(721 days)
Not Found
No
The summary describes a robotic-assisted colonoscopy system with novel mechanical features (drive unit, bellows for deflection) but does not mention any AI or ML components for image analysis, navigation assistance, or other functions.
Yes
The device is described as providing "diagnostic / therapeutic access" and explicitly mentions "biopsies and polypectomies" which are therapeutic procedures.
Yes
The "Intended Use / Indications for Use" section states that the system is intended to "provide visualization and diagnostic / therapeutic access". The ability to provide visualization for medical professionals to assess and diagnose conditions, along with the mention of detecting lesions and polyps in the performance study, confirms its diagnostic purpose.
No
The device description clearly outlines hardware components including a single-use disposable colonoscope with a camera, LEDs, working channel, drive unit, and bellows, as well as a base system and handheld control unit. This is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) outside of the body to provide information about a person's health.
- Device Function: The invendo C20 Colonoscopy System is used for direct visualization and access to the lower gastrointestinal tract inside the patient's body. It's an endoscopic system used for imaging and therapeutic procedures performed in vivo.
- Intended Use: The intended use clearly states "to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract... for endoscopy and endoscopy surgery." This describes an in vivo procedure.
- Device Description: The description details a colonoscope with a camera, working channel, insufflation, irrigation, and suction functions, all used within the body.
The device is a medical device used for diagnostic and therapeutic procedures performed directly on the patient, not on specimens taken from the patient.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
FDF
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.
| 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 |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CMOS camera
Anatomical Site
adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve)
Indicated Patient Age Range
adult
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study Summary: A prospective single arm study was conducted in Germany with 61 asymptomatic subjects (between 50 and 75 years of age) who were willing to undergo screening colonoscopy and were at average risk for colorectal cancer. The study measured the rate of successful cecal intubation. Cecal intubation was achieved in 98.4% (60/61) of the subjects. Two device malfunctions and no device-related adverse events were reported. Thirty-nine lesions in 26 subjects (42.6%) were detected, with 36 being polyps in 23 subjects (37.7%) ranging from 2mm to 18mm. The study concluded that the device can successfully provide visualization and diagnostic/therapeutic access to the adult lower gastrointestinal tract.
Nonclinical performance data: Bench tests were conducted to measure forces encountered during device use, product stability, biocompatibility of device components (per ISO 10993 and FDA Guidance G959-1), and constructive safety (IEC 60601-2-18). The results indicated that the invendo SC20 Colonoscope and invendo C20 base system functioned as intended and met specifications. Forces exerted were less than what would cause perforation. Biocompatibility requirements were met. The product demonstrated stability over a 6-month shelf life. The system met the general and particular safety requirements of endoscopic equipment per IEC 60601.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Cecal intubation rate: 98.4% (60/61) (95% Cl: 91.2 - 99.9%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K001241, K040048, K032688, K052930, K070622, K070330, K092156, K043544, K021368, K030854, K060962, K051645
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K100624
Pages 1 of 7
FEB 2 3 2012
510(k) Summary invendo medical C20 Colonoscopy System
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
| Owner: | invendo medical GmbH |
|---|---|
| Address: | Peterhofstr. 3b |
| 86438 Kissing | |
| Germany | |
| Contact: | Oliver v. Ruepprecht |
| Manager QA/RA | |
| Phone : +49 - 8233 - 744 98 16 | |
| Fax: +49 - 8233 - 744 98 15 | |
| Mail: oliver.ruepprecht@invendo-medical.de |
1
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 |
2
Device Description, 21 CFR 807.92(a)(4):
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.
| 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:
3
Intended Use / Indications for Use, 21 CFR 807.92(a){5):
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.
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
4
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.
5
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
6
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.
7
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
8
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,
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
9
Indications for Use Statement
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