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The EnVan Heart Rate Monitor is indicated for use to measure the heart rate of patients who require routine periodic vital signs monitoring. It is intended to provide heart rate information on a wristwatch display for interpretation by a healthcare professional in a hospital, outpatient or ambulatory care setting. It is neither designed nor intended for use in the place of cardiac (electrocardiograph) monitoring.

The EnVan Heart Rate Monitor is not suitable for use within emergency rooms, intensive care or cardiac care units, or operating room or post anesthesia units where cardiac monitors, pacemakers and other types of electrical or electronic medical devices are in use. These devices may interfere with the operation of the EnVan Heart Rate Monitor.

The EnVän Heart Rate Monitor is currently marketed as a consumer product for use as a sports training aid, and intended for use in conjunction with either exercise devices or exercise routines with no medical indications. Clearance of this 510(k) premarket notification will allow the device to be labeled for use to measure heart rate in patients who require routine, periodic vital signs monitoring.

Major Components: Heart rate signals are acquired and transmitted by conductive synthetic rubber pads (IndePad™) then processed and displayed on a digital wristwatch worn by the healthcare professional. The heart rate display on the screen is updated every few seconds, to assure an accurate measurement of heart rate.

The provided text from the 510(k) summary for the EnVän Heart Rate Monitor does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document primarily focuses on:

• Administrative details: Sponsor, manufacturer, contact information, device trade name, common name, classification, product code, and regulation number.
• Device description: Currently marketed as a consumer product for sports training and proposed for medical indications (routine, periodic vital signs monitoring).
• Intended use/indications for use: To measure heart rate in patients requiring routine periodic vital signs monitoring, displayed on a wristwatch for interpretation by a healthcare professional in specific settings (hospital, outpatient, ambulatory care), explicitly stating it's not for cardiac (ECG) monitoring or use in critical care environments where other medical devices might interfere.
• Major components: Indepad™ conductive synthetic rubber pads and a digital wristwatch display.
• Basis for substantial equivalence: Claims equivalence to predicate devices (Criticare Systems Vital Signs Monitor and Masimo SET® Radical Pulse Oximeter) in indications for use, technological characteristics, performance characteristics, and instructions for use, specifically for heart rate monitoring capabilities.
• FDA correspondence: The FDA's letter of substantial equivalence approval, reiterating the regulatory information and general controls.

Therefore, I cannot extract the requested information regarding acceptance criteria and the study proving adherence to them from this document. The document lists "performance characteristics" as a point of comparison to predicate devices but does not elaborate on what those characteristics are for the EnVän device itself, nor does it present any study data to support them.

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