(60 days)
Intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures.
The VS3 Stereoscopic High Definition Vision System, Model VS3-NE consists of the following components: Endoscope, Light source, Camera Control Unit (CCU), Camera, Display monitors, 2D Endoscope coupler. The VS3 Stereoscopic High Definition ("3DHD") Vision System, Model VS3-NE is based on the proximal HD camera concept with a stereoscopic camera block located on the proximal side of the endoscope (the handle). This allows high resolution capture of the 3D video stream. The stereoscopic images are transmitted from the visual field at the distal tip of the endoscope to the proximal camera block containing the HD sensor module. The VS3 Stereoscopic High Definition Vision System, Model VS3-NE allows for separation of the camera module with image sensor module and electronics from the endoscope shaft housing optical relay components and light fibers. The VS3 Stereoscopic High Definition Vision System, Model VS3-NE also includes 2D coupler capability that allows the VS3 Stereoscopic High Definition Vision System, Model VS3-NE to be used with FDA-cleared, third party 2D scopes at user sites to display monocular video.
This submission describes a Substantial Equivalence (SE) determination for a medical device, meaning the device's acceptable performance is demonstrated by its similarity to already legally marketed predicate devices, rather than through independent studies with specific acceptance criteria. Therefore, most of the requested information (acceptance criteria, study details, ground truth, expert involvement, etc.) is not applicable in the context of this 510(k) summary.
Here's a breakdown of what can be extracted and why other parts are not available:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. In a 510(k) for substantial equivalence, the "acceptance criteria" are effectively that the new device's technological characteristics, indications for use, and principles of operation are sufficiently similar to those of a legally marketed predicate device such that no new questions of safety or effectiveness are raised. The performance is "reported" by showing these similarities, not by meeting specific quantifiable performance metrics in independent studies for this particular submission.
Instead, the submission presents a comparison table demonstrating the similarities between the subject device (VS3-NE) and its predicate devices (VSII System K081102 and VS3 K123467).
| Characteristic | VS3-NE (subject device) | VSII System (K081102) (primary predicate) | VS3 for General Surgery (K123467) (secondary predicate) |
|---|---|---|---|
| Manufacturer | Visionsense Ltd. | Visionsense Ltd. | Visionsense Ltd. |
| Classification | Endoscope, Neurological 21 C.F.R. §882.1480 Product code GWG | Endoscope, Neurological 21 C.F.R. §882.1480 Product code GWG | Laparoscope, General & Plastic Surgery 21 C.F.R. §876.1500 Product code GCJ |
| Indications for Use | Intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures | Intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures | Intended for viewing internal surgical sites during general endoscopic and laparoscopic surgical procedures |
| Endoscope type | Rigid Stainless Steel | Rigid Stainless Steel | Rigid Stainless Steel |
| Endoscope diameter | 4 - 5.5 mm | 4 - 5 mm | 4 - 5.5 mm |
| Endoscope length | 175 - 300 mm (±5 mm) | 175 - 300 mm (±5 mm) | 175 - 300 mm (±5 mm) |
| Field of view | 70°-95° | 70° | 70°-95° |
| Direction of view | 0° - 70° | 0° - 70° | 0° - 70° |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This 510(k) submission does not include a clinical or performance test set in the conventional sense (i.e., a set of medical images or patient data used to evaluate algorithm performance). The "test" for substantial equivalence is the comparison of the device's specifications and intended use against predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No ground truth establishment by experts is described in this submission, as it focuses on substantial equivalence to existing devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. There is no test set or adjudication process described as this is a substantial equivalence submission.
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
- Not Applicable. This device is a stereoscopic high definition vision system (an endoscopic camera system), not an AI algorithm designed to assist human readers or perform diagnostic tasks. Therefore, an MRMC study related to AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware vision system, not an algorithm, so standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. There is no ground truth, in the sense of medical diagnostic accuracy, required for this substantial equivalence submission. The "ground truth" for a 510(k) is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- Not Applicable. There is no AI component or training set described in this submission.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set mentioned, this question is not applicable.
Summary of the K131434 Submission:
The K131434 submission is for the VS3 Stereoscopic High Definition Vision System, Model VS3-NE, an endoscope. The device's approval is based on its Substantial Equivalence to two predicate devices:
The submission argues for substantial equivalence based on the following:
- Same Intended Use/Indications for Use: Viewing internal surgical sites during general surgical procedures and for visualization of ventricles and structures within the brain during neurological surgical procedures.
- Similar Principles of Operation: Proximal HD camera concept with a stereoscopic camera block, capturing right and left images for a 3D video stream.
- Similar Technological Characteristics: The device shares core components and specifications (e.g., rigid stainless steel endoscope, similar diameter, length, field of view, and direction of view) with the predicate devices.
The submission also notes compliance with several recognized consensus standards for electrical safety, electromagnetic compatibility, and biocompatibility (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-18, ISO 14971, ISO 8600 series). These standards are device-specific performance criteria for safety and manufacturing, not diagnostic acceptance criteria.
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).