The Biotres is indicated for use on adult patients 18 years or older who may be asymptomatic or who suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety and may require cardiac recording on a continuous basis for up to 30 days. The signal acquired by the Biotres is not intended and should not be used for automated or semi-automated analysis.

Device Description

The Biotres system consists of 1) the Biotres Recorder, 2) a dedicated Biotres AC wall charger, 3) Biotres Gateway application for use on mobile devices using Android or iOS, and 4) Biotres Configured Secure Server. The Biotres Recorder is an ECG recording only device and does not include ECG analysis, alarms and is not a real time ECG monitor. The Biotres recorder is a small, lightweight, ambulatory, reusable 3 channel ECG recorder that is placed on the center of the chest. The Biotres Recorder has two buttons: 1) power button and 2) patient event marking button. There is an LED "status indicator light" in the middle of the patient event marking button that provides recorder status indications. The Biotres Recorder attaches to the patient's chest through three standard commercially available ECG electrodes. Biotres includes a Bluetooth modem to communicate with the Biotres Configured Secure Server through the Biotres Gateway Application. The Biotres Recorder integrated memory can store up to 30-days of ECG data. This data can be uploaded by the clinician to the Biotres Configured Secure Server. The dedicated Biotres AC Wall charger is used to charge the Biotres Recorder daily when disconnected from the patient. The ECG recorded data is transferred via the Biotres Gateway App via a Bluetooth connection and subsequently to the Biotres Configured Secure Server. Clinicians can use the Biotres Gateway Application using their privileged login credentials to connect Biotres Recorders to the Biotres Configured Secure Server so that patient studies may be started and completed. The Biotres Gateway Application can be used by the patient once registered (nonprivileged login credentials) and the patient can use the application to monitor the status indicators of the Biotres Recorder and to enter symptoms if the Event Marking Button is pressed on the recorder. The ECG recorded data from the Biotres Recorder can be transferred, by the clinician, from the Biotres Configured Secure Server when the recorder is connected to the Biotres Gateway App at the end of a patient study. The Biotres Configured Secure Server is an SFTP server that is configured to work with the Biotres System. The server enables the Clinician, through secured login, to command the Biotres Recorder (e.g. initiate ECG data collection) and to access uploaded MIT16 ECG data recordings when the ECG data collection is complete. Biotres does not provide the patient or clinician with diagnostic or interpretive statements based on the ECG data. Biotres ECG recordings can be viewed through the Bioflux Software II (K201040) by qualified medical personnel.

AI/ML Overview

The provided text is a 510(k) summary for the Biotres device. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, this document does not contain the detailed clinical study information typically found when proving a device meets specific acceptance criteria through performance data.

The crucial piece of information for your request is that the Biotres device is not an AI or algorithmic analysis device. The text explicitly states: "The signal acquired by the Biotres is not intended and should not be used for automated or semi-automated analysis." Its purpose is to record ECG data for up to 30 days, which is then to be reviewed and interpreted by qualified medical personnel using an ECG viewer software.

Therefore, the concepts of acceptance criteria for algorithmic performance, sample sizes for AI test sets, expert ground truth establishment for AI, MRMC studies, or standalone algorithm performance do not apply to this device as described.

The performance testing mentioned (IEC 60601-2-47:2012) is a standard for basic safety and essential performance of ambulatory electrocardiographic systems, which typically involves testing electrical safety, signal quality, and functional parameters, not the accuracy of an AI algorithm in detecting or classifying conditions.

Given this, I cannot fill in the requested table and details for the points related to AI/algorithmic performance because the device, as described, does not perform automated or semi-automated analysis that would require such validation.

However, I can provide what is present in the document.

Based on the provided document, the Biotres device is a medical magnetic tape recorder (ECG recorder) and explicitly states it is NOT intended for "automated or semi-automated analysis." Therefore, the detailed acceptance criteria and study proving algorithmic performance (as typically seen in AI/ML medical devices) are not applicable or present in this 510(k) summary.

The device's performance is established through substantial equivalence to a predicate device (K211709) and compliance with relevant safety and performance standards for ECG recording devices.

Below is information that can be extracted or inferred from the document, with explanations for why certain requested fields cannot be filled:

A table of acceptance criteria and the reported device performance

Given that this device is a recorder and not an analytical AI tool, there are no acceptance criteria for algorithmic performance (e.g., sensitivity, specificity, AUC for disease detection). The "performance" as described is its ability to record ECG data and meet general safety and essential performance standards.

Acceptance Criteria (Inferred for a Recorder)	Reported Device Performance (Summary)
Basic Safety and Essential Performance	Device passed IEC 60601-2-47:2012
Ability to record 3-lead ECG data	Records 3-lead ECG, continuous
Recording duration	Up to 30 days
Defibrillator Protection	Not Defibrillator Proof (IEC 60601-1 passed)
Data Transfer	Via Bluetooth to Biotres Gateway App, then to Secure Server
Charging	Via dedicated AC wall charger; USB for charging
Physical form factor	Small, lightweight, body-worn ambulatory cardiac monitor
Interface	Power button, patient event marking button, LED indicator

Sample sizes used for the test set and the data provenance

Not applicable in the context of AI/ML performance testing for this device. The document mentions general "performance and safety tests" (IEC 60601-2-47:2012) but does not detail a "test set" in the sense of a dataset for algorithmic validation. Device testing for hardware and basic functionality typically uses a limited number of physical units, not large patient datasets for performance metrics.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for algorithmic performance is not established because the device does not perform automated analysis. The interpretation of the ECG data recorded by Biotres is explicitly left to "qualified medical personnel" and "physician or trained healthcare professional."
Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no algorithmic test set requiring ground truth adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The device does not provide AI assistance for human readers. Its function is data recording.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. The device does not have a standalone algorithm for diagnostic performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as there is no algorithmic performance claim that would require ground truth.
The sample size for the training set

Not applicable, as there is no AI algorithm being trained by this device.
How the ground truth for the training set was established

Not applicable, as there is no AI algorithm being trained by this device.

Summary of Device Functionality Relevant to the 510(k) Summary:

The Biotres is a hardware device designed to continuously record 3-channel ECG data from adult patients for up to 30 days. It has buttons for power and patient event marking, an LED status indicator, and connects to mobile devices via Bluetooth for data transfer to a secure server. The recorded ECG data is intended for review and interpretation by qualified medical professionals using separate ECG viewing software (Bioflux Software II). The key point reiterated is that the device "is not intended and should not be used for automated or semi-automated analysis." Its 510(k) clearance is based on substantial equivalence to a previously cleared predicate device (K211709) and compliance with general medical device safety and performance standards.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

July 28, 2022

Biotricity Spencer Ladow VP Engineering 203 Redwood Shores Pkwv Suite 600 Redwood City, California 94065

Re: K222017

Trade/Device Name: Biotres Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II Product Code: MWJ Dated: July 6, 2022 Received: July 8, 2022

Dear Spencer Ladow:

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 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 medical devices and radiation-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,

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)

Device Name Biotres

K222107

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image contains the logo for Biotricity. The logo consists of a teal-colored geometric flower-like design on the left, followed by the word "biotricity" in a teal sans-serif font. The flower design has eight petals, each made up of smaller teal shapes. The word "biotricity" is written in lowercase letters and is positioned to the right of the flower design.

510(k) SUMMARY

Date Prepared: July 6, 2022

SUBMITTER

Biotricity 203 Redwood Shores Pkwy, Suite 600 Redwood City, CA 94065 Contact Person: Spencer LaDow sladow(@biotricity.com Phone: 585-414-7407

DEVICE II.

Name of Device: Classification Regulation: Common Name: Device Panel: Regulatory Class: Product Code:

Biotres 21 CFR§870.2800 Medical Magnetic Tape Recorder Cardiovascular Class II MWJ Electrocardiograph, Ambulatory (without Analysis)

PREDICATE DEVICE III.

The Biotres (Biotricity) was cleared under K211709.

Name of Device: Classification Regulation: Common Name: Device Panel: Regulatory Class: Product Code:

Biotres 21 CFR§870.2800 Medical Magnetic Tape Recorder Cardiovascular Class II MWJ Electrocardiograph, Ambulatory (without Analysis)

Biotricity K22207

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IV. DEVICE DESCRIPTION

Biotres Recorder

The Biotres Recorder is an ECG recording only device and does not include ECG analysis, alarms and is not a real time ECG monitor. The Biotres recorder is a small, lightweight, ambulatory, reusable 3 channel ECG recorder that is placed on the center of the chest (Reference Below).

Biotres Recorder – Front View

Image /page/4/Figure/5 description: The image shows a diagram of a device with several labeled components. The components include a 'Status Indicator Light' at the top center, a 'Marking Button' to the right, and a 'Power Button' on the left side. Additionally, there is a 'Charging Port' on the right and a 'Snap for ECG electrode' at the bottom.

FRONT VIEW

Biotres Recorder – Back View

BACK VIEW

Image /page/4/Figure/9 description: The image shows a top-down view of a round, medical device with three electrode connectors extending from its sides. The device has a label with the Biotricity logo, model number "Biotree 1.0", serial number "1230000089", FCC ID "2AKGEBIOTRES1", and FDA cleared status. The label also includes regulatory symbols such as "FC" and "IP22". An arrow points to one of the electrode connectors with the text "Snap connection for electrodes".

Biotricity K222107

Page 2 of 7

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The Biotres Recorder has two buttons: 1) power button and 2) patient event marking button. The pash the patient event marking button when the patient is feeling symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, fatigue, chest pain and/or anxiety. There is an LED "status indicator light" in the middle of the patient event marking button that provides recorder status indications when powering on, electrodes are disconnected, low battery, charged, encountered internal error, acknowledgment of the patient event marking button, and study not engaged/start/running/paused/completed state.

The Biotres Recorder attaches to the patient's chest through three standard commercially available ECG electrodes (not include with the system) supplied by a clinic or a monitoring center. Biotres includes a Bluetooth modem to communicate with the Biotres Configured Secure Server through the Biotres Gateway Application. The Biotres Recorder integrated memory can store up to 30-days of ECG data. This data can be uploaded by the clinician to the Biotres Configured Secure Server.

Biotres AC Wall Charger

The dedicated Biotres AC Wall charger is used to charge the Biotres Recorder daily when disconnected from the patient.

Biotres Gateway Application

The ECG recorded data is transferred via the Biotres Gateway App (Downloaded from the app store for iOS or Android respectively) via a Bluetooth connection and subsequently to the Biotres Configured Secure Server. Clinicians can use the Biotres Gateway Application using their privileged login credentials to connect Biotres Recorders to the Biotres Configured Secure Server so that patient studies may be started and completed. The Biotres Gateway Application can be used by the patient once registered (nonprivileged login credentials) and the patient can use the application to monitor the status indicators of the Biotres Recorder and to enter symptoms if the Event Marking Button is pressed on the recorder. The ECG recorded data from the Biotres Recorder can be transferred, by the clinician, from the Biotres Configured Secure Server when the recorder is connected to the Biotres Gateway App at the end of a patient study.

Biotres Secure Server

The Biotres Configured Secure Server is an SFTP server that is configured to work with the Biotres System. The server enables the Clinician, through secured login, to command the Biotres Recorder (e.g. initiate ECG data collection) and to access uploaded MIT16 ECG data recordings when the ECG data collection is complete. Biotres does not provide the patient or clinician with diagnostic or interpretive statements based on the ECG data. Diagnosis and interpretation of ECG data is dependent upon the medical advice and guidance provided by a physician or trained healthcare professional. The Biotres is for home use and not for use in the hospital. Clinical judgment and experience are used to check and interpret the data.

ECG Viewer Software

Biotres ECG recordings can be viewed through the following software tool by qualified medical personnel. Bioflux Software II (K201040) - The ECG viewer software displays ECG records in a browser on a computer and provides tools for trained clinicians to annotate (store, retrieve and report) those ECG recordings. It is utilized by manually opening ECG files or through an API that allows for third parties to integrate their devices and directly push ECG files into the viewer.

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INDICATIONS FOR USE V.

contraindications for USE VI.

The Biotres device is not intended for use under the following conditions:

Patients with potentially life-threatening arrhythmias who require ● inpatient monitoring.
. Patients who the attending physician thinks should be hospitalized.
Infants weighing less than 10 kg. (22 lbs.).
. Patients with implanted pacemakers.
. Defibrillator Use.

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VII. SUMMARY OF TECHNOLIGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Category	Identical/Different	Biotres	Biotres (predicate)
510(k) Number		K222107	K211709
ClassificationName	Identical	MedicalMagnetic Tape Recorder	MedicalMagnetic Tape Recorder
Product Code	Identical	MWJ	MWJ
Intended Use	Identical	The Biotres is indicated for use onadult patients 18 years or olderwho may be asymptomatic orwho suffer from transientsymptoms such as palpitations,shortness of breath, dizziness,light headedness, pre-syncope,syncope, fatigue, chest painand/or anxiety and may requirecardiac recording on a continuousbasis for up to 30 days. The signalacquired by the Biotres is notintended and should not be usedfor automated or semi-automatedanalysis.	The Biotres is indicated for use onadult patients 18 years or olderwho may be asymptomatic orwho suffer from transientsymptoms such as palpitations,shortness of breath, dizziness,light headedness, pre-syncope,syncope, fatigue, chest painand/or anxiety and may requirecardiac recording on a continuousbasis for up to 30 days. The signalacquired by the Biotres is notintended and should not be usedfor automated or semi-automated analysis.
DefibrillatorProtection	Identical	Not Defibrillator Proof, 8.5.5.2 ofIEC 60601-1 passed	Not Defibrillator Proof, 8.5.5.2 ofIEC 60601-1 passed
Wear Time	Identical	Up to 30 Days	Up to 30 Days
Recording Format	Identical	Continuous	Continuous
Delivered deviceincludes	Identical	-3 lead ECG monitor-internal rechargeable battery-Wall Battery charger	-3 lead ECG monitor-internal rechargeable battery-Wall Battery charger
Monitor functionalblocks	Identical	Analog ECG front end,MCU,Flash data storage,BLE modem fordata transmission,LED indicator, and	Analog ECG front end,MCU,Flash data storage,BLE modem fordata transmission,LED indicator, and
Category	Identical/Different	Biotres	Biotres (predicate)
The App:	Identical	Record buttonMobile App, iOS, Android	Record buttonMobile App, iOS, Android
The server:	Identical	Facilitate data communicationwith the Biotres device,provide data storage, andpresent the data for evaluation bya medical professional	Facilitate data communicationwith the Biotres device,provide data storage, andpresent the data for evaluation bya medical professional
Device form factor	Identical	Small, lightweight body wornambulatory cardiac monitors.	Small, lightweight body wornambulatory cardiac monitors.
Wireless technologyused to transmit datato server	Identical	Yes	Yes
Device is batterypowered by arechargeable Li-Ionbattery	Identical	Yes	Yes
Using an app, canadjust deviceprogrammingparameters such aspre-post recordingtimes and auto-triggeringconfiguration.	Identical	Yes, app is android or IOS based	Yes, app is android or IOS based
Devices have Recordbutton for manualevent recordings anda user led to indicatedevice status andmode of operation.	Identical	Yes	Yes
Device has at least 2ECG channels and 3-lead electrodes	Identical	Yes	Yes
Functional,Environmental andElectricalcharacteristics	Identical	Yes	Yes
USB connection	Identical	Yes, used for battery chargingcannot be connected during ECGrecording	Yes, used for battery chargingcannot be connected during ECGrecording
ECG Viewer Software	Different	Bioflux Software II (K201040)	None

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PERFORMANCE TESTING VIII.

The following performance and safety tests have been passed successfully:

IEC 60601-2-47:2012 Medical electrical equipment Part 2-47: . Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.

IX. CONCLUSION

The analysis of the differences between Biotres and the predicate device does not raise different questions of safety and effectiveness. Based on device performance test results, Biotricity determined that the Biotres performed within its design specifications and is considered to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).