(294 days)
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.
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.
Here's an analysis of the acceptance criteria and study details for the Endotics device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Primary Endpoints) | Reported Device Performance (Endotics) |
|---|---|
| Efficacy: | Efficacy: |
| * Statistical comparison between the Polyp Detection Rate (PDR)/Adenoma Detection Rate (ADR) of Traditional Colonoscopy (TC) and that of the ENDOTICS. ENDOTICS performance must be not inferior to TC with p-value < 0.05. | * Not less effective and efficient than traditional colonoscopy (compared to predicate device K001241). Previous studies also demonstrated non-inferior diagnostic capacity, confirmed by this study. |
| * ADR (ENDOTICS) should be greater or equal than 25% (according to ASGE guidelines). | * ADR compatible with ASGE guidelines. |
| Safety: | Safety: |
| * Statistical comparison between Adverse Events (EA)/Serious Adverse Events (SEA) occurring with TC compared to those with ENDOTICS. ENDOTICS must be not inferior to TC with P < 0.05. | * No adverse events, minor or serious, or deaths were recorded. This implies it is no less safe than traditional colonoscopy (compared to predicate device K001241). |
| Acceptance Criteria (Secondary Endpoints) | Reported Device Performance (Endotics) |
| Cecal Intubation Rate (CIR): | Cecal Intubation Rate (CIR): |
| * Statistical comparison between CIR (ENDOTICS) and CIR (TC). CIR (ENDOTICS) has to be not inferior to CIR (TC) with p-value < 0.05. | * Not explicitly stated in the summary results if statistically not inferior to TC, but reported as "CIR guidelines as of 100%". This implies it met or exceeded the criteria. |
| * CIR (ENDOTICS) should be greater or equal than 90%. | * Achieved 100%. |
| Tolerability: | Tolerability: |
| * Statistical comparison of parameters related to pain and discomfort between ENDOTICS and TC. ENDOTICS has to be superior compared to TC with p-value < 0.05. | * Superior to TC: average discomfort for ENDOTICS was 1.45 versus 6.5 for TC, and average pain for ENDOTICS was 1.3 versus 7.4 for TC. (Implies p-value < 0.05 criteria was met for superiority). No patient requested sedation. |
| Cecal Intubation Time (CIT) and Procedure Time (PT): | Cecal Intubation Time (CIT) and Procedure Time (PT): |
| * Statistical comparison between CIT/PT of the CT and that of ENDOTICS. CIT/PT (ENDOTICS) must not be inferior compared to CT with p-value < 0.05. | * Not explicitly stated in the summary results if statistically not inferior to TC, it just states that the device was not inferior across various measured parameters in the section "Endotics robotic endoscopic system proved to be effective (ADR compatible with ASGE and CIR guidelines as of 100%), safe (no adverse events, minor or serious, were recorded during the procedure or within the following 30 days) and very well tolerated by patients". So comparison against the p-value criteria is not directly reported, but the overall conclusion implies non-inferiority was met. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: 20 patients (Planned: 20; Analyzed: 20)
- Data Provenance: The study was a "Single center, controlled and randomized NO PROFIT study." The text does not explicitly state the country of origin, but the applicant (Era Endoscopy s.r.l.) is based in Peccioli, Italy, suggesting the study was likely conducted in Italy. The study period was "5 months from May to September 2018." This was a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., radiologist with X years of experience). However, the study involves a comparison with "traditional colonoscopy" to evaluate diagnostic accuracy (efficacy) in identifying colorectal diseases. This implies that the diagnosis from the traditional colonoscopy would serve as a form of ground truth, typically established by trained gastroenterologists/endoscopists performing and interpreting the colonoscopies.
4. Adjudication Method for the Test Set:
The document does not specify an adjudication method like 2+1, 3+1, or none. It describes a "Single center, controlled and randomized NO PROFIT study" comparing Endotics to traditional colonoscopy. The determination of efficacy (PDR/ADR) and adverse events would have been based on the findings during these procedures.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a clinical investigation comparing the performance of the Endotics system (a self-propelled robotic colonoscope) against traditional colonoscopy, focusing on its own efficacy, safety, and tolerability, rather than the improvement of human readers with AI assistance. The Endotics system itself is a device for performing colonoscopy, not an AI-assisted interpretation tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The Endotics System is a robotic colonoscope guided by an operator using a joystick. It is not a standalone algorithm, but a device that facilitates the human operator's performance of colonoscopy. Therefore, its performance necessarily includes human-in-the-loop operation, and a standalone algorithm-only performance assessment would not be applicable or relevant for this type of device.
7. The type of ground truth used:
The ground truth for the clinical study comparing Endotics to traditional colonoscopy would primarily be clinical findings and expert assessment during the procedures themselves. For efficacy endpoints like Polyp Detection Rate (PDR) and Adenoma Detection Rate (ADR), the findings from both Endotics and traditional colonoscopy would be compared, and ultimately confirmed through histopathology of biopsied or resected lesions. For safety, adverse events would be documented by clinical observation.
8. The Sample Size for the Training Set:
The document does not provide details about a "training set" in the context of machine learning. The Endotics device is a robotic endoscope, not an AI-based diagnostic algorithm that typically relies on large training datasets. The "development" of the device would have involved engineering design, bench testing, animal studies, and initial human clinical studies, but these are not referred to as a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set was Established:
As there is no mention of a "training set" in the context of an AI algorithm, details on how its ground truth was established are not provided. The development and validation process focused on engineering verification and validation (bench tests, biocompatibility, electrical safety, etc.) and clinical studies to demonstrate safety and efficacy of the physical device.
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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
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(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
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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 56037Peccioli (Pi) - Italy |
|---|---|
| Contact | ing. Alberto Arena (Quality and Regulatory Manager)Phone: +39 0587 635235Fax Number: +39 0587 829970e-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-scopeColonoscope System | GI View, Ltd. |
| K121582 | FDF | 21 CFR § 876.1500 | Invendo C25Colonoscopy System | Invendo MedicalGmbH |
| K001241 | FDF | 21 CFR § 876.1500 | OLYMPUS CF-Q160 | Olympus MedicalSystems 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.
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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:
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- 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
| EndoticsK190669 | Aer-o-scopeK141286 | Invendo C25K121582 | Olympus CF-Q160K001241 | |
|---|---|---|---|---|
| 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 mmFront- 10 to 60 mm | - | 3-100 mm |
| EndoticsK190669 | Aer-o-scopeK141286 | Invendo C25K121582 | Olympus CF-Q160K001241 | |
| Chip | CMOS 1Mpixels | CMOS 1.3 M pixels | CMOS0.25MPixels | CCD color |
| Illumination | LEDs | LEDs | LEDs | Light guide |
| Max. diameterinsertion point | 17.5 mm | 13 mm | 18 mm | 12.8 mm |
| Multilumen maxdiameter | 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 alldirections | 160° in alldirections | 180° in alldirections | 180° Up-down160° right-left |
| Diameter workingchannel | 3 mm | - | 3.1 mm | 3.7 mm |
| N. of workingchannels | 1 | - | 1 | 1 |
| N. of otherchannels(suction/insufflation Fluids) | 1 air/water2 air | 1 | 1 | 1 air/water 1 water |
| Power supply baseunit | 100-240 V50/60Hz | 100-240 V 50/60Hz | 100-240 V50/60Hz | 100-240 V50/60Hz |
| Max internalpressurebase unit | 450 KPa | 450 KPa | 600 KPa | - |
| Max internalvacuum base unit | -75Kpa | - | -75KPa | - |
| Workstationweight | 37 Kgw/Panel PC | 167 Kg | - | - |
| Workstationdimensions | 280 (H) x650 (W) x580 (D) mm | 1200 (H) x 400 (W)x 600 (D) mm | - | - |
| Main materials incontact withpatient | Silicone,ABS andPVC | Polyurethane,PEBAX andhydrophilic coating | Silicone,polycarbonate andlubricant | - |
| Type ofsterilization | EthyleneOxide | - | EthyleneOxide | - |
| 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
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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) -
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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.
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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< 0.05.Moreover, ADR (ENDOTICS) should be greater or equal than 25% (according toASGE guidelines).SafetyStatistical comparison between EA/SEA occurring with the traditional colonoscopy(TC) compared to those occurred with the ENDOTICS. ENDOTICS have to be notinferior to TC with P<0.05. | |
|---|---|
| SecondaryEndpoints | Cecal intubation rate:Statistical comparison between CIR (ENDOTICS) and CIR (TC). CIR (ENDOTICS)has to be not inferior to CIR (TC) with pvalue< 0.05. Moreover, CIR (ENDOTICS)should be greater or equal than 90%.Tolerability: Statistical comparison of parameters related to pain and discomfort |
| between ENDOTICS and TC. ENDOTICS has to be superior compared to TC withpvalue< 0.05.Cecal intubation time (CIT) and procedure time (PT): Statistical comparisonbetween CIT/PT of the CT and that of ENDOTICS. CIT/PT (ENDOTICS) must notbe inferior compared to CT with p-value<0.05. | |
| Summary Results | EfficacyBased on the results of this study, statistically Endotics colonoscopy is at least notless effective and efficient than traditional colonoscopy (see predicate deviceK001241). Previous studies had already demonstrated the not inferior diagnosticcapacity of Endotics if compared to TC, and these data are confirmed by this study.Safety |
| No adverse events, minor or serious, or deaths were recorded in this study, so itmakes no sense to calculate the statistical parameters that were set (mean,standard deviation and confidence interval). No patient requested sedation eitherduring robotic or traditional procedures. Oxygen saturation was monitored for eachpatient and there were no cases of vagal crisis. No adverse events occurred duringpolyp's removal, such as perforation with both types of instruments used in thestudy. Therefore, it can be concluded that Endotics robotic colonoscopy is no lesssafe than traditional colonoscopy (see predicate device K001241). |
Endotics robotic endoscopic system proved to be effective (ADR compatible with ASGE and CIR guidelines as of 100%), safe (no adverse events, minor or serious, were recorded during the procedure or within the following 30 days) and very well tolerated by patients (on a scale of 0 to 10, it recorded an average discomfort for the entire procedure of 1.45 and an average pain of 1.3). Also compared with the predicate colonoscopy system, Endotics proved to be not inferior and more tolerated by the patient (annoyance ES 1.45 versus 6.5 for TC and pain ES 1.3 versus 7.4 for TC).
VIII. Conclusions
Era Endoscopy s.r.l. has determined, by using comparisons and tests, that Endotics is substantially equivalent to the listed predicate devices in terms of intended use, typical clinical use, operational characteristics, and fundamental technological characteristics.
§ 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.