(230 days)
No
The summary explicitly states that the device is "not intended and should not be used for automated or semi-automated analysis" and that it "does not include ECG analysis".
No.
The device is an ECG recorder used for diagnostic purposes, specifically for continuous cardiac recording and data collection, not for providing therapy or treatment.
No
The Biotres is an ECG recording device that captures and stores ECG data for later evaluation by a medical professional. It explicitly states it "does not include ECG analysis" and is "not a real time ECG monitor," indicating it does not perform diagnostic interpretation itself. The data is accessed by a clinician to make a diagnosis.
No
The device description clearly outlines multiple hardware components: the Biotres Recorder (an ECG recording device) and a dedicated Biotres AC wall charger. While software components (Gateway application and Secure Server) are present, the system relies on physical hardware for data acquisition and charging.
Based on the provided information, the Biotres device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body. IVDs typically involve testing blood, urine, tissue, or other biological samples to diagnose or monitor conditions.
- The Biotres records electrical signals from the body. The Biotres is an ECG recorder that captures electrical activity of the heart directly from the patient's chest. It does not analyze biological samples.
- The intended use is for cardiac recording. The primary function is to acquire and store ECG data for later review by a clinician.
- The device description focuses on ECG recording and data transfer. The components and their functions are all related to capturing and transmitting ECG signals.
Therefore, the Biotres falls under the category of a medical device that records physiological signals, not an In Vitro Diagnostic device.
N/A
Intended Use / 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, 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.
Product codes
MWJ
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, an ECG viewer/EGG display, 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. It has two buttons: a power button and a patient event marking button. An LED "status indicator light" on the marking button provides status indications. The Biotres Recorder attaches to the patient's chest through three standard commercially available ECG electrodes. It includes a Bluetooth modem to communicate with the Biotres Configured Secure Server through the Biotres Gateway Application. The integrated memory can store up to 30-days of ECG data.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest
Indicated Patient Age Range
adult patients 18 years or older
Intended User / Care Setting
Home use, Clinician, Medical professional. Not for use in the hospital.
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)
Bench test results verify that Biotres system can continuously record ECG signal, store ECG data in the device memory, and transmit manual activated event recordings to the server via Bluetooth Biotres Gateway app connection for evaluation by a medical professional. Test results verify that all requirements were met and that the Biotres System performs as designed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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.
January 19, 2022
Biotricity Spencer Ladow VP Engineering 275 Shoreline Drive, Suite 150 Redwood City, California 94065
Re: K211709
Trade/Device Name: Biotres Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MWJ Dated: December 20, 2021 Received: December 22, 2021
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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,
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) K211709
Device Name Biotres
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, 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY
(as required by 21CFR 807.92)
Date Prepared: January 10, 2022
SUBMITTER l.
Biotricity 275 Shoreline Drive, Suite 150 Redwood City CA 94065 Contact Person: Spencer LaDow sladow@biotricity.com Phone: 585-414-7407
II. DEVICE
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)
III. PREDICATE DEVICE
The ePatch (Braemar Manufacturing, LLC) was cleared under K171410.
Name of Device: Classification Regulation: Common Name: Device Panel: Regulatory Class: Product Code:
ePatch 21 CFR§870.2800 Medical Magnetic Tape Recorder Cardiovascular Class II DSH
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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, an ECG viewer/EGG display, 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: This image is a diagram of a device with several labeled parts. The diagram labels the 'Status Indicator Light' and 'Marking Button' at the top of the device. The diagram also labels the 'Power Button' and 'Charging Port' on the side of the device, as well as the 'Snap for ECG electrode' at the bottom.
Biotres Recorder – Back View
BACK VIEW
Image /page/4/Figure/8 description: The image shows a top-down view of a Biometric device with three electrode connectors. The device has a circular body with the word "biotricity" and a logo printed on the top. There is also a QR code and some text that reads "Model: Blotree 1.0, Serial: 1230000089, Contains FCC ID: 2AKGEBIOTRES1, FDA CLEARED". The bottom of the device has the text "FC IP22 B".
FRONT VIEW
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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, charging, fully 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.
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.
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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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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS WITH THE VII. PREDICATE DEVICE
| Category | Identical/
Different | Biotres | ePatch |
|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Identical | K211709 | K171410 |
| Classification Name | Identical | Medical
Magnetic Tape Recorder | Medical
Magnetic Tape Recorder |
| Product Code | Similar | MWJ | DSH |
| Intended Use | Similar | 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. | ePatch® is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety. The ePatch® is intended for use by adolescents 18-21 and adults. |
| Defibrillator Protection | Similar | Not Defibrillator Proof, 8.5.5.2 of IEC 60601-1 passed | Not Defibrillator Proof |
| Wear Time | Different | Up to 30 Days | Up to 5 days |
| Recording Format | Identical | Continuous | Continuous |
| Delivered device includes | Similar | -3 lead ECG monitor
-internal rechargeable battery
-Wall Battery charger | ePatch monitor
Battery
Sensor Patch
Skin prep kit |
| Monitor functional blocks | Similar | Analog ECG front end,
MCU,
Flash data storage,
BLE modem for
data transmission,
LED indicator, and | Analog ECG front end,
Accelerometer,
MCU,
Flash data storage,
USB cable for
data transmission |
| Category | Identical/
Different | Biotres | ePatch |
| | | Record button | LED indicator, and
Record button |
| The App: | Similar | Mobile App, iOS, Android | PC based |
| The server: | Similar | Facilitate data communication
with the Biotres device,
provide data storage, and
present the data for evaluation by
a medical professional | Facilitate data communication
with the ePatch device, provide
data storage, and
present the data for evaluation by
a medical professional |
| Device form factor | Identical | Small, lightweight body worn
ambulatory cardiac monitors. | Small, lightweight body worn
ambulatory cardiac monitors. |
| Wireless technology
used to transmit data
to server | Different | Yes | No |
| Device is battery
powered by a
rechargeable Li-Ion
battery | Identical | Yes | Yes |
| Using an app, can
adjust device
programming
parameters such as
pre-post recording
times and auto-
triggering
configuration. | Similar | Yes, app is android or IOS based | Yes, app is PC based |
| Devices have Record
button for manual
event recordings and
a user led to indicate
device status and
mode of operation. | Similar | Yes | Yes |
| Device has at least 2
ECG channels and 3-
lead electrodes | Similar | Yes | Yes |
| Functional,
Environmental and
Electrical
characteristics | Similar | Yes | Yes |
| USB connection | Different | Yes, used for battery charging
cannot be connected during ECG
recording | Yes, used for data download and
communication, battery charging
cannot be connected during ECG
recording |
8
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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.
- IEC 60601-1:2012 3rd Edition with amendment 1. Medical electrical equipment ● - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2014 4th Edition, Medical Electrical Equipment Part ● 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC 60601-1-11:2015 Edition 1.1. Medical electrical equipment Part ● 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 62366-1:2015 Edition 1.0. Medical devices Part 1: Application ● of usability engineering to medical devices
- Biocompatibility testing of patient contacting materials according to ISO 10993-1.
- Bench test results verify that Biotres system can continuously record ECG signal, store ECG data in the device memory, and transmit manual activated event recordings to the server via Bluetooth Biotres Gateway app connection for evaluation by a medical professional. Test results verify that all requirements were met and that the Biotres System performs as designed.
CONCLUSION IX.
The analysis of the differences between Biotres and the predicate device does not raise new questions of safety and effectiveness. Based on device performance test results. Biotricity determined that the Biotres system performed within its design specifications and is considered to be substantially equivalent to the predicate device.