(104 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 ducts (cystic 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 and viewing fluorescent images 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 or open surgery. The system components are a HOPKINS ICG/NIR Endoscope and a VITOM II ICG/NIR Telescope 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 a standard fiber-optic light cable for transmission of VIS and NIR light and the Image1S Camera Control Unit (CCU). All components except for the VITOM II ICG/NIR Telescope were cleared in K152583. The KARL STORZ ICG Imaging System can be used with any medical grade HD monitor with a DVI-D or 3G-SDI input. The VITOM II ICG/NIR Telescope is a Class I device under 21 CFR 878.4700.
The provided text describes a 510(k) submission for the "KARL STORZ ICG Imaging System". This document focuses on demonstrating the substantial equivalence of the new device to previously cleared predicate devices, rather than proving that the device meets specific acceptance criteria through a standalone clinical or "algorithm only" study. Therefore, much of the requested information about acceptance criteria, detailed study design, ground truth establishment, and multi-reader multi-case studies is not present in the provided text.
Specifically, 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."
This indicates that the submission relies on demonstrating comparable performance to predicate devices through non-clinical (bench and animal) testing, rather than establishing specific performance metrics against a predefined acceptance criterion in human clinical data.
However, I can extract information about the non-clinical testing performed and how it aims to demonstrate equivalence, which implicitly serves as the "study" proving the device's acceptable performance in the context of this 510(k).
Here's the information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" in the format of a table with specific metrics (e.g., minimum sensitivity, maximum false positive rate). Instead, the performance is demonstrated by showing that the new system is "as safe as and as effective as" the predicate devices in various non-clinical tests. The reported 'performance' is qualitative: the system "successfully tested for its functions and performance" and "enable a selective visualization of the ICG fluorescence signal."
| Category | Acceptance Criteria (Implicit / Demonstrated Equivalence) | Reported Device Performance (Qualitative) |
|---|---|---|
| Device Function | The device should function as intended, providing real-time VIS and NIR fluorescence imaging, and selectively visualize ICG fluorescence signal. | "The KARL STORZ ICG Imaging System has been successfully tested for its functions and performance, including verification that the spectral characteristics of the ICG system illumination light source, light transmission system, and telescope enable a selective visualization of the ICG fluorescence signal as detected by the camera system." |
| Key Performance Aspects | Parameters such as UV Exposure, Color Reproduction, Irradiance Levels, Depth Dependency, and Visualization of ICG Signal should be comparable to predicate devices. | Comparative testing was conducted for: |
| • UV Exposure | ||
| • Color Reproduction | ||
| • Irradiance Levels | ||
| • Depth Dependency | ||
| • Visualization of ICG Signal |
While specific quantitative results are not provided, the conclusion states that these tests "demonstrated that the subject device is as safe as and as effective as the primary predicate device," implying satisfactory performance on these aspects. |
| Biocompatibility | Should not change from the previously cleared system. | "The addition of the VITOM II ICG Telescope to the system does not change the biocompatibility... conducted for the KARL STORZ Endoscopic ICG System cleared in K152583." |
| Electromagnetic Compatibility (EMC) | Should not change from the previously cleared system. | "The addition of the VITOM II ICG Telescope to the system does not change the ... electromagnetic compatibility... conducted for the KARL STORZ Endoscopic ICG System cleared in K152583." |
| Electrical Safety | Should not change from the previously cleared system. | "The addition of the VITOM II ICG Telescope to the system does not change the ... electrical safety... conducted for the KARL STORZ Endoscopic ICG System cleared in K152583." |
| Software Validations | Should not change from the previously cleared system. | "The addition of the VITOM II ICG Telescope to the system does not change the ... software validations conducted for the KARL STORZ Endoscopic ICG System cleared in K152583." |
| Cleaning & Sterilization | Validation for the new component (VITOM II ICG Telescope) is required. | "Cleaning method validation and sterilization validation were performed on the VITOM II ICG Telescope." |
| Animal Study Performance | Performance in animal model should be adequate for evaluation. | "a GLP animal study was successfully performed by the NAMSA testing facility to evaluate the performance of the KARL STORZ ICG Imaging System with the VITOM II ICG Telescope in the porcine open surgery laparoscopy model." |
| Compliance with Standards | Device must meet relevant safety standards. | The device (and its predicates) are listed as meeting IEC 60601-1-2 and IEC 60601-1. The Visionsense predicate also met IEC 60825-1. "Bench testing was performed per IEC 62471." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated with numerical values. The document refers to "comparative testing" and a "GLP animal study" without specifying the number of samples or animals used.
- Data Provenance:
- Bench Testing: Conducted in-house or by testing laboratories (e.g., "NAMSA testing facility"). The country of origin is not specified but implied to be within the scope of FDA regulations (likely USA or a country with recognized testing standards).
- Animal Study: Performed by "NAMSA testing facility" using a "porcine open surgery laparoscopy model."
- Retrospective/Prospective: All described tests are non-clinical and would be conducted prospectively as part of the device development and submission process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a non-clinical study for substantial equivalence. The "ground truth" was based on the physical and optical properties of the device and its ability to visualize ICG fluorescence as measured by established testing methods and verified by the testing facility. There's no mention of human experts establishing "ground truth" in the diagnostic sense for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This was a non-clinical study. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical imaging studies involving multiple human readers.
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. No MRMC study was performed as this was a 510(k) submission based on non-clinical substantial equivalence. The device is an imaging system, not an AI-powered diagnostic tool, and the submission explicitly states "Clinical testing was not required."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept doesn't directly apply here. The device itself is an integrated imaging system (camera, endoscope/telescope, light source). Its "standalone performance" is demonstrated through its physical and optical characteristics (e.g., light transmission, spectral characteristics, visualization of ICG signal) as measured in bench and animal studies, rather than an "algorithm."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests would have been based on:
- Physical measurements and optical properties: For tests like "spectral characteristics," "irradiance levels," and "depth dependency," the ground truth is derived from established physics principles and calibrated measurement equipment.
- Known ICG fluorescence: For "visualization of ICG signal," the ground truth is the known presence and location of the fluorescent dye.
- Biological outcomes (animal model): In the GLP animal study, the "performance" would have been evaluated based on the ability of the system to correctly visualize blood flow/perfusion and biliary ducts as expected in the porcine model, potentially against direct observation or other validated methods if used in the study.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/machine learning device.
§ 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.