(452 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and focuses on data collection, transmission, and standard performance metrics.
No.
Explanation: The device is intended for the continuous collection of physiological data as an aid to diagnosis, disease management, and treatment, but it does not directly provide therapy or treatment itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The data from the device are intended as an aid to diagnosis, diseases management, and treatment."
No
The device description explicitly states that the BioButton System consists of a "single-use wearable hardware sensor module" and mentions "Electronics hardware verification and validation testing," indicating it includes 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:
- Definition of IVD: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. These tests are performed in vitro (in a lab setting, outside the body).
- BioButton System's Function: The BioButton System is a wearable device that collects physiological data in vivo (from within the body) through sensors placed on the skin. It measures parameters like heart rate, respiratory rate, and skin temperature directly from the patient.
- Intended Use: The intended use describes the device as a remote monitoring wearable for continuous collection of physiological data. While the data is used as an "aid to diagnosis, diseases management, and treatment," the device itself is not performing a diagnostic test on a biological sample.
- Device Description: The description reinforces that the device collects data from the patient using a wearable sensor module.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the BioButton System falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic device.
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, 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.
Product codes
DRG, NDC
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 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. 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.
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
Home and healthcare settings / healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 electromagnetic compatibility (EMC):
Electrical safety and EMC testing were conducted on the BioSticker 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 this device is determined as a "moderate" level of concern 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 Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" 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 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 . 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Heart Rate Accuracy: Mean absolute error of less than 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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
1
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
2
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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3
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
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 (Primary) and NDC (Secondary) |
| BioIntellisense Inc. | Page 1 of 7 |
|---|---|
| ---------------------- | ------------- |
4
| Image: BioIntelliSense logo | K212957 |
|---|---|
| BioButton 510(k) Summary |
III. Predicate Device
| Predicate Device
| Manufacturer | BioIntelliSense Inc. |
|---|---|
| Predicate Device Trade | |
| Name | BioSticker System |
| Predicate Device 510(k) | |
| 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
1 "At Rest" means the device will not output measurement data to the user undergoes significant motion or is active.
5
| 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
(K191614) | Justification of Difference |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Product Code | DRG | DRG | Equivalent |
| Classification | Class II | Class II | Equivalent |
| Intended 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 symptomatic or biometric data. | The BioSticker System is a 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 | Different |
| | BioIntellisense Inc. | | Page 3 of 7 |
| Comparison
Items | BioButton System (New Submission) | BioSticker System
(K191614) | Justification of Difference |
| | 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 use on
critical care patients. | skin temperature. Data are
transmitted via wireless connection
from the BioSticker for storage and
analysis.
The device is intended for use on
general care patients who are 21
years of age or older as a general
patient monitor, to provide
physiological information. The data
from the BioSticker System are
intended for use by healthcare
professionals as an aid to diagnosis
and treatment.
The device is not intended for use
on critical care patients. | |
| Prescription
Use / OCT | Prescription use only | Prescription use only | Same |
| Mode of
Operation | Continuous operation | Continuous operation | Same |
| Physical
Dimension | 41.2x37.5.x5.7mm | 81.82 x 37.75 x 8.20 mm | Different |
| Weight | 9.4g | 23g | Different |
| Patient
Population | General care patients who are 18 years
of age or older | General care patients who are 21
years of age or older | Different |
| 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° | 10°C - 40 C° | Equivalent |
| 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 | -20 C°- 40 C° | 0 C°- 50 C° | Equivalent |
| Transport &
Storage
Humidity | 10 – 95% RH | 10 – 95% RH | Same |
| | BioIntellisense Inc. | | Page 4 of 7 |
6
K212957 BioButton 510(k) Summary
7
| 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
Items | BioButton System (New Submission) | BioSticker System
(K191614) | Justification of Difference |
|-----------------------------------|-----------------------------------|--------------------------------|-----------------------------|
| Battery
Operated | Yes | Yes | Same |
| Battery Life | Up to 60 days | 30 days | Equivalent |
| 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 |
Safety
BioIntellisense Inc.
| Comparison Items | BioButton System (New Submission) | BioSticker System
(K191614) | 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 |
Page 5 of 7
8
| 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 | |||
| Software Warning | |||
| and Indication | |||
| Signals | On-device LED indicator for power | On-device LED indicator for power | Same |
Performance / Effectiveness
| Comparison
ltems | BioButton System (New
Submission) | BioSticker System
(K191614) | Justification of Difference |
|---------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------|
| Heart Rate
Range | 40-125 Beats per Minute | 40-125 Beats per Minute | Same |
| Heart Rate
Accuracy | Mean absolute error of less
than 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
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part
1: Evaluation and testing within a risk management process"
All skin-contacting materials meet or exceed the biocompatibility requirements, per testing
against ISO 10993-5 and ISO 10993-10 standards. |
| BioIntellisense Inc. | Page 6 of 7 | |
|---|---|---|
| ---------------------- | -- | ------------- |
9
| Image: BioIntelliSense logo | K212957 |
|---|---|
| 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 . 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 |
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 |
|---|---|
| ---------------------- | ------------- |