(20 days)
Not Found
No
The device description explicitly states that the signal acquired is "not intended and should not be used for automated or semi-automated analysis" and that the device "does not include ECG analysis, alarms and is not a real time ECG monitor." Furthermore, there is no mention of AI, DNN, or ML in the document.
No.
The device is described as an "ECG recording only device" that "does not include ECG analysis, alarms and is not a real time ECG monitor." It records data for later clinician review and does not provide diagnostic or interpretive statements directly, nor does it deliver any therapy.
Yes
The device is indicated for use on patients experiencing symptoms that may require cardiac recording. It collects ECG data for up to 30 days, which clinicians can then view to assess cardiac function. While the device itself doesn't provide diagnostic statements, the data it collects is intended for use in diagnosing conditions related to the listed symptoms.
No
The device description clearly outlines hardware components including the "Biotres Recorder," a physical ECG recording device, and a "dedicated Biotres AC wall charger." While software components are part of the system, the device is not solely software.
Based on the provided information, the Biotres device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples from the human body. The Biotres records electrical signals from the heart (ECG data) through electrodes placed on the skin. It does not analyze biological samples like blood, urine, or tissue.
- The intended use is for cardiac recording. The device is designed to capture and store ECG data for later review by qualified medical personnel. It explicitly states that the signal is "not intended and should not be used for automated or semi-automated analysis" and that it "does not provide the patient or clinician with diagnostic or interpretive statements based on the ECG data."
- The device description focuses on ECG recording and data transfer. The components and functionality described are related to capturing, storing, and transmitting ECG signals, not analyzing biological samples.
Therefore, the Biotres falls under the category of a medical device for physiological monitoring, specifically ambulatory ECG recording, rather than 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, 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 (comma separated list FDA assigned to the subject device)
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.
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. The patient can push 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.
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 (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.
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.
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.
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. Clinicians, physician or trained healthcare professional for diagnosis and interpretation.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
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
1
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
2
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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3
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: 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
Page 1 of 7
4
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
Page 2 of 7
5
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.
6
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.
7
VII. SUMMARY OF TECHNOLIGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Category | Identical/
Different | Biotres | Biotres (predicate) |
|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K222107 | K211709 |
| Classification
Name | Identical | Medical
Magnetic Tape Recorder | Medical
Magnetic Tape Recorder |
| Product Code | Identical | MWJ | MWJ |
| Intended Use | Identical | 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. | 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. |
| Defibrillator
Protection | Identical | Not Defibrillator Proof, 8.5.5.2 of
IEC 60601-1 passed | Not Defibrillator Proof, 8.5.5.2 of
IEC 60601-1 passed |
| Wear Time | Identical | Up to 30 Days | Up to 30 Days |
| Recording Format | Identical | Continuous | Continuous |
| Delivered device
includes | Identical | -3 lead ECG monitor
-internal rechargeable battery
-Wall Battery charger | -3 lead ECG monitor
-internal rechargeable battery
-Wall Battery charger |
| Monitor functional
blocks | Identical | Analog ECG front end,
MCU,
Flash data storage,
BLE modem for
data transmission,
LED indicator, and | Analog ECG front end,
MCU,
Flash data storage,
BLE modem for
data transmission,
LED indicator, and |
| Category | Identical/
Different | Biotres | Biotres (predicate) |
| The App: | Identical | Record button
Mobile App, iOS, Android | Record button
Mobile App, iOS, Android |
| The server: | Identical | 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 Biotres 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 | Identical | Yes | Yes |
| 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. | Identical | Yes, app is android or IOS based | Yes, app is android or IOS based |
| Devices have Record
button for manual
event recordings and
a user led to indicate
device status and
mode of operation. | Identical | Yes | Yes |
| Device has at least 2
ECG channels and 3-
lead electrodes | Identical | Yes | Yes |
| Functional,
Environmental and
Electrical
characteristics | Identical | Yes | Yes |
| USB connection | Identical | Yes, used for battery charging
cannot be connected during ECG
recording | Yes, used for battery charging
cannot be connected during ECG
recording |
| ECG Viewer Software | Different | Bioflux Software II (K201040) | None |
Page 5 of 7
8
Page 6 of 7
9
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.