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.

Device Description

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 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.

AI/ML Overview

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):

Acceptance Criterion (Implied for new indication: Iron Sucrose)	Reported Device Performance
Ability of the device to detect signal changes consistent with infiltration of iron sucrose infusates.	Mean signal drops: - 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.

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.
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.
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.
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.
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.
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.
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.
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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."

March 15, 2024

ivWatch, LLC Holly Novak Vice President, Regulatory Affairs & Quality Assurance 700 Tech Center Parkway Suite 300 Newport News, Virginia 23606

Re: K233881

Trade/Device Name: ivWatch® Model 400 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: PMS Dated: February 16, 2024 Received: February 16, 2024

Dear Holly Novak:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Walloschek

David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K233881

Device Name ivWatch® Model 400

Indications for Use (Describe)

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 iv Watch Model 400 is intended for use by healthcare practitioners who have been tramed in the use of the device.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	☑
Over-The-Counter Use (21 CFR 801 Subpart C)	☐

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K233881 - 510(K) SUMMARY

Device Submitter	ivWatch, LLC
	700 Tech Center Parkway, Suite 300
	Newport News, VA 23606
Contact Person	Holly Novak, Vice President of Regulatory Affairsand Quality Assurance
	holly.novak@ivwatch.com 855-489-2824 x7046
	Fax: 757-224-5009
Date Prepared	December 07, 2023

Subject Device

Trade Name	ivWatch® Model 400
Device Class	II
Regulation Number	21 CFR 880.5725
Product Code	PMS
Common Name	Peripheral Intravenous (PIV) Infiltration Monitor
Classification Name	Infusion pump

Predicate Device

Trade Name	ivWatch® Model 400
510(k) Number	K192385
Device Class	II
Regulation Number	21 CFR 880.5725
Product Code	PMS
Common Name	Peripheral Intravenous (PIV) Infiltration Monitor
Classification Name	Infusion pump

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Device Description

Intended Use

The ivWatch Model 400 is intended to aid in the detection of infiltrations and extravasations during peripheral IV infusion therapy in pediatric and adult patients. The user profile is healthcare practitioners who are experienced in IV administration and management and located at hospitals and similar medical care facilities.

The intended use of the subject device is the same as the predicate (K192385).

Indications for Use

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The indications for use of the subject device are the predicate (K192385), with the addition of iron sucrose as an indicated infusate.

Comparison of the Subject Device to the Predicate Devices

The subject device includes all the same device accessories as the predicate. Under this 510K submission, the only change is to the Indications for use to add iron sucrose as an indicated infusate. There are no changes to the devices.

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Image /page/7/Picture/0 description: The image shows the logo for IVWatch. The logo consists of a stylized teardrop shape on the left, with the letters "iv" inside the teardrop. To the right of the teardrop is the word "Watch" in a sans-serif font. The logo is simple and modern, and the use of the teardrop shape likely represents intravenous fluids.

ivWatch, LLC 700 Tech Center Parkway, Suite 300 Newport News, VA 23606

1.855.IVWATCH (489.2824) Fax: 757.224.5009 www.ivwatch.com

Summary Table

Item	Predicate DeviceK192385	Subject Device	SubstantialEquivalenceDiscussion
Trade Name	ivWatch Model 400	Same	Equivalent
Manufacturer	ivWatch, LLC	Same	Equivalent
510(k) Number	K192385	K233881	N/A
Product Code	PMS	Same	Equivalent
Device Class	II	Same	Equivalent
Common Name	Peripheral Intravenous (PIV) InfiltrationMonitor	Same	Equivalent
Regulation Number	21 CFR 880.5725	Same	Equivalent
Intended Use	The ivWatch Model 400 is intended to aid inthe detection of infiltrations andextravasations during peripheral IVinfusion therapy in pediatric and adultpatients. The user profile is healthcarepractitioners who are experienced in IVadministration and management andlocated at hospitals and similar medicalcare facilities.	Same	Equivalent
Indications for Use	The ivWatch Model 400 is indicated for thedetection of subcutaneous infiltrations andextravasations of 10 cc or less of opticallyclear infusates, as an adjunctive device tothe clinical evaluation in the healthcare	The ivWatch Model 400 is indicated forthe detection of subcutaneousinfiltrations and extravasations of 10 ccor less of optically clear and iron sucroseinfusates, as an adjunctive device to the	EquivalentBench testing resultssupport devicedetection of iron
Item	Predicate DeviceK192385	Subject Device	SubstantialEquivalenceDiscussion
	setting of adults and pediatrics withperipherally-inserted catheters (PIVs). Thedevice is indicated to assess patients forsubcutaneous infiltrations andextravasations but should not serve as asubstitute for regular clinician assessmentof the PIV site. The ivWatch Model 400 isintended for use by healthcarepractitioners who have been trained in theuse of the device.	clinical evaluation in the healthcaresetting of adults and pediatrics withperipherally-inserted catheters (PIVs).The device is indicated to assess patientsfor subcutaneous infiltrations andextravasations but should not serve as asubstitute for regular clinicianassessment of the PIV site. The ivWatchModel 400 is intended for use byhealthcare practitioners who have beentrained in the use of the device.	sucrose; iron infusatedo not impact devicesafety or effectiveness
Sterilization	The SmartTouch Sensor and SensorReceptacles are sterilized using the EOhalf-cycle overkill approach. A minimumSAL of$10^{-6}$ per ISO 11135, EO residuals of < 4mgand ECH residuals of < 9mg were achieved.	Same	Equivalent
Shelf-Life	Packaging passed Burst Testing per ASTMF1140, and Bubble Emission Leak Test perASTM F2096.Sensor Receptacle 2 yearsSmartTouch Sensor 1 year	Packaging passed Burst Testing perASTM F1140, and Bubble Emission LeakTest per ASTM F2096.Sensor Receptacle 3 yearsSmartTouch Sensor 3 years	EquivalentShelf life wasdetermined bymeeting acceptancecriteria in compliancewith requirementsoutlined in ASTMF1886, ASTM F2096and ASTM F1140
Item	Predicate DeviceK192385	Subject Device	SubstantialEquivalenceDiscussion
Reprocessing	The Patient Monitor, Extension Module,Fiber Optic Sensor Cable and PatientCables are to be cleaned/disinfected inbetween uses. Cleaning and low-leveldisinfection validation testing passed allpre-defined acceptance criteria incompliance with AAMI TIR12 and AAMITIR30.	Same	Equivalent
Biocompatibility	The Sensor Receptacle, Fiber Optic SensorCable, SmartTouch Sensor and PatientCable are classified as having prolongedduration (greater than 24 hours but lessthan 30 days) patient-contactingcomponents.Biocompatibility testing was conducted incompliance with ISO 10993-1, 10993-5,10993-10. Results show that the patient-contacting components pass all pre-defined acceptance criteria defined forcytotoxicity, sensitization, and irritationtesting.	Same	Equivalent
ElectromagneticCompatibility (EMC) andElectrical Safety	EMC and electrical safety testing wereconducted on the and results show that theivWatch® Model 400 with DeviceAccessories complies with therequirements of EN / IEC 60601-1-2 4thEdition and IEC 60601-1 3rd Edition.	Same	Equivalent
Item	Predicate DeviceK192385	Subject Device	SubstantialEquivalenceDiscussion
Software Verification andValidation Testing	Software verification and validation testing for the ivWatch® Model 400 with Device Accessories were conducted and documentation was provided in accordance FDA's Guidance for Industry and Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304.	Same	Equivalent
Performance Testing	Optical safety testing was performed and indicated that the optical radiation emitted by the sensors significantly less than the limits defined in ANSI Z136.1.	Same	Equivalent
	A series of IRB-approved clinical studies were performed for the verification and validation of the ivWatch Model 400 with Device Accessories. All submitted clinical studies were conducted in the United States and in compliance with 21 CRF 50, 21 CFR 54, 21 CFR 56 and 21 CRF 812, ICH E6 and ISO 14155. The results demonstrated that the ivWatch Model 400 with Device Accessories meets the devices intended use and raises no concerns regarding safety and efficacy.	Same	Equivalent
Item	Predicate DeviceK192385	Subject Device	SubstantialEquivalenceDiscussion
	N/A, Iron data and claims were notincluded in predicate submission.	Data supports the update to the ivWatchPatient Monitoring System's Indicationsfor Use to detect iron sucrose infusions inaddition to optically clear infusions. Ironconcentrations from 1mg/ml to 20mg/mlwere tested.Results showed:Mean signal dropsSaline: 23.7% (std: 6.79%)Iron: 47.1% (std: 7.97%) Iron injection signals not weaker thansaline signals (p≈1.000) Diluted iron signal (1mg/ml) isstronger signal than saline. Signal strength increases with higherconcentration of iron.	EquivalentBench testing resultssupport devicedetection of ironsucrose; iron infusatesdo not impact devicesafety or effectiveness.

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Image /page/8/Picture/0 description: The image shows the logo for IVWatch. The logo consists of a stylized black teardrop shape with a grid pattern inside, followed by the text "ivWatch" in a sleek, modern font. The logo is simple, clean, and professional.

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Image /page/9/Picture/0 description: The image shows the logo for "ivWatch". The logo consists of a stylized teardrop shape on the left, with the letters "iv" inside the teardrop. To the right of the teardrop is the word "Watch" in a simple, sans-serif font. The logo is black and white.

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Image /page/10/Picture/0 description: The image shows the logo for IVWatch. The logo consists of a stylized water droplet shape with a grid pattern in the upper left portion. The text "ivWatch" is written in a modern, sans-serif font to the right of the droplet. A small circle is present to the right of the text.

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Image /page/11/Picture/0 description: The image shows the logo for "ivWatch". The logo consists of a stylized black teardrop shape with the letters "iv" inside, formed by white squares. To the right of the teardrop is the word "Watch" in a simple, sans-serif font, with a trademark symbol next to it.

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Image /page/12/Picture/0 description: The image shows the logo for "ivWatch". The logo consists of a stylized black teardrop shape on the left, with the letters "iv" inside the teardrop. To the right of the teardrop, the word "Watch" is written in a simple, sans-serif font. The logo is clean and modern, with a focus on the company name.

ivWatch, LLC 700 Tech Center Parkway, Suite 300 Newport News, VA 23606

1.855.IVWATCH (489.2824) Fax: 757.224.5009 www.ivwatch.com

Conclusions

The technological characteristics, principles of operation and intended use of the ivWatch® Model 400 subject device and the predicate device are similar. Test results show that the ivWatch® Model 400 subject device meets all pre-defined acceptance criteria. The nonclinical and clinical tests demonstrate that the ivWatch® Model 400 is substantially equivalent to the predicate device, K192385.

Regulation Number and Section

§ 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).