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The ivWatch Model 400 is indicated for the detection of subcutaneous infiltrations and extravasations of 10 cc or less of optically clear infusates, as an adjunctive device to the clinical evaluation in the healthcare setting of adults and pediatrics with peripherally-inserted catheters (PIVs). The device is indicated to assess patients for subcutaneous infiltrations and extravasations but should not serve as a substitute for regular clinician assessment of the PIV site. The ivWatch Model 400 is intended for use by healthcare practitioners who have been trained in the use of the device.

The predicate device (K162478), the ivWatch® Model 400, consists of the ivWatch® Patient Monitor, a reusable Fiber Optic Sensor Cable and a single-use sterile Sensor Receptacle. The subject device includes the addition of Device Accessories to the ivWatch® Model 400 including an Extension Module, reusable Patient Cable and a single-use electronic SmartTouch™ Sensor. The Device Accessories expand the current ivWatch® Model 400 architecture to support the reusable Fiber Optic Sensor (predicate device) and an electronic single-use sterile SmartTouch™ Sensor (subject device). Both the predicate and subject device provide continuous, non-invasive monitoring of human tissue adjacent to peripheralintravenous (PIV) insertion sites to aid in the early detection of infiltration and extravasation events.

The ivWatch® Model 400 with Device Accessories uses visible and near-infrared light to measure changes in the optical properties of the tissue near a PIV insertion site. Light signals generated by the SmartTouch™ Sensor are sent to the patient's tissue near an PIV site. Changes to the light signals are received by the SmartTouch™ Sensor and electrical signals are transferred through the Patient Cable to the Extension Module where embedded software analyzes the data to determine whether conditions indicate that an infiltration event may have occurred. The information is then sent from the Extension Module to the ivWatch® Patient Monitor for display. If changes in the diffuse reflectance in the tissue near the PIV site are consistent with an infusate pooling in the subcutaneous tissue, the ivWatch® Patient Monitor emits audible and visual notifications intended to prompt the clinician to inspect the peripheral IV site for a possible infiltration event.

The provided text describes the performance data for the ivWatch Model 400 with Device Accessories, focusing on its ability to detect infiltrations and extravasations.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document does not explicitly list numerical acceptance criteria for many of the performance metrics. Instead, it presents the results of the performance testing and implies that these results demonstrate the device meets an acceptable level of performance, similar to the predicate device, thereby supporting its substantial equivalence. The "Pass" or "Compliant" remarks in the summary table for other tests (EMC, Biocompatibility, etc.) serve as their acceptance criteria.

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: The document mentions "series of five verification and two validation IRB-approved clinical studies." However, specific patient numbers for these studies are not provided.
     • For the non-infiltrated tissue study, it states "6 false red notifications in 922 hours" and "8 false yellow notifications in 922 hours." This suggests the "922 hours" represents the cumulative observation time across participants in that specific validation study. The number of individual patients or IV sites contributing to these hours is not specified.
     • For the infiltrated tissue study, it reports "99.0% (97/98)" detection, indicating that 98 infiltration events were analyzed in this validation study. It doesn't specify if these 98 events came from 98 different patients or multiple events from fewer patients.
   • Data Provenance: Not explicitly stated, but implied to be prospective clinical studies conducted for the device development and validation. The country of origin is not specified but given the FDA submission, it is likely that parts of these studies, or at least the analysis, were conducted in the US or in a manner compliant with US regulatory guidelines.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical studies. It mentions the device should be used as "an adjunctive device to the clinical evaluation" and "should not serve as a substitute for regular clinician assessment." This implies that clinical evaluation by healthcare practitioners would be the reference for ground truth on infiltration events, but no specific team or panel of experts is described for this purpose in the context of the study's ground truth establishment.

3. Adjudication Method for the Test Set:

   • No specific adjudication method (e.g., 2+1, 3+1) is mentioned for establishing the ground truth of infiltration events in the clinical studies. The reliance on "clinical evaluation" suggests standard clinical practice for identifying infiltrations.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study was mentioned. The study focuses on the device's standalone performance in detecting infiltrations rather than its impact on human reader performance. This device is described as an "adjunctive device" meant to provide alerts, not to replace human assessment, so a human-in-the-loop MRMC study might not be directly relevant to its primary function or regulatory pathway.

5. Standalone (Algorithm Only) Performance:

   • Yes, the performance data provided appears to be for the standalone performance of the algorithm and device. The device itself emits notifications (audible and visual) based on its internal analysis of optical signals. The reported percentages and volumes (e.g., 99.0% detection, average 2.13 mL for red notifications) refer to the device's direct output, not its interaction with a human reader's interpretation.

6. Type of Ground Truth Used:

   • The ground truth for infiltration events appears to be based on clinical evaluation of actual or simulated infiltrations in patients. The document refers to "early stage infiltrations" and "infiltrated saline," suggesting direct observation or controlled induction of infiltrations confirmed by clinical signs, rather than solely pathology or outcomes data.

7. Sample Size for the Training Set:

   • The document does not provide a specific sample size for the training set. It mentions "a series of five verification and two validation IRB-approved clinical studies were performed for the development and validation." This implies that data from some of these studies (likely verification studies) might have been used for development and refinement of the device's algorithms, which would include training. However, explicit training set details are missing.

8. How the Ground Truth for the Training Set Was Established:

   • Similar to the test set, the method for establishing ground truth for any potential training data is not explicitly detailed. Given the nature of the device and its function, it can be inferred that ground truth was established through clinical observation and assessment by healthcare professionals of IV sites. This would involve noting when an infiltration occurred, confirming it, and correlating it with the device's readings.

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