(721 days)
The invendo C20 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 endoscopy surgery.
The colonoscope component of the invendo C20 Colonoscopy System, the SC20 Colonoscope, is a single use disposable device. The SC20 Colonoscope cannot be reprocessed.
The device is contraindicated in patients with fulminant colitis; acute diverticulitis; severe cardiopulmonary illness; or where there is a lack of cooperation on the part of the patient.
The invendo C20 Colonoscopy System has many features in common with currently marked colonoscopes. The invendo C20 Colonoscopy System consists of two separate components: a single use disposable colonoscope and a base system that supplies and controls the colonoscope according to user commands via a handheld control unit. 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 invendo C20 Colonoscopy System is equipped with insufflation, irrigation and suction functions. Deflection, rinsing, insufflation and suction are activated and controlled by the base unit, according to user commands.
Unlike other colonoscopes, the invendo C20 Colonoscopy System is not manually pushed or otherwise manually manipulated by the operator, but instead, moves under the operator's direction through use of a handheld controller that controls, among other things, the device's drive unit. The colonoscope uses a lubricated inverted sleeve technology for advancement and retraction. Unlike other colonoscopes, the invendo C20 Colonoscopy System uses pressure controlled bellows for the deflecting function. The endoscope deflects in any direction depending on the pressure in the bellows. The handheld control is connected to the base unit. Depending on the user commands, the base unit activates and controls the functions of the invendo SC20 Colonoscope.
The colonoscope component of the system is a single-use disposable device. The SC20 colonoscope cannot be reprocessed. The main materials with direct contact with the patient are silicone and polycarbonate. The whole colonoscope, including the lubricant, were demonstrated to be biocompatible per ISO 10993.
Acceptance Criteria and Device Performance for The invendo C20 Colonoscopy System
The invendo C20 Colonoscopy System relies on both non-clinical (bench) and clinical data to demonstrate its safety and effectiveness, showing substantial equivalence to predicate devices. The primary clinical acceptance criterion was the rate of successful cecal intubation.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Bench/Non-Clinical) | Reported Device Performance (Bench/Non-Clinical) | Acceptance Criteria (Clinical) | Reported Device Performance (Clinical) |
|---|---|---|---|---|---|
| Mechanical Performance | Force Exertion (during advancement/deflection) | Maximum forces exerted by deflection and advancement must be less than the force necessary to cause a perforation (as determined by Thomas, K. Wu; Gastrointest. Endosc. 1978 Volume 24). | Forces exerted by the colonoscope while moving through small curves with and without deflection were less than the force necessary to cause a perforation. | N/A | N/A |
| Biocompatibility | Patient Contact Materials | Tested materials must meet the biocompatibility requirements as per ISO 10993 and FDA Guidance G959-1. | All tested materials met the biocompatibility requirements. The whole colonoscope, including lubricant, was demonstrated to be biocompatible per ISO 10993. | N/A | N/A |
| Product Stability | Shelf Life | Demonstrated stability over the labeled shelf life. | The invendo SC20 Colonoscope was demonstrated to be stable over its labeled 6-month shelf life. | N/A | N/A |
| Electrical/Safety | Constructive Safety | System must meet the general requirements of safety and the particular safety requirements of endoscopic equipment per IEC 60601-2-18 (Constructive Safety for endoscopic equipment) and IEC 60601-1 (General requirements of safety). | The system met the general requirements of safety (IEC 60601-1) and the particular safety requirements of endoscopic equipment (IEC 60601-2-18). | N/A | N/A |
| Clinical Effectiveness | Successful Cecal Intubation Rate (Primary Endpoint) | Not explicitly stated as a numerical a priori acceptance criterion, but implicitly expected to be high and comparable to conventional colonoscopes to demonstrate effectiveness. | N/A | High rate of successful cecal intubation. | 98.4% (60/61 subjects; 95% CI: 91.2 - 99.9%) |
| Clinical Safety | Device-related Adverse Events | Low incidence of device-related adverse events. | N/A | Low incidence of device-related adverse events. | No device-related adverse events reported. |
| Clinical Functionality | Ability to perform visualization, diagnostic/therapeutic access | The system should successfully provide visualization and diagnostic/therapeutic access. | N/A | Demonstrated ability to provide visualization and diagnostic/therapeutic access. | Successfully detected 39 lesions in 26 subjects, 32 polyps removed. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 61 subjects.
- Data Provenance: The study was conducted in Germany and was prospective in nature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided document does not explicitly state the number of experts used to establish ground truth for the test set or their specific qualifications (e.g., "radiologist with 10 years of experience").
However, it mentions:
- "Investigators underwent 'pre-study' training where 2-4 training cases were needed to gain proficiency."
- "The investigators were experienced endoscopists that insufflated the colon with either CO2 or water."
This indicates that experienced endoscopists (who acted as the primary users and observers) were involved, and their findings (e.g., successful intubation, lesion detection) likely formed the ground truth for the clinical outcomes. The clinical study was published in "The American Journal of Gastroenterology," suggesting peer-reviewed medical expertise validated the study design and results.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in the clinical study. The "experienced endoscopists" performing the procedures and documenting the outcomes (e.g., cecal intubation, lesion detection) served as the primary evaluators. The results were then reported, implying the investigators' findings formed the basis of the reported performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study was a "prospective single arm study" focusing on the performance of the invendo C20 Colonoscopy System alone. It did not compare human readers' performance with and without AI assistance, nor did it involve a direct comparison of the device's diagnostic accuracy against a "gold standard" or another device in a multi-reader setting.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The invendo C20 Colonoscopy System is a device that requires a human operator (an endoscopist) to control its advancement and utilize its visualization and therapeutic capabilities. Therefore, a standalone (algorithm only) performance study was not performed nor would it be applicable since the device inherently operates with a human in the loop. The "device performance" in the clinical study is the performance of the entire system (device + human operator).
7. Type of Ground Truth Used
The ground truth used in the clinical study was primarily based on expert observation and direct procedural outcomes by experienced endoscopists during a prospective study.
- Cecal Intubation: Verified by the endoscopist during the procedure.
- Lesion Detection and Removal: Identified by the endoscopist during the procedure, with polyps removed and potentially histologically confirmed (though not explicitly detailed in this summary). The summary mentions "Thirty-two polyps (88.9%) were removed by either forceps (22) or snare (10)," which implies direct observation and intervention.
This type of ground truth is analogous to "clinical findings by expert practitioners" rather than a separate, external pathology review for every identified lesion.
8. Sample Size for the Training Set
The document does not describe a training set in the context of an algorithm or AI model development. The invendo C20 Colonoscopy System is a mechanical and electronic device, not an AI software. Therefore, the concept of a "training set" for an algorithm is not applicable here. The "training" mentioned for investigators refers to user proficiency with the device, not an algorithm's learning phase.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, there was no algorithm or AI model that required a training set with established ground truth in the typical sense. The "pre-study" training for investigators was about gaining proficiency in operating the device, not training an 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.