(259 days)
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, long-term 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.
The Biobeat Platform and the BB-613WP Patch sensor include a device that is attached to the patient'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 the tissue and detected by a photo-diode. This allows measurement of arterial oxygenation, pulse rate, 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.
Here is an analysis of the acceptance criteria and study information for the Biobeat Platform, BB-613WP Patch, based on the provided FDA 510(k) summary:
Analysis of Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary provides accuracy specifications for several physiological parameters. These can be considered the acceptance criteria for those parameters. The document states that the clinical validations showed the Biobeat Platform met the pre-specified efficacy requirements and performed in a manner substantially equivalent to the predicate devices. Therefore, the reported device performance is indicated to be within these accuracy ranges.
| Parameter | Acceptance Criteria (Accuracy) | Reported Device Performance (Implied) |
|---|---|---|
| Oxygen Saturation (SpO2) | ±2% | Within ±2% |
| Pulse Rate (PR) | ±3% | Within ±3% |
| Blood Pressure (BP) | ±5 mmHg | Within ±5 mmHg |
| Respiration Rate (RRp) | ±3 RPM | Within ±3 RPM |
| Body Temperature | ±0.3 °C | Within ±0.3 °C |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Clinical validations of respiration rate and body temperature were performed to evaluate the efficacy of the new parameters." However, it does not explicitly state the sample sizes for these clinical test sets.
The data provenance is not specified. It does not mention the country of origin of the data, nor whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide information on the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method
The document does not specify any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of an MRMC comparative effectiveness study or any effect size for human reader improvement with AI assistance. This device is an automated physiological data collection system, not an AI-assisted diagnostic imaging tool that typically involves human readers.
6. Standalone Performance Study (Algorithm Only)
The document implies a standalone performance study. It states that the device "uses the same algorithm to compute SpO2 and pulse rate and to compute and track changes in blood pressure. Therefore, these signals' evaluation testing, which was submitted in K190792, remains applicable to the subject device." For respiration rate and body temperature, "Clinical validations... were performed to evaluate the efficacy of the new parameters." This indicates that the device's algorithms were evaluated for their ability to measure these parameters against a reference, which constitutes a standalone performance evaluation.
7. Type of Ground Truth Used
The type of ground truth used for the clinical validations of respiration rate and body temperature is not explicitly stated. However, for physiological monitoring devices, the ground truth is typically established using:
- Reference medical devices: Often, highly accurate, clinically accepted devices (e.g., a spirometer for respiration rate, a core body temperature probe for temperature, or an invasive blood pressure monitor for BP) are used as the "ground truth" during validation studies.
- Given the "clinical validation" claim, it's highly probable these reference measurements were taken directly from human subjects.
The document mentions that the device tracks blood pressure "following a calibration process using an FDA-cleared oscillometric blood pressure monitor." This suggests that an FDA-cleared oscillometric device serves as the reference for BP calibration.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for any training set. It primarily discusses performance data (validation testing) rather than aspects of model training. It mentions "a new algorithm, derived from the existing photoplethysmogram, was added for measuring respiration rate (RRp)." This implies an algorithm was developed, but details on its training are absent.
9. How Ground Truth for the Training Set Was Established
Since information on a training set or its sample size is not provided, there is no information on how ground truth for a training set was established.
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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
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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
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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)
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)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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
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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.
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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.
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| Device (Knumber) | Subject Device BB-613WP Patch | Primary PredicateDeviceBB-613 WatchOximeter(K190792) | Predicate DeviceMightySat Rx(K181956) | Predicate DeviceVitalConnect(K183078) |
|---|---|---|---|---|
| Indications foruse | The Biobeat Platform is awireless noninvasiveremote monitoring systemintended for use byhealthcare professionalsfor spot-checkingcollection ofphysiologicaldata in home andhealthcare settings. Thiscan include, functionaloxygen saturation ofarterial hemoglobin(%SpO2), pulse rate, bloodpressure, respiration rate(RRp), and bodytemperature.The Biobeat Platformtracks changes in bloodpressure based on PulseWave TransitTime (PWTT)which is obtained utilizingpulse measurements fromthe integrated SpO2sensor, following acalibration process usingan FDA-clearedoscillometric bloodpressure monitor.The Biobeat Platform isintended for spot- checkingand tracking changes ofadult patients in hospitals,clinics, long-term care, andat home . The data from theBiobeat | The BB-613 WP is awrist-worn or skinattached deviceindicated for use inmeasuring anddisplaying functionaloxygen saturation ofarterial hemoglobin(%SpO2) and pulserate.The BB-613WP can alsotrack changes in bloodpressure based on PulseWave TransitTime (PWTT)which isobtained utilizing pulsemeasurements from theintegrated SpO2 sensor,following a calibrationprocess using oscillometricblood pressure monitor.The BB-613WP isintended for spot-checking of adult patientsin hospitals, clinics, long-term care, and home use. | The Masimo MightySatRx Fingertip PulseOximeter is intended forhospitals, hospital-typefacilities, homeenvironments, andtransport.The Masimo MightySatRx Fingertip PulseOximeter is indicated forthe noninvasive spotchecking of functionaloxygen saturation ofarterial hemoglobin(SpO2) and pulse rate(PR) for adult andpediatric patientsduring both no motionand motion conditions,and for patients whoare well or poorlyperfused.The Masimo MightySatRx Fingertip PulseOximeter is indicated forthe noninvasive spotchecking of respirationrate (RRp) for adultpatients. | The VitalConnectPlatform is a wirelessremote monitoringsystem intended foruse byhealthcareprofessionals forcontinuous collectionof physiological data inhome and healthcaresettings. This caninclude heart rate,electrocardiography(ECG), heart ratevariability, R-Rinterval, respiratoryrate, bodytemperature, skintemperature, activity(including step count),and posture (bodyposition relative togravity including fall).Data are transmittedwirelessly from theVitalConnectBiosensor for storageand analysis. TheVitalConnect Platformcan include the abilityto notify healthcareprofessionals whenphysiological data falloutside selectedparameters.The device is intendedfor use on |
| Device (Knumber) | Subject Device BB-613WP Patch | Primary PredicateDeviceBB-613 WatchOximeter(K190792) | Predicate DeviceMightySat Rx(K181956) | Predicate DeviceVitalConnect(K183078) |
| Platform are intended foruse by healthcareprofessionals as an aidtodiagnosis and treatment.The device is not intendedfor use on critical carepatients. | general care patientswho are 18years of ageor older as a generalpatient monitor, toprovide physiologicalinformation. The datafrom the VitalConnectPlatform are intendedfor use by healthcareprofessionals as an aidto diagnosis andtreatment. The deviceis not intended for useon critical carepatients. | |||
| Use Population | Adults | Adults | Adults and pediatrics | Adults |
| UseEnvironment | Hospitals, clinics, long-term care, and home use | Hospitals, clinics, long-term care, and home use | Hospitals, hospital-type facilities, homeenvironments, andtransport. | Home and healthcaresettings |
| Monitoring | Spot-checking | Spot-checking | Spot-checking | Spot-checking |
Comparison of Intended Use
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Table 7.2: Comparison of Technological Characteristics:
| Device (Knumber) | Subject Device BB-613WP Patch | Primary PredicateDeviceBB-613 WatchOximeter(K190792) | Predicate DeviceMightySat Rx(K181956) | Predicate DeviceVitalConnect(K183078) |
|---|---|---|---|---|
| Principle ofOperation | Pulse reflectancetechnology,Four LED (red + IR) andphoto diode absorbsreflected light.Tracking changes of bloodpressure is doneby pulsewave transit time (PWTT)which isobtained utilizing pulse | Pulse reflectancetechnology,Four LED (red + IR) andphoto diode absorbsreflected light.Tracking changes of bloodpressure is doneby pulsewave transit time (PWTT)which isobtained utilizing pulse | Finger SpO2 sensormeasurement offunctional oxygensaturation of arterialhemoglobin (SpO2),pulse rate (PR),calculation of PerfusionIndex (Pi) and optionalPleth Variability Index(PVi) | Electrocardiographyand accelerometer |
| Device (Knumber) | Subject Device BB-613WP Patch | Primary PredicateDeviceBB-613 WatchOximeter(K190792) | Predicate DeviceMightySat Rx(K181956) | Predicate DeviceVitalConnect(K183078) |
| measurements from theintegrated skin attachedSpO2 sensor. | measurements from theintegrated skin attachedSpO2 sensor. | in adults andpediatrics. | ||
| RRp measured byanalyzing cyclicvariations in thephotoplethysmogramdue to respiration.Body temperaturemeasured withthermistors. | RRp measured byanalyzing cyclicvariations in thephotoplethysmogramdue to respiration | Body temperaturemeasured withthermistors. | ||
| Outputs | Oxygen Saturation(SpO2)Pulse Rate (PR) BloodPressure (BP)Respiration Rate (RRp)Body Temperature | Oxygen Saturation(SpO2)Pulse Rate (PR) BloodPressure (BP) | Oxygen Saturation(SpO2)Pulse Rate (PR)Perfusion Index (Pi)Pleth VariabilityIndex (PVi)Respiration rate(RRp) | ECG DynamicRangeHeart Rate (HR)Respiration Rate(RRp)Fall DetectionStep CountHeart RateVariabilityBody Temperature |
| Measurementsite | Chest-patch attached to theskin | Wrist area and attached tothe skin | Fingertip | Chest-patch attachedto the skin |
| Includesadhesivesheet | Yes | N/A | N/A | Yes |
| Measurementtype | Spot | Spot | Spot | Spot |
| Emitted lightpeakwavelength | 880nm (IR), 650nm(Red) | 880nm (IR), 650nm(Red) | Similar | N/A |
| MeasurementRange SpO2 | 40% to 100% | 40% to 100% | 70% to 100% | N/A |
| Arms, SpO2 | ±2% | ±2% | ±2% | N/A |
| MeasurementRange, 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 (Knumber) | Subject Device BB-613WP Patch | Primary PredicateDeviceBB-613 WatchOximeter(K190792) | Predicate DeviceMightySat Rx(K181956) | Predicate DeviceVitalConnect(K183078) |
| MeasurementRange, BP | 0 mmHg – 299 mmHg | 0 mmHg – 299 mmHg | N/A | N/A |
| Accuracybloodpressure | $ \pm $ 5 mmHg | $ \pm $ 5 mmHg | N/A | N/A |
| MeasurementRange,Respiration rate | 4 to 40 RPM | N/A | 4 to 70 RPM | 10 to 30 RPM |
| Accuracyrespirationrate | $ \pm $ 3 RPM | N/A | $ \pm $ 3 RPM | < $ \pm $ 3 RPM |
| MeasurementRange, BodyTemperature | 32 °C to 42 °C | N/A | N/A | 32 °C to 42 °C |
| Body temperatureiscalculated fromskin temp' andambient temp' | Yes | N/A | N/A | Yes |
| AccuracyTemperature | $ \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 oftwo AAA alkalinebatteries | 120 hours |
| Contactmaterial | Polycarbonate,photodiode window,silicone, adhesive unit | Polycarbonate,photodiode window,silicone | Unknown | Hydrocolloidadhesive |
| ApplicationMethod | The device is attached tothechest skin using abiocompatible adhesive unit | The device is attached tothe skin using a wrist bandor a biocompatibleadhesiveunit | User attaches thedevice to thefingertip | The device isattached to the chestskin using abiocompatibleadhesive unit |
| Sterility | Supplied and used non-sterile | Supplied and used non-sterile | Supplied and usednon-sterile | Supplied and usednon-sterile |
| Data display | Handheld display unit(e.g. tablet) | LCD on device or handhelddisplay unit | OLED color displayscreen on device and | Handheld displayunit |
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| Device (Knumber) | Subject Device BB-613WP Patch | Primary Predicate DeviceBB-613 WatchOximeter(K190792) | Predicate DeviceMightySat Rx(K181956) | Predicate DeviceVitalConnect(K183078) |
|---|---|---|---|---|
| handheld display unit(e.g. mobile phone) | ||||
| Data storage | Limited, but can transmitthedata for storage and analysis | Yes | Yes, and can transmitthe data tohandhelddevice | No, but can transmitthe data for storageand 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
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Patch is as safe and effective as the predicates. Thus, the Biobeat Platform and BB-613WP Patch is substantially equivalent.
§ 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).