(294 days)
Not Found
No
The description focuses on the mechanical, pneumatic, and optical aspects of the device, controlled by "specifically designed command software" and a "computerised system" for displaying status and images. There is no mention of AI, ML, or advanced image processing for analysis or decision-making.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Endotics System is intended to provide "diagnostic/therapeutic access" to the lower gastrointestinal tract, and the "Device Description" mentions that it "allows the use of specific surgical tools through a working channel."
Yes
The "Intended Use / Indications for Use" explicitly states that the Endotics System is intended to provide "diagnostic/therapeutic access" and the "Device Description" details its use for "examination" of the colonrectum, which are functions of a diagnostic device. The performance studies also mention "detection of polyps" and "diagnostic capacity," further reinforcing its diagnostic purpose.
No
The device description clearly outlines hardware components including a disposable probe with a camera and light source, a workstation with an electro-pneumatic system, a command console, and associated accessories. While software controls the system, it is an integral part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "360° visualization and diagnostic/therapeutic access to the adult lower gastrointestinal tract... for endoscopy and endoscopic surgery." This describes a procedure performed in vivo (within the living body) for direct visualization and intervention.
- Device Description: The description details a system for examining the colonrectum using a camera, light source, steering system, and working channel for surgical tools. This is consistent with an endoscopic device used for internal examination and procedures.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or treatment. This device does not collect or analyze specimens in this manner.
The device is clearly an endoscopic system for performing procedures directly within the patient's body, which falls under the category of medical devices used for diagnosis and treatment in vivo, not IVDs.
N/A
Intended Use / Indications for Use
The Endotics System is intended to provide 360° visualization and diagnostic/therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, transverse colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.
The Endotics Probe (colonoscope component of the Endotics Colonoscope System) is a single use disposable device. The Endotics Probe cannot be reprocessed.
Product codes
FDF
Device Description
Endotics is an endoscopic system to be used for the examination of the final section of the intestine, the ends of which are marked by the anal sphincter and by the ileocecal valve, known as the colonrectum.
The system comprises two parts, which can be sold separately, namely: the"disposable probe", and the "workstation", equipped with a command console.
Thanks to its flexibility, the disposable probe can easily adapt its shape to that of the colon. The motion, based on the "caterpillar" principle, is ensured by an anchoring system, placed by the ends of a flexible body.
The colonoscope includes on its distal segment a viewing system, featuring a CMOS digital camera and a LED light source.
The probe is further equipped with a steering system, which enhances the efficiency in terms of both motion and vision (maximum flexion angle: 180° in every direction).
The endoscope is activated pneumatically.
This device allows the use of specific surgical tools through a working channel.
The exit of the working channel is centred compared to the robot and it is located near the camera, which is therefore slightly decentred. When the tool exits the probe, it is immediately detected and the operator can then visually pilot it over the zone to be treated.
The anchoring system performs a double action. By extracting the air from inside the intestine it enables the intestine linings to approach the robot precisely at the point in which they will then be mechanically anchored. This system produces a steady hold on the intestine lining but prevents any damage or trauma from occurring.
Endotics Workstation is composed of an electro-pneumatic system, controlled by a Panel PC which displays the different progress phases of the device and the images delivered by the internal camera, and of a command console for controlling the probe's movements.
Only the Endotics disposable probe can be connected to this workstation. The probe is linked to the workstation by means of an electro-pneumatic connector is placed on a twistable arm which is connected to the machine's main block. This arm is fitted on the inside with pneumatic tubes and electric cables which connect the probe to the workstation's electro-pneumatic system and which connect the camera (placed by the probe's head) to a video system. The arm is also equipped with an electronic board which acts as an opto-insulator between the camera and the electric features of the workstation. The electro-pneumatic distributor is controlled by a computerised system, on which specifically designed command software has been installed.
The monitor also displays the probe's status, indicating its current motion phase e the captured pictures. The associated accessories include:
- Stiffening accessory
- Waterjet accessory
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CMOS digital camera
Anatomical Site
lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, transverse 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)
Animal Studies:
- Study type: Clinical study on animals (domestic pig model).
- Sample size: n=3 female pigs.
- Key results: The clamping mechanism does not create significant lesions in the bowel wall (such as mucosal lacerations) and no bleeding was found. Even with prolonged clamping of 5 minutes duration, no relevant lesions were seen. Marks on the colonic wall were temporary and left no visible remains after 7 days. The clamping system of the device is considered safe in the animal model.
Clinical Studies:
- Study type: Functional evaluation of the Endotics System in vitro; Endotics system vs colonoscopy for the detection of polyps; Functional assessment in terms of safety and efficacy of the Endotics system in endoscopic colorectal studies (Single center, controlled and randomized NO PROFIT study).
- Sample size: Planned: 20 patients; Analyzed: 20 patients.
- Study Population: 20 patients, both sexes, aged between 18 and 65, meeting inclusion/exclusion criteria, consecutively selected among those for whom routine colonoscopy was indicated.
- Objectives: To evaluate the diagnostic accuracy (efficacy), safety, and tolerability for the patient of the Endotics system in comparison with traditional Colonoscopy.
- Primary Endpoints:
- Efficacy: Statistical comparison between the PDR/ADR of TC and ENDOTICS. ENDOTICS had to be not inferior to TC with p-value
§ 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.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 3, 2020
Era Endoscopy s.r.1. Alberto Arena, Eng Via Boccioni, 1 56037 Peccioli, ITALY
K190669 Re: Trade/Device Name: Endotics Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: November 25, 2019 Received: December 2, 2019
Dear Alberto Arena:
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). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions 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 may be 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling
1
(21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shanil P. Haugen, PhD Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K190669
Device Name Endotics
Indications for Use (Describe)
The Endotics System is intended to provide 360° visualization and diagnostic/therapeutic access to the adult lower volvo for and eases and and limited to, the anus, rectum, sigmoid colon, transvers colon, cecum additioner valve) for endoscopy and endoscopic surgery.
The Endotics Probe (colonoscope component of the Endotics Colonoscope System) is a single use disposable device. The Endotics Probe cannot be reprocessed.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5 510(k) Summary
I. SUBMITTER
| Applicant Information | Era Endoscopy s.r.l.
Via Boccioni, 1 56037
Peccioli (Pi) - Italy |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | ing. Alberto Arena (Quality and Regulatory Manager)
Phone: +39 0587 635235
Fax Number: +39 0587 829970
e-mail: qualita@endotics.com |
| Date Prepared | 1st February 2019 |
| | II. DEVICE |
| Device Trade Name | ENDOTICS |
| Common Name | Colonoscope And Accessories |
| Device Class | II |
| Classification Name | Endoscope and accessories |
| Regulation | 21 CFR 876.1500 |
| Product Code | FDF |
III. PREDICATE DEVICE
Legally Marketed Predicate Device (s)
| 510(k) Number | Product Code | Regulation Number | Trade Name | Applicant |
|---|---|---|---|---|
| K141286 | FDF | 21 CFR § 876.1500 | Aer-o-scope | |
| Colonoscope System | GI View, Ltd. | |||
| K121582 | FDF | 21 CFR § 876.1500 | Invendo C25 | |
| Colonoscopy System | Invendo Medical | |||
| GmbH | ||||
| K001241 | FDF | 21 CFR § 876.1500 | OLYMPUS CF-Q160 | Olympus Medical |
| Systems Corporation |
IV. Device Description
Endotics is an endoscopic system to be used for the examination of the final section of the intestine, the ends of which are marked by the anal sphincter and by the ileocecal valve, known as the colonrectum.
4
The system comprises two parts, which can be sold separately, namely: the"disposable probe", and the "workstation", equipped with a command console.
Thanks to its flexibility, the disposable probe can easily adapt its shape to that of the colon. The motion, based on the "caterpillar" principle, is ensured by an anchoring system, placed by the ends of a flexible body.
The colonoscope includes on its distal segment a viewing system, featuring a CMOS digital camera and a LED light source.
The probe is further equipped with a steering system, which enhances the efficiency in terms of both motion and vision (maximum flexion angle: 180° in every direction).
The endoscope is activated pneumatically.
This device allows the use of specific surgical tools through a working channel.
The exit of the working channel is centred compared to the robot and it is located near the camera, which is therefore slightly decentred. When the tool exits the probe, it is immediately detected and the operator can then visually pilot it over the zone to be treated.
The anchoring system performs a double action. By extracting the air from inside the intestine it enables the intestine linings to approach the robot precisely at the point in which they will then be mechanically anchored. This system produces a steady hold on the intestine lining but prevents any damage or trauma from occurring.
Endotics Workstation is composed of an electro-pneumatic system, controlled by a Panel PC which displays the different progress phases of the device and the images delivered by the internal camera, and of a command console for controlling the probe's movements.
Only the Endotics disposable probe can be connected to this workstation. The probe is linked to the workstation by means of an electro-pneumatic connector is placed on a twistable arm which is connected to the machine's main block. This arm is fitted on the inside with pneumatic tubes and electric cables which connect the probe to the workstation's electro-pneumatic system and which connect the camera (placed by the probe's head) to a video system. The arm is also equipped with an electronic board which acts as an opto-insulator between the camera and the electric features of the workstation. The electro-pneumatic distributor is controlled by a computerised system, on which specifically designed command software has been installed.
The monitor also displays the probe's status, indicating its current motion phase e the captured pictures. The associated accessories include:
5
- Stiffening accessory
- -Waterjet accessory
V. Indication for Use
The Endotics System is intended to provide 360° visualization and diagnostic/therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, transverse colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.
The Endotics Probe (colonoscope component of the Endotics Colonoscope System) is a single use disposable device. The Endotics Probe cannot be reprocessed.
VL. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
Colonoscopy is the technological principle for both the Endotics and predicate devices. It is based on the use of endoscopic instrumentation for the examination of the final section of the intestine, the ends of which are marked by the anal sphincter and by the ileocecal valve, known as the colonrectum.
The Endotics and predicate devices (K141286 and K121582) are based on the following same technological elements:
- । A controlling workstation
- -A single use disposable colonoscope
Like the predicate Aer-o-scope Colonoscope System and Invendo, the ENDOTICS Disposable Probe is not directly manually manipulated by the operator and moves through the colon under the direction and control of the operator using a joystick.
The only difference between Endotics and the predicates consists in propulsion mechanism inside the intestine: Endotics probe is not a pushed device, while the predicates result in externally pushed devices.
In the follow table are reported a side-by-side comparison of technological characteristics of Endotics device and the predicate devices
| | Endotics
K190669 | Aer-o-scope
K141286 | Invendo C25
K121582 | Olympus CF-Q160
K001241 |
|--------------------------------------------------------------|--------------------------------------|---------------------------------------------------|-------------------------------------------------|---------------------------------|
| Viewing direction | Forward | OMNY | Forward | Forward |
| Field of view | 140° | Front 90°
Angular 360° | 114° | Forward 140° |
| Depth of Field | 3-100 mm | Omni- 11-50 mm
Front- 10 to 60 mm | - | 3-100 mm |
| | Endotics
K190669 | Aer-o-scope
K141286 | Invendo C25
K121582 | Olympus CF-Q160
K001241 |
| Chip | CMOS 1M
pixels | CMOS 1.3 M pixels | CMOS
0.25M
Pixels | CCD color |
| Illumination | LEDs | LEDs | LEDs | Light guide |
| Max. diameter
insertion point | 17.5 mm | 13 mm | 18 mm | 12.8 mm |
| Multilumen max
diameter | 7.5 mm | 7.5 mm | 18 mm | 12.8 mm |
| Working length | 2030 mm | 2000 mm | 2100 mm | 1680 mm |
| Total length | 2390 mm | 2300 mm | 3600 mm | - |
| Bending capacity | 180° in all
directions | 160° in all
directions | 180° in all
directions | 180° Up-down
160° right-left |
| Diameter working
channel | 3 mm | - | 3.1 mm | 3.7 mm |
| N. of working
channels | 1 | - | 1 | 1 |
| N. of other
channels
(suction/insufflati
on Fluids) | 1 air/water
2 air | 1 | 1 | 1 air/water 1 water |
| Power supply base
unit | 100-240 V
50/60Hz | 100-240 V 50/60Hz | 100-240 V
50/60Hz | 100-240 V
50/60Hz |
| Max internal
pressure
base unit | 450 KPa | 450 KPa | 600 KPa | - |
| Max internal
vacuum base unit | -75Kpa | - | -75KPa | - |
| Workstation
weight | 37 Kg
w/Panel PC | 167 Kg | - | - |
| Workstation
dimensions | 280 (H) x
650 (W) x
580 (D) mm | 1200 (H) x 400 (W)
x 600 (D) mm | - | - |
| Main materials in
contact with
patient | Silicone,
ABS and
PVC | Polyurethane,
PEBAX and
hydrophilic coating | Silicone,
polycarbonat
e and
lubricant | - |
| Type of
sterilization | Ethylene
Oxide | - | Ethylene
Oxide | - |
| Disposable | YES | YES | YES | NO |
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Moreover, the results of the bench tests and clinical tests show that differences in propulsion systems provide equivalent levels of safety and efficacy compared to the predicate devices and that clinical
7
performance of Endotics compared to conventional colonoscopy systems (see predicate K001241), have the similar characteristics.
The product specification, functionality and indication for use of the ENDOTICS are the same or very similar to the legally marketed, claimed predicate devices for the purpose of this 510(k) submission.
VII. Performance Data
The ENDOTICS has been tested and is in compliance with:
Biocompatibility (according to ISO 10993)
The battery of testing included the following tests:
- Cytotoxicity Test Report Nº2249-1/13 (Attach 13) B Cytotoxicity Test) -
- -Sensitization - Test Report Nº2249-4/13 and Nº2249-3/13 (Attach 13 C Sensitization test Apolar and Attach 13 D Sensitization test Polar)
- Irritation/Intracutaneous Test Report N°2249-2/13 (Attach 13) E Irritation Test) -
The disposable probe is considered tissue contacting for a duration of less than 24 hours.
Electrical Safety, Electromagnetic Compatibility EMC (according to EN 60601-1 and EN 60601-1-2)
The battery of testing included the following tests:
- Electrical Safety Test: Test Report R-EL-27-0414-01A (see attachment 15 A) -
- Electromagnetic Compatibility: Test Report R-EM-227-0119-01A (see attachment 15 B) -
Sterilization Process Validation (According to ISO 11135)
The battery of testing included the following tests:
- Validation Protocol of Sterilization Process (see Attachment 12) A.) -
- -Validation Report of Sterilization Process (see Attachment 12 B)
- Sterilization Process Validation ERA Endoscopy and Steril Verona Documentation Annex 1 -(see Attachment 12 C)
- Sterilization Process Validation Result of Physical Performance 2 -(see Annex Attachment 12 D)
- -Sterilization Process Validation - Result of Microbiological Performance - Annex 3 (see Attachment 12 E)
Shelf life (According to ISO 11607-1)
- Medical Devices Shelf-Life (3 years) Final Report (see Attach 12 F Shelf life 3 years validation) -
8
ETSI EN 300-019-2.2 V2.2.1 Enviromental condition and enviromental test for telecomunications equipment; Part 2-2 Specification of enviromental tests; Transportation
Test Report R-EL-227- 1014 - 02A (Attach 12 G Enviromental Conditions and trasportation test for Workstation)
Software Validation (According to ISO 62304)
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could not directly result in serious injury or death to the patient or operator.
The documentation of Software Validation can be found in the annexes of Section 14
Usability (According to IEC 62366-1:2015)
The usability of the product was conducted in accordance with IEC 62366-1:2015 and concerns various aspects of the device use.
The documentation can be found in the annexes of Section 16:
- Usability File (see Attachment 16 A) -
Mechanical Testing
Bench Test of the Endotics were performed to support the efficacy/safety of the device and substantial equivalence.
Tests carried out have covered the following areas (see Attachment 16 B Bench Testing):
- Mechanical resistance test -
- Fatigue strength test -
- Breaking Pressure Test -
- -Tensile Strength Test
- Mechanical Characterization Test -
- -Simulated use testing
ANIMAL STUDIES
Era Endoscopy during the development of the Endotics System performed a clinical study on animals (Attach 17 A Animal test). The study was designed to provide objective parametric data that allow excluding that the device is imposing relevant trauma with acute or delayed response of the colon tissue.
9
The study was carried out in the domestic pig model (n=3), female pigs, the post-operative followup survival period was 1 week.
The clamping mechanism does not create significant lesions in the bowel wall, such as mucosal lacerations. No bleeding was found as a result of the interaction of the clamping mechanism with the colonic wall. Also in case of prolonged clamping of 5 minutes duration no relevant lesions were seen. The marks on the colonic wall inherent to the procedure proved to be temporary and left no visible remains after a follow-up period of 7 days.
In these regards the clamping system of the device can be considered safe in the animal model. Bowel wall thickness in the adult pig correlates well with the human, therefore we do not anticipate the device clamping mechanism should be harmful for the human colon.
CLINICAL STUDIES
Era Endoscopy, during the Endotics project development, carried out thr following clinical investigations to demonstrate the safety and efficacy of the device.
- -Functional evaluation of the Endotics System, a new disposable self-propelled robotic colonoscope: in vitro (see Attachment 18 A).
- -Endotics system vs colonoscopy for the detection of polyps (see Attachment 18 B).
- Functional assessment in terms of safety and efficacy of the Endotics system in endoscopic colorectal studies (Attachment 18 C).
| Title | Functional assessment in terms of safety and efficacy of the Endotics® system in |
|---|---|
| endoscopic colorectal studies | |
| Methodology | Single center, controlled and randomized NO PROFIT study |
| Study Description | A controlled and randomized NO PROFIT study for the functional evaluation in |
| terms of safety, effectiveness and efficacy of the Endotics® system, a single-use | |
| semi-automatic robotic colonoscope, in the identification of colorectal diseases. | |
| Number of patients | Planned: 20; Analysed: 20 |
| Objectives | To evaluate the diagnostic accuracy (efficacy), safety and tolerability for the patient |
| of the Endotics system in comparison with the traditional Colonoscopy | |
| Study Population | 20 (twenty) patients, of both sexes, aged between 18 and 65, meeting the inclusion |
| / exclusion criteria, have been recruited, consecutively selected among those in | |
| whom routine colonoscopy was indicated. | |
| Criteria for inclusion | Patients aged between 18 and 65 in which a colonoscopy examination was |
| indicated. | |
| Study period | 5 months from May to September 2018 |
| Participant Duration | 3 days for bowel preparation and 2 hours for both procedures (ENDOTICS and CT). |
| Statistical methods | The statistical analysis has been conducted according to the principles of the PP/AT |
| analysis (per protocol / as treated). All participants with a recorded exam have been | |
| randomized. | |
| Primary Endpoints | Efficacy |
The results of this latest study are summarized in the table below:
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| | Statistical comparison between the PDR/ADR of the TC and that of the ENDOTICS.
ENDOTICS have to result not inferior if compared to TC with pvalue