Search Results

The Scivita 4KINSIGHT ICG Imaging System consists of a 4KINSIGHT UHD Fluorescence Imaging System, a Near-Infrared LED Light Source, and a 4K UHD LAPAROSCOPE.

Upon intravenous administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used with TRADENAME to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraoperative cholangiography.

The Scivita 4KINSIGHT ICG Imaging System is indicated for use to provide real time endoscopic visible and nearinfrared fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct or common hepatic duct), using near-infrared imaging.

Fluorescence imaging of biliary ducts with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Upon interstitial administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The subject device, Scivita 4KINSIGHT ICG Imaging System is consisting of a 4KINSIGHT UHD Fluorescence Imaging System including a 4K Fluorescence Camera Control Unit and a 4K Fluorescence camera head, a Near-Infrared LED Light Source and a 4K UHD Laparoscope.

The subject device can be offered in multiple configuration based on different combination of component models and subcomponent models. Details refer to Table 1 System Configuration.

The component, 4KINSIGHT UHD Fluorescence Imaging System, is designed to be used with endoscopes, light source, monitors, light guide cables and other ancillary equipment for endoscopic diagnosis, treatment and observation. It is comprised of a 4K Fluorescence Camera Control Unit (model: 4KIR321, 4KIR311) and a 4K Fluorescence camera head (model 4KIR320C). The only difference between 4KIR321 and 4KIR3114K is: two HDMI output signal of 4KIR321 both are 4096×2160p; two HDMI output signal of 4KIR311 are respectively 4096×2160p and 1920×1080p.

The component, 4K UHD Laparoscope, is a rigid endoscope intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities. The subject device is also indicated for visualization of transanal and transvaginal applications.

The 4K UHD Laparoscope has 18 models which are available in two insertion widths (5.5 mm and 10 mm), four working lengths (290mm, 424mm, 450mm) and three different directions of view (0 ; 30 ° 45 9. The 4K UHD Laparoscope is a reusable device that is cleaned and sterilized before first use and each use.

The provided text is a 510(k) Summary for the Scivita 4KINSIGHT ICG Imaging System. It outlines the device's characteristics, indications for use, and a comparison to a predicate device (PINPOINT Endoscopic Fluorescence Imaging System, K182606) to demonstrate substantial equivalence.

Here's an analysis to extract the requested information about acceptance criteria and the study proving the device meets them:

Crucial Finding: The document explicitly states: "No clinical study is included in this submission." This means that the device's performance was not proven through a clinical study with human data. Instead, the focus is on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical (engineering and lab-based) tests.

Therefore, for many of the requested points, direct answers regarding clinical study acceptance criteria, ground truth from human experts, MRMC studies, etc., cannot be provided from this document.

Acceptance Criteria and Reported Device Performance

Since no clinical study was performed, the "acceptance criteria" here refer to the performance characteristics compared against the predicate device to establish substantial equivalence based on non-clinical testing. The "reported device performance" refers to the results of these non-clinical tests.

Table of Acceptance Criteria and Reported Device Performance (based on comparison to predicate)

The document primarily compares various technical specifications of the subject device to the predicate device to argue substantial equivalence. The "acceptance criteria" are implicitly that the subject device's performance is either "Same" as the predicate, "Better" than the predicate, or that any "Different" aspect does not affect safety or effectiveness.

Study Information (Based on the document provided):

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not applicable. The document explicitly states: "No clinical study is included in this submission." The evaluation is based on non-clinical (laboratory/bench) testing and comparison to a predicate device's specifications.
   • Data Provenance: Not applicable for clinical data. For non-clinical testing, the tests were conducted by Scivita Medical Technology Co., Ltd. (China-based company).

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • Not applicable. As no clinical study was performed, no expert ground truth was established for a test set of clinical images. The "ground truth" for non-clinical performance (e.g., resolution measurements) would be established by standard engineering measurement techniques and equipment.

3. Adjudication Method for the Test Set:

   • Not applicable. No human-read clinical test set.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:

   • No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical study is included in this submission."

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is an imaging system (hardware and software for image acquisition and display), not an AI algorithm intended to perform standalone diagnostic tasks. Its performance is evaluated fundamentally on image quality metrics and compliance with standards.

6. The Type of Ground Truth Used:

   • For the non-clinical tests, the "ground truth" implicitly comes from established engineering standards and measurement methodologies for optical performance, electrical safety, EMC, etc. (e.g., light intensity measured by a photometer, resolution determined by test charts and lenses, etc.). This is not clinical ground truth (e.g., pathology, expert consensus).

7. The Sample Size for the Training Set:

   • Not applicable. This is not an AI/ML device that requires a training set in the typical sense. It's a medical imaging hardware system.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as there is no training set for an AI/ML algorithm.

In summary, the provided 510(k) summary focuses entirely on demonstrating substantial equivalence through non-clinical testing and direct comparison of technical specifications to a predicate device. It explicitly states that no clinical study was conducted. Therefore, questions related to clinical performance, human readers, ground truth establishment for clinical data, and AI/ML specific criteria are not addressed by this document.

Ask a specific question about this device