(143 days)
The Innovative Endoscopy Components (IEC) MedSIGHT and MedBRIGHT is a video system for endoscopes. MedSIGHT is a color, television camera system (supplies image) and MedBRIGHT is a xenon/halogen light source system (supplies light). Both can be used with all rigid endoscopes (like Arthroscopes, Cystoscopes, Hysteroscopes, Laparoscopes, Ureterorenoscopes, etc.) and some flexible endoscopes (Sinuscope and Bronchoscope) and it is designed for surgical procedures.
The Innovative Endoscopy Components (IEC) MedSIGHT and MedBRIGHT is a video system for endoscopes.
The IEC MedSIGHT is a endoscopic color camera system and used in a variety of endoscopic surgical procedures (orthopedic, laparoscopic, urologic, sinuscopic, plastic, ... ) to capture and visualize the image from the endoscope on a monitor. The system consists of a control unit and a video head. The cable of the video head connects to the control unit. The video head connects to all rigid endoscopes (like Arthroscopes, Cystoscopes, Hysteroscopes, Laparoscopes, Ureterorenoscopes, etc.) and some flexible endoscopes (Sinuscope and Bronchoscope).
The IEC MedBRIGHT is a endoscopic light source system and used with all rigid endoscopes (like Arthroscopes, Cystoscopes, Hysteroscopes, Laparoscopes, Ureterorenoscopes, etc.) and some flexible endoscopes (Sinuscope and Bronchoscope) to provide light for a high visual and photographic clarity for color rendition. The system consists of a control unit and a fiber optic cable. The fiber optic cable connects on one site with the control unit and the other side it connects to the endoscope.
All these components are designed, constructed and intended to be operated exclusivelv as a unit.
The provided document is a 510(k) summary for the IEC MedSIGHT and MedBRIGHT, an endoscopic camera and light source system. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert adjudication methods.
The document focuses on:
- Submitting entity and manufacturer information.
- Device names and classification.
- Indications for Use.
- Device description.
- A list of predicate devices used for substantial equivalence.
- A brief statement on safety, largely referencing biocompatibility and similarity to predicate devices.
- The FDA's letter of clearance.
Therefore, I cannot provide the requested information from this document. The document primarily establishes substantial equivalence to legally marketed predicate devices, rather than detailing analytical or clinical performance studies with specific metrics and acceptance criteria.
§ 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.