(28 days)
The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.
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 duct, common bile duct and common hepatic duct), using near infrared imaging. Fluorescence 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.
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.
The KARL STORZ ICG Imaging System is used to provide real-time high definition (HD) endoscopic or telescope images of visible (VIS) and near-infrared (NIR) indocyanine green (ICG) dye fluorescence during minimally invasive surgery as well as plastic, micro- and reconstructive surgical procedures.
The overall system includes a 5mm &10mm HOPKINS ICG/NIR Endoscope for use in minimally invasive procedures and a VITOM II ICG/NIR Telescope for use in plastic, micro- and reconstructive surgical procedures for VIS and NIR illumination and imaging, a light source with foot switch for emission of VIS and NIR illumination, a color video camera head capable of capturing both VIS and NIR imaging, and KARL STORZ ICG Kit. Additional accessories used with the KARL STORZ ICG Imaging System include two standard fiber-optic light cables for transmission of VIS and NIR light and the Image1S Camera Control Unit (CCU).
The KARL STORZ ICG Imaging System can be used with any medical grade HD monitor with a DVI-D or 3G-SDI input.
The provided document is a 510(k) summary for the KARL STORZ ICG Imaging System. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria in the context of diagnostic accuracy or a similar measure typically associated with AI/algorithm performance.
The document states:
- "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications."
- "Additional bench testing was performed to ensure the device met its design specifications."
- "The bench testing performed verified and validated that the KARL STORZ ICG Imaging System has met all its design specification and is substantially equivalent to its predicate devices."
This indicates that the device's approval was based on demonstrating safety, effectiveness, and substantial equivalence to existing devices through non-clinical (bench) testing, primarily focusing on aspects like electrical safety, electromagnetic compatibility, biocompatibility, and mechanical properties, not on diagnostic performance against ground truth in a clinical setting.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance in the context of diagnostic accuracy, as this type of information is not present in the provided text.
Based on the nature of the device (an imaging system for real-time visible and near-infrared fluorescence imaging) and the approval process described, it is highly probable that the "acceptance criteria" referred to in the document pertain to technical specifications, safety standards, and functional performance benchmarks rather than clinical diagnostic accuracy metrics (like sensitivity, specificity, or AUC).
If this were a typical AI/algorithm-based diagnostic device, the requested information would be crucial. However, for a medical imaging system like this, the focus is often on its ability to produce clear, reliable images and its safety for patient use, with appropriate regulatory standards and bench testing serving as the "proof."
§ 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.