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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 and iron sucrose 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 the 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 ivWatch Model 400 is a medical device that provides continuous, non-invasive monitoring of human tissue adjacent to peripheral intravenous (PIV) insertion sites to aid in the early detection of infiltration and extravasation events. The predicate device includes a Patient Monitor, a Fiber Optic Sensor Cable, and a disposable Sensor Receptacle. Under K192385 the system was expanded to add three Device Accessories including an Extension Module, a Patient Cable and SmartTouch Sensor. The Device Accessories expand system's functionality to support two sensor technologies (fiber optic and electronic).

The ivWatch Model 400 is a medical device that provides continuous, non-invasive monitoring of human tissue adjacent to peripheral intravenous (PIV) insertion sites to aid in the early detection of infiltration and extravasation events.

The ivWatch Model 400 uses visible and near-infrared light to measure changes in the optical properties of the tissue near a PIV insertion site. The ivWatch Patient Monitor (IPM) contains an optical system that generates visible and near-infrared light signals that are sent through the sensor cable to the patient's skin. Simultaneously, the IPM measures the light reflected back through the sensor cable from the patient's skin. Measured changes between the emitted and reflected signal are processed by ivWatch signal processing algorithms to determine if an infiltration event may have occurred. If changes in the optical properties of the tissue near the peripheral IV insertion site are consistent with an infusate pooling in the subcutaneous tissue, the IPM emits audible and visual notifications intended to prompt the clinician to inspect the peripheral IV site for a possible infiltration event.

The provided document (K233881) is a 510(k) summary for the ivWatch® Model 400. This document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K192385) rather than detailing a specific de novo study for a novel device. The key change in the subject device is the addition of iron sucrose as an indicated infusate.

Therefore, the information typically found in a de novo study report regarding acceptance criteria and performance (especially for AI/ML validation) is not extensively detailed. However, I can extract the relevant information pertaining to the acceptance criteria and the study that supports the expanded indications for use.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The document states that the primary change to the device is the expansion of its Indications for Use to include iron sucrose infusates. The performance evaluation for this expansion is presented as bench testing results, indicating the device's ability to detect iron sucrose.

Table of Acceptance Criteria and Reported Device Performance (as implied for the new indication):

• Saline: 23.7% (std: 6.79%)
• Iron: 47.1% (std: 7.97%)
  Comparison:
• Iron injection signals not weaker than saline signals (p≈1.000)
• Diluted iron signal (1mg/ml) is stronger signal than saline.
• Signal strength increases with higher concentration of iron (tested from 1mg/ml to 20mg/ml).
  |
  | Device performance with iron sucrose infusates does not negatively impact device safety or effectiveness (compared to optically clear infusates). | Bench testing results support device detection of iron sucrose; iron infusates do not impact device safety or effectiveness. |

Note: The document states, "Test results show that the ivWatch® Model 400 subject device meets all pre-defined acceptance criteria." However, it does not explicitly list these criteria for the iron sucrose detection beyond the signal strength metrics provided. The overarching acceptance criterion is likely demonstrating that the device functions equivalently or better for iron sucrose as it does for optically clear infusates, upholding its safety and effectiveness.

Study Details for the Expanded Indication (Iron Sucrose)

The information provided does not describe an AI/ML model or a complex clinical trial for performance evaluation. Instead, it refers to bench testing for the new indication.

1. Sample size used for the test set and the data provenance:

   • The document mentions "Iron concentrations from 1mg/ml to 20mg/ml were tested." It does not specify the number of individual tests, samples, or the in vivo or in vitro nature of this "bench testing."
   • Data Provenance: Not explicitly stated, but "bench testing" typically implies laboratory-controlled experiments. There is no indication of country of origin or whether it was retrospective or prospective in a clinical setting for this specific iron sucrose data. The clinical studies mentioned for the predicate device were conducted in the United States and were prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as this was "bench testing" focusing on optical signal changes, not human interpretation or a clinical diagnostic setting requiring expert ground truth in the traditional sense. The ground truth for this test set would be the controlled infusion of known concentrations of iron sucrose and saline.

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

   • Not applicable. As this was bench testing measuring signal properties, there would be no human adjudication process involved.

4. 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:

   • No. The device is a "Peripheral Intravenous (PIV) Infiltration Monitor." It provides audible and visual notifications to clinicians, but it's not described as an AI-powered image analysis tool that a human would interpret. Therefore, an MRMC study or an AI-assisted human reader improvement study is not relevant to this device's function or the claims being made for this 510(k). The device acts as an adjunct to clinical evaluation.

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

   • The "bench testing results" for iron sucrose detection represent the standalone performance of the device's optical properties and signal processing algorithms in a controlled environment. The reported percentage signal drops and comparisons represent algorithm-only performance against known infusates.

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

   • For the iron sucrose bench testing, the ground truth was controlled, known volumes and concentrations of infusates (iron sucrose and saline) instilled/tested in a controlled environment. The 'truth' was the physical presence of the infusate and its expected optical properties.

7. The sample size for the training set:

   • The document implies that the device's core algorithm was developed and validated with the predicate device (K192385). It states that for the predicate, "A series of IRB-approved clinical studies were performed for the verification and validation of the ivWatch Model 400 with Device Accessories." However, it does not specify a separate "training set" in the context of an AI/ML model for this specific 510(k). The current submission focuses on demonstrating the device's existing technology's capability with a new infusate through bench testing, rather than a re-training or significant algorithm modification.

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

   • For the original predicate device (K192385), the ground truth for its clinical validation was established through "IRB-approved clinical studies." This likely involved direct clinical observation and diagnosis of infiltrations by healthcare professionals, serving as the ground truth for the device's ability to detect these events. Specific details of how clinical ground truth was established (e.g., direct visualization, palpation, aspiration, etc.) are not provided in this summary.

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