(73 days)
Endoscopes (GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190, COLONOVIDEOSCOPE CF-HQ190L/I, CF-H190L/I, PCF-H190L/I, PCF-PH190L/I)
This instrument is intended to be used with an Olympus video system center, endoscope position detecting unit (for CF-HQ190L/), light source, document, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190 are indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
The EVIS EXERA III COLONOVIDEOSCOPE CF-H190L/I, CF-HQ190L/I, PCF-PH190U/I, PCF-H190L/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
CV-190 VIDEO SYSTEM CENTER
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
CLV-190 XENON LIGHT SOURCE
This light source is intended to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
The EVIS EXERA III VIDEO SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation within the upper and lower digestive tract.
The primary components of the subject system are:
- VIDEO SYSTEM CENTER OLYMPUS CV-190
- XENON LIGHT SOURCE OLYMPUS CLV-190
- ENDOSCOPES
- GASTROINTESTINAL VIDEOSCOPE (GIF-H190,GIF-HQ190, GIF-XP190N)
- COLONOVIDEOSCOPE (CF-HQ190L/I, CF-H190L/I, PCF- PH190L/I, PCF- H190L/I)
The provided document is a 510(k) Summary for the Olympus EVIS EXERA III VIDEO SYSTEM. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlining indications for use, rather than presenting a performance study with acceptance criteria for a new and distinct functional claim.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning the following points:
- A table of acceptance criteria and the reported device performance: This information is not present. The document states that "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007," but it does not specify what those criteria were or how the device's performance against them was measured or reported.
- Sample size used for the test set and the data provenance: Not applicable as no specific device performance study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: This document is for a video system, not an AI-assisted diagnostic device, so this type of study is not relevant here and is not mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is hardware, not a standalone AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document states that the purpose of the notification is to "add an additional colonoscopy-related marketing claim" to the existing device and that "There are no new technological features incorporated... No design changes have been made... other than this marketing claim modification." It relies on the substantial equivalence to the predicate device (K112680) and conformity to applicable safety standards (like ISO 14971:2007) and software guidance.
§ 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.