(133 days)
The CMOS Video Esophagoscope SSU is intended to provide visualization of nasal sinuses, larynx, esophagus and gastroesophageal junction during diagnostic procedures.
The E-Box serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.
The CMOS Video Esophagoscope SSU System includes three main components: (1) the CMOS Video Esophagoscope SSU (091370-01), (2) E-Box adaptor (TP010) and (3) the CCU. CMOS Video Esophagoscope SSU is compatible with two KARL STORZ CCUs: C-HUB and C-MAC. CMOS Video Esophagoscope SSU is provided sterile single-use.
The provided document describes the Karl Storz SE & Co. KG CMOS Video Esophagoscope SSU, a flexible video endoscope intended for visualization during diagnostic procedures of nasal sinuses, larynx, esophagus, and gastroesophageal junction. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving device performance against specific acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding clinical study design, performance metrics (like sensitivity, specificity, AUC), expert adjudication, and effect sizes of AI assistance is not available in this filing.
Here's a breakdown of the available information and an explanation of the missing components:
1. A table of acceptance criteria and the reported device performance
The submission does not define specific clinical acceptance criteria (e.g., sensitivity, specificity, AUC) for the CMOS Video Esophagoscope SSU's diagnostic performance, as no clinical study was conducted for this purpose to demonstrate substantial equivalence. Instead, the acceptance criteria are related to technical performance and safety, assessed through non-clinical testing against recognized standards, and direct comparison of technological characteristics to the predicate device.
| Acceptance Criteria Category | Details and Reported Performance |
|---|---|
| Electrical Safety & EMC | Criteria: Compliance with recognized standards. |
| Performance: Complied with ANSI/AAMI ES:60601-1:2005 and IEC 60601-1-2:2007. | |
| Bench Testing Performance | Criteria: Compliance with recognized standards for endoscopes. |
| Performance: Complied with ISO 8600-1:2015, ISO 8600-3:1997, ISO 8600-4:2014, ISO 8600-5:2005, IEC 62471:2006, and IEC 60601-2-18:2009. | |
| Biocompatibility | Criteria: Evaluation according to ISO 10993-1 and FDA Guidance for patient-contacting components. |
| Performance: Tests conducted in accordance with ISO 10993-1:2009/(R)2013, ISO 10993-5:2009/(R)2014, ISO 10993-10:2010/(R)2014, ISO 10993-11:2006/(R)2010, and ISO 10993-12:2012. | |
| Sterilization Validation | Criteria: Validation of the sterilization cycle for a sterile, single-use device. |
| Performance: Sterilization with EO validated in accordance with ANSI AAMI ISO 11135:2014 for cycle "6.Storz" (1.75 bar / 50° C / 80 min / 17.5h", 8.5 ± 0.5 % EO in CO2). | |
| Software Verification & Validation | Criteria: Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." |
| Performance: Software verification and validation testing conducted, categorized as "minor" level of concern. | |
| Technological Characteristics Comparison | Criteria: Demonstrate substantial equivalence to the predicate device (KARL STORZ Endoscopy-America's Trans-Nasal Esophagoscope Model 11302BD1 (K051972)) based on physical and optical characteristics. |
| Performance: The subject device (CMOS Video Esophagoscope SSU) has similar characteristics to the predicate, with minor differences in insertion shaft diameter (3.5mm vs 3.7mm), length (750mm vs 650mm), deflection (210° Up, 140° Down vs 140° Up, 140° Down), field of view (110° vs 87°), and light source (Internal LED vs External). The primary technological difference is the use of CMOS imager in the subject device vs. "None" specified for the predicate, and subject device being single-use and sterile while predicate is reusable and unsterile. This was deemed acceptable as the overall intended use and fundamental scientific technology for visualization remains the same. |
2. Sample size used for the test set and the data provenance
Not Applicable. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate device. Non-clinical bench testing and labeling were sufficient to establish the substantial equivalence of the modifications." Therefore, there is no clinical test set, sample size, or data provenance from clinical trials to report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. As no clinical study was conducted for performance evaluation using a test set requiring ground truth, this information is not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. No clinical test set means no adjudication method was used.
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 an endoscope for "visualization" during diagnostic procedures. It is not an AI-powered diagnostic algorithm or an AI-assisted device. Therefore, no MRMC study, AI assistance, or related effect sizes are relevant or present in the submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is directly operated by a human. It is not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable. No clinical study was performed to establish diagnostic performance, therefore no ground truth was established through external means like expert consensus, pathology, or outcomes data. Ground truth in this context typically refers to a definitive diagnosis or finding against which a device's diagnostic output is compared.
8. The sample size for the training set
Not Applicable. This device is a medical instrument (hardware with internal software), not a machine learning model that requires a "training set" in the context of AI/ML development. The software for the device underwent standard software verification and validation, but not in the framework of a training set for an AI algorithm.
9. How the ground truth for the training set was established
Not Applicable. As there is no training set for an AI/ML model, this question is not applicable.
§ 874.4710 Esophagoscope (flexible or rigid) and accessories.
(a)
Identification. An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the hypopharynx to the stomach. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.