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.

Device Description

The BB-613 device is a wrist-worn device consisting of a light source (LEDs) and sensor array on the backside of the device, with a user interface on the front side of the device. The LEDs transmit light into the subject's skin at their wrist, 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 and pulse rate results. It also displays symbols that show if there was no signal or a weak signal. The device is powered by a rechargeable battery.

AI/ML Overview

Here's an analysis of the acceptance criteria and study data for the BB-613 Watch Oximeter, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Item	Acceptance Criteria	Reported Device Performance (BB-613)
SpO2 Accuracy (Arms, 70-100%)	Not explicitly stated as a separate acceptance criterion from predicate's performance. Predicate (PulseOX 7500) has an accuracy of ±2%.	±3% (for SpO2 range of 70% to 100%)
Heart Rate Accuracy (Arms, for Measurement Range)	Not explicitly stated as a separate acceptance criterion from predicate's performance. Predicate (PulseOX 7500) has an accuracy of ±3%.	±3% (for HR range of 40 to 240 bpm)
Measurement Range SpO2	Not explicitly stated as a specific acceptance criteria. Predicate (PulseOX 7500) is 40% to 99%.	70% to 100%
Measurement Range, HR	Not explicitly stated as a specific acceptance criteria. Predicate (PulseOX 7500) is 40 to 250 bpm.	40 to 240 bpm
Biocompatibility	Per ISO 10993-5, and 10993-11.	Cytotoxicity, sensitization and irritation per ISO 10993-5, and 10993-11 successfully evaluated for permanent contact of materials with intact skin.
Software Validation	Per FDA guidance, including cybersecurity.	Documented and validated per FDA guidance, including cybersecurity.
Electrical Safety and EMC	Per ANSI/AAMI/IEC 60601-1 and IEC 60601-1-2.	Successfully tested per ANSI/AAMI/IEC 60601-1 and IEC 60601-1-2.
Home Use Validation	Per IEC 60601-1-11.	Successfully validated per IEC 60601-1-11.
Equivalence to Predicate Oximeter (SpO2 Clinical Validation)	Equivalence to simultaneous measurements from the predicate oximeter.	Clinical validation on 10 patients showed equivalence to simultaneous measurements from the predicate oximeter.
Pulse Rate Validation	Per ISO 80601-2-61:2011.	Successfully validated per ISO 80601-2-61 using a custom-built simulator.

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

Sample Size for Oximeter Clinical Validation: 10 patients
Data Provenance: The document does not explicitly state the country of origin. It indicates the study involved "patients with varying Fitzpatrick skin types (I – V)" and their ages ranged from 18 to 40, with 6 males and 4 females. It is a prospective clinical validation.
Sample Size for Pulse Rate Validation: Not explicitly stated beyond "a custom built simulator." This implies it was a laboratory-based validation rather than human subjects for this specific test.

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

The document does not specify the number of experts or their qualifications for establishing ground truth in the clinical validation. It only states that the clinical validation showed "equivalence to simultaneous measurements from the predicate oximeter." This implies the predicate oximeter itself served as the reference for ground truth in this comparison, rather than independent expert adjudicated measurements.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the traditional sense of multiple human readers or experts reviewing data for ground truth establishment. For the clinical validation, the BB-613's readings were compared to a "predicate oximeter" simultaneously. For pulse rate, a "custom built simulator" was used.

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, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed or described in this document. This device is an oximeter, which provides direct physiological measurements, not interpretations that would typically involve human readers or AI assistance in the way a diagnostic imaging device might.

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

Yes, the studies described are essentially standalone performance evaluations of the device. The clinical validation compares the device's output to a predicate, and the pulse rate validation uses a simulator. These tests assess the algorithm and hardware's ability to accurately measure and display SpO2 and pulse rate without user interpretation or interaction being a variable in the performance metric. However, it's important to note that the device's intended use is "spot-checking," implying a user still reads the display.

7. The Type of Ground Truth Used

For SpO2 Clinical Validation: The "simultaneous measurements from the predicate oximeter" served as the reference or ground truth.
For Pulse Rate Validation: A "custom built simulator" provided the reference for pulse rate.
Other tests (biocompatibility, software, electrical safety, home use) relied on adherence to specified international standards and guidances, where the ground truth is defined by the criteria within those standards.

8. The Sample Size for the Training Set

The document does not explicitly reference or provide details for a "training set" in the context of the device's algorithms. If there was machine learning involved in developing the device's algorithms, the training data used is not disclosed here. The performance data focuses on validation/testing.

9. How the Ground Truth for the Training Set was Established

Since a training set is not described, the method for establishing its ground truth is also not provided.

Summary

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Bio-Beat Technologies Ltd. % Yarmela Pavlovic Partner Hogan Lovells US LLP 3 Embarcadero Center Suite 1500 San Francisco, California 94111

Re: K181006

Trade/Device Name: BB-613 Watch Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: August 30, 2018 Received: August 30, 2018

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 mav, 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 avare 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

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requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Todd D. Courtney -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

K181006

Device Name

BB-613 Watch Oximeter

Indications for Use (Describe)

The BB-613 Watch Oximeter is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO-) and pulse rate. It 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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K181006

510(k) SUMMARY

Bio-Beat Technologies Ltd.'s BB-613 Watch Oximeter

Submitter

Bio-Beat Technologies Ltd. 26 Magshimim Street Petach Tikva lsrael 44425

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

Contact Person: Johanan May

Date Prepared: September 18, 2018

Name of Device: BB-613 Watch Oximeter

Common or Usual Name: Oximeter

Classification Name: 21 C.F.R. 870.2700 Oximeter

Regulatory Class: Class II

Product Code: DQA

Predicate Devices

K163382 Oxitone Medical's Oxitone 1000

Reference Devices

K040178 SPO's PulseOX 7500 K100428 Masimo's Rainbow SET Radical 7R

Device Description

Intended Use / Indications for Use

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Comparison of Technological Characteristics and Indications

BB-613 is substantially equivalent to other legally marketed oximeters. Specifically, the BB-613 is substantially equivalent to primary predicate Oxitone Medical's Oxitone 1000 (K163382) and the reference predicates, SPO's PulseOX 7500 (K040178) and Masimo's Radical 7 (K100428). All devices are indicated for measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, although the PulseOX 7500 can also store this information. All devices are used in hospitals, clinics, long-term care, and home use, although PulseOX 7500 can also be used in sleep study environments. All devices are indicated for spot-checking of adults except for Radical 7 which is indicated for continuous noninvasive monitoring. The BB-613 has identical indications to the Oxitone 1000 except that it does not have a limitation on compatible wrist size as this limitation is not applicable to the BB-613.

Both the BB-613 and the predicates measure SpO2 by monitoring relative changes to signal intensity of light that has passed through the patient's skin. The devices are similar in regards to the wavelengths of the emitted light and the use of reflected light measurement to assess SpQ2. The devices differ with respect to the specific anatomic structures off of which the light is reflecting. The company has performed clinical validation to show equivalent device performance in regards to SpO2 measurements, and the pulse rate algorithm has been validated per ISO 80601-2-61:2011.

All of the devices are wrist worn and raise similar concerns of biocompatibility of 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 software has been documented and validated per FDA guidance. All devices contain electronics that present electrical hazard and EMC risks. These risks have been mitigated via IEC 60601 testing. In sum, although there are minor differences in technological characteristics, these differences do not raise different questions and the provided testing establishes equivalent performance as compared to the predicates.

Item	Subject Device BB-613	Primary Predicate Oxitone 1000 (K163382)	Reference Device PulseOX 7500 (K040178)	Reference Device Masimo Radical 7 (K100428)
Device	BB-613	Oxitone 1000	PulseOX 7500 Wrist Device	Rainbow SET Radical 7R
Principle of Operation	Pulse reflectance technology, Four LED (red + IR) and photo diode absorbs reflected light	Pulse reflectance technologyOne LED (red + IR)	Pulse reflectance technology,One LED (red + IR) and photo diode absorbs reflected light	Absorption of red and infrared light
Measurement site	Wrist	Wrist	Finger	Finger

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ltem	Subject Device BB-613	Primary PredicateOxitone 1000(K163382)	Reference DevicePulseOX 7500(K040178)	Reference DeviceMasimo Radical 7(K100428)
Measurementtype	Spot	Spot	Spot	Continuous
Emitted lightpeakwavelength	880nm (IR), 650nm(Red)	940nm (IR), 640nm(Red)	880nm (IR), 650nm(Red)	Not specified
MeasurementRange SpO2	70% to 100%	Not specified	40% to 99%	60% to 100%
Arms, SpO2	±3%	Not specified	±2%	No motion (adults,pediatrics, infants)60% to 80%: ±3%70% to 100%: ±2%
MeasurementRange, HR	40 to 240 bpm	Not specified	40 to 250 bpm	25 to 240 bpm
Arms, HR	±3%	Not specified	±3%	No motion±3 bpm
Contactmaterial	Polycarbonate,photodiode window,silicone	Polycarbonate, ABS	Silicone, photodiodewindow	Not specified
ApplicationMethod	User wears thedevice as a watchand powers it on	User wears thedevice as a watchand powers it on	User wears the deviceas a watch, places thefinger measurementattachment, and powersit on	User wears the deviceon finger
Sterility	Supplied and usednon-sterile	Supplied and usednon-sterile	Supplied and used non-sterile	Supplied and usednon-sterile
Data display	LCD on device	LCD on device	LCD on device	LCD on device
Data storage	No	No	Yes	Not specified

Performance Data

The following tests were performed to demonstrate substantial equivalence:

. Clinical validation of the oximeter per FDA pulse oximeter guidance on 10 patients with varying Fitzpatrick skin types (I – V). Patient's age ranged from 18 – 40 and 6 were male and 4 were female. Testing showed equivalence to simultaneous measurements from the predicate oximeter. No adverse events were observed.
Pulse rate validation per ISO 80601-2-61 using a custom built simulator for . reflectance oximetery.
Software validation per FDA guidance including cybersecurity .
Electrical safety and EMC testing per ANSI/AAMI/IEC 60601-1 and IEC 60601-1-2 ●
. Home use validation per IEC 60601-1-11

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Cytotoxicity, sensitization and irritation per ISO 10993-5, and 10993-11 to evaluate . permanent contact of silicone, polycarbonate, carbon black, and stainless steel with intact skin.

Conclusions

The BB-613 Watch Oximeter is as safe and as effective as the Oxitone 1000. The BB-613 Watch Oximeter 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 when used as labeled. In addition, the minor technological differences between the BB-613 Watch Oximeter and its predicate devices do not raise different questions of safety or effectiveness. Performance data demonstrate that the BB-613 Watch Oximeter is as safe and as effective as the predicates. Thus, the BB-613 Watch Oximeter 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).