Biotres

K222017 · Biotricity · MWJ · Jul 28, 2022 · Cardiovascular

Device Facts

• Record ID: K222017
• Device Name: Biotres
• Applicant: Biotricity
• Product Code: MWJ · Cardiovascular
• Decision Date: Jul 28, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Indications for Use

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 Story

Biotres is a 3-channel ambulatory ECG recorder for home use; captures continuous ECG data via chest-worn electrodes; stores data on internal memory for up to 30 days. Device features power button and patient event marking button; LED status indicator provides feedback on device state. Data transmission occurs via Bluetooth to Biotres Gateway App (iOS/Android) and then to Biotres Configured Secure Server. Clinicians access recordings via Bioflux Software II for manual annotation and review. Device does not perform automated/semi-automated analysis; diagnosis relies on physician interpretation. Benefits include long-term cardiac monitoring for transient symptom correlation.

Clinical Evidence

Bench testing only. Device passed IEC 60601-2-47:2012 (particular requirements for basic safety and essential performance of ambulatory electrocardiographic systems). No clinical data presented.

Technological Characteristics

3-channel ambulatory ECG recorder; rechargeable Li-Ion battery; Bluetooth connectivity; 3-lead electrode interface. Complies with IEC 60601-1 (8.5.5.2) and IEC 60601-2-47:2012. System includes recorder, AC wall charger, mobile gateway app, and secure server. Software is non-analytical/manual review only.

Indications for Use

Indicated for adult patients 18+ years, asymptomatic or experiencing transient symptoms (palpitations, dyspnea, dizziness, lightheadedness, pre-syncope, syncope, fatigue, chest pain, anxiety) requiring continuous cardiac recording up to 30 days. Contraindicated for patients requiring inpatient monitoring, those requiring hospitalization, infants <10kg, patients with implanted pacemakers, or defibrillator use.

Regulatory Classification

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.

Predicate Devices

• Biotres (K211709)

Reference Devices

• Bioflux Software II (K201040)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| 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

l.

Biotricity 203 Redwood Shores Pkwy, Suite 600 Redwood City, CA 94065 Contact Person: Spencer LaDow sladow(@biotricity.com Phone: [phone]

#### 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

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.

#### 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

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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.

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.

#### 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/<br>Different | Biotres | Biotres (predicate) |
|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K222107 | K211709 |
| Classification<br>Name | Identical | Medical<br>Magnetic Tape Recorder | Medical<br>Magnetic Tape Recorder |
| Product Code | Identical | MWJ | MWJ |
| Intended Use | Identical | The Biotres is indicated for use on<br>adult patients 18 years or older<br>who may be asymptomatic or<br>who suffer from transient<br>symptoms such as palpitations,<br>shortness of breath, dizziness,<br>light headedness, pre-syncope,<br>syncope, fatigue, chest pain<br>and/or anxiety and may require<br>cardiac recording on a continuous<br>basis for up to 30 days. The signal<br>acquired by the Biotres is not<br>intended and should not be used<br>for automated or semi-automated<br>analysis. | The Biotres is indicated for use on<br>adult patients 18 years or older<br>who may be asymptomatic or<br>who suffer from transient<br>symptoms such as palpitations,<br>shortness of breath, dizziness,<br>light headedness, pre-syncope,<br>syncope, fatigue, chest pain<br>and/or anxiety and may require<br>cardiac recording on a continuous<br>basis for up to 30 days. The signal<br>acquired by the Biotres is not<br>intended and should not be used<br>for automated or semi-<br>automated analysis. |
| Defibrillator<br>Protection | Identical | Not Defibrillator Proof, 8.5.5.2 of<br>IEC 60601-1 passed | Not Defibrillator Proof, 8.5.5.2 of<br>IEC 60601-1 passed |
| Wear Time | Identical | Up to 30 Days | Up to 30 Days |
| Recording Format | Identical | Continuous | Continuous |
| Delivered device<br>includes | Identical | -3 lead ECG monitor<br>-internal rechargeable battery<br>-Wall Battery charger | -3 lead ECG monitor<br>-internal rechargeable battery<br>-Wall Battery charger |
| Monitor functional<br>blocks | Identical | Analog ECG front end,<br>MCU,<br>Flash data storage,<br>BLE modem for<br>data transmission,<br>LED indicator, and | Analog ECG front end,<br>MCU,<br>Flash data storage,<br>BLE modem for<br>data transmission,<br>LED indicator, and |
| Category | Identical/<br>Different | Biotres | Biotres (predicate) |
| The App: | Identical | Record button<br>Mobile App, iOS, Android | Record button<br>Mobile App, iOS, Android |
| The server: | Identical | Facilitate data communication<br>with the Biotres device,<br>provide data storage, and<br>present the data for evaluation by<br>a medical professional | Facilitate data communication<br>with the Biotres device,<br>provide data storage, and<br>present the data for evaluation by<br>a medical professional |
| Device form factor | Identical | Small, lightweight body worn<br>ambulatory cardiac monitors. | Small, lightweight body worn<br>ambulatory cardiac monitors. |
| Wireless technology<br>used to transmit data<br>to server | Identical | Yes | Yes |
| Device is battery<br>powered by a<br>rechargeable Li-Ion<br>battery | Identical | Yes | Yes |
| Using an app, can<br>adjust device<br>programming<br>parameters such as<br>pre-post recording<br>times and auto-<br>triggering<br>configuration. | Identical | Yes, app is android or IOS based | Yes, app is android or IOS based |
| Devices have Record<br>button for manual<br>event recordings and<br>a user led to indicate<br>device status and<br>mode of operation. | Identical | Yes | Yes |
| Device has at least 2<br>ECG channels and 3-<br>lead electrodes | Identical | Yes | Yes |
| Functional,<br>Environmental and<br>Electrical<br>characteristics | Identical | Yes | Yes |
| USB connection | Identical | Yes, used for battery charging<br>cannot be connected during ECG<br>recording | Yes, used for battery charging<br>cannot be connected during ECG<br>recording |
| 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.