(158 days)
No
The summary does not mention AI, ML, or any related terms, and the device description and performance studies focus on standard pulse oximetry technology and validation methods.
No.
The device is indicated for measuring and displaying functional oxygen saturation and pulse rate, which are diagnostic or monitoring functions, not therapeutic.
Yes
The device measures and displays functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate, which are physiological parameters used to assess a patient's health status, therefore serving a diagnostic purpose by providing objective measures of a patient's condition.
No
The device description explicitly states it 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," and mentions it is "powered by a rechargeable battery," indicating it is a hardware device with integrated software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- BB-613 Function: The BB-613 Watch Oximeter measures oxygen saturation and pulse rate directly from the patient's body through the skin using light. It does not analyze samples taken from the body.
Therefore, based on the provided information, the BB-613 Watch Oximeter is a non-invasive medical device used for physiological monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
DQA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Pulse reflectance technology
Anatomical Site
Wrist
Indicated Patient Age Range
adult patients
Intended User / Care Setting
hospitals, clinics, long-term care, and home use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Arms, SpO2: ±3%
Measurement Range SpO2: 70% to 100%
Measurement Range, HR: 40 to 240 bpm
Arms, HR: ±3%
Predicate Device(s)
K163382 Oxitone Medical's Oxitone 1000
Reference Device(s)
K040178 SPO's PulseOX 7500, K100428 Masimo's Rainbow SET Radical 7R
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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
1
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
2
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
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.
Intended Use / Indications for Use
4
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.
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 technology | ||
| One 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 |
5
| ltem | Subject Device BB-
613 | Primary Predicate
Oxitone 1000
(K163382) | Reference Device
PulseOX 7500
(K040178) | Reference Device
Masimo Radical 7
(K100428) |
|-------------------------------------|---------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Measurement
type | Spot | Spot | Spot | Continuous |
| Emitted light
peak
wavelength | 880nm (IR), 650nm
(Red) | 940nm (IR), 640nm
(Red) | 880nm (IR), 650nm
(Red) | Not specified |
| Measurement
Range 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% |
| Measurement
Range, 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 |
| Contact
material | Polycarbonate,
photodiode window,
silicone | Polycarbonate, ABS | Silicone, photodiode
window | Not specified |
| Application
Method | User wears the
device as a watch
and powers it on | User wears the
device as a watch
and powers it on | User wears the device
as a watch, places the
finger measurement
attachment, and powers
it on | User wears the device
on finger |
| Sterility | Supplied and used
non-sterile | Supplied and used
non-sterile | Supplied and used non-
sterile | Supplied and used
non-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.