(202 days)
These instruments have been designed to be used with an Olympus Light Source, Documentation Equipment, Display Monitor, Suction Pump, Endo-Therapy Accessories, elecrosurgical Unit, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, and kidneys.
Do not use this instrument for any purpose other than its intended use.
The Olympus XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE has been specifically designed to be used with an Olympus Light Source, documentation, equipment, and display monitor. The XCYF-1T3 is equipped with a large Instrument Channel of bright optical quality compared to the predicate device, XCYF-1T3. These characteristics facilitate operation under endoscopic-surgery including high-frequency treatment within the bladder, urethra and kidnev.
This document is a 510(k) premarket notification for a medical device (Olympus XCYF-1T3 OES Cystofiberscope/Nephrofiberscope) and does not contain the detailed information required to fill out a table of acceptance criteria, reported device performance, or specific study details often found in clinical trial reports or validation studies.
Here's why and what information can be extracted:
- 510(k) Purpose: A 510(k) submission primarily aims to demonstrate substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. It's not a direct submission of clinical trial results proving specific performance metrics against an acceptance criterion in the same way a PMA (Premarket Approval) or a clinical study report would.
Therefore, most of the requested information regarding detailed acceptance criteria, study specifics, and performance metrics is not available in this document.
However, I can extract and state what is present:
Key Information from the Document:
- Device Name: Olympus XCYF-1T3 OES Cystofiberscope/Nephrofiberscope, accessories and ancillary equipment.
- Intended Use: Endoscopic diagnosis and treatment within the bladder, urethra, and kidneys, to be used with an Olympus Light Source, Documentation Equipment, Display Monitor, Suction Pump, Endo-Therapy Accessories, electrosurgical Unit, and other ancillary equipment.
- Predicate Devices: K843084 Olympus Nephroscope/Cystoscope and K904940 Infant Resectoscope & Accessories.
- Safety Standards: The device is manufactured and tested according to voluntary safety standards IEC60601-1 and IEC60601-2-18.
Why specific details are missing:
- Acceptance Criteria & Reported Performance: The document states that the new device has a "large Instrument Channel of bright optical quality compared to the predicate device, XCYF-1T3" and "facilitate operation under endoscopic-surgery including high-frequency treatment." However, it does not provide quantitative acceptance criteria (e.g., "optical clarity must be >X lumens") or specific performance values (e.g., "achieved Y lumens"). The comparison to the predicate device is implicit rather than a formal side-by-side performance table.
- Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone Study, Training Set, Training Ground Truth: These are all aspects associated with detailed performance evaluation studies, especially for AI/algorithm-driven devices or clinical trials. This document pertains to a medical device (fiber optic endoscope) and does not describe such studies. Its substantial equivalence argument relies on comparing the design and materials to a predicate, and adherence to performance standards, rather than complex clinical outcome studies for this classification of device at the 510(k) stage. The mention of "electrosurgical treatment" being a new feature compared to the predicate "Nephroscope/Cystoscope Model CHF-P10" is a key difference being addressed, and the safety standards (IEC60601-1 and IEC60601-2-18) likely cover the electrical safety aspects of such an addition.
Conclusion:
Based on the provided document, I cannot fill out the requested table or provide most of the study details because the document is a 510(k) premarket notification for an endoscope, not a clinical study report for an AI-driven device or one requiring extensive clinical performance data in this format. The acceptance is based on demonstrating substantial equivalence to predicate devices and adherence to recognized safety standards.
§ 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.