(101 days)
The invendoscopy E200 System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.
The colonoscope component of the invendoscopy E200 System, the invendoscope SC200, is a sterile single use disposable device. The invendoscope SC200 cannot be reprocessed.
The invendoscopy E200 System consists of an invendoscope SC200, an invendo SPU E200, an invendo ScopeController and an invendo E200 Drying Adapter.
The invendoscope SC200 is a sterile single-use disposable colonoscope. The distal tip of the colonoscope is deflectable and equipped with a CMOS camera and LEDs for illumination. A working channel is incorporated for biopsies and polypectomies. The invendoscope SC200 is furthermore equipped with insufflation, irrigation and suction functions.
The invendo SPU E200 contains the video signal processing technology which enables the endoscope to illuminate, view, record and transmit video data of endoscopic images. The invendo SPU E200 supplies the colonoscope and controls its functions according to the commands of the operator.
The operator uses the invendo ScopeController unit to control the invendoscopy E200 System. The invendo ScopeController allows the operator to control following functions of the colonoscope: deflection of the tip; insufflation; irrigation and suction. The invendo ScopeController also allows the user to record images.
The invendo E200 Drying Adapter is intended to support drying of the inner parts of the invendo SPU E200. It is used to connect a waste container to the invendo SPU E200.
This document describes the regulatory submission for the invendoscopy E200 System (K161355) and focuses on the performance testing carried out to demonstrate its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text discusses performance testing in a general sense, stating that the device "functioned as intended, performed as well as or better than the predicate and met individual test specifications." However, it does not explicitly provide a table detailing specific quantitative acceptance criteria or granular performance metrics for the device. Instead, it lists the standards against which testing was performed and draws a general conclusion about the device's performance relative to these standards and the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for performance testing (e.g., number of devices tested, number of simulated procedures, or number of patients). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) for any clinical or non-clinical studies. The focus is on non-clinical engineering and biocompatibility tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The performance testing described primarily relates to engineering and material standards, not to clinical efficacy or diagnostic accuracy that would typically require expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided, as the nature of the testing described (largely engineering and compliance with technical standards) does not typically involve adjudication in the clinical sense.
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
An MRMC comparative effectiveness study was not conducted as this device is an endoscope system (hardware and associated control units), not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
A standalone performance study for an algorithm was not done. The invendoscopy E200 System is a physical medical device for visualization and diagnostic/therapeutic access, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical performance testing described, the "ground truth" would be the specifications and requirements defined by the referenced international and national standards (e.g., IEC 60601-1, ISO 10993 series, ASTM standards) and the established in-house acceptance criteria based on ISO 14971. The device's performance was measured against these technical and safety thresholds. It is not based on expert consensus, pathology, or outcomes data in the traditional sense of clinical diagnostic accuracy.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The invendoscopy E200 System is a physical medical device, not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided, as there is no training set for this type of 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.