Q: What distinguishes the ivWatch SmartTouch Sensor from other IV monitoring devices, particularly in terms of its technology and regulatory classification?

The ivWatch SmartTouch Sensor Model 400 uses non-invasive optical technology (visible and near-infrared light) to detect IV infiltration or extravasation by measuring changes in tissue properties. Unlike some devices that rely on electrical or mechanical sensors, this approach is non-active ('ACTIVE: 0') and non-implantable, making it a Class I device under both FDA 510(k) and MDR regulations. Its regulatory classification reflects a lower-risk profile, though it remains critical for early warning of IV complications.

Question 1

Is the ivWatch SmartTouch Sensor reusable or designed for single-use, and how does this affect its sterility and handling requirements?

Accepted Answer

The ivWatch SmartTouch Sensor Model 400 is explicitly designed for single-use only, as indicated by the 'REUSABLE: 0' field. Since it is supplied sterile ('STERILE: 0' denotes it is sterile upon packaging), it must be handled according to standard sterile disposable medical device protocols. This means each sensor is intended for one patient use only, after which it should be discarded, and no reprocessing is required or permitted.

Question 2

What types of intravenous fluids is the ivWatch SmartTouch Sensor compatible with, and does this limit its use in any way?

Accepted Answer

The device is compatible with optically clear fluids, as noted in the description. This means it can be used with standard IV solutions like saline, dextrose, or other clear medications, but it may not be suitable for opaque or highly pigmented fluids. Clinicians should verify fluid compatibility before use to ensure accurate monitoring of IV site conditions.

Question 3

How is the ivWatch SmartTouch Sensor stored, and are there any special conditions that must be met to maintain its performance?

Accepted Answer

The sensor follows standard sterile disposable medical device storage protocols, though specific storage conditions (e.g., temperature, humidity) are not detailed in the provided data. Generally, this means keeping it in its sealed, sterile packaging until use and avoiding exposure to contamination or extreme environmental conditions. Always refer to the manufacturer’s instructions for precise storage guidance.

Question 4

What distinguishes the ivWatch SmartTouch Sensor from other IV monitoring devices, particularly in terms of its technology and regulatory classification?

Accepted Answer

The ivWatch SmartTouch Sensor Model 400 is a disposable, non-invasive peripheral intravenous (IV) site monitoring device (Nomenclature Code: V9099). It detects IV infiltration and extravasation by measuring changes in tissue optical properties using visible and near-infrared light, enabling early warning of complications during IV therapy.

This sensor is intended for single-use in clinical settings and is classified as Class I under FDA 510(k) and MDR regulations. Supplied sterile, it requires no reprocessing and is compatible with optically clear fluids. The device is non-implantable, non-active, and non-latex, with a UDI of 081408802AC-1002000JW. Storage and handling follow standard sterile disposable medical device protocols.

Region	Authorization	Number	Date	Status
United States	FDA 510(k) 510(k)	NumberK233881	Date15 Mar 2024Issued	StatusActive
European Union	CE/MDR EUDAMED	Number081408802AC-1002000JW Basic UDI-DI 00814088020108UDI-DI	Date24 Oct 2022Registered	StatusActive
United States	FDA 510(k) 510(k)	NumberK222212	Date24 Aug 2022Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK162478	Date22 Dec 2016Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK153605	Date11 Feb 2016Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK142374	Date13 Feb 2015Issued	StatusActive

ivWatch SmartTouch Sensor Model 400

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