhesive patch; collects physiological data via LEDs (red/IR) and photodiode (pulse reflectance) and thermistors (temperature). Inputs: light reflection from skin; thermistor readings. Transforms inputs via algorithms to compute SpO2, pulse rate, blood pressure (via PWTT), respiration rate (via cyclic photoplethysmogram variations), and body temperature. Data transmitted via Bluetooth to gateway, then to cloud for web application review by healthcare professionals. Used in hospitals, clinics, long-term care, and home settings. Aids diagnosis and treatment; no alarms. Benefits: noninvasive, remote spot-checking of vital signs.

Clinical Evidence

Clinical validation performed for respiration rate and body temperature. Bench testing included software validation, cybersecurity assessment, EMC (IEC 60601-1-2), basic safety (IEC 60601-1), and wireless coexistence (ANSI C63.27). Temperature validation per ISO 80601-2-56:2018. Results met pre-specified efficacy requirements.

Technological Characteristics

Chest-patch; polycarbonate, silicone, adhesive. Pulse reflectance (4 LEDs: red/IR, photodiode). Thermistors for temperature. Bluetooth connectivity to gateway/cloud. Non-sterile. Software-based analysis. SpO2 range 40-100%, PR 40-250 bpm, BP 0-299 mmHg, RRp 4-40 RPM, Temp 32-42°C.

Indications for Use

Indicated for adult patients in hospitals, clinics, long-term care, and home settings for spot-check collection of SpO2, pulse rate, blood pressure, respiration rate, and body temperature. Not for use on critical care patients.

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

Biobeat's BB-613 WP (K190792)
Masimo Corporation's MightySat Rx Fingertip Pulse Oximeter (K181956)
VitalConnect, Inc,'s VitalConnect Platform (K183078)

Related Devices

K222010 — Biobeat Platform-2 and BB-613WP Patch · Biobeat Technologies , Ltd. · Dec 30, 2022
K212957 — BioButton System · Biolntellisense, Inc. · Dec 12, 2022
K241066 — BB-613-BPM · Biobeat Technologies , Ltd. · Jan 14, 2025
K190792 — BB-613WP · Biobeat Technologies , Ltd. · Aug 22, 2019
K132407 — VITAL SIGNS PATCH SYSTEM (IN SHORT VSP) · Lifewatch Technologies , Ltd. · Dec 19, 2014

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 25, 2022 BioBeat Technologies Ltd. % John Smith Partner Hogan Lovells US LLP 555 Thirteenth St., NW Washington, District of Columbia 20004 Re: K212153 Trade/Device Name: Biobeat Platform, BB-613WP Patch Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DQA, DRG, BZQ, DXG, FLL Dated: July 9, 2021 Received: July 9, 2021 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. 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 {1}------------------------------------------------ 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 (OS) 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 mediation-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, 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 {2}------------------------------------------------ # DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K212153 Device Name Biobeat Platform, BB-613WP Patch Indications for Use (Describe) The Biobeat Platform 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), and body temperature. The Biobeat Platform tracks changes in blood pressure based on Pulse Wave Transit Time (PWTT) which is obtained utilizing pulse measurements from the integrated SpO2 sensor, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. The Biobeat Platform is intended for spot-checking changes of adult patients in hospitals, clinics, longterm care, and at home. The Biobeat Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients. Type of Use (Select one or both, as applicable) | <div> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |------------------------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## 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}------------------------------------------------ #### K212153 #### 510(k) SUMMARY #### Biobeat Technologies Ltd.'s BB-613 WP Patch #### Submitter: Biobeat Technologies Ltd. 26 Magshimim Street Petah Tikva lsrael 4934835 Phone: +972 3 933 3022 Facsimile: +972 77 460 1636 Contact Person: Johanan May Date Prepared:February 14, 2022 Name of Device: Biobeat Platform, BB-613WP Patch Common or Usual Name: Breathing frequency monitor ## Classification Name/Product Code: - 868.2375 Breathing frequency monitor, BZQ - 870.1130 Noninvasive blood pressure measurement system, DXN ● - 870.1435 Single-function, preprogrammed diagnostic computer, 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's BB-613 WP (K190792) (Primary Predicate) Masimo Corporation's MightySat Rx Fingertip Pulse Oximeter (K181956) (SecondaryPredicate) VitalConnect, Inc,'s VitalConnect Platform (K183078) (Secondary Predicate) ## System Description The Biobeat Platform and the BB-613WP Patch sensor include a device that is attached to thepatient'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 LEDs transmit light into the subject's skin and part of this light is reflected from thetissue and detected by a photo-diode. This allows measurement of arterial oxygenation, pulserate, change in blood pressure, and respiration rate. Body temperature is measured by the thermistors. Data is transmitted to a gateway via Bluetooth and then uploaded to the cloud. From the cloud, data is transmitted and presented in a web application for review by a healthcare professional. The device does not contain any alarms. {4}------------------------------------------------ ## Intended Use / Indications for Use The Biobeat Platform is a wireless nonitoring system intended for use by healthcare professionals for spot-checking 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), and body temperature. The Biobeat Platform tracks changes in blood pressure based on Pulse Wave Transit Time (PWTT) which is obtained utilizing pulse measurements from the integrated SpO2 sensor, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. The Biobeat Platform is intended for spot-checking and tracking changes of adult patients in hospitals, clinics, long-term care, and at home. The data from the Biobeat Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. The deviceis not intended for use on critical care patients. # Summary of Technological Characteristics The subject and predicate devices are all intended to measure and display physiological signals. The subject device combines the parameters measured by the three predicates into one device. Specifically, the subject device uses identical technology (i.e., the same sensor unit and algorithms) for measuring SpO2, pulse rate, and blood pressure compared to the primary predicate (BB-613 WP; K190792), which is an earlier iteration of the subject device also manufactured by Biobeat. Both devices are adhesive unitbased devices intended to be attached to the chest to collect the data. As compared to the primary predicate, a new algorithm, derived from the existing photoplethysmogram, was added for measuring respiration rate (RRp). RRp relies upon cyclic variations in the photoplethysmogram due to respiration. This measurement capability is nearly identical to the methodology used by the MightySat Rx predicate (K181956) to measure the same parameter. In addition, a sensor array (two thermistors) that was inactive in the prior version (K190792) has been activated as part of this submission to allow for the measurement of body temperature. The measurement methodology is nearly identical to another previously-cleareddevice (VitalConnect; K183078), which serves as the third predicate device for this submission. There have been no physical modifications to the BB-613WP itself as compared to the versioncleared in K190792. A gateway device has been added to the system for transmission of datato the cloud and software to access the data on the cloud has been added. 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 testingestablishes equivalent performance as compared to the predicate devices. {5}------------------------------------------------ | Device (K number) | Subject Device BB-613WP Patch | Primary Predicate Device BB-613 Watch Oximeter (K190792) | Predicate Device MightySat Rx (K181956) | Predicate Device VitalConnect (K183078) | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications foruse | The Biobeat Platform is a wireless noninvasive remote monitoring system intended for use by healthcare professionals for spot-checking collection ofphysiological data in home and healthcare settings. This can include, functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, blood pressure, respiration rate (RRp), and body temperature. The Biobeat Platform tracks changes in blood pressure based on Pulse Wave TransitTime (PWTT) which is obtained utilizing pulse measurements from the integrated SpO2 sensor, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. The Biobeat Platform is intended for spot- checking and tracking changes of adult patients in hospitals, clinics, long-term care, and at home . The data from the Biobeat | 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 TransitTime (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. | The Masimo MightySat Rx Fingertip Pulse Oximeter is intended for hospitals, hospital-type facilities, home environments, and transport. The Masimo MightySat Rx Fingertip Pulse Oximeter is indicated for the noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused. The Masimo MightySat Rx Fingertip Pulse Oximeter is indicated for the noninvasive spot checking of respiration rate (RRp) for adult patients. | The VitalConnect Platform is a wireless remote monitoring system intended for use byhealthcare professionals for continuous collection of physiological data in home and healthcare settings. This can include heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, body temperature, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data are transmitted wirelessly from the VitalConnect Biosensor for storage and analysis. The VitalConnect Platform can include the ability to notify healthcare professionals when physiological data fall outside selected parameters. The device is intended for use on | | Device (K number) | Subject Device BB- 613WP Patch | Primary Predicate Device BB-613 Watch Oximeter (K190792) | Predicate Device MightySat Rx (K181956) | Predicate Device VitalConnect (K183078) | | | Platform are intended for use by healthcare professionals as an aidto diagnosis and treatment. The device is not intended for use on critical care patients. | | | general care patients who are 18years of age or older as a general patient monitor, to provide physiological information. The data from the VitalConnect Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients. | | Use Population | Adults | Adults | Adults and pediatrics | Adults | | Use Environment | Hospitals, clinics, long- term care, and home use | Hospitals, clinics, long- term care, and home use | Hospitals, hospital- type facilities, home environments, and transport. | Home and healthcare settings | | Monitoring | Spot-checking | Spot-checking | Spot-checking | Spot-checking | # Comparison of Intended Use {6}------------------------------------------------ # Table 7.2: Comparison of Technological Characteristics: | Device (K number) | Subject Device BB- 613WP Patch | Primary PredicateDevice BB-613 Watch Oximeter (K190792) | Predicate Device MightySat Rx (K181956) | Predicate Device VitalConnect (K183078) | |--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Principle of Operation | Pulse reflectance technology, Four LED (red + IR) and photo diode absorbs reflected light. Tracking changes of blood pressure is doneby pulse wave transit time (PWTT) which is obtained utilizing pulse | Pulse reflectance technology, Four LED (red + IR) and photo diode absorbs reflected light. Tracking changes of blood pressure is doneby pulse wave transit time (PWTT) which is obtained utilizing pulse | Finger SpO2 sensor measurement of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), calculation of Perfusion Index (Pi) and optional Pleth Variability Index (PVi) | Electrocardiography and accelerometer | | Device (K number) | Subject Device BB- 613WP Patch | Primary PredicateDevice BB-613 Watch Oximeter (K190792) | Predicate Device MightySat Rx (K181956) | Predicate Device VitalConnect (K183078) | | | measurements from the integrated skin attached SpO2 sensor. | measurements from the integrated skin attached SpO2 sensor. | in adults and pediatrics. | | | | RRp measured by analyzing cyclic variations in the photoplethysmogram due to respiration. Body temperature measured with thermistors. | | RRp measured by analyzing cyclic variations in the photoplethysmogram due to respiration | Body temperature measured with thermistors. | | Outputs | Oxygen Saturation (SpO2) Pulse Rate (PR) Blood Pressure (BP) Respiration Rate (RRp) Body Temperature | Oxygen Saturation (SpO2) Pulse Rate (PR) Blood Pressure (BP) | Oxygen Saturation (SpO2) Pulse Rate (PR) Perfusion Index (Pi) Pleth Variability Index (PVi) Respiration rate (RRp) | ECG Dynamic Range Heart Rate (HR) Respiration Rate (RRp) Fall Detection Step Count Heart Rate Variability Body Temperature | | Measurement site | Chest-patch attached to the skin | Wrist area and attached to the skin | Fingertip | Chest-patch attached to the skin | | Includes adhesive sheet | Yes | N/A | N/A | Yes | | Measurement type | Spot | Spot | Spot | Spot | | Emitted light peak wavelength | 880nm (IR), 650nm (Red) | 880nm (IR), 650nm (Red) | Similar | N/A | | Measurement Range SpO2 | 40% to 100% | 40% to 100% | 70% to 100% | N/A | | Arms, SpO2 | ±2% | ±2% | ±2% | N/A | | Measurement Range, PR/HR | 40 to 250 bpm | 40 to 250 bpm | 25 to 240 bpm | 30 to 200 bpm | | Arms, PR/HR | ±3% | ±3% | ±3 bpm | <±5 or 10% bpm, whichever is greater | | Device (K number) | Subject Device BB- 613WP Patch | Primary PredicateDevice BB-613 Watch Oximeter (K190792) | Predicate Device MightySat Rx (K181956) | Predicate Device VitalConnect (K183078) | | Measurement Range, BP | 0 mmHg – 299 mmHg | 0 mmHg – 299 mmHg | N/A | N/A | | Accuracy blood pressure | $ \pm $ 5 mmHg | $ \pm $ 5 mmHg | N/A | N/A | | Measurement Range, Respiration rate | 4 to 40 RPM | N/A | 4 to 70 RPM | 10 to 30 RPM | | Accuracy respiration rate | $ \pm $ 3 RPM | N/A | $ \pm $ 3 RPM | < $ \pm $ 3 RPM | | Measurement Range, Body Temperature | 32 °C to 42 °C | N/A | N/A | 32 °C to 42 °C | | Body temperature iscalculated from skin temp' and ambient temp' | Yes | N/A | N/A | Yes | | Accuracy Temperature | $ \pm $ 0.3 °C | N/A | N/A | $ \pm $ 1.0 °C | | Single use | Yes | No | No | Yes | | Wireless BLE | Yes | No | Yes | Yes | | Operation time | 120 hours | 72 hours | Operation time of two AAA alkaline batteries | 120 hours | | Contact material | Polycarbonate, photodiode window, silicone, adhesive unit | Polycarbonate, photodiode window, silicone | Unknown | Hydrocolloid adhesive | | Application Method | The device is attached tothe chest skin using a biocompatible adhesive unit | The device is attached to the skin using a wrist band or a biocompatibleadhesive unit | User attaches the device to the fingertip | The device is attached to the chest skin using a biocompatible adhesive unit | | Sterility | Supplied and used non- sterile | Supplied and used non- sterile | Supplied and used non-sterile | Supplied and used non-sterile | | Data display | Handheld display unit (e.g. tablet) | LCD on device or handheld display unit | OLED color display screen on device and | Handheld display unit | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ | Device (K number) | Subject Device BB- 613WP Patch | Primary Predicate Device BB-613 Watch Oximeter (K190792) | Predicate Device MightySat Rx (K181956) | Predicate Device VitalConnect (K183078) | |----------------------|---------------------------------------------------------------|-------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------| | | | | handheld display unit (e.g. mobile phone) | | | Data storage | Limited, but can transmitthe data for storage and analysis | Yes | Yes, and can transmit the data tohandheld device | No, but can transmit the data for storage and analysis | ## Performance Data The Biobeat Platform and the BB-613WP Patch uses the same hardware as the cleared BB- 613WP but features some software changes, including activation of two thermistors to measure body temperature and an option of an additional gateway device. The device contains the samesensor unit and uses the same algorithm to compute SpO2 and pulse rate and to compute andtrack changes in blood pressure. Therefore, these signals' evaluation testing, which was submitted in K190792, remains applicable to the subject device. Additional testing was conducted on the updated product features, including: - Respiration rate validation - Clinical validation of temperature per ISO 80601-2-56:2018 - Software validation per FDA quidance, General Principles of Software ● Validation; Final Guidance for Industry and FDA Staff (January 11, 2002) - Cybersecurity assessment - IEC 60601-1-2:2014 (4th Edition) EMC Requirements and tests ● - IEC 60601-1:2012 (3.1 Edition) General requirements for basic safety ● andessential performance - ANSI C63.27-2017 Standard for Evaluation of Wireless Coexistence ## Performance Data - Clinical Tests Clinical validations of respiration rate and body temperature were performed to evaluate the efficacy of the new parameters. It was shown that the Biobeat Platform met the pre-specified efficacy requirements and performed in a manner that was substantially equivalent to the predicate devices. ## Conclusions The Biobeat Platform 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 and BB-613WP Patch and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Biobeat Platform and BB-613WP {10}------------------------------------------------ Patch is as safe and effective as the predicates. Thus, the Biobeat Platform and BB-613WP Patch is substantially equivalent.