(81 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.
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.
The modified KARL STORZ ICG Imaging System includes the following components:
i) Modified 10mm and 5mm HOPKINS ICG/NIR Rigid Endoscopes (0°, 30°, 45°): have an improved optical design with the white light and NIR images in good focus simultaneously.
ii) Power LED Rubina Light Source and Footswitch: The light source has two LEDs, white light and NIR.
iii) Image1 S 4U Rubina Camera Head: uses a 2 chip 4K camera head that houses 2 CMOS sensors: one for white light and the other for NIR.
iv) Camera Control Unit: Image1 S Connect II (TC201US) and Image1 S 4U- Link (TC304US): is used with the Image1 S 4U Rubina Camera Head to output a 4K image to the monitor.
The provided text describes a 510(k) submission for the KARL STORZ ICG Imaging System. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. Therefore, there is no information provided regarding acceptance criteria for device performance related to a clinical study, or details about such a study.
The document details various non-clinical performance data and validation tests conducted to ensure the device meets its design specifications and complies with relevant standards. Here's a breakdown based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific acceptance criteria with reported device performance in a format typically used for clinical endpoints. Instead, it lists various non-clinical tests that were performed to demonstrate that the device met its design specifications and complied with standards.
Here's a summary of the non-clinical performance data categories mentioned:
| Acceptance Criteria Category (Non-Clinical) | Reported Device Performance (Summary) |
|---|---|
| Electrical Safety and EMC | Device follows IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18 standards. |
| ISO Endoscopic Standards | Device follows ISO 8600-1, ISO 8600-3, ISO 8600-4, ISO 8600-5, ISO 8600-6 standards. |
| Software Verification and Validation | Testing conducted according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device" (Level of concern: Moderate). |
| Cleaning and Sterilization Validations | Validations conducted for the Image1 S 4U Rubina camera head. |
| Bench Testing (Optical/Imaging) | Testing performed to ensure device met design specifications for: |
- Depth of Field
- Distortion
- Latency
- Dynamic Range
- Signal to Noise Ratio (SNR) & Sensitivity
- Spatial Resolution
- Color Reproduction and Color Contrast Enhancement
- Illumination Detection Uniformity
- Detection Linearity
- Direction of View
- Field of View
- Zoom Characterization
- Penetration Depth
- ICG Contrast Concentration Sensitivity
- Color Rendering
- Coregistration
- Photobiological Safety (UV Exposure and Distal Irradiance) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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 the substantial equivalence of the modifications." Therefore, there is no information about a test set sample size or data provenance from a clinical study.
The "test set" in this context refers to the methods and components used in the described non-clinical bench tests and validations (e.g., specific endoscopes, camera heads, light sources, etc., as detailed in the "Device Description" and "Technological Characteristics" sections). These are not patient data.
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)
Since no clinical study was performed or required, there is no mention of experts establishing a ground truth for a test set, nor their qualifications. The ground truth for the non-clinical tests would be defined by the technical specifications and standards against which the device's performance was measured.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study or expert adjudication for a test set is mentioned.
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. The device is an imaging system (endoscope and related components), not an AI-assisted diagnostic tool. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a medical imaging system intended for use by surgeons during procedures, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance data, the "ground truth" would be the engineering specifications and established performance parameters of the device, as evaluated through bench testing against recognized standards (e.g., IEC, ISO). No clinical ground truth (like pathology or outcomes data) was used.
8. The sample size for the training set
Not applicable. The document describes a medical imaging hardware system and its components. It does not mention any machine learning or AI components that would require a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set.
§ 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.