(157 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on data collection, transmission, storage, and basic analysis (displaying data outside clinician-specified parameters). There is no mention of algorithms that learn or adapt from data.
No.
The "Intended Use / Indications for Use" states that "The data from the Device are intended as an aid to diagnosis, disease management, and treatment," and that it is "a remote monitoring wearable device intended for continuous collection of physiological data." It collects data but does not actively apply any form of therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The data from the Device are intended as an aid to diagnosis, disease management, and treatment."
No
The device description explicitly states that the BioButton System "consists of a multiple-use and rechargeable wearable hardware sensor module to collect data from a patient". This indicates the presence of physical hardware components beyond just software.
Based on the provided information, the BioButton System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the body (in vitro).
- BioButton System Function: The BioButton System is a wearable device that collects physiological data directly from the patient's body (in vivo) through sensors. It measures things like heart rate, respiratory rate, and skin temperature.
- Intended Use: The intended use clearly states it's for "continuous collection of physiological data in home and healthcare settings while the patient is at rest." This data is used as an "aid to diagnosis, disease management, and treatment," but the device itself is not performing a test on a specimen.
The BioButton System falls under the category of a physiological monitoring device, not an IVD.
N/A
Intended Use / 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 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.
Product codes
DRG
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,
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper left chest
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Healthcare professionals in home and healthcare settings.
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
Clinical studies were performed on the general population to confirm the measurement performance for heart rate and respiratory rate. The device is tested on general adult patient population. The study population consisted of 52 qualified subjects. 1394 datasets were collected 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%); and Female: 27 (51.2%). Subject age subgroups information is as follows: 21-29 years: 6 (~11.5%); 30-39 years: 13 (~25.0%); 40-49 years: 10 (~19.2%); 50-59 years: 5 (~9.6%); 60-69 years: 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 (BMI less than 24.9): 17 (~32.7%); Overweight (BMI 25 -29.9): 18 (~34.6%); and Obese (BMI 30 or above): 17 (~32.7%).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the Device. The Device complies with the IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11 standards.
Software Verification and Validation Testing: The software for the Device is determined as a "Basic" documentation level per FDA Guidance Document . Software documentation and verification are performed per the guidance document.
Biocompatibility: Complies with ISO 10993-1 and collateral standards, as well as FDA guidance document . All skin-contacting materials meet or exceed the biocompatibility requirements, per testing against ISO 10993-5 and ISO 10993-10 standards.
Benchtop Testing: Wireless coexistence testing conducted on the Device. Temperature measurement performance validation per ASTM E1112 standard per the Device's measurement range. Electronics hardware verification and validation testing - Testing shows that the electronics hardware of the Device functions as intended. Battery life testing - Testing verifies the battery life of the Device. Cleaning validation – testing validates cleaning and disinfection instructions for multiple-patient use.
Animal Study: No animal / pre-clinical study was conducted.
Clinical Studies: Clinical studies were performed on the general population to confirm the measurement performance for heart rate and respiratory rate. The device is tested on general adult patient population. The study population consisted of 52 qualified subjects. 1394 datasets were collected 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%); and Female: 27 (51.2%). Subject age subgroups information is as follows: 21-29 years: 6 (~11.5%); 30-39 years: 13 (~25.0%); 40-49 years: 10 (~19.2%); 50-59 years: 5 (~9.6%); 60-69 years: 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 (BMI less 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 rate and respiratory rate measurements. There is no known clinically meaningful subgroup disparities between race/ethnicity, gender, age, or BMI subgroups regarding device performance.
Human Factors: Human factor engineering and evaluation for Device was conducted per FDA guidance document . Human factor study was conducted to ensure lay person could use the Device correctly with no human factor concerns.
Cybersecurity: Cybersecurity risk assessment and controls of the Device was carried out per the FDA guidance document .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Heart Rate Accuracy: 5 Beats per minute (
§ 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).
0
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.
1
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
2
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
3
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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4
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 and
Address | BioIntelliSense Inc.
570 El Camino Real, #200
Redwood City
CA 94063
USA |
|-------------------------------|------------------------------------------------------------------------------------------------|
| Contact Person | Yusi Liu – VP of Regulatory Affairs
Tel: +1 703-776-0119
Email: 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 |
|---|---|
| ---------------------- | ------------- |
5
| Image: BioIntelliSense logo | Regulatory Affairs |
|---|---|
| BioButton 510(k) Summary |
III. Predicate Device
| Predicate Device
| Manufacturer | BioIntelliSense Inc. |
|---|---|
| Predicate Device Trade | |
| Name | BioButton System |
| Predicate Device 510(k) | |
| Number | K212957 |
III.A. Reference Device
| Reference Device
| Manufacturer | Reference Device Name | Reference Device 510(k) Number |
|---|---|---|
| Vios Medical, Inc. | Vios Monitoring System™ Model | |
| 2050 | 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.
6
- 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
| Comparison
Items | BioButton System (The Subject
Device) | The Predicate Device
(K212957) | Justification of Difference |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Product Code | DRG | DRG | Same |
| Classification | Class II | Class II | Same |
| Intended use | The BioButton System ("the
Device") is a remote monitoring
wearable device intended for
continuous collection of | The BioButton System is a
remote monitoring wearable
device intended for continuous
collection of physiological data | Same |
| Comparison | BioButton System (The Subject | The Predicate Device | Justification of Difference |
| Items | Device) | (K212957) | |
| | 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. | in home and healthcare settings
while the patient is at rest. This
could include heart rate,
respiratory rate, skin
temperature, and other
symptomatic or biometric data. | |
| | Data are securely transmitted via
wireless connection for storage,
review, and further analysis. | Data are securely transmitted
via wireless connection from
the device for storage, review,
and further analysis. | |
| | The data from the Device are
intended as an aid to diagnosis,
disease management, and
treatment. | The data from the device are
intended as an aid to diagnosis,
diseases management, and
treatment. | |
| | The Device is intended for use on
patients who are 18 years of age or
older. | 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 patient undergoes
significant motion or is active. | 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. | The device is not intended for
critical care. | |
| Prescription
Use / OCT | Prescription use only | Prescription use only | Same |
| Mode of
Operation | Continuous operation | Continuous operation | Same |
| Physical
Dimension | 42.4x40.0x8.5mm | 41.2x37.5x5.7mm | Similar |
| Weight | 11.6g | 9.4g | Similar |
| Patient
Population | General care patients who are 18 years
of age or older | General care patients who are 18
years of age or older | Same |
| Use
Environment | Home and healthcare setting | Home and healthcare setting | Same |
| Device
Placement | Upper left chest | Upper left chest | Same |
| Usability | Single button on device.
Single LED indicator. | Single button on device.
Single LED indicator. | Same |
| Operating
Temperature | 0°C - 40 C° | 0°C - 40 C° | Same |
| Comparison
Items | BioButton System (The Subject
Device) | The Predicate Device
(K212957) | Justification of Difference |
| Operating
Relative
Humidity (RH) | 10-95% RH | 10-95% RH | Same |
| Operating
atmosphere
pressure | 70 kPa to 102 kPa | 70 kPa to 102 kPa | Same |
| Transport &
Storage
Temperature | 10 C°- 35C° | -20 C°- 40 C° | Equivalent |
| Transport &
Storage
Humidity | 10 - 75% RH | 10 - 95% RH | Equivalent |
| Single-use /
Multiple-use | Multiple-use | Single-use | Different |
| Sterilization | No | No | Same |
| Re-processing
between each
use? | No | No | Same |
| Biologics or
drugs? | No | No | Same |
| Data Display
and
Notifications | Through software portal included in
Device | Through 3rd party portals (such as
EMR) | Different |
Page 3 of 8
7
& BioIntelliSense
Regulatory Affairs BioButton 510(k) Summary
8
& BioIntelliSense
Regulatory Affairs BioButton 510(k) Summary
Technical Specifications
| Comparison
Items | BioButton System (The Subject
Device) | The Predicate Device (K212957) | Justification of Difference |
|--------------------------------|------------------------------------------|--------------------------------|-----------------------------|
| Battery
Operated | Yes | Yes | Same |
| Sensor for
Axillary Temp | Thermistor | Thermistor | Same |
| Sensor for
Heart Rate | Accelerometer | Accelerometer | Same |
| Sensor for
Respiratory Rate | Accelerometer | Accelerometer | Same |
| Data Storage -
media | Flash storage | Flash storage | Same |
| Data Transfer | Wireless - Bluetooth | Wireless - Bluetooth | Same |
| On-device
Controls | Physical push button | Physical push button | Same |
| Biointellisense Inc. | Page 5 of 8 | |
|---|---|---|
| ---------------------- | -- | ------------- |
9
Regulatory Affairs BioButton 510(k) Summary
Safety
| Comparison Items | BioButton System (The Subject
Device) | The Predicate Device (K212957) | Justification of Difference |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| General electrical
and mechanical
safety | Complies with IEC 60601-1 and
EC 60601-1-11 | Complies with IEC 60601-1 and
EC 60601-1-11 | Same |
| EMC | Complies with IEC 60601-1-2 | Complies with IEC 60601-1-2 | Same |
| Biocompatibility
for Patient-
contacting
materials | Complies with ISO 10993-1 and
collateral standards, as well as FDA
guidance document Use of
International Standard ISO 10993-1,
"Biological evaluation of medical
devices - Part 1: Evaluation and
testing within a risk management
process" | Complies with ISO 10993-1 and
collateral standards, as well as FDA
guidance document Use of
International Standard ISO 10993-1,
"Biological evaluation of medical
devices - Part 1: Evaluation and
testing within a risk management
process" | Same |
| Ingress Protection | IP47 | IP47 | Same |
| On-device or
Software Warning
and Indication
Signals | On-device LED indicator for power | On-device LED indicator for power | Same |
Performance
| Comparison
Items | BioButton System (New
Submission) | BioSticker System
(K191614) | Justification of Difference |
|---------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|-----------------------------|
| Heart Rate
Range | 40-150 Beats per Minute | 40-125 Beats per Minute | Similar |
| Heart Rate
Accuracy | 5 Beats per minute ( | | | |
| | Software documentation and verification are performed per the guidance document. | | | |
| Biocompatibility | Complies with ISO 10993-1 and collateral standards, as well as FDA guidance
document | | | |
| | All skin-contacting materials meet or exceed the biocompatibility requirements, per
testing against ISO 10993-5 and ISO 10993-10 standards. | | | |
| Benchtop Testing | Wireless coexistence testing conducted on the DeviceTemperature measurement performance validation per ASTM E1112 standard
per the Device's measurement rangeElectronics hardware verification and validation testing - Testing shows that the
electronics hardware of the Device functions as intendedBattery life testing - Testing verifies the battery life of the DeviceCleaning validation – testing validates cleaning and disinfection instructions for
multiple-patient use | | | |
| Animal Study | No animal / pre-clinical study was conducted. | | | |
| Clinical Studies | Clinical studies were performed on the general population to confirm the
measurement performance for heart rate and respiratory rate. The device is tested
on general adult patient population. | | | |
| | The study population consisted of 52 qualified subjects. 1394 datasets were
collected 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%); and
Female: 27 (51.2%). | | | |
| | Subject age subgroups information is as follows: 21-29 years: 6 (~11.5%); 30-39
years: 13 (~25.0%); 40-49 years: 10 (~19.2%); 50-59 years: 5 (~9.6%); 60-69
years: 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 (BMI
less 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 rate
and respiratory rate measurements. There is no known clinically meaningful
subgroup disparities between race/ethnicity, gender, age, or BMI subgroups
regarding 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 FDA
guidance document .
Human factor study was conducted to ensure lay person could use the Device
correctly with no human factor concerns. | | | |
| Cybersecurity | Cybersecurity risk assessment and controls of the Device was carried out per the | | | |
11
| Cybersecurity | Cybersecurity risk assessment and controls of the Device was carried out per the
FDA guidance document |
| --------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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.
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