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SnapshotNIR (KD205) is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of:

• oxygen saturation (St02),
• relative oxyhemogoblin level (Hb02), and
• relative deoxyhemoglobin (Hb) level
  in superficial tissue. SnapshotNIR (KD205) displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports multispectral tissue oxygenation measurements for selected tissue regions.

SnapshotNIR (KD205) is indicated for use to determine oxygenation levels in superficial tissues.

SnapshotNIR (KD205) is a medical device that operates like a camera. The SnapshotNIR device is completely non-contact, capturing images from 12 inches away from the patient or other imaging field-ofviews. The device uses six near-infrared wavelengths of light and white light emitting diodes (LEDs) to produce a resultant tissue oxygenation image and a colour-based "RGB" or clinical image, respectfully, that can be viewed on the touchscreen display.

SnapshotNIR is based on multispectral imaging technology and performs spectral analysis at each pixel to determine the approximate values of tissue oxygen saturation (StO2), oxyhemoglobin levels (HbO2), and deoxyhemoglobin levels (Hb) in superficial tissues and displays a two-dimensional, color-coded image of the tissue oxygen saturation (StO2).

SnapshotNIR consists of:

• · SnapshotNIR
• · Recharger
• · User Guide
• · Quick Start Guide
• · Sterile Drape (Optional)

The intended use and user interaction remained the same in the new model (KD205). The user will notice that the modified device no longer requires the user to take a calibration image prior to image capture. SnapshotNIR now uses an embedded computer module and a touchscreen LCD. Additional minor form factor changes were made on the new model (KD205) to accommodate the hardware change. With respect to the software used by SnapshotNIR, the predicate and new model (KD205) operate similarly.

This document, K240601, is a 510(k) Premarket Notification from the FDA regarding the Kent Imaging SnapshotNIR model KD205. It's a clearance letter, not a study report or a detailed technical submission. Therefore, it does not contain the information requested regarding acceptance criteria and performance studies in the level of detail typically found in a clinical study report or a more comprehensive technical submission to the FDA.

Specifically, the document states:

• "Nonclinical engineering-based tests (e.g., IEC 60601-1-2, etc) among other performance bench tests support conclusions that the KD205 device is safe for use with a low risk of adverse events occurring during the intended use scenarios."
• "These tests and findings are analogous to those conducted on the predicate KD204 SnapshotNIR device and demonstrate that the KD205 device is similarly safe, and effective compared to a current legally marketed device."
• "In a sub-analysis of the pre-clinical dataset, the KD205 device demonstrated no significant differences (derived via 2-way ANOVA models) in STO2 across the ischemia-reperfusion test when comparing cohorts of low versus high tissue scattering effects."

While it mentions "pre-clinical dataset" and "tests and findings," it does not provide any specific acceptance criteria, reported performance values, sample sizes, provenance of data, expert qualifications, or details about MRMC studies, standalone performance studies, or ground truth establishment. The purpose of this 510(k) summary is to establish substantial equivalence to a predicate device, not to detail the full performance study results.

Therefore, I cannot populate the requested table or answer most of the questions based solely on the provided text. The document focuses on the conclusion of substantial equivalence rather than the raw data and detailed methodology of the performance studies conducted.

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