(79 days)
The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.
Upon intravenous administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System enables surgeons to perform minimally invasive surgery using standard endoscopic 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 ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging of biliary ducts with the KARL STORZ Endoscopic ICG 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.
Additionally, the KARL STORZ Endoscopic ICG System enables surgeon to perform minimally invasive cranial neurosurgery in adults and pediatrics and endonasal skull base surgery in adults and pediatrics > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.
The KARL STORZ VITOM II ICG System is intended for capturing fluorescent mages for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures. The VITOM II ICG System is intended to provide a magnified view of the surgical field in standard white light.
Upon interstitial administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
The subject device, KARL STORZ ICG Imaging System includes the following components: 4mm, 5mm & 10mm HOPKINS ICG/NIR Endoscopes, VITOM II ICG Telescope, Image1 S Rubina Camera head, Power LED Rubina light source, footswitch, Fiber Light Cables, Image1 S CCU.
The expanded indication for visualization of the lymphatic vessel is only to the Endoscopic ICG system that includes the 4mm, 5mm & 10mm HOPKINS ICG/NIR Endoscopes.
The addition of the reprocessing modalities is to the 4mm, 5mm & 10mm HOPKINS ICG/NIR Endoscopes and the VITOM II ICG/NIR telescope.
The endoscopes/telescope are intended to be connected to the optical coupler of the camera head, which connects to the CCU for image processing, as well as to the light source via compatible light cable as the source of illumination to allow visualization of internal anatomy. The users can switch between WLi (standard white light) mode, for visualization of the endoscopic and microscopic procedures and NIR (Near Infrared) mode to detect ICG presence.
The KARL STORZ ICG Imaging System can be used with any medical grade monitor with a DVI-D or 12G/3G-SDI input.
The provided text describes a 510(k) submission for the KARL STORZ ICG Imaging System (K202925). It outlines the device's intended use and compares it to predicate devices to establish substantial equivalence. However, this document does not contain information about acceptance criteria, clinical study results, sample sizes for training or test sets, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance.
The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish substantial equivalence of the expanded indications." This indicates that the regulatory clearance for this device was based on non-clinical data and comparison to existing predicate devices, rather than a clinical study with detailed performance metrics against predefined acceptance criteria for AI/ML performance.
Therefore, I cannot provide the requested information about acceptance criteria and study proving device performance as it is not present in the provided text.
To answer your request precisely, based on the provided document, the following information is NOT available:
- A table of acceptance criteria and the reported device performance: Not provided. The submission relies on substantial equivalence to predicates based on non-clinical data.
- Sample sizes used for the test set and the data provenance: Not provided, as clinical testing was not performed for this clearance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided, as clinical testing and ground truth establishment for AI/ML performance are not detailed.
- Adjudication method for the test set: Not provided.
- 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 provided. The submission focuses on the imaging system itself, not an AI component assisting human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided. The device is an imaging system, not an AI algorithm with standalone performance metrics mentioned.
- The type of ground truth used: Not provided.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.