(30 days)
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No
The description focuses on data management, display, and reporting, with no mention of AI/ML terms or functionalities like learning, prediction, or automated analysis beyond basic statistics. The clinician is explicitly stated as being solely responsible for analysis criteria and interpretation.
No
The device is described as data management software that reviews, summarizes, and generates reports of regional oximetry data for interpretation by a clinician; it does not provide any therapy or treatment.
No
Explanation: The device description states that eVISION software is an "adjunct system requiring clinician interpretation of results; it does not suggest a course of treatment or generate a diagnosis." This explicitly indicates that it is not a diagnostic device.
Yes
The device is described as "eVISION® Data Management Software" and its function is to display, summarize, and manage data from a separate hardware device (Model 7600 Regional Oximeter System) on a personal computer. The description focuses solely on the software's capabilities and verification/validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to manage, review, and report data from a regional oximeter. It's about handling data from a medical device, not performing a test on a biological sample to diagnose or monitor a condition.
- Device Description: The description explicitly states that the software displays and summarizes downloaded patient data for review and interpretation by a clinician. It does not perform any analysis on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
The software is a data management tool for a medical device (the regional oximeter), not a diagnostic test itself.
N/A
Intended Use / Indications for Use
eVISION® Data Management Software (eVISION) is an optional accessory for use with Nonin's Model 7600 Regional Oximeter System. It is intended for use by healthcare professionals when 1) transferring data from the Model 7600 to a computer in order to maintain individual records of regional oximetry data, 2) reviewing data according to user-selected parameters, and 3) generating reports.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
eVISION® Data Management Software (eVISION) is an optional accessory for use with the Model 7600 Regional Oximeter System to display and summarize downloaded patient regional oxygen saturation (rSO2) data on a personal computer. Data can be displayed as data graphs and/or statistics for review and interpretation by a clinician. Data is obtained from the Model 7600 via Bluetooth® connection provided by the host computer on which eVISION is installed. The software also allows regional oximetry data and patient information to be saved in a "library" for future retrieval and analysis. The clinicain using eVISION software is solely responsible for selecting the analysis criteria used to calculate summary statistics included in the reports. eVISION® software is an adjunct system requiring clinician interpretation of results; it does not suggest a course of treatment or generate a diagnosis.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Risk Management process is used to assess the safety of the device; no new risks were identified with the modification to the eVISION Data Management Software. Software Verification and Validation was completed to verify the performance, functionality, and features of eVISION.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0