(42 days)
The ENDOCAM® Logic HD Camera System 5525 has been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions. The ENDOCAM® Logic HD Camera System 5525 is used in conjunction with other video equipment and endoscopic accessories.
The Richard Wolf ENDOCAMB Logic HD Camera System 5525 is an endoscopic camera system for rigid and flexible endoscopes (e.g. Arthroscopes, Bronchoscopes, Hosteroscopes. Laparoscopes, Ureteroscopes, etc.). The Richard Wolf ENDOCAM® Logic HD Camera System 5525 allows the doctor to visualize the image of natural and artificial cavities through the endoscope by projecting images to a monitor for visual display and data storage during endoscopic diagnostic and therapeutic surgical procedures.
The Richard Wolf ENDOCAM® Logic HD Camera System 5525 consists of:
- ENDOCAM® Logic HD Controller(s)
- ENDOCAM & Logic HD Camera Head(s), and
- Objective Lens (Coupler).
Devices are used in conjunction with other ancillary equipment such as endoscopes, light source, monitors, printers, recorders, required cabling, etc.
The Richard Wolf ENDOCAM® Logic HD Camera Head(s) use ICCD or 3CCD imaging systems to provide high definition (HD) visualization and quality images. The Richard Wolf ENDOCAM® Logic HD Camera Head cable connects to the ENDOCAM® Logic HD Controller, the ENDOCAM® Logic HD Controller relays the image from the endoscope with/without the use of an objective lens (coupler) to a video monitor; projection can be either analog or digital at the user's preference.
The Richard Wolf ENDOCAM® Logic HD Controller(s) is equipped with pre-programmed presets which can be selected via touch-screen, remote control, and/or keyboard. Self-made adjustments can be stored and individually named by user. Patient data and endoscopic images can be printed or stored directly onto USB flash drive.
The Richard Wolf ENDOCAM® Logic HD Camera System 5525 is compatible and can be integrated with the Richard Wolf RiwoNet / Core operating room system.
Devices included in the Richard Wolf ENDOCAM® Logic HD Camera System 5525 are reusable and do not require sterilization before use because there is no direct patient contact. Methods of cleaning, disinfection, and sterilization are detailed in the Instruction for Use Manual: these instructions were developed by Richard Wolf using standards outlined in ANSI / AAMI ST:2004/(R) 2010 and FDA's Guidance "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance. Office of Device Evaluation April 1996.
This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained persons.
Here's a breakdown of the acceptance criteria and study information for the Richard Wolf ENDOCAM® Logic HD Camera System 5525, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Safety Standards | IEC 60601-1 (General Requirements for Safety), 1988 with Amendments | Conforms |
| Safety Standards | IEC 60601-1-2 Ed. 3 (EMC Requirements and Test) | Conforms |
| Functionality | Devices function as intended | Design verification testing demonstrates this. |
| Identification of New Safety/Effectiveness Issues | No new issues of safety and effectiveness | Design verification testing demonstrates this. |
2. Sample Sizes and Data Provenance
The document does not specify separate "test sets" or discuss data provenance in terms of country of origin or retrospective/prospective data for a clinical study with patients. The performance data is based on design verification testing, which typically involves laboratory and engineering testing of the device itself.
3. Number of Experts and Qualifications for Ground Truth
The document explicitly states: "No clinical tests performed." Therefore, there were no experts used to establish ground truth for a clinical test set from patient data. The "ground truth" for the device's performance was established through engineering and safety standard compliance testing.
4. Adjudication Method
Not applicable, as no clinical tests were performed, and thus no patient data required adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. The document states, "No clinical tests performed."
6. Standalone Performance
The design verification testing and conformity to safety standards (IEC 60601-1 and IEC 60601-1-2) represent the standalone performance of the algorithm/device. The device's performance was assessed in isolation through these engineering and compliance tests.
7. Type of Ground Truth Used
The "ground truth" for this device's performance was established through:
- Compliance with recognized safety standards (IEC 60601-1 and IEC 60601-1-2).
- Design verification testing to ensure the device functions as intended and does not raise new safety or effectiveness concerns.
8. Sample Size for the Training Set
Not applicable. This device is a hardware system (endoscopic camera system), not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "design" and "engineering" of the device are analogous to its development process, but not a data-driven training set.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of medical device functionality. The "ground truth" for its design and operation would be based on engineering principles, material science, optical performance standards, and the intended use requirements for an endoscopic video camera system.
§ 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.