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K Number
K131000
Device Name
V-PATCH SYSTEM
Manufacturer
INTELESENS LIMITED
Date Cleared
2014-01-08

(273 days)

Product Code
DSI
Regulation Number
870.1025
Type
Traditional
Panel
CV
Reference & Predicate Devices
K100155
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Intelesens V-Patch System is designed to monitor and transmit ECG data to a web based host application for display or analysis by a clinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare or home environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation.

The re-usable device is intended to be used with a single use electrode on the patient for up to seven days.

The V-Patch System uses an on-board ECG arrhythmia detection algorithm to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device transmits the data to the host application at user defined intervals or upon the detection of an arrhythmia event. The V-Patch also has a patient activated button that allows ECG to be recorded and transmitted on-demand should the patient experience any relevant symptoms.

Device Description

The V-Patch device is a small, lightweight wearable device that is connected to an accessory electrode that is applied to the patient's body. The electrodes are a proprietary Intelesens design. The patient wearable monitor is named the V-Pod operates on user replaceable coin cells. The device wirelessly transmits physiological data relating to ECG and heart rate to a receiving station - the V-Cell via a wireless ANT connection.

The V-Cell interfaces to the Internet via GPRS allowing for web-based analysis by a clinician on the Canberra System. There are also on-board algorithms that continuously monitor for, and record ECG on detection of nine cardiac arrhythmias and a patient activated event button. The cardiac arrhythmias detected are:

  • . Bradyarrhythmia
  • . Ventricular Tachycardia
  • . Supraventricular Tachycardia
  • Ventricular Fibrillation .
  • . Atrial Flutter
  • . Atrial Fibrillation
  • l st degree Heart Block .
  • . 2nd degree Heart Block
  • . 3rd degree Heart Block
AI/ML Overview

The provided text describes the V-Patch System, a physiological patient monitor, and its 510(k) submission. However, it does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria beyond general statements of compliance with standards.

The document states:

  • "The V-Patch System has been tested in accordance with the relevant test plans/reports included with this 510(k) submission using the production equivalent units prior to release to market."
  • It lists tests performed: Hardware Verification, Compliance with IEC 60601-1, Compliance with IEC 60601-1-2, System Validation, Electrode Validation Summary inclusive of AAMI EC12 compliance, Compliance with AAMI EC 57, Electrode Storage test, and AAMI ANSI EC38.
  • "The V-Patch has equivalent specifications of performance as the predicate."

Without access to the "relevant test plans/reports" mentioned, specific numerical acceptance criteria and reported device performance are not available in this summary.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided 510(k) summary.

Based on the provided text, I can extract the following information, but many requested details are missing:

  1. A table of acceptance criteria and the reported device performance:

    • Information Missing: The document states the device was tested for compliance with various standards (IEC 60601-1, IEC 60601-1-2, AAMI EC12, AAMI EC57, AAMI ANSI EC38) and underwent Hardware Verification, System Validation, and Electrode Storage tests. However, the specific numerical acceptance criteria for these tests and the reported device performance against those criteria are not detailed in this summary. It only states "Compliance with AAMI EC 57" for example, not the specific metrics within EC 57 that were met and by what margin.

  2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

    • Information Missing: The document does not specify the sample size used for any test sets or the provenance of the data (e.g., country of origin, retrospective/prospective nature).

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

    • Information Missing: The document makes no mention of experts or the establishment of ground truth for specific test sets. The device has "on-board algorithms that continuously monitor for, and record ECG on detection of nine cardiac arrhythmias," implying an automated detection process, but no human expert review process for evaluation is described in the provided summary.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • Information Missing: No adjudication method is described, as there's no mention of human expert review.

  5. 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:

    • Information Missing: No MRMC study is mentioned. The device's purpose is to "monitor and transmit ECG data to a web based host application for display or analysis by a clinician" and to "automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event." This implies a potential assistance role, but no study on the effectiveness of human readers with vs. without AI assistance is described.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Partial Information: The document states, "The V-Patch System uses an on-board ECG arrhythmia detection algorithm to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event." This confirms the existence of a standalone algorithm for arrhythmia detection. The "Compliance with AAMI EC 57" suggests evaluation of rhythm and ST-segment measurement algorithms, which would typically involve standalone performance assessment. However, specific performance metrics for this standalone algorithm are not listed.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

    • Information Missing: The specific type of ground truth used for evaluating the arrhythmia detection algorithm is not stated. AAMI EC57 involves established arrhythmia databases and methods for performance evaluation against known truth, but the details of how that truth was established for the specific data used by Intelesens are not in this summary.

  8. The sample size for the training set:

    • Information Missing: No information about a training set or its sample size is provided.

  9. How the ground truth for the training set was established:

    • Information Missing: As no training set information is provided, how its ground truth was established is also not mentioned.

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.