(171 days)
The iv Watch Model 400 is indicated for the detection of subcutaneous infiltrations and extravasations of 10 cc or less of optically clear, uncolored infusates, as an adjunctive device to the clinical evaluation in the hospital setting of patients 18 years old or greater with peripherally-inserted IVs (PIVs) on the forearm or dorsal aspect of the hand.
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 physicians, or under the direction of a physician, who have been trained in the use of the iv Watch Model 400.
The ivWatch Model 400 is a medical device that provides continuous, noninvasive monitoring of human tissue adjacent to peripheral intravenous (PIV) insertion sites on the forearm and dorsal aspect of the hand to aid in the early detection of infiltration and extravasation events. The ivWatch Model 400 ("Device") consists of the ivWatch Patient Monitor (IPM), a reusable optical sensor cable, and a single-use sensor receptacle.
The device uses visible and near-infrared light to measure changes in the optical properties of the tissue near a PIV insertion site; the measured changes are processed by proprietary ivWatch signal processing algorithms to determine if an infiltration event may have occurred. The device is indicated for use by medical professionals who are experienced with administering or monitoring peripheral IV therapy.
The IPM mounts to an IV pole, typically above the infusion pump. The sensor is secured in the receptacle and subsequently placed on the patient's skin near the peripheral IV insertion site for the duration of the IV monitoring. The fiberoptic sensor cable follows the IV line back to the pole-mounted IPM.
One end of the sensor cable attaches to the IPM; the other end snaps into the ivWatch sensor receptacle, which secures the sensor to the patient's skin. The sensor cable is a multiple-use disposable with a total useful life of approximately 240 hours of IV monitoring; it is intended to be cleaned between uses.
The ivWatch sensor receptacle is molded out of biocompatible plastics and includes biocompatible adhesives for attaching the receptacle to the patient's skin. The sensor receptacle is a single-use disposable and supplied sterile.
The IPM contains an optical system that generates light signals that are sent to the patient's skin (via the sensor cable) and measures the light returning from the patient's skin (also via the sensor cable). The Device uses low power LEDs as sources of visible and near-infrared (NIR) light. Optical fibers in the sensor cable deliver the light from the IPM to the sensor and transmit reflected light back to the IPM. The IPM also contains the hardware for executing the proprietary ivWatch signal processing algorithm.
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.
Here's a breakdown of the acceptance criteria and study information for the ivWatch Model 400, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria alongside specific measured device performance metrics (e.g., sensitivity, specificity, PPV, NPV) with numerical thresholds for infiltration detection. Instead, it describes the device's ability to assist clinicians in identifying early stages of PIV infiltration and mentions "sensitivity, false notification rate" as performance aspects assessed in validation studies without providing specific values or targets.
However, based on the description, the primary functional acceptance criterion appears to be:
| Acceptance Criterion (Inferred from device function) | Reported Device Performance (Summary) |
|---|---|
| Early detection of PIV infiltration/extravasation | The results demonstrated that the ivWatch Model 400 could assist clinicians in identifying the early stages of a PIV infiltration. |
| Safety (biocompatibility, electrical, optical) | Compliant with ISO 10993-1, IEC 60601-1-2, ANSI/AAMI ES60601-1, ANSI Z136.1-2007. Performed without adverse events during clinical studies. |
| Functional (software, hardware) | Software V&V compliant with FDA guidance and IEC 62304. Bench testing validated optimal sensor design using ex vivo porcine foot model. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: "A series of six IRB-approved verification and validation clinical studies were performed." The exact total number of patients or infiltration events across these six studies is not specified in the provided document.
- Data Provenance: The studies were prospective clinical studies given the mention of "IRB-approved verification and validation clinical studies" and active monitoring during IV infusions. The country of origin of the data is not explicitly stated, but the FDA submission suggests it was likely in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications to establish ground truth for the test set. It mentions the device is "adjunctive... to the clinical evaluation" and "intended for use by physicians, or under the direction of a physician, who have been trained in the use of the ivWatch Model 400." This implies that physicians/clinicians were involved in the ground truth assessment, but details are lacking.
4. Adjudication Method for the Test Set
The document does not specify the adjudication method used for the test set (e.g., 2+1, 3+1, none). Ground truth establishment is only broadly referred to as "clinical evaluation."
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not detailed or mentioned in the provided document. The device is described as "adjunctive" to clinical evaluation, implying it works alongside clinicians, but no study comparing human performance with and without the device is presented.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
A standalone performance assessment without human intervention was done to some extent. The document states:
- "The ivWatch Model 400 could assist clinicians in identifying the early stages of a PIV infiltration." This implies the device provides an alert based on its algorithm's detection.
- "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." This further indicates its primary function is automated detection.
- "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..." This describes the algorithm's standalone output (notifications) without immediate human intervention as part of the detection step.
The validation studies assessed "performance (e.g., sensitivity, false notification rate)" of the device, which are metrics typically associated with standalone algorithm performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth used for the test set is implicitly clinical evaluation by clinicians/physicians. The "Indications for Use" explicitly states the device is "adjunctive device to the clinical evaluation."
8. The Sample Size for the Training Set
The document does not specify the sample size used for the training set. It mentions "Computer simulations were used to identify the optimal design for the ivWatch sensor," which might involve simulated data, but no real-world training data size is provided.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly describe how ground truth for a training set (if any real-world data was used for training the proprietary algorithms) was established. It refers to "proprietary ivWatch signal processing algorithms" and "Computer simulations...validated in bench tests using an ex vivo porcine foot model" for sensor design. This suggests a blend of simulation, bench testing, and perhaps prior knowledge/data informing algorithm development, rather than a distinct, described process for establishing ground truth on a specific training dataset from human subjects.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).