(90 days)
These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment.
Use the EVIS EXERA II COLONOVIDEOSCOPE CF-Y0023-L/I for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
The CF-Y0023-L/I Colonovideoscope is a flexible video endoscope used for endoscopic diagnosis and treatment within the colon. The CF-Y0023-L/I Colonovideoscope is basically identical to the predicate device, Olympus XCF-H160AY2L Colonovideoscope, hereinafter referred to as XCF-H160AY2L in intended use, specifications, performance. The optical system of the CF-Y0023-L/I is a charge coupled device (CCD) based system, allowing endoscopic image display on a video monitor.
The major differences of the subject CF-Y0023-L/I Colonovideoscope from the predicate XCF-H160AY2L device are as follows:
-The number of objective lens and the width of the field of view for the subject and predicate devices differ. ( CF-Y0023-L/l:140° (forward view) and 141- 233° (side view), XCF-H160AY2L: 170° (forward view))
-The shape of distal ends differ.
-The layout of the light guide lens differ.
-The number of air/water nozzles differ.( CF-Y0023-L/I:n=3, XCF-H160AY2L:n=1)
The new colonovideoscope CF-Y0023-L/I has both 140 degree forward view and 141-233 degree side view. Both forward view and side view are focused on one CCD, and the user can observe both 140 degree forward view and 141-233 degree side view at once.
The provided text is a 510(k) summary for the OLYMPUS MEDICAL SYSTEMS CORP. COLONOVIDEOSCOPE CF-Y0023-L/I. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a novel medical device like an AI algorithm.
Therefore, many of the requested elements (e.g., acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance, expert qualifications, adjudication methods) are not applicable or not present in this type of submission.
The 510(k) summary primarily compares the technological characteristics of the new device (CF-Y0023-L/I) to a predicate device (XCF-H160AY2L) to argue that it does not raise new questions of safety or effectiveness.
Here's how the available information relates to your request:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document does not establish performance criteria for a diagnostic or AI-driven device with specific metrics like sensitivity, specificity, or accuracy. The comparison is based on technical specifications.
| Acceptance Criteria (N/A for this type of device) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| N/A | Field of View: |
- Subject Device: forward view: 140°, side view: 141°~233°
- Predicate Device: 170° |
| N/A | Depth of Field: - Subject Device: forward view: 3.1
100mm, side view: 060mm - Predicate Device: 2-100mm |
| N/A | Direction of View: - Subject Device: forward view: 0°, side view: 93.5°
- Predicate Device: forward viewing: 0° |
| N/A | Type of CCD: - Subject Device: Color
- Predicate Device: Color |
| N/A | Outer Diameter of Distal End: - Subject Device: φ13.9mm
- Predicate Device: φ13.9mm |
| N/A | Outer Diameter of Insertion Tube: - Subject Device: φ12.8mm
- Predicate Device: φ12.8mm |
| N/A | Bending Section Angulation UP/DOWN: - Subject Device: UP:180°, DOWN:180°
- Predicate Device: UP: 180°, DOWN:180° |
| N/A | Working Length: - Subject Device: CF-Y0023-L=1680mm, CF-Y0023-I=1330mm
- Predicate Device: 1680mm |
| N/A | Inner Diameter of Instrument Channel: - Subject Device: φ3.7mm
- Predicate Device: φ3.7mm |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes a medical device, not an AI or diagnostic algorithm tested with a dataset. It's a review of the physical characteristics and intended use in comparison to an existing device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No ground truth establishment by experts for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method is 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
- Not Applicable. This device is a colonovideoscope, not an AI system designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a manual colonovideoscope, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth is mentioned as this is a physical device submission.
8. The sample size for the training set
- Not Applicable. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established
- Not Applicable. No ground truth for a training set is mentioned.
§ 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.