(14 days)
The XTJF-160AF has been designed to be used with an Olympus EVIS video system center, light source, Documentation Equipment, Video Monitor, Endo-Therapy accessories (such as a Forceps, Electrosurgical Accessories, etc.), Electrosurgical Unit, and other Ancillary Equipment for endoscopy and endoscopic surgery within the duodenum.
Do not use these instruments for any purpose other than their intended uses.
This premarket notification is proposed to establish the safety and effectiveness of the variable stiffness scope that is intended for endoscopy and endoscopic surgery, including electrocautery application, within the duodenum. The intended use of the XTJF-160AF is identical to that of previously cleared device, the TJF-140R and JF-V10. The mechanical structure of variable stiffness is identical to that of another predicate device, the EVIS EXERA Colonovideoendoscopes. While the variable stiffness scope is brand new device in the duodenum, endoscopy and endoscopic surgery, including electrocautery, within the duodenum is popular and the mechanical structure of variable stiffness has been confirmed to be safe by the EVIS EXERA Colonovideoendoscopes. Any new insertion method or techniques in consequence of the added mechanical structure of variable stiffness are not considered. Therefore, this modification does not affect the safety and effectiveness of the proposed device,
XTJF-160AF has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirement of IEC60601-1, IEC60601-1-2 and IEC60601-2-18.
There are no new patient contacting materials. All of patient contacting materials is cleared by previous 510(k). And all materials have been confirmed with ISO 10993-1.
The provided document is a 510(k) summary for the Olympus XTJF-160AF Duodenovideoscope. It discusses the device's substantial equivalence to previously marketed devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies.
The document primarily focuses on establishing substantial equivalence based on:
- Intended Use: The intended use of the XTJF-160AF is identical to previously cleared devices (TJF-140R and JF-V10).
- Mechanical Structure: The variable stiffness mechanism is identical to another predicate device (EVIS EXERA Colonovideoendoscopes), which has already been deemed safe.
- Materials: No new patient-contacting materials are used, and all materials have been cleared by previous 510(k)s and confirmed with ISO 10993-1.
- Safety Standards: The device complies with IEC60601-1, IEC60601-1-2, and IEC60601-2-18.
Therefore, I cannot populate the requested table or answer the specific questions about studying device performance as this information is not present in the provided text.
§ 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.