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.

Device Description

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.

AI/ML Overview

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.

Summary

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K100624
Pages 1 of 7

FEB 2 3 2012

510(k) Summary invendo medical C20 Colonoscopy System

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

Owner:	invendo medical GmbH
Address:	Peterhofstr. 3b86438 KissingGermany
Contact:	Oliver v. RuepprechtManager QA/RAPhone : +49 - 8233 - 744 98 16Fax: +49 - 8233 - 744 98 15Mail: oliver.ruepprecht@invendo-medical.de

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Device Name, 21 CFR807.92(a){2}.

Trade Name: invendo C20 Colonoscopy System; includes SC20 Colonoscope and the C20 Base System (base unit, drive, and handheld) Common Name: Colonoscope Classification Name: Endoscope and accessories, 21CFR 876.1500, product code: FDF

Predicate Devices, 21 CFR 807.92(a)(3):

Predicate Device	510(k) No.
Olympus CF-Q160AL/I	K001241
Fujinon EN 450P5/20 Double Balloon	K040048
ColonoSight 510B	K032688
NeoGuideEndoscopy System	K052930;
	K070622
Avantis 3rd Eye Retroscope	K070330
Softscope CAD 12	K092156
Medela Dominat 35c/i suction pump	K043544
Medela Basic 30	K021368
PROTOCO2LTM Colon Insufflator with Performance Improvements	K030854
EndoGatorEndoscopy Irrigation Pump	K060962
Olympus Exera 160A videoprocessor	K051645

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Device Description, 21 CFR 807.92(a)(4):

Viewing direction	Forward
Field ofview	114°
Chip	CMOS, 250.000 Pixels
Max. Diameter Device	18mm
Working length	2100mm
Total length	3600mm
Bending capacity	180° in each direction at 37°C
Diameter working channel	3.1mm
Max. speed colonoscope via drive unit	500mm/min
Power supply baseunit	100 - 240V 50/60Hz
Max. internal pressure bas eunit	600kPa
Max. internal vacuum base unit	-75kPa

Specification Chart:

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Intended Use / Indications for Use, 21 CFR 807.92(a){5):

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.

Predicate Comparison, 21 CFR 807.92(a)(6):

The invendo C20 Colonoscopy System has the same intended use and indications for use as the predicate devices. The C20 Colonoscopy System has similar technological characteristics, however, the principles of operation with respect to advancing and retracting the endoscope in the colon are different from the predicate devices. The invendo SC20 Colonoscope is not manually pushed or otherwise manually manipulated by the operator, but instead, moves under the operator's control and direction with the help of the drive unit and user selected commands. The colonoscope uses an inverted sleeve technology for advancing and retracting.

Like the predicate devices, the invendo SC20 Colonoscope is a long, flexible endoscope that features a working channel, deflectable tip, and optics at the tip of the device. The working length of the predicate devices is somewhat less since those devices adjust the length and conformation of the colon to the device, this minor difference does not raise new questions of safety and effectiveness.

The invendo SC20 Colonoscope uses an overtube mechanism for the transmission of advanced power like the SoftScope CAD12. In both cases the sleeve systems are disposable.

The deflecting tip of the invendo C20 Colonoscopy System is electrohydraulically controlled via fluid-filled bellows while the deflecting tips of the predicate devices are controlled by Bowden wires. The performance bench and clinical testing demonstrate that these differences do not raise new questions of safety or effectiveness as compared

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to the cleared predicate devices and that the device is as safe and effective as its predicates.

The invendo C20 Colonoscopy System is capable of performing rinsing, suction and insufflation like the predicate devices.

The invendo C20 Colonoscopy System uses the same basic technology for visualization and illumination as the predicate devices.

The materials used in the invendo C20 Colonoscopy System are somewhat different from those of the predicate devices, the company has provided complete biocompatibility data demonstrating that the materials used are biocompatible and thus as safe as those used in the predicate devices.

Performance data demonstrate that the device is as safe and effective as the predicate devices. Thus, the invendo C20 Colonoscopy System is substantially equivalent.

Clinical data confirms that the device can successfully navigate the colon and perform polyp/lesion removals.

Nonclinical performance data, 21 CFR 807.92(b)(1):

To assess the performance of the invendo C20 Colonoscopy System, invendo conducted bench tests to measure forces encountered during device use, product stability, biocompatibility of device components (according ISO Standard ISO-10993 and FDA Guidance G959-1), and constructive safety (IEC 60601-2-18). In all instances, the SC20 Colonoscope and the invendo C20 base system functioned as intended and met individual test specifications.

Forces: The forces exerted by the colonoscope while moving through small curves with and without deflection were measured. The maximum forces exerted by the deflection, and advancement of the colonoscope were less than the force necessary to cause a perforation as determined by Thomas, K. Wu; Gastrointest. Endosc. 1978 Volume 24.

Biocompatibility: The tested materials met the biocompatibility requirements as per ISO 10993.

Product stability: The invendo SC20 Colonoscope has been demonstrated to be stable over the labeled 6 month shelf life of the product.

Constructive safety: The system met the general requirements of safety and the particular safety requirements of endoscopic equipment per IEC 60601.

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The results of the tests demonstrate that the device is as safe and effective as the predicate devices.

Clinical Study Summary, 21 CFR 807.92(b)(2):

Groth et al., "High Cecal Intubation Rates with a New Computer-Assisted Colonoscope: A Feasibility Study," The American Journal of Gastroenterology, vol. 106, pp. 1075-1080, June 2011.

A study was conducted in Germany to measure the rate of successful cecal intubation for the assessment of the safety and effectiveness of the invendo C20 Colonoscopy System. The study was a prospective single arm study of 61 asymptomatic subjects (between 50 and 75 years of age) that were willing to undergo screening colonoscopy and were at average risk for colorectal cancer. Exclusion criteria included (but were not limited to) subjects with:

history of colorectal neoplasia including familial adenomatous polyposis (FAP) or o hereditary non-polyposis colorectal cancer;
suspected diagnosis of inflammatory bowel disease, bowel obstruction, acute o diverticulitis, known severe diverticulosis or any known large bowel disease
GI-related symptoms, complaints or diseases; o
previous abdominal surgery except for uncomplicated cholecystectomy, o appendectomy or minor pelvic surgery (e.g., hernia repair, oophorectomy).

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. The subjects were examined in the left lateral position, with shifting to the supine position in most cases.

Cecal intubation was achieved in 98.4% (60/61) of the subjects (95% Cl: 91.2 - 99.9%). Two device malfunctions and no device-related adverse events were reported. Thirtynine lesions in 26 subjects (42.6%) were detected. Of those lesions, 36 were polyps in 23 subjects (37.7%), ranging in size from 2mm to 18mm (average 4.8mm). The remaining 3 lesions consisted of one abnormally large ileocecal valve which underwent biopsy, one varicose knot (no intervention) and one lipoma (no intervention). Thirty-two polyps (88.9%) were removed by either forceps (22) or snare (10). There were two cases where a second conventional colonoscope was used for the removal of a 12mm flat lesion and for the treatment of post-polypectomy bleeding.

Therapeutic maneuvers other than biopsy and polypectomy were not evaluated because cecal intubation was the primary endpoint. Although not required by the

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protocol, investigators performed retroflexions as needed to ensure thoroughness of examination; retroflexion did not pose a problem and was well tolerated.

This study demonstrates that the invendo C20 Colonoscopy System can successfully 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.

Summary, 21 CFR 807.92(b)(3)

The laboratory studies, which include determinations of exerted forces, product stability, biocompatibility and constructive safety, demonstrate that the invendo C20 Colonoscopy System performs as well as the predicate devices. The clinical data demonstrate that the invendo C20 Colonoscopy System can successfully 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB 2 3 2012

Mr. Oliver V. Ruepprecht Manager OA/RA Invendo Medical GmbH Peterhofstr. 3b KISSING 86438 GERMANY

Re: K100624

Trade/Device Name: Invendo C20 Colonoscopy System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: February 15, 2012 Received: February 15, 2012

Dear Mr. Ruepprecht:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Occinetie fore, market the device, subject to the general controls provisions of the Act. The I ou mayy insteresy size of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your de subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oe as note a determination that your device complies with other requirements of the Act that I Drinas Intact and regulations administered by other Federal agencies. You must or uny with all the Act's requirements, including, but not limited to: registration and listing confirs will and the North of I CFR Part 801); medical device reporting (reporting of medical

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Page 2-

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 Jou action ips . fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin K. Twitchell

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K100624

Device Name: invendo C20 Colonoscopy System

Indications for Use:

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 an ileocecal valve) for endoscopy and endoscopic surgery.

The colonoscope component of the invendo C20 Colonoscopy System, the rne colonoscope, is a single use disposable device. The SC20 colonoscope cannot be reprocessed.

Prescription Use × (Part 21 CFR 801 Subpart D) AND Over-The-Counter Use (21 CFR 801 Subpart C) OR

121

00018

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Beniamin K. Kihara
(Division Sign-Off)

ylston Sign-Off sion of Reproductive, Gastro-Renal, and I Device

Regulation Number and Section

§ 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.