(151 days)
The D Camera Controller 5522101 has been designed for high-definition video endoscopy and can be used for both, diagnostic and therapeutic interventions. The Camera Controller is used in conjunction with other video equipment and endoscopic accessories.
The D Camera Controller 5522101 has been designed for high-definition video endoscopy and can be used for both, diagnostic and therapeutic interventions. The Camera Controller is used in conjunction with other video equipment and endoscopic accessories. The subject device is used in combination with sensor endoscopes and a monitor for visualization. In this context, the D Camera Controller is the control unit, its primary performance characteristics are signal processing of the image data and image recording. No further light source is required for the intervention. The D Camera Controller supplies the distal LED of the endoscope with light. The electrical signals provided by the sensor endoscope are processed and adequately converted to render a visible image of the endoscopic scene on a connected display device for the user.
This document is a 510(k) Summary for the Richard Wolf D Camera Controller (K211332), filed with the FDA. It declares substantial equivalence to a predicate device, the LOGIC HD LITE CAMERA CONTROLLER (K200617). The core argument for equivalence primarily rests on non-clinical performance testing and software verification.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Important Note: This device, the "D Camera Controller," is a hardware component (a camera controller) for endoscopy, not an AI or imaging diagnostic device in the traditional sense. Therefore, many of the typical acceptance criteria and study types associated with AI/ML diagnostic tools (like those involving image classification, human reader performance, ground truth establishment by expert consensus, etc.) are not applicable or described in this document. The focus here is on the functional safety and effectiveness of the device as a video endoscopy component.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/ML diagnostic device, the acceptance criteria are largely related to functional performance, electrical safety, electromagnetic compatibility, and software validation. The document describes that the device met these criteria rather than providing a quantitative table of thresholds vs. observed performance in a diagnostic context.
| Acceptance Criteria Category | Description of Performance / Met Status |
|---|---|
| Functional Performance (Image Data Processing & Recording) | "The efficacy and safety of Richard Wolf's D Camera Controller is documented by the verification and validation testing which confirms that the product meets all the requirements and specifications for overall design, basic safety, essential performance, and that the design inputs and specifications are met." The device processes electrical signals from sensor endoscopes to render a visible image and records images/videos. |
| Electromagnetic Compatibility (EMC) | "Tested according to, and compliance was demonstrated with... IEC 60601-1-2:2014 and IEC 60601-2-18:2009." Performance shown to be "safe and as effective as the predicate device." |
| Electrical Safety | "Tested according to, and compliance was demonstrated with... EN 60601-1:2005 + A1:2012, IEC 60601-1-6:2010 + A1:2013, IEC 60601-2-18:2009." Performance shown to be "safe and as effective as the predicate device." |
| Software Verification & Validation | "Verification and validation testing were performed on the software system and the corresponding software sub-components following the corresponding guidelines... and IEC 62304 Edition 1.1 2015-06." "The software functions of the D Camera Controller are a subset of the software functions of the predicate device. The only additional feature... is the video archive function. This difference... does not affect safety or effectiveness as shown by the software testing." |
| Packaging & Transportation | Tested/validated due to changes in dimensions and weight compared to the predicate. |
| Operating Conditions | Tested/validated due to changes in operating conditions, power consumption, and cooling method compared to the predicate. |
| Temperature Monitoring | Tested/validated. |
| Biocompatibility | Not applicable as the device does not have patient contact. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "test set" sample size in terms of clinical cases or patient data. The testing described is primarily bench testing (performance, electrical safety, EMC) and software testing, not a clinical study involving a dataset of medical images or patient outcomes.
- Data Provenance: Not applicable in the context of clinical image data. The testing is described as internal verification and validation of the device's engineering performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. The "ground truth" for this device is its adherence to engineering specifications, electrical safety standards, electromagnetic compatibility, and software functionality, as verified through standard testing procedures. It is not an AI diagnostic device where expert interpretation of clinical data constitutes "ground truth."
4. Adjudication Method for the Test Set
- Not applicable. As the performance testing is against technical specifications and standards, there is no need for expert adjudication of medical findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
- No. An MRMC study is relevant for AI image analysis tools where human reader performance (with and without AI assistance) is being evaluated. This device is a camera controller, not such an AI tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Study was done
- Not applicable. This device is a hardware component with integrated software for image acquisition and processing. Its "standalone" performance is its ability to meet specified technical and functional requirements, which are detailed implicitly through the various compliance tests mentioned (EMC, electrical safety, software V&V, functional tests). It's not a standalone diagnostic algorithm that produces a finding independent of human interaction.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is:
- Engineering Specifications: The device must meet its design requirements for signal processing, image recording, user interface functions, etc.
- Regulatory Standards: Compliance with electrical safety (e.g., EN/IEC 60601-1), electromagnetic compatibility (e.g., IEC 60601-1-2), and software development/validation standards (e.g., IEC 62304).
- Predicate Device Equivalence: The ultimate "ground truth" sought by the 510(k) pathway is demonstrating that the device is "substantially equivalent" to a legally marketed predicate device in terms of safety and effectiveness. This is achieved by showing that any differences do not raise new questions of safety or effectiveness.
8. The Sample Size for the Training Set
- Not applicable. This device does not use machine learning or AI models that require a "training set" of data in the common sense. Its software performs fixed algorithms for image processing and control, not adaptively learning from data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8).
In Summary:
The provided document describes the regulatory submission for a medical device (a camera controller for endoscopy) that is primarily a hardware component with integrated software. The "acceptance criteria" and "study" proving it meets them are focused on engineering and regulatory compliance (e.g., electrical safety, EMC, software validation) rather than the clinical performance metrics often associated with AI/ML diagnostic tools (like sensitivity, specificity, or human reader study endpoints). The substantial equivalence claim is built on non-clinical performance testing and software verification, demonstrating that any technological differences from the predicate device do not raise new questions of safety or effectiveness. No clinical or image-based diagnostic performance studies are mentioned or required for this type of 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.