BioButton System
Device Facts
| Record ID | K212957 |
|---|---|
| Device Name | BioButton System |
| Applicant | Biolntellisense, Inc. |
| Product Code | DRG · Cardiovascular |
| Decision Date | Dec 12, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2910 |
| Device Class | Class 2 |
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 gait 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, 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.
Device Story
Wearable, single-use sensor module; collects heart rate, respiratory rate, skin temperature via accelerometer and thermistor; transmits data via Bluetooth to data exchange hubs and cloud platform. Used in home/healthcare settings; operated by healthcare professionals for patient monitoring. Output viewed by clinicians via generated reports; aids in diagnosis, disease management, and treatment. Benefits include continuous, long-term physiological monitoring (up to 60 days) without requiring in-person clinical visits.
Clinical Evidence
Clinical studies performed on general population to confirm measurement performance for heart rate and respiratory rate. Bench testing included wireless coexistence, temperature validation per ASTM E1112, hardware V&V, battery life testing, and human factors engineering. No animal studies conducted.
Technological Characteristics
Single-use wearable sensor; thermistor for axillary temperature; accelerometer for heart/respiratory rate. Dimensions: 41.2x37.5x5.7mm; Weight: 9.4g. Connectivity: Bluetooth. Battery life: up to 60 days. Biocompatibility: ISO 10993-1. Electrical safety: IEC 60601-1, IEC 60601-1-11. EMC: IEC 60601-1-2. Ingress protection: IP47.
Indications for Use
Indicated for continuous collection of physiological data (heart rate, respiratory rate, skin temperature) in home and healthcare settings for patients 18+ years old while at rest. Not for critical care or active/moving patients.
Regulatory Classification
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.
Predicate Devices
- BioSticker System (K191614)
Submission Summary (Full Text)
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December 12, 2022
BioIntelliSense Inc. Yusi Liu VP of Regulatory Affairs 570 El Camino Real. Suite 200 Redwood City, California 94063
Re: K212957
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, NDC Dated: July 25, 2022 Received: November 15, 2022
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 (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.
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 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,
Shruti N. Mistry -S
for
Jennifer Shih 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
510(k) Number (if known) K212957
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, skin temperature, and other data such as activity level, body position, sleep, and step and gait 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, 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.
Type of Use (Select one or both, as applicable)X 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 BioButton System.
Date Prepared: December 12, 2022
## l. Submitter
| Submitter Name and<br>Address | BioIntelliSense Inc.<br>570 El Camino Real, #200<br>Redwood City<br>CA 94063<br>USA |
|-------------------------------|------------------------------------------------------------------------------------------------|
| Contact Person | Yusi Liu – VP of Regulatory Affairs<br>Tel: +1 703-776-0119<br>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 (Primary) and NDC (Secondary) |
| BioIntellisense Inc. | Page 1 of 7 |
|----------------------|-------------|
|----------------------|-------------|
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| Image: BioIntelliSense logo | K212957 |
|-----------------------------|---------|
| BioButton 510(k) Summary | |
## III. Predicate Device
| Predicate Device<br>Manufacturer | BioIntelliSense Inc. |
|-----------------------------------|----------------------|
| Predicate Device Trade<br>Name | BioSticker System |
| Predicate Device 510(k)<br>Number | K191614 |
# IV. Device Description
The BioButton System 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 BioButton for storage and analysis.
The BioButton System (the System), is an extension of the BioSticker System with the same/similar intended use. The System is intended to monitor physiological parameters of the patient/users for relatively long duration (up to 60 days with medical data collection). The System should now enable the connectivity with the BioButton sensor device (BBN) with the rest of the system components.
The BioButton System consists of a single-use 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. See main components of the BioButton System. The main components of the BioButton System could include the following:
- BioButton Sensor -
- -BioButton adhesives (accessory)
- Data Exchange Hubs (MDDS) -
- -Cloud-based data platform (MDDS)
The BioButton System is used to collect physiological information from a patient using the BioButton 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 rest¹. The medical physiological data collected includes:
- . Heart rate at rest,
- . Respiratory rate at rest, and
- Skin temperature
<sup>1 &</sup>quot;At Rest" means the device will not output measurement data to the user undergoes significant motion or is active.
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| | K212957 |
|--|--------------------------|
| | BioButton 510(k) Summary |
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 Bluetooth connection using the Offload Software. The data offloading is performed and qualified personnel. Also using the Offload Software, a report will be generated to be viewed by a healthcare professional. The report is not intended to be viewed by the patient.
# 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 further analysis.
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.
# VI. Technology Characteristics in Comparison with the Predicate Device
#### Overview
| Comparison Items | BioButton System (New Submission) | BioSticker System<br>(K191614) | Justification of Difference |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Product Code | DRG | DRG | Equivalent |
| Classification | Class II | Class II | Equivalent |
| Intended use | The BioButton System is a remote<br>monitoring wearable device intended<br>for continuous collection of<br>physiological data in home and<br>healthcare settings while the patient is<br>at rest. This could include heart rate,<br>respiratory rate, skin temperature, and<br>other symptomatic or biometric data. | The BioSticker System is a remote<br>monitoring system intended for<br>use by healthcare professionals for<br>continuous collection of<br>physiological data in home and<br>healthcare settings while the<br>patient is at rest. This can include<br>heart rate, respiratory rate, and | Different |
| | BioIntellisense Inc. | | Page 3 of 7 |
| Comparison<br>Items | BioButton System (New Submission) | BioSticker System<br>(K191614) | Justification of Difference |
| | Data are securely transmitted via<br>wireless connection from the device<br>for storage, review, and further<br>analysis.<br>The data from the device are intended<br>as an aid to diagnosis, diseases<br>management, and treatment.<br>The device is intended for use on users<br>who are 18 years of age or older.<br>The device is not intended to output<br>physiological measurements while the<br>user undergoes significant motion or is<br>active.<br>The device is not intended for use on<br>critical care patients. | skin temperature. Data are<br>transmitted via wireless connection<br>from the BioSticker for storage and<br>analysis.<br>The device is intended for use on<br>general care patients who are 21<br>years of age or older as a general<br>patient monitor, to provide<br>physiological information. The data<br>from the BioSticker System are<br>intended for use by healthcare<br>professionals as an aid to diagnosis<br>and treatment.<br>The device is not intended for use<br>on critical care patients. | |
| Prescription<br>Use / OCT | Prescription use only | Prescription use only | Same |
| Mode of<br>Operation | Continuous operation | Continuous operation | Same |
| Physical<br>Dimension | 41.2x37.5.x5.7mm | 81.82 x 37.75 x 8.20 mm | Different |
| Weight | 9.4g | 23g | Different |
| Patient<br>Population | General care patients who are 18 years<br>of age or older | General care patients who are 21<br>years of age or older | Different |
| Use<br>Environment | Home and healthcare setting | Home and healthcare setting | Same |
| Device<br>Placement | Upper left chest | Upper left chest | Same |
| Usability | Single button on device.<br>Single LED indicator. | Single button on device.<br>Single LED indicator. | Same |
| Operating<br>Temperature | 0°C - 40 C° | 10°C - 40 C° | Equivalent |
| Operating<br>Relative<br>Humidity (RH) | 10-95% RH | 10-95% RH | Same |
| Operating<br>atmosphere<br>pressure | 70 kPa to 102 kPa | 70 kPa to 102 kPa | Same |
| Transport &<br>Storage<br>Temperature | -20 C°- 40 C° | 0 C°- 50 C° | Equivalent |
| Transport &<br>Storage<br>Humidity | 10 – 95% RH | 10 – 95% RH | Same |
| | BioIntellisense Inc. | | Page 4 of 7 |
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#### K212957 BioButton 510(k) Summary
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| Image: BioIntelliSense logo | K212957 |
|-----------------------------|---------|
| BioButton 510(k) Summary | |
| Comparison Items | BioButton System (New Submission) | BioSticker System (K191614) | Justification of Difference |
|---------------------------------|-----------------------------------|-----------------------------|-----------------------------|
| Single-use / Multiple-use | Single-use | Single-use | Same |
| Sterilization | No | No | Same |
| Re-processing between each use? | No | No | Same |
| Biologics or drugs? | No | No | Same |
#### Technical Specifications
| Comparison<br>Items | BioButton System (New Submission) | BioSticker System<br>(K191614) | Justification of Difference |
|-----------------------------------|-----------------------------------|--------------------------------|-----------------------------|
| Battery<br>Operated | Yes | Yes | Same |
| Battery Life | Up to 60 days | 30 days | Equivalent |
| Sensor for<br>Axillary Temp | Thermistor | Thermistor | Same |
| Sensor for<br>Heart Rate | Accelerometer | Accelerometer | Same |
| Sensor for<br>Respiratory<br>Rate | Accelerometer | Accelerometer | Same |
| Data Storage -<br>media | Flash storage | Flash storage | Same |
| Data Transfer | Wireless - Bluetooth | Wireless - Bluetooth | Same |
| On-device<br>Controls | Physical push button | Physical push button | Same |
#### Safety
BioIntellisense Inc.
| Comparison Items | BioButton System (New Submission) | BioSticker System<br>(K191614) | Justification of Difference |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| General electrical<br>and mechanical<br>safety | Complies with IEC 60601-1 and<br>EC 60601-1-11 | Complies with IEC 60601-1 and<br>EC 60601-1-11 | Same |
| EMC | Complies with IEC 60601-1-2 | Complies with IEC 60601-1-2 | Same |
| Biocompatibility<br>for Patient-<br>contacting<br>materials | Complies with ISO 10993-1 and<br>collateral standards, as well as FDA<br>guidance document Use of<br>International Standard ISO 10993-1,<br>"Biological evaluation of medical<br>devices - Part 1: Evaluation and<br>testing within a risk management<br>process" | Complies with ISO 10993-1 and<br>collateral standards, as well as FDA<br>guidance document Use of<br>International Standard ISO 10993-1,<br>"Biological evaluation of medical<br>devices - Part 1: Evaluation and<br>testing within a risk management<br>process" | Same |
Page 5 of 7
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| Image: BioIntelliSense logo | K212957 |
|-----------------------------|--------------------------|
| | BioButton 510(k) Summary |
| Comparison Items | BioButton System (New Submission) | BioSticker System (K191614) | Justification of Difference |
|---------------------------------------------------------------|-----------------------------------|-----------------------------------|-----------------------------|
| Ingress Protection | IP47 | IP47 | Same |
| On-device or<br>Software Warning<br>and Indication<br>Signals | On-device LED indicator for power | On-device LED indicator for power | Same |
#### Performance / Effectiveness
| Comparison<br>ltems | BioButton System (New<br>Submission) | BioSticker System<br>(K191614) | Justification of Difference |
|---------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------|
| Heart Rate<br>Range | 40-125 Beats per Minute | 40-125 Beats per Minute | Same |
| Heart Rate<br>Accuracy | Mean absolute error of less<br>than 5 Beats per minute (<±5<br>Beats per minute) | Mean absolute error of less than<br>5 Beats per minute (<±5 Beats<br>per minute) | Same |
| Respiratory<br>Rate Range | 10-30 Breaths per Minute | 10-30 Breaths per Minute | Same |
| Respiratory<br>Rate<br>Accuracy | Mean absolute error of less<br>than 3 Breaths per Minute (<±3<br>Breaths per Minute) at rest | Mean absolute error of less than<br>3 Breaths per Minute (<±3<br>Breaths per Minute) at rest | Same |
| Skin<br>Temperature | Meets ASTM E1112-00<br>standard<br>Range 86°F - 107°F (30°C -<br>42°C) | Meets ASTM E1112-00<br>standard<br>Range 86°F - 107°F (30°C -<br>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:
| Electrical safety and<br>electromagnetic<br>compatibility (EMC) | Electrical safety and EMC testing were conducted on the BioSticker device. The device<br>complies with the IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11 standards. |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software Verification<br>and Validation Testing | The software for this device is determined as a "moderate" level of concern per FDA<br>Guidance Document < Content of Premarket Submissions for Software Contained in<br>Medical Devices><br>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<br>Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part<br>1: Evaluation and testing within a risk management process"<br>All skin-contacting materials meet or exceed the biocompatibility requirements, per testing<br>against ISO 10993-5 and ISO 10993-10 standards. |
| BioIntellisense Inc. | | Page 6 of 7 |
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| Image: BioIntelliSense logo | K212957 |
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| | BioButton 510(k) Summary |
| Benchtop Testing | Wireless coexistence testing conducted on the new device Temperature measurement performance validation per ASTM E1112 standard per 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 shows that the battery life of the device is no less than 30 days |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Animal Study | No animal / pre-clinical study was conducted. |
| Clinical Studies | Clinical studies was performed on general population to confirm the measurement performance for heart rate and respiratory rate. |
| Human Factor | Human factor engineering and evaluation for BioButton System was conducted per FDA guidance document < Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff>. 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 BioButton System was carried out per the FDA guidance document < Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food 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 BioButton device and the predicate device (K191614) do not raise new concerns. Thus, the BioButton Platform and the predicate device (K191614) are substantially equivalent.
| Biointellisense Inc. | Page 7 of 7 |
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