(204 days)
The invendo C25 Colonoscopy 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, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.
The colonoscope component of the invendo C25 Colonoscopy System, the SC20 colonoscope, is a single-use disposable device. The SC20 colonoscope cannot be reprocessed.
The invendo C25 Colonoscopy System is a modified version of the invendo C20 Colonoscopy System.
Like the predicate device, the invendo C25 Colonoscopy System is steered and controlled by the operator. The distal tip of the colonoscope is deflectable and includes a CMOS camera and LEDs for illumination. A working channel is incorporated to enable biopsies and polypectomies. The invendo C25 Colonoscopy System includes insufflation, irrigation and suction functions.
The invendo C25 Colonoscopy System consists of two components: (1) the invendo C25 base system; and (2) a single-use, disposable colonoscope, the SC20 colonoscope.
The invendo C25 base system provides the SC20 colonoscope with the above mentioned functions and transfers user commands to the colonoscope. To control the colonoscope, the operator uses a handheld control unit. All colonoscope functions are solely activated by the user. The invendo C25 base system consists of the Supply and Processing Unit (SPU or base unit), the handheld control and the drive unit.
The provided document is a 510(k) premarket notification for the invendo C25 Colonoscopy System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study for novel performance claims.
Therefore, many of the requested details about acceptance criteria, clinical study methodology, and training/test set specifics are not applicable or available within this document, as it describes a technical modification and equivalence demonstration, not a de novo clinical performance study against pre-defined metrics.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance
Since this filing is for substantial equivalence to a predicate device (invendo C20 Colonoscopy System), the "acceptance criteria" are primarily related to meeting established safety standards and demonstrating that the new device performs at least as well as the predicate with its modifications.
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| IEC 60601-1 (General safety) | System functioned as intended, met test specifications. |
| IEC 60601-2-18 (Endoscopic equipment safety) | System functioned as intended, met test specifications. |
| IEC 60601-1-2 (EMC) | System functioned as intended, met test specifications. |
| ISO 10993-5 (In vitro cytotoxicity) | System functioned as intended, met test specifications. |
| ISO 10993-10 (Irritation & sensitization) | System functioned as intended, met test specifications. |
| Test of check valve under worst-case conditions | System functioned as intended, met test specifications. |
| Evaluation of decompression line and system tests | System functioned as intended, met test specifications. |
| Evaluation of backflow without check valves | System functioned as intended, met test specifications. |
| Evaluation of reprocessing performance | System functioned as intended, met test specifications. |
| Performance compared to predicate device | Performed as well as or better than the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: This document does not specify sample sizes for any human clinical test sets, as the testing described is primarily non-clinical (engineering and biocompatibility). The "Evaluation of the performance compared to the predicate device" would have been a non-clinical, comparative engineering/functional test, not a clinical trial.
- Data Provenance: Not applicable, as the document details non-clinical laboratory testing.
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. This document describes non-clinical testing against engineering standards and a predicate device, not a study requiring expert-established ground truth on medical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for the type of testing described in this 510(k).
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
- No, an MRMC comparative effectiveness study was not done as this is a device modification submission, not an AI-enabled diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable, as this is a medical device (colonoscope system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests were the specified engineering standards (e.g., IEC, ISO) and the functional and safety performance of the predicate device.
8. The sample size for the training set
- Not applicable, as this is not an AI/algorithm device that requires a training set. The "design validation" mentioned refers to engineering design and testing, not machine learning model training.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for an AI/algorithm.
§ 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.