(230 days)
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.
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.
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.
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.
This FDA 510(k) submission for the Biotres device does not include the detailed information required to describe acceptance criteria and associated study results for an AI/ML powered device. The Biotres is described as an ECG recording-only device that does not include ECG analysis, an ECG viewer/display, alarms, or real-time ECG monitoring. It explicitly states: "The signal acquired by the Biotres is not intended and should not be used for automated or semi-automated analysis."
Therefore, the following information cannot be extracted from the provided document:
- A table of acceptance criteria and the reported device performance: Not applicable, as there are no automated analysis functionalities to evaluate.
- Sample size used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document primarily focuses on regulatory clearances, device description, comparison to a predicate device (ePatch), and performance testing related to electrical safety, electromagnetic compatibility, usability, and biocompatibility, as well as bench tests verifying ECG signal recording and transmission capabilities. These are standard tests for a medical device that records data but does not perform automated analysis.
§ 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).