(157 days)
The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This could include heart rate, respiratory rate, skin temperature, and other data such as activity level, body position, sleep, and step and gait analysis.
Data are securely transmitted via wireless connection for storage, review, analysis, and display.
The Device can include the ability to display data and notify healthcare professionals when physiological data fall outside clinician-specified parameters.
The data from the Device are intended as an aid to diagnosis, disease management, and treatment. The Device is intended for use on patients who are 18 years of age or older.
The Device is not intended to output physiological measurements while the patient undergoes significant motion or is active.
The Device is not intended for critical care.
The BioButton System (the "Device") is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This can include heart rate, respiratory rate, and skin temperature. Data are transmitted from the Device for storage and analysis.
The Device is an extension of the Predicate Device (K212957) with the same intended use. The Device consists of a multiple-use and rechargeable wearable hardware sensor module to collect data from a patient and other Medical Device Data System (MDDS) components that enables remote transfer of collected data. The main components of the Device include the following:
- A wearable sensor to collect data from a patient
- A device-based Medical Device Data System (MDDS) data gateway to transfer data from the wearable sensor to the cloud
- A cloud-based Medical Device Data System (MDDS) for data storage and transmission
- A cloud-based system for configuration of the wearable sensor and data analysis
- A cloud-based system for healthcare professionals to view patient information
The Device is used to collect physiological information from a patient using the sensor for a set duration (as defined by different use cases) in home and healthcare settings. Physiological data is collected continuously while the patient is at rest. The medical physiological data collected includes:
- Heart rate at rest,
- Respiratory rate at rest, and
- Skin temperature
There are other wellness parameters that can be collected by the device that include: activity level, body position, sleep, and step and gait analysis. These wellness data types are not discussed in detail the regulatory submission since they do not meet the definition of medical device.
Upon completion of a physiological data collection period, the data offload is conducted via wireless Bluetooth connection using the Offload Software. The data offloading is performed and qualified personnel. The Device also provides a web display for healthcare professionals to view patient information.
The provided text is a 510(k) summary for the BioButton System, a remote monitoring wearable device. It describes the device, its intended use, and comparisons to a predicate device, along with performance testing conducted to support substantial equivalence.
Based on the provided text, here's a detailed breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document provides the following performance specifications for the BioButton System:
| Performance Item | Acceptance Criteria (Claimed) | Reported Device Performance (Achieved) |
|---|---|---|
| Heart Rate Range | 40-150 Beats per Minute | 40-150 Beats per Minute (Implied to be met, as it's the claimed range) |
| Heart Rate Accuracy | 5 Beats per minute (<±5 Beats per minute) | Met (Clinical studies confirmed accuracy claims for heart rate measurements) |
| Respiratory Rate Range | 5-35 Breaths per Minute | 5-35 Breaths per Minute (Implied to be met, as it's the claimed range) |
| Respiratory Rate Accuracy | 3 Breaths per Minute (<±3 Breaths per Minute) at rest | Met (Clinical studies confirmed accuracy claims for respiratory rate measurements) |
| Skin Temperature Standard | Meets ASTM E1112-00 standard | Met (Benchtop testing) |
| Skin Temperature Range | 86°F - 107°F (30°C - 42°C) | Met (Benchtop testing) |
Note: The document states that "all subgroups independently met device accuracy claims for heart rate and respiratory rate measurements" in the clinical studies section, which directly addresses the heart rate and respiratory rate accuracy criteria. For skin temperature, it explicitly says "Temperature measurement performance validation per ASTM E1112 standard per the Device's measurement range," indicating compliance.
2. Sample size used for the test set and the data provenance
- Sample Size: The clinical study for heart rate and respiratory rate involved 52 qualified subjects.
- For heart rate, 1394 datasets were collected.
- For respiratory rate, 1898 datasets were collected.
- Data Provenance: The document does not explicitly state the country of origin. However, the FDA 510(k) submission process implies that the studies were conducted to US regulatory standards. The study was a clinical study performed on the general population, which means it was prospective data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications used to establish the ground truth for heart rate, respiratory rate, or skin temperature. It only states that clinical studies were performed to "confirm the measurement performance" and benchtop testing was done for temperature. This typically means the device's measurements were compared against a reference standard or validated method, rather than an expert consensus process.
4. Adjudication method for the test set
The document does not mention any adjudication method for the test set. Given the nature of physiological measurements (heart rate, respiratory rate, skin temperature), ground truth is usually established via highly accurate reference devices or methods, rather than expert adjudication.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The BioButton System is a device for collecting physiological data, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. The closest relevant statement is that "The data from the device are intended as an aid to diagnosis, disease management, and treatment," but this does not imply a human-in-the-loop AI effectiveness study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance testing described for heart rate, respiratory rate, and skin temperature is effectively a standalone (algorithm only) performance evaluation. The device's measurements are validated against a reference standard to confirm its accuracy, without directly involving human interpretation assisted by the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth used is implied to be concurrent measurement against a reference standard or validated method.
- For heart rate and respiratory rate, the "clinical studies were performed... to confirm the measurement performance," which suggests comparison against a validated, highly accurate physiological monitoring system.
- For skin temperature, it explicitly states "Temperature measurement performance validation per ASTM E1112 standard," indicating the use of a calibrated temperature reference.
8. The sample size for the training set
The document does not provide information regarding a separate training set or its sample size. This submission is for a 510(k) of a continuous physiological data collection device, not necessarily an AI/ML driven diagnostic device that would typically have distinct training and test sets in the same way. The performance data presented are from validation studies of the device itself.
9. How the ground truth for the training set was established
Since information about a specific training set and its sample size is not provided, how its ground truth was established is also not described in the document.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 26, 2024
BioIntelliSense Inc. Yusi Liu Senior Vice President, Regulatory Affairs and Quality Assurance 570 El Camino Real. Suite 200 Redwood City, California 94063
Re: K241101
Trade/Device Name: BioButton System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG Dated: August 28, 2024 Received: August 28, 2024
Dear Yusi Liu:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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,
Jennifer W. Shih -S
Jennifer Kozen 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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Indications for Use
Submission Number (if known)
Device Name
BioButton System
Indications for Use (Describe)
The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This could include heart rate, respiratory rate, skin temperature, and other data such as activity level, body position, sleep, and step and gait analysis.
Data are securely transmitted via wireless connection for storage, review, analysis, and display.
The Device can include the ability to display data and notify healthcare professionals when physiological data fall outside clinician-specified parameters.
The data from the Device are intended as an aid to diagnosis, disease management, and treatment. The Device is intended for use on patients who are 18 years of age or older.
The Device is not intended to output physiological measurements while the patient undergoes significant motion or is active.
The Device is not intended for critical care.
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)
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510k Summary for BioButton System
Overview
This summary of 510(k) substantial equivalence (SE) information can be found in sections below in accordance with the requirements of 21 CFR §807.92.
This document applies to the submission of the BioButton System.
l. Submitter
| Submitter Name andAddress | BioIntelliSense Inc.570 El Camino Real, #200Redwood CityCA 94063USA |
|---|---|
| Contact Person | Yusi Liu – VP of Regulatory AffairsTel: +1 703-776-0119Email: yliu@biointellisense.com |
II. Device
| Name of Device | BioButton System |
|---|---|
| Regulation Name | Radiofrequency Physiological Signal Transmitter and Receiver |
| Regulation Number | 21 CFR 870.2910 |
| Regulatory Class | Class II |
| Product Code(s) | DRG |
| BioIntellisense Inc. | Page 1 of 8 |
|---|---|
| ---------------------- | ------------- |
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| Image: BioIntelliSense logo | Regulatory Affairs |
|---|---|
| BioButton 510(k) Summary |
III. Predicate Device
| Predicate DeviceManufacturer | BioIntelliSense Inc. |
|---|---|
| Predicate Device TradeName | BioButton System |
| Predicate Device 510(k)Number | K212957 |
III.A. Reference Device
| Reference DeviceManufacturer | Reference Device Name | Reference Device 510(k) Number |
|---|---|---|
| Vios Medical, Inc. | Vios Monitoring System™ Model2050 | K172586 |
| Vivify Health, Inc. | Vivify Health Inc. Care Team Portal | K222398 |
IV. Device Description
The BioButton System (the "Device") is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This can include heart rate, respiratory rate, and skin temperature. Data are transmitted from the Device for storage and analysis.
The Device is an extension of the Predicate Device (K212957) with the same intended use. The Device consists of a multiple-use and rechargeable wearable hardware sensor module to collect data from a patient and other Medical Device Data System (MDDS) components that enables remote transfer of collected data. The main components of the Device include the following:
-
- A wearable sensor to collect data from a patient
-
- A device-based Medical Device Data System (MDDS) data gateway to transfer data from the wearable sensor to the cloud
-
- A cloud-based Medical Device Data System (MDDS) for data storage and transmission
-
- A cloud-based system for configuration of the wearable sensor and data analysis
-
- A cloud-based system for healthcare professionals to view patient information
The Device is used to collect physiological information from a patient using the sensor for a set duration (as defined by different use cases) in home and healthcare settings. Physiological data is collected continuously while the patient is at rest . The medical physiological data collected includes:
- Heart rate at rest,
| BioIntellisense Inc. | Page 2 of 8 | ||
|---|---|---|---|
| -- | ---------------------- | -- | ------------- |
4 "At Rest" means the device will not output measurement data to the user undergoes significant motion or is active.
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- Respiratory rate at rest, and
- . Skin temperature
There are other wellness parameters that can be collected by the device that include: activity level, body position, sleep, and step and gait analysis. These wellness data types are not discussed in detail the requlatory submission since they do not meet the definition of medical device.
Upon completion of a physiological data collection period, the data offload is conducted via wireless Bluetoth connection using the Offload Software. The data offloading is performed and qualified personnel. The Device also provides a web display for healthcare professionals to view patient information.
V. Intended Use and Indications for Use
The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This could include heart rate, respiratory rate, skin temperature, and other data such as activity level, body position, sleep, and qait analysis.
Data are securely transmitted via wireless connection from the device for storage, review, and display.
The Device can include the ability to display date and notify healthcare professionals when physiological data
fall outside clinician-specified parameters.
The data from the device are intended as an aid to diagnosis, diseases management, and treatment.
The device is intended for use on users who are 18 years of age or older.
The device is not intended to output physiological measurements while the user undergoes significant motion or is active.
The device is not intended for critical care.
BioIntellisense Inc.
VI. Technology Characteristics in Comparison with the
| ComparisonItems | BioButton System (The SubjectDevice) | The Predicate Device(K212957) | Justification of Difference |
|---|---|---|---|
| Product Code | DRG | DRG | Same |
| Classification | Class II | Class II | Same |
| Intended use | The BioButton System ("theDevice") is a remote monitoringwearable device intended forcontinuous collection of | The BioButton System is aremote monitoring wearabledevice intended for continuouscollection of physiological data | Same |
| Comparison | BioButton System (The Subject | The Predicate Device | Justification of Difference |
| Items | Device) | (K212957) | |
| physiological data in home andhealthcare settings while thepatient is at rest. This could includeheart rate, respiratory rate, skintemperature, and other data suchas activity level, body position,sleep, and step and gait analysis. | in home and healthcare settingswhile the patient is at rest. Thiscould include heart rate,respiratory rate, skintemperature, and othersymptomatic or biometric data. | ||
| Data are securely transmitted viawireless connection for storage,review, and further analysis. | Data are securely transmittedvia wireless connection fromthe device for storage, review,and further analysis. | ||
| The data from the Device areintended as an aid to diagnosis,disease management, andtreatment. | The data from the device areintended as an aid to diagnosis,diseases management, andtreatment. | ||
| The Device is intended for use onpatients who are 18 years of age orolder. | The device is intended for useon users who are 18 years ofage or older. | ||
| The Device is not intended tooutput physiological measurementswhile the patient undergoessignificant motion or is active. | The device is not intended tooutput physiologicalmeasurements while the userundergoes significant motion oris active. | ||
| The Device is not intended forcritical care. | The device is not intended forcritical care. | ||
| PrescriptionUse / OCT | Prescription use only | Prescription use only | Same |
| Mode ofOperation | Continuous operation | Continuous operation | Same |
| PhysicalDimension | 42.4x40.0x8.5mm | 41.2x37.5x5.7mm | Similar |
| Weight | 11.6g | 9.4g | Similar |
| PatientPopulation | General care patients who are 18 yearsof age or older | General care patients who are 18years of age or older | Same |
| UseEnvironment | Home and healthcare setting | Home and healthcare setting | Same |
| DevicePlacement | Upper left chest | Upper left chest | Same |
| Usability | Single button on device.Single LED indicator. | Single button on device.Single LED indicator. | Same |
| OperatingTemperature | 0°C - 40 C° | 0°C - 40 C° | Same |
| ComparisonItems | BioButton System (The SubjectDevice) | The Predicate Device(K212957) | Justification of Difference |
| OperatingRelativeHumidity (RH) | 10-95% RH | 10-95% RH | Same |
| Operatingatmospherepressure | 70 kPa to 102 kPa | 70 kPa to 102 kPa | Same |
| Transport &StorageTemperature | 10 C°- 35C° | -20 C°- 40 C° | Equivalent |
| Transport &StorageHumidity | 10 - 75% RH | 10 - 95% RH | Equivalent |
| Single-use /Multiple-use | Multiple-use | Single-use | Different |
| Sterilization | No | No | Same |
| Re-processingbetween eachuse? | No | No | Same |
| Biologics ordrugs? | No | No | Same |
| Data DisplayandNotifications | Through software portal included inDevice | Through 3rd party portals (such asEMR) | Different |
Page 3 of 8
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& BioIntelliSense
Regulatory Affairs BioButton 510(k) Summary
{8}------------------------------------------------
& BioIntelliSense
Regulatory Affairs BioButton 510(k) Summary
Technical Specifications
| ComparisonItems | BioButton System (The SubjectDevice) | The Predicate Device (K212957) | Justification of Difference |
|---|---|---|---|
| BatteryOperated | Yes | Yes | Same |
| Sensor forAxillary Temp | Thermistor | Thermistor | Same |
| Sensor forHeart Rate | Accelerometer | Accelerometer | Same |
| Sensor forRespiratory Rate | Accelerometer | Accelerometer | Same |
| Data Storage -media | Flash storage | Flash storage | Same |
| Data Transfer | Wireless - Bluetooth | Wireless - Bluetooth | Same |
| On-deviceControls | Physical push button | Physical push button | Same |
| Biointellisense Inc. | Page 5 of 8 | |
|---|---|---|
| ---------------------- | -- | ------------- |
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Regulatory Affairs BioButton 510(k) Summary
Safety
| Comparison Items | BioButton System (The SubjectDevice) | The Predicate Device (K212957) | Justification of Difference |
|---|---|---|---|
| General electricaland mechanicalsafety | Complies with IEC 60601-1 andEC 60601-1-11 | Complies with IEC 60601-1 andEC 60601-1-11 | Same |
| EMC | Complies with IEC 60601-1-2 | Complies with IEC 60601-1-2 | Same |
| Biocompatibilityfor Patient-contactingmaterials | Complies with ISO 10993-1 andcollateral standards, as well as FDAguidance document Use ofInternational Standard ISO 10993-1,"Biological evaluation of medicaldevices - Part 1: Evaluation andtesting within a risk managementprocess" | Complies with ISO 10993-1 andcollateral standards, as well as FDAguidance document Use ofInternational Standard ISO 10993-1,"Biological evaluation of medicaldevices - Part 1: Evaluation andtesting within a risk managementprocess" | Same |
| Ingress Protection | IP47 | IP47 | Same |
| On-device orSoftware Warningand IndicationSignals | On-device LED indicator for power | On-device LED indicator for power | Same |
Performance
| ComparisonItems | BioButton System (NewSubmission) | BioSticker System(K191614) | Justification of Difference |
|---|---|---|---|
| Heart RateRange | 40-150 Beats per Minute | 40-125 Beats per Minute | Similar |
| Heart RateAccuracy | 5 Beats per minute (<±5 Beatsper minute) | 5 Beats per minute (<±5 Beatsper minute) | Same |
| RespiratoryRate Range | 5-35 Breaths per Minute | 10-30 Breaths per Minute | Similar |
| RespiratoryRateAccuracy | 3 Breaths per Minute (<±3Breaths per Minute) at rest | 3 Breaths per Minute (<±3Breaths per Minute) at rest | Same |
| SkinTemperature | Meets ASTM E1112-00standardRange 86°F - 107°F (30°C -42°C) | Meets ASTM E1112-00standardRange 86°F - 107°F (30°C -42°C) | Same |
VI. Performance Testing
Verification and validation activities established the safety and performance characteristics of the proposed device with respect to the predicate. The following performance data have been provided in support of the substantial equivalence determination:
| BioIntellisense Inc. | Page 6 of 8 |
|---|
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| BioIntelliSense | Regulatory Affairs | K241101 | ||
|---|---|---|---|---|
| BioButton 510(k) Summary | ||||
| Electrical safety andelectromagneticcompatibility (EMC) | Electrical safety and EMC testing were conducted on the Device. The Devicecomplies with the IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11 standards. | |||
| Software Verificationand Validation Testing | The software for the Device is determined as a "Basic" documentation level perFDA Guidance Document < Content of Premarket Submissions for Device SoftwareFunctions - Guidance for Industry and Food and Drug Administration Staff > | |||
| Software documentation and verification are performed per the guidance document. | ||||
| Biocompatibility | Complies with ISO 10993-1 and collateral standards, as well as FDA guidancedocument < Use of International Standard ISO 10993-1, "Biological evaluation ofmedical devices - Part 1: Evaluation and testing within a risk management process"– Guidance for Industry and Food and Drug Administration Staff > | |||
| All skin-contacting materials meet or exceed the biocompatibility requirements, pertesting against ISO 10993-5 and ISO 10993-10 standards. | ||||
| Benchtop Testing | Wireless coexistence testing conducted on the DeviceTemperature measurement performance validation per ASTM E1112 standardper the Device's measurement rangeElectronics hardware verification and validation testing - Testing shows that theelectronics hardware of the Device functions as intendedBattery life testing - Testing verifies the battery life of the DeviceCleaning validation – testing validates cleaning and disinfection instructions formultiple-patient use | |||
| Animal Study | No animal / pre-clinical study was conducted. | |||
| Clinical Studies | Clinical studies were performed on the general population to confirm themeasurement performance for heart rate and respiratory rate. The device is testedon general adult patient population. | |||
| The study population consisted of 52 qualified subjects. 1394 datasets werecollected for heart rate and 1898 datasets were collected for respiratory rate. | ||||
| Subjects race/ethnicity subgroups information is as follows: white: 10 (~20.0%);Hispanic or Latino: 13 (~25.0%); Black or African American: 6 (~11.5%); Asian: 19(~36.5%); and Others: 4 (~7.7%). | ||||
| Subjects gender subgroups information is as follows: Male: 25 (~48.1%); andFemale: 27 (51.2%). | ||||
| Subject age subgroups information is as follows: 21-29 years: 6 (~11.5%); 30-39years: 13 (~25.0%); 40-49 years: 10 (~19.2%); 50-59 years: 5 (~9.6%); 60-69years: 12 (~23.1%); 70-79 years: 6 (~11.5%); and 80 or above: 0 (0%). | ||||
| Subjects Body Mass Index (BMI) subgroups information is as follows: Normal (BMIless than 24.9): 17 (~32.7%); Overweight (BMI 25 -29.9): 18 (~34.6%); and Obese(BMI 30 or above): 17 (~32.7%). | ||||
| In summary, all subgroups independently met device accuracy claims for heart rateand respiratory rate measurements. There is no known clinically meaningfulsubgroup disparities between race/ethnicity, gender, age, or BMI subgroupsregarding device performance. | ||||
| Biolntellisense Inc. | Page 7 of 8 | |||
| Image: BiolntelliSense logo | Regulatory Affairs | |||
| BioButton 510(k) Summary | ||||
| Human Factor | Human factor engineering and evaluation for Device was conducted per FDAguidance document < Applying Human Factors and Usability Engineering toMedical Devices - Guidance for Industry and Food and Drug Administration Staff>.Human factor study was conducted to ensure lay person could use the Devicecorrectly with no human factor concerns. | |||
| Cybersecurity | Cybersecurity risk assessment and controls of the Device was carried out per the |
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| Cybersecurity | Cybersecurity risk assessment and controls of the Device was carried out per theFDA guidance document < Cybersecurity in Medical Devices: Quality SystemConsiderations and Content of Premarket Submissions – Guidance for Industry andFood and Drug Administration Staff > |
|---|---|
| --------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
VII. Conclusions
There are many similarities between the devices in comparison regarding intended use, technology, and most of the indications for use. The minor differences between the Predicate Device (K212957) do not raise new concerns. Thus, the Device, BioButton System and the Predicate Device (K212957) are substantially equivalent.
| BioIntellisense Inc. | Page 8 of 8 | |
|---|---|---|
| ---------------------- | -- | ------------- |
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).