(85 days)
Olympus BIOPSY FORCEPS has been designed to be used with an Olympus endoscope to collect tissue samples within the upper and lower digestive tract and to extract the tissue samples though the biopsy forceps with suction.
This instrument has been designed to be used with an Olympus endoscope to collect tissue within the upper and lower digestive tract and to extract the tissue sample through the biopsy forceps with suction.
The Olympus Biopsy Forceps XBO1-824-18/19/20 are composed with three major components as follows:
- Biopsv Forceps (XBO1-824-18/19/20)
The mechanism of subject device for collecting blopsied tissue is that biopsled tissue is caught onto Specimen trap by injected water through the biopsy forceps and it is possible to collect 5 samples continually. - Suction Tube (XBO1-824-18C)
This device is for connecting the thumb ring valve to the suction source. - Specimen Trap (XBO1-824-18D)
The Specimen Trap has a fitter for the specimen to be aspirated through the Aspiration Lumen, which can be attached onto the proximal section of the Biopsy Forceps. The Specimen Trap is comprised with five independent filters, which are arrayed serially. After it catches the specimen, the filter that holds the specimen, is extruded from the proximal handle of the Biopsy Forceps, and snapped off into an individual section. To avoid unexpected breakage of the Trap, the Trap Support guides the sections of the Traps. When the section of the Specimen Trap is inserted into the proximal handle, it will make a "click" sound, and the first Trap will be centered at the axis of the Aspiration automatically.
This FDA 510(k) summary for the Olympus XBO1-824-18/19/20 Biopsy Forceps does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a premarket notification for substantial equivalence, meaning the manufacturer is asserting their device is as safe and effective as a legally marketed predicate device, and thus does not require submission of clinical data. Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, ground truth, and comparative effectiveness studies is not present in this document.
Here's why each point cannot be addressed from the provided text:
- A table of acceptance criteria and the reported device performance: Not present. The document focuses on demonstrating substantial equivalence to predicate devices, not on meeting specific performance criteria through a study.
- Sample sized used for the test set and the data provenance: No test set or associated data is described, as clinical data was not required for this 510(k) submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment is detailed.
- Adjudication method for the test set: Not applicable, as no test set requiring adjudication is described.
- 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: Not applicable. This device is a biopsy forceps, not an AI-powered diagnostic tool, and no MRMC study or AI-assistance is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical instrument, not an algorithm.
- The type of ground truth used: Not applicable, as no ground truth is described.
- The sample size for the training set: Not applicable, as no training set or machine learning components are part of this device.
- How the ground truth for the training set was established: Not applicable, as no training set or ground truth establishment is detailed.
The document explicitly states:
- "Compared to the predicate devices, 'Biopsy Forceps XBO1-824-18/19/20' does not incorporate any significant changes in intended use, methods of operations, materials, or design that could affect the safety and effectiveness." (Section F: Reason for not requiring clinical data)
This statement is the core of their 510(k) submission and explains why detailed performance studies with acceptance criteria are not included in this particular document.
§ 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.