Search Results

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 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 consists of the ivWatch Patient Monitor (IPM), a reusable optical sensor cable and a single-use Sensor Receptacle. 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 IPM contains an optical system that generates visible and near-infrared light signals that are sent through the optical sensor cable to the patient's skin. Simultaneously, the IPM measures the light reflected back through the optical 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.

Based on the provided FDA 510(k) summary for the ivWatch Model 400 (K222212), this submission primarily concerns a change in the sterilization method for the Sensor Receptacle component of the device. Therefore, the "study" proving the device meets acceptance criteria is specifically focused on demonstrating the equivalence of the new sterilization method to the previous one and showing that the device, with this new sterilization, still meets relevant standards for sterility and biocompatibility.

Here's an breakdown of the information requested, drawing from the provided text:

1. A table of acceptance criteria and the reported device performance

Ask a specific question about this device

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.

Ask a specific question about this device

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 iv Watch 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 consists of the ivWatch Patient Monitor (IPM), a reusable optical sensor cable and a single-use sensor receptacle.

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 IPM contains an optical system that generates visible and near-infrared light signals that are sent through the optical sensor cable to the patient's skin. Simultaneously, the IPM measures the light reflected back through the optical sensor cable from the patient's skin. Measured changes between the emitted and reflected signal are processed by proprietary 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 ivWatch Model 400 is an adjunctive device to aid in the early detection of subcutaneous infiltrations and extravasations of 10 cc or less of optically clear, uncolored infusates in patients 18 years or older with peripherally-inserted IVs (PIVs) on the forearm or dorsal aspect of the hand. The device was submitted for a 510(k) premarket notification (K153605).

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The device under review is an updated version of the ivWatch Model 400 (K153605), with modifications only to the sensor cable sheathing. The performance data presented focuses on verifying that these modifications do not negatively impact the device's safety and effectiveness compared to the predicate device (K142374). Therefore, the acceptance criteria and results specifically address biocompatibility and reprocessing, as clinical efficacy was not re-evaluated for this submission.

2. Sample Size Used for the Test Set and Data Provenance

The document does not detail specific sample sizes for the individual biocompatibility and reprocessing tests beyond indicating that the tests were performed. It broadly states that the testing was performed on the "sheathing of the sensor cable" and "the sensor cable."

Given the nature of the tests (biocompatibility and reprocessing validation), the "test set" would typically refer to the samples of the modified sensor cable sheathing and sensor cable that underwent the evaluations. The provenance of this data is from tests conducted by ivWatch, LLC for regulatory submission. The document does not specify country of origin for the data or whether it was retrospective or prospective, but such testing is typically prospective, conducted specifically for the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For the biocompatibility and reprocessing tests, "ground truth" is established by adherence to recognized international standards and guidelines (ISO 10993 series and AAMI guidance documents). The "experts" involved would be the certified laboratories and personnel performing these tests, who are qualified to interpret the standards and conduct the specific assays (e.g., cell culture for cytotoxicity, animal models for sensitization/irritation, microbiology for disinfection). The document does not specify the number or specific qualifications of these experts beyond referencing the ISO and AAMI standards.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 (common in image review studies) are not applicable to the type of non-clinical "test sets" described (biocompatibility and reprocessing validation). The results are objectively determined based on the outcomes of standardized scientific assays and compared against predefined pass/fail criteria outlined in the relevant standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done for this specific submission (K153605). The document explicitly states, "Clinical testing was not required for this submission." This indicates that the safety and effectiveness of the device's core functionality (detection of infiltrations) was established in a prior submission (K142374), and the current submission only addresses modifications that do not impact that core functionality or clinical performance. Therefore, there is no effect size reported for human readers improving with or without AI assistance, as AI functionality for interpretive purposes is not central to this device's regulatory review.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone study presenting algorithm-only performance metrics (e.g., sensitivity, specificity for infiltration detection) was performed or discussed in this submission. Similar to the MRMC study, this type of performance data would have been part of the original K142374 submission that established the device's fundamental function. The current submission focuses on material and reprocessing changes.

7. Type of Ground Truth Used

For the biocompatibility tests (sensitization, irritation, cytotoxicity), the "ground truth" is determined by the biological response observed in standardized in vitro or in vivo tests, as interpreted against the acceptance criteria defined by the ISO 10993 standards.

For the reprocessing validation (low-level disinfection and cleaning), the "ground truth" is established by demonstrating a predefined reduction in microbial load or removal of organic soil from the device, verified through validated laboratory methods according to AAMI guidance.

8. Sample Size for the Training Set

The concept of a "training set" is generally applicable to machine learning algorithms. While the ivWatch Model 400 uses "proprietary ivWatch signal processing algorithms," the document does not discuss the algorithms' development or any associated training sets for this particular submission. The focus is on the physical components of the device. Any algorithm training would have occurred during the development of the original predicate device (K142374).

9. How the Ground Truth for the Training Set Was Established

As no training set is discussed in this specific 510(k) summary, the method for establishing its ground truth is not provided. For such a device, if an algorithm were indeed trained, the ground truth for infiltration detection would likely involve direct clinical observation by healthcare professionals, potentially confirmed by imaging or other objective measures of fluid extravasation, collected prospectively or retrospectively. However, this level of detail is absent from the provided document.

Ask a specific question about this device

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:

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.

Ask a specific question about this device