(122 days)
EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180: This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180: This video system center has been designed to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180, OLYMPUS GIF TYPE XP180N: 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 for transoral or transnasal endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, and duodenum).
EVIS EXERA II. GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q180, OLYMPUS GIF TYPE H180: 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 for endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, and duodenum).
EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL, OLYMPUS CF TYPE Q180AI, OLYMPUS CF TYPE H180AL, QLYMPUS CF TYPE H180AI, OLYMPUS PCF TYPE Q180AL (Pediatric), OLYMPUS PCF TYPE Q180AL (Pediatric), OLYMPUS PCF TYPE H180AL (Pediatric), OLYMPUS PCF TYPE H180Al (Pediatric), 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 for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
The EVIS EXERA II 180 SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract.
The primary components of the subject system, which are part of this submission, are:
- EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180
- EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE XP180N .
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q180 .
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AI .
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AL
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AI
- . EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180AL (PEDIATRIC)
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180AI (PEDIATRIC)
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AL (PEDIATRIC)
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AI (PEDIATRIC)
The EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 is intended for endoscopic diagnosis, treatment and video observation. The CLV-180 has an optional filter which allows the user to enhance endoscopic white light images by selective processing of green and blue light. This feature, referred to as Narrow Band Imaging (NBI), employs an optical filter to filter the white light spectrum, changing it from a broad band to a narrow band.
The EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 is a video processing system intended for use with Olympus endoscopes such as the subject gastrointestinal videoscopes and colonovideoscopes. The CV-180 contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The CV-180 incorporates Image Enhancement and NBI Observation features.
The provided text is a 510(k) summary for the OLYMPUS EVIS EXERA II 180 SYSTEM, and its primary purpose is to establish substantial equivalence to a predicate device. It primarily focuses on comparing technological characteristics and intended use, rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment are not present in this type of regulatory submission. The document explicitly states: "The clinical literatures provided in this submission support new sales promotional claims for Barrett's esophagus, colorectal polyp detection and histology prediction." However, these clinical literatures are not included in the provided text.
Based on the provided information, I can only provide limited answers as the core data regarding performance studies is absent.
Here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly stated in terms of acceptance criteria with numerical performance targets. The submission establishes substantial equivalence by demonstrating that the subject device is "basically identical to its predicate device in intended use, and similar in specifications." The performance is implicitly accepted if it is similar to the predicate device. The tables provided (Table 16-2 to 16-11) compare specifications between the subject device and its predicate devices. For most specifications, the subject device is stated as "Identical to the Predicate Device," or minor differences in size/weight are noted.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use | Identical to the Predicate Device |
| Specifications (e.g., Field of View, Depth of Field, Angulation) | Primarily "Identical to the Predicate Device" with some minor variations (e.g., Working Length, Outer Diameter for specific endoscope models). |
| Safety and Effectiveness | No significant changes in material, design, or operation that could affect safety or effectiveness compared to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
Not specified in the provided text. The submission references "clinical literatures" to support new claims, but these studies themselves are not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not specified.
4. Adjudication Method for the Test Set
Not specified.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not specified. The document mentions that "The clinical literatures provided in this submission support new sales promotional claims for Barrett's esophagus, colorectal polyp detection and histology prediction." However, the details of these clinical literatures (including whether they were MRMC studies or involved AI assistance) are not provided in the submitted text. Given the filing date (2010), advanced AI assistance in clinical endoscopy studies was less common than today.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done
Not applicable. This device is an endoscopic video imaging system, not an AI algorithm designed for standalone performance. The NBI feature (Narrow Band Imaging) enhances images for human interpretation, it's not described as standalone diagnostic software.
7. The Type of Ground Truth Used
Not specified in the provided text for any performance studies. For the comparative effectiveness claims mentioned (Barrett's esophagus, colorectal polyp detection and histology prediction), it is implied that there would be some form of clinical ground truth (e.g., pathology, expert diagnosis), but details are absent.
8. The Sample Size for the Training Set
Not applicable. The device is a hardware system, not an AI algorithm trained on a dataset in the typical sense. The NBI feature uses an optical filter and image processing to enhance visuals, not machine learning from a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 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.