(78 days)
GASTROINTESTINAL VIDEOSCOPE XGIF-Q140M, XGIE-2T140M
This instrument has been designed to be used with the OLYMPUS Video System Center, Light Source, Documentation Equipment, Video Monitor, Electrosurgical unit, Endo-Therapy Accessories such as a Biopsy Forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach and duodenum).
COLONOVIDEOSCOPE XCF-Q140ML/L XPCF-160AML/I
This instrument has been designed to be used with the OLYMPUS Video System Center, Light Source, Documentation Eguipment, Video Monitor, Electrosurgical unit, Endo-Therapy Accessories such as a Biopsy Forceps and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, and sigmoid colon, colon, and ileocecal valve).
The subject devices. XGIF-Q140M. XGIF-2T140M. XCF-Q140ML/I. XPCF-160AML/I are basically identical to the predicate devices, GIF-Q140, GIF-2T140, CF-Q140L/I, PCF-140L/I except that the mechanical structure of variable stiffness* and Multi-bending function has been added.
*This feature has been added to XPCF-160AML/I only.
While XPCF-160AML/I has the mechanical structure of variable stiffness (Refer to Attachment 2. "Flexibility Adiustment Function") this feature is identical to those of another predicate device, the EVIS EXERA Colonovideoendoscopes (#K001241). The addition of the variable stiffness function does not require any new insertion method or technique.
The Multi-bending function has two independent bending sections in the insertion portion of the scope. This new function provides an easier approach in reaching the lesion and also a better view of the lesion from the front. Some lesions in the upper digestive tract were difficult to perform a perfect biopsy and endoscopy with the conventional forward-viewing gastroscope. (Refer to Appendix-3, "Clinical Literature"). The subject devices improve the approach to the lesion in the lower digestive tract compared with the predicate devices. We have evaluated the approach performance of the XPCF-160AMI compared to the predicate device using a colon model. (Refer to Attachment 1, "Comparison between approach performance of Predicate and Subject Device using a colon model").
This document is a 510(k) summary for OLYMPUS OPT-ELECTRONICS CO., LTD.'s Gastrointestinal Videoscopes and Colonovideoscopes. It describes the device, its intended use, and claims substantial equivalence to predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly define specific performance acceptance criteria in terms of numerical thresholds for clinical metrics (e.g., sensitivity, specificity, accuracy, or other quantifiable performance measures). Instead, it relies on demonstrating substantial equivalence to existing legally marketed predicate devices.
The "reported device performance" in this context is the assertion that the new devices XGIF-Q140M, XGIF-2T140M, XCF-Q140ML/I, XPCF-160AML/I perform equivalently to their predicate devices GIF-Q140, GIF-2T140, CF-Q140L/I, PCF-140L/I, and EVIS EXERA Colonovideoendoscopes.
The document states:
- "The subject devices... are basically identical to the predicate devices... except that the mechanical structure of variable stiffness* and Multi-bending function has been added."
- "The addition of the variable stiffness function does not require any new insertion method or technique."
- "The subject devices improve the approach to the lesion in the lower digestive tract compared with the predicate devices."
The study mentioned directly related to performance is:
- "We have evaluated the approach performance of the XPCF-160AMI compared to the predicate device using a colon model. (Refer to Attachment 1, 'Comparison between approach performance of Predicate and Subject Device using a colon model')."
Specifically, for acceptance criteria and performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (GIF-Q140, GIF-2T140, CF-Q140L/I, PCF-140L/I for GI/Colonoscopes; EVIS EXERA Colonovideoendoscopes for variable stiffness) for safety and effectiveness in intended use. | The subject devices are "basically identical" to predicates, with added mechanical features (variable stiffness, multi-bending) that do not alter safety or fundamental efficacy. |
| Compliance with voluntary safety standards IEC60601-1, IEC60601-1-1, IEC60601-2-18. | Devices "designed, manufactured and tested in compliance" with these standards. |
| Biocompatibility of patient-contacting materials. | All patient contacting materials are "identical materials that have been cleared in the past 510(k) submissions" and "confirmed with ISO 10993-1." |
| Improved lesion approach performance (for XPCF-160AML/I Multi-bending function). | "Evaluated the approach performance... using a colon model." (Specific quantitative results are not provided in this summary but referenced in Attachment 1). |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document mentions a study evaluating "approach performance... using a colon model." However, it does not specify the sample size (e.g., number of attempts, number of users, number of colon models) for this test set within the provided text.
- Data Provenance: The study was conducted "using a colon model," suggesting it was a simulated, non-clinical study rather than using human data. The country of origin for this specific "colon model" test is not stated, but the applicant is based in Japan.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not describe the use of human experts to establish "ground truth" for the colon model test. The test described appears to be a performance assessment on a physical model, likely measuring physical parameters of scope maneuverability or reach.
- The concept of "ground truth" as typically applied in AI/image analysis (e.g., expert consensus on diagnoses) is not relevant to this type of mechanical device performance study.
4. Adjudication method for the test set:
- The document does not mention any adjudication method as it relates to expert review. This is consistent with the type of non-clinical, mechanical performance testing described.
5. 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:
- No MRMC study was done. The device described is a gastrointestinal videoscope/colonovideoscope, which is an imaging and intervention tool, not an AI-assisted diagnostic software. Therefore, human reader improvement with or without AI assistance is not applicable to this device submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No standalone algorithm performance study was done. As noted above, this is a hardware medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the only specific study mentioned (approach performance on a colon model), the "ground truth" would likely be objective, measurable physical characteristics or outcomes on the model itself (e.g., successful navigation, time to reach a target, visualization of simulated lesions). It would not involve expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set:
- No training set is applicable or mentioned. This is not an AI/machine learning device. The design, manufacturing, and testing refer to engineering and safety standards, not a data-driven training process.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set mentioned for this device.
§ 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.