(106 days)
ENDOCAM Logic 5525 Camera Controller:
LOGIC HD CAMERA CONTROLLER / LOGIC 4K CAMERA CONTROLLER:
The Logic HD Camera Controller and the Logic 4K Camera Controller have been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions. The Camera Controllers are used in conjunction with other video equipment and endoscopic accessories.
LOGIC HD LITE CAMERA CONTROLLER:
The Logic HD lite Camera Controller 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 ENDOCAM Logic 5525 Camera Controller describes all Richard Wolf ENDOCAM Logic Camera Controllers, by name LOGIC 4K CAMERA CONTROLLER, LOGIC HD CAMERA CONTROLLER and LOGIC HD Lite CAMERA CONTROLLER.
The main purpose of the ENDOCAM Logic 5525 Camera Controller is identifying the applied part(s) and configuring the data stream, managing the interaction and providing an access point for the user.
The ENDOCAM Logic 5525 Camera Controller contains software which is classified as a minor Level of Concern. The main features of the software are configuration of the image processing, archiving and providing different views and a user interface to the user.
The ENDOCAM Logic 5525 Camera Controller is not intended to contact the patient directly or indirectly.
The ENDOCAM Logic 5525 Camera Controller is delivered non-sterile. The devices are reusable and do require cleaning and reprocessing during their use-life, i.e. users are required to clean and disinfect the device before every application and before returning for repairs. Methods of cleaning and reprocessing are detailed in the Instruction for Use.
The provided text describes a 510(k) premarket notification for the ENDOCAM Logic 5525 Camera Controller. This submission focuses on demonstrating substantial equivalence to a predicate device, specifically the LOGIC 4K CAMERA CONTROLLER (K180583), rather than presenting a novel device that requires extensive clinical studies or a new set of acceptance criteria with detailed performance metrics.
Therefore, many of the requested points regarding acceptance criteria, specific study designs, sample sizes, expert involvement, and ground truth establishment are not applicable or explicitly stated in the provided document. The document primarily focuses on verifying that an updated software version and the subject devices maintain the same performance and safety characteristics as the predicate device.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating that the updated device continues to meet the safety and performance standards established for the predicate device. The general "acceptance criteria" are implied to be compliance with relevant standards and demonstration of equivalent performance to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software Functionality & Safety: | |
| * Meets requirements for "Minor Level of Concern" software. | The software documentation was prepared for a Minor Level of Concern. All changes (including new features) were verified and validated, showing they "do not raise new questions regarding safety or performance." |
| * Complies with relevant software guidance documents. | The documentation followed guidance from: "Content of Premarket Submissions for Software Contained in Medical Devices," "Off-The Shelf Software Use in Medical Devices," "Cybersecurity for Networked Medical Devices," "Content of Premarket Submissions for Management of Cybersecurity," "General Principles of Software Validation," and "Deciding when to submit a 510(k) for a Software Change." |
| Electromagnetic Compatibility (EMC) & Electrical Safety: | |
| * Complies with IEC 60601-1, IEC 60601-1-6, IEC 60601-1-2, | Electromagnetic compatibility testing proved compliance with these standards. The changes "do not raise new questions regarding safety or performance." |
| and IEC 60601-2-18 standards. | |
| General Performance & Operational Functionality: | |
| * Meets all requirements and specifications for overall design, | Verification and validation testing confirm that the product "meets all the requirements and specifications for overall design, basic safety and essential performance, and that the design inputs and specifications are met." Functional testing was performed to "prove the performance of the devices." Testing demonstrated proper operation and functionality after specified storage and transport conditions. |
| basic safety, and essential performance. | |
| * Functionality after storage and transport conditions. | |
| Intended Use Equivalence: | The ENDOCAM Logic 5525 Camera Controller "has the same intended use as the predicate device." |
| Technical Characteristics Equivalence (Hardware/Design): | The device "has equivalent technical characteristics and design as the predicate device. The operating principle, mechanical design, dimensions and device material are equivalent or the same." The only major difference noted is a software upgrade from Version 2.0.1 to 2.0.8. |
| Overall Safety and Effectiveness Equivalence to Predicate: | The nonclinical tests demonstrate that the devices are "as safe, as effective, and perform as well as or better than the legally marketed device." Hence, the device is deemed "substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The studies cited are "verification and validation testing" and "functional testing" which are typically internal engineering tests performed on the device itself, rather than testing with a "test set" of clinical data.
- Data Provenance: Not applicable in the context of clinical data. The testing described is non-clinical (engineering and software verification/validation).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts & Qualifications: Not applicable. This type of information would be relevant for studies involving the interpretation of results (e.g., image analysis by radiologists). The described testing focuses on the camera's technical performance and safety compliance.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no evidence of a "test set" that requires adjudication by human experts.
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
- No MRMC comparative effectiveness study was done.
- The device is an endoscopic camera controller, not an AI diagnostic aid. Therefore, this type of study is not relevant to its regulatory submission as described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. The device is a camera controller, an imaging component, not a standalone algorithm. Its function is to process and manage video streams for human operators.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable in the clinical sense. For the non-clinical testing, the "ground truth" would be established engineering specifications, performance standards (e.g., signal-to-noise ratio, resolution, color accuracy), and regulatory compliance requirements.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. The device relies on embedded software/firmware for camera control and image processing, not on machine learning or deep learning models that require a "training set" of data in the AI sense.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment for Training Set: Not applicable, as there is no "training set" in the context of this 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.