(452 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 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.
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.
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.
The provided text describes the BioButton System, a remote monitoring wearable device, and its acceptance criteria as part of a 510(k) submission to the FDA. The information focuses on demonstrating substantial equivalence to a predicate device (BioSticker System K191614).
Here's a breakdown of the requested information based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for performance are clearly stated in the "Performance / Effectiveness" section (page 8).
| Comparison Items | Acceptance Criteria (BioButton System) | Reported Device Performance (BioButton System) |
|---|---|---|
| Heart Rate Range | 40-125 Beats per Minute | 40-125 Beats per Minute (stated as "Same" as predicate, implying it meets this range) |
| Heart Rate Accuracy | Mean absolute error of less than 5 Beats per minute (<±5 Beats per minute) | Mean absolute error of less than 5 Beats per minute (<±5 Beats per minute) (stated as "Same" as predicate, implying it meets this criterion) |
| Respiratory Rate Range | 10-30 Breaths per Minute | 10-30 Breaths per Minute (stated as "Same" as predicate, implying it meets this range) |
| Respiratory Rate Accuracy | Mean absolute error of less than 3 Breaths per Minute (<±3 Breaths per Minute) at rest | Mean absolute error of less than 3 Breaths per Minute (<±3 Breaths per Minute) at rest (stated as "Same" as predicate, implying it meets this criterion) |
| Skin Temperature | Meets ASTM E1112-00 standard; Range 86°F - 107°F (30°C - 42°C) | Meets ASTM E1112-00 standard; Range 86°F - 107°F (30°C - 42°C) (stated as "Same" as predicate, implying it meets this criterion) |
Beyond these explicit performance measures, the document also mentions compliance with various safety, EMC, biocompatibility, and software standards as "acceptance criteria" through compliance.
2. Sample Size for the Test Set and Data Provenance
The document states: "Clinical studies was performed on general population to confirm the measurement performance for heart rate and respiratory rate." (page 9)
- Sample Size: The exact sample size for the clinical study (test set) is not specified in the provided text.
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not specified. "Clinical studies was performed" generally implies prospective data collection, but this is not explicitly stated.
3. Number of Experts and Qualifications for Ground Truth
This information is not provided in the given text. The document refers to "clinical studies" for performance confirmation but does not detail how the ground truth in these studies was established (e.g., number or qualifications of experts).
4. Adjudication Method for the Test Set
This information is not provided in the given text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention nor describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human readers improving with or without AI assistance. The context is a device measuring physiological parameters, not an AI-assisted diagnostic imaging tool.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop)
The study described for performance confirmation ("Clinical studies was performed on general population to confirm the measurement performance for heart rate and respiratory rate") seems to be evaluating the device's ability to measure these parameters directly. Since the device collects data and aids diagnosis, it inherently functions as a "standalone" measurement device in terms of its primary data collection function. The "report will be generated to be viewed by a healthcare professional" (page 5), implying a human-in-the-loop for interpretation, but the core measurement accuracy validation is for the device's output. Therefore, the "performance testing" described (clinical studies) can be considered a form of standalone performance evaluation for its measurement capabilities.
7. Type of Ground Truth Used
The document refers to "clinical studies" to "confirm the measurement performance for heart rate and respiratory rate." While not explicitly stated, in such device validation studies, the ground truth for physiological parameters like heart rate and respiratory rate would typically involve simultaneous measurement with a highly accurate, often gold-standard, reference device. This would be considered outcomes data / reference standard comparison rather than expert consensus or pathology in the context of physiological measurement devices.
For skin temperature, it states "Meets ASTM E1112-00 standard," which is a standard for electronic thermometry, implying comparison to a reference standard or validated methodology.
8. Sample Size for the Training Set
The document does not mention or differentiate between a training set and a test set, nor does it provide a sample size specifically for a training set. This suggests that the submission focuses on the performance of the final device based on clinical validation, rather than detailing the machine learning model development process (if applicable beyond basic signal processing).
9. How the Ground Truth for the Training Set Was Established
Since a training set is not explicitly mentioned or detailed, the method for establishing its ground truth is not provided. The submission details performance testing and verification, implying the device's algorithms or measurement methods were developed prior to these validation studies.
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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.
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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 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 (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 DeviceManufacturer | BioIntelliSense Inc. |
|---|---|
| Predicate Device TradeName | 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.
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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(K191614) | Justification of Difference |
|---|---|---|---|
| Product Code | DRG | DRG | Equivalent |
| Classification | Class II | Class II | Equivalent |
| Intended use | The BioButton System is a remotemonitoring wearable device intendedfor continuous collection ofphysiological data in home andhealthcare settings while the patient isat rest. This could include heart rate,respiratory rate, skin temperature, andother symptomatic or biometric data. | The BioSticker System is a remotemonitoring system intended foruse by healthcare professionals forcontinuous collection ofphysiological data in home andhealthcare settings while thepatient is at rest. This can includeheart rate, respiratory rate, and | Different |
| BioIntellisense Inc. | Page 3 of 7 | ||
| ComparisonItems | BioButton System (New Submission) | BioSticker System(K191614) | Justification of Difference |
| Data are securely transmitted viawireless connection from the devicefor storage, review, and furtheranalysis.The data from the device are intendedas an aid to diagnosis, diseasesmanagement, and treatment.The device is intended for use on userswho are 18 years of age or older.The device is not intended to outputphysiological measurements while theuser undergoes significant motion or isactive.The device is not intended for use oncritical care patients. | skin temperature. Data aretransmitted via wireless connectionfrom the BioSticker for storage andanalysis.The device is intended for use ongeneral care patients who are 21years of age or older as a generalpatient monitor, to providephysiological information. The datafrom the BioSticker System areintended for use by healthcareprofessionals as an aid to diagnosisand treatment.The device is not intended for useon critical care patients. | ||
| PrescriptionUse / OCT | Prescription use only | Prescription use only | Same |
| Mode ofOperation | Continuous operation | Continuous operation | Same |
| PhysicalDimension | 41.2x37.5.x5.7mm | 81.82 x 37.75 x 8.20 mm | Different |
| Weight | 9.4g | 23g | Different |
| PatientPopulation | General care patients who are 18 yearsof age or older | General care patients who are 21years of age or older | Different |
| 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° | 10°C - 40 C° | Equivalent |
| OperatingRelativeHumidity (RH) | 10-95% RH | 10-95% RH | Same |
| Operatingatmospherepressure | 70 kPa to 102 kPa | 70 kPa to 102 kPa | Same |
| Transport &StorageTemperature | -20 C°- 40 C° | 0 C°- 50 C° | Equivalent |
| Transport &StorageHumidity | 10 – 95% RH | 10 – 95% RH | Same |
| BioIntellisense Inc. | Page 4 of 7 |
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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
| ComparisonItems | BioButton System (New Submission) | BioSticker System(K191614) | Justification of Difference |
|---|---|---|---|
| BatteryOperated | Yes | Yes | Same |
| Battery Life | Up to 60 days | 30 days | Equivalent |
| Sensor forAxillary Temp | Thermistor | Thermistor | Same |
| Sensor forHeart Rate | Accelerometer | Accelerometer | Same |
| Sensor forRespiratoryRate | 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 |
Safety
BioIntellisense Inc.
| Comparison Items | BioButton System (New Submission) | BioSticker System(K191614) | 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 |
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 orSoftware Warningand IndicationSignals | On-device LED indicator for power | On-device LED indicator for power | Same |
Performance / Effectiveness
| Comparisonltems | BioButton System (NewSubmission) | BioSticker System(K191614) | Justification of Difference |
|---|---|---|---|
| Heart RateRange | 40-125 Beats per Minute | 40-125 Beats per Minute | Same |
| Heart RateAccuracy | Mean absolute error of lessthan 5 Beats per minute (<±5Beats per minute) | Mean absolute error of less than5 Beats per minute (<±5 Beatsper minute) | Same |
| RespiratoryRate Range | 10-30 Breaths per Minute | 10-30 Breaths per Minute | Same |
| RespiratoryRateAccuracy | Mean absolute error of lessthan 3 Breaths per Minute (<±3Breaths per Minute) at rest | Mean absolute error of less than3 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:
| Electrical safety andelectromagneticcompatibility (EMC) | Electrical safety and EMC testing were conducted on the BioSticker 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 this device is determined as a "moderate" level of concern per FDAGuidance Document < Content of Premarket Submissions for Software Contained inMedical Devices>Software documentation and verification are performed per the guidance document. |
| Biocompatibility | Complies with ISO 10993-1 and collateral standards, as well as FDA guidance documentUse of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part1: Evaluation and testing within a risk management process"All skin-contacting materials meet or exceed the biocompatibility requirements, per testingagainst ISO 10993-5 and ISO 10993-10 standards. |
| BioIntellisense Inc. | Page 6 of 7 | |
|---|---|---|
| ---------------------- | -- | ------------- |
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| 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 < 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 |
|---|---|
| ---------------------- | ------------- |
§ 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).