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The invendoscopy E210 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 E210 System, the invendoscope SC210, is a sterile single use disposable device. The invendoscope SC210 cannot be reprocessed.

The invendoscopy E210 System consists of an invendoscope SC210, an invendo E210 Processing Unit, an invendo E210 Power Unit, an invendo ScopeController and an invendo Drying Adapter. The invendo E210 Processing Unit and the invendo E210 Power Unit together form the invendo SPU E210.

The invendoscope SC210 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 SC210 is furthermore equipped with insufflation, irrigation and suction functions.

The invendo E210 SPU (consisting of invendo E210 Processing Unit and invendo E210 Power Unit) contains the video signal processing technology which enables the endoscope to illuminate, view, record and transmit video data of endoscopic images. The invendo SPU E210 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 E210 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 Drying Adapter is intended to support drying of the inner parts of the invendo SPU E210. It is used to connect a waste container to the invendo SPU E210.

The provided text describes the invendoscopy E210 System and its substantial equivalence to predicate devices, but it does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria.

The document details:

• The device's intended use and components.
• A comparison of its technology/specifications to predicate devices.
• A list of non-clinical performance testing conducted to validate the design and assure conformity with various design standards (e.g., electrical safety, biocompatibility, packaging integrity, sterilization).
• A statement that "In all instances, the invendoscopy E210 System functioned as intended, performed as well as or better than the predicate and met individual test specifications." and "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment."

However, it does not provide:

1. A table of acceptance criteria and reported device performance with specific metrics.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method.
5. Information on any MRMC comparative effectiveness study.
6. Details of a standalone algorithm performance study.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence primarily through technical comparison and compliance with general safety and performance standards for medical devices, rather than a specific clinical or technical performance study with quantitative acceptance criteria and results.

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