ENDORAIL is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope (i.e., an endoscope with an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization) during endoscopy of the large intestine.
Device Story
Colonoscopy accessory; facilitates endoscope progression in large intestine. Input: manual operator control via inflation tube. Principle: magnetic anchoring; balloon catheter inserted through endoscope instrument channel; balloon filled with magnetorheological ferromagnetic fluid (carbonyl iron powder in water/sodium chloride/sodium citrate); anchored to external magnetic handpiece placed on patient abdomen. Output: straightened colon curves/loops; improved endoscope navigation. Used in hospitals/clinics by specialized medical staff. Benefits: prevents incomplete colonoscopies in challenging/long-lasting procedures; allows standard endoscopic visualization and use of therapy tools (biopsy forceps, snares).
Clinical Evidence
Multicenter, post-market, single-arm, open-label interventional study (n=38). Primary endpoints: colonoscopy incompletion rate ≤ 10% and absence of device-related serious adverse events (SAEs). Results: 100% completion rate (0% incompletion); 0% device-related SAEs. p-value < 0.001 vs. 20% threshold. Study terminated at interim analysis due to statistical significance.
Technological Characteristics
Balloon catheter (single-use, non-sterile) and external magnetic handpiece (reusable, non-sterile). Balloon filled with magnetorheological ferromagnetic fluid (carbonyl iron powder, sodium chloride, sodium citrate). Compatible with endoscopes having ≥ 3.7mm instrument channel. Complies with ISO 10993 (biocompatibility), IEC 60601-1 (electrical safety), and ISO 14971 (risk management).
Indications for Use
Indicated for patients aged 22-75 years undergoing diagnostic or surveillance colonoscopy of the large intestine, specifically to facilitate endoscope progression in long-lasting procedures. Contraindicated in patients with BMI > 30, obstructing masses/strictures, dense diverticulosis/diverticulitis, ferromagnetic foreign bodies, large abdominal hernias, severe coagulopathy/thrombocytopenia/granulocytopenia, peritonitis, colonic ischemia/necrosis, peritoneal carcinomatosis, or implanted ferromagnetic medical devices (e.g., pacemakers, stents).
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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March 15, 2024
Endostart s.r.l. % Fabio Pasquale Sr. Director, OA/RA QA & RA Medical Device Consulting, Ltd. 842 Clarke Road Brentwood Bay, BC V8M 2G1 Canada
Re: K232327
Trade/Device Name: Endorail Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODC Dated: February 16, 2024 Received: February 16, 2024
Dear Fabio Pasquale:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
# Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. 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) K232327
Device Name ENDORAIL
Indications for Use (Describe)
ENDORAIL is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope (i.e. an endoscope with an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization) during endoscopy of the large intestine.
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;"><b>☑</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# Section 8 - 510(k) Summary
(in accordance with 21 CFR 807.92)
510(k) Number:
### l. Applicant Information
| Applicant: | Endostart s.r.l. |
|----------------------------|-----------------------------------------|
| | Via delle Regioni 265 |
| | 50052 Certaldo (FI) |
| | ITALY |
| Contact Person: | Alessandro Tozzi |
| | CEO |
| | Endostart s.r.l. |
| | Tel: +39-0571-843-033 |
| | e-mail: a.tozzi@endostart.com |
| Application Correspondent: | Fabio De Pasquale |
| | Sr. Director QA/RA |
| | QA & RA Medical Device Consulting, Ltd. |
| | Tel: 1-250-920-6501 |
| | e-mail: ga.ra.meddev@outlook.com |
July 28, 2023 Date Prepared:
#### ll. Subject Device Identification
Proprietary Name:
ENDORAIL
Classification Name: Endoscope Channel Accessory Regulation Name: Endoscope and Accessories Regulation Number: 21 CFR 876.1500 Product Code: ODC
Regulatory Class: Classification Panel:
Class II Gastroenterology/Urology
#### lll. Predicate Devices
The subject device, the ENDORAIL, is substantially equivalent to the following two cleared predicate devices. The subject and predicate device have the same fundamental scientific technology and intended use.
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# Primary Predicate Device (#1):
| 510(k) Number: | K111760 |
|-----------------------|-------------------------------------------|
| Proprietary Name: | NaviAid BGC (later renamed "NaviAid ABC") |
| Manufacturer Name: | Smart Medical Systems, Ltd. |
| Common/Usual Name: | NaviAid Balloon Guided Colonoscopy |
| Classification Name: | Endoscope Channel Accessory |
| Requlation Name: | Endoscope and Accessories |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | ODC |
| Regulatory Class: | Class II |
| Classification Panel: | Gastroenterology/Urology |
### Predicate Device (#2):
| 510(k) Number: | |
|-----------------------|--|
| Proprietary Name: | |
| Manufacturer Name: | |
| Common/Usual Name: | |
| Classification Name: | |
| Regulation Name: | |
| Regulation Number: | |
| Product Code: | |
| Regulatory Class: | |
| Classification Panel: | |
# K183057 PUMA-G System
CoapTech LLC Gastrointestinal Tube Accessory Tube, Gastro-Enterostomy Gastrointestinal Tube and Accessories 21 CFR 876.5980 KGC Class II Gastroenterology/Urology
#### IV. Subiect Device Description
ENDORAIL is a colonoscopy add-on device developed to be used without any modification to colonoscopes and peripheral devices currently utilized. It is an accessory for colonoscopy aimed at facilitating progression of the endoscope in the large intestine. The device works as a magnetic anchor that allows the operator to quide the colonoscope and to straighten colon curves and loops.
ENDORAIL includes a Balloon Guide that can be introduced, when needed, through the endoscope instrument channel during the colonoscopy, if this procedure becomes challenging. The system does not require to be premounted and does not interfere with the normal colon examination process. The Balloon Guide is advanced beyond the colonoscope tip where the balloon is filled with a ferromagnetic fluid and magnetically anchored to a magnetic Handpiece placed on the patient's abdomen. Once anchored, the colonoscope can be easily straightened and guided along the device, allowing a fast and safe inspection of the entire colon. Once the challenging segment of the colon is resolved, or the colonoscopy procedure is completed, the Balloon Guide can be retrieved.
As discussed in the following sections, the intended use, technological characteristics, principles of operation and materials of the subject device are substantially equivalent to the respective ones of the predicate devices.
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#### V. Indications for Use
ENDORAIL is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope (i.e., an endoscope with an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization) during endoscopy of the large intestine.
#### VI. Substantial Equivalence
### Intended Use/Indications for Use
ENDORAIL and its Primary Predicate device have substantially equivalent Intended Use/Indications for Use, with the minor difference being that the primary predicate device is meant to facilitate positioning of standard endoscopes in both the small and large intestine, whereas ENDORAIL is meant to ensure positioning of standard endoscopes exclusively in the large intestine.
### Technological Characteristics
The Substantial Equivalence Comparison Table provided in the following pages includes a comparison of each of the technological features of the ENDORAIL device with those of the primary predicate and the reference devices.
The following two main differences in technological characteristics between the subject and the predicate devices are summarized in the following sections.
The Primary Predicate device (NaviAid BGC) achieves its balloon anchoring function by inflating the balloon with air and stretching it beyond the diameter of the colon, whereas the subject ENDORAIL achieves its balloon anchoring function by filling the balloon with a ferromagnetic fluid in combination with the placement of a permanent maqnet externally over the patient abdomen.
The magnetic anchoring of the ENDORAIL balloon functions in a similar fashion to the magnetic anchoring system utilized by the Reference device, the PUMA-G System, which is an accessory to enteral feeding tubes that enables ultrasound-based placement of percutaneous gastrostomy feeding tubes.
The following table summarizes the substantial equivalence comparison between the subject and the predicate devices.
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# Substantial Equivalence Comparison Table
| Comparison<br>Elements | Subject Device: | Primary Predicate Device<br>(#1): (K111760) | Reference Device (#2):<br>(K183057) |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ENDORAIL | NaviAid BGC<br>(renamed "NaviAid ABC") | PUMA-G System |
| Product Code | ODC | ODC | KGC<br>(N/A) |
| Regulation # | 876.1500 | 876.1500 | 876.5980<br>(N/A) |
| Class | II | II | II |
| Intended Use | ENDORAIL is an<br>accessory to an endoscope<br>and is intended to ensure<br>positioning of a standard<br>endoscope (i.e., an<br>endoscope that has an<br>instrument channel that is<br>at least 3.7mm diameter<br>and is used for standard<br>endoscopic visualization)<br>during endoscopy of the<br>large intestine. | The NaviAid BGC is an<br>accessory to an endoscope<br>and is intended to ensure<br>positioning of a standard<br>endoscope (i.e., an<br>endoscope that has an<br>instrument channel that is<br>at least 3.7mm diameter<br>and is used for standard<br>endoscopic visualization)<br>during endoscopy of the<br>small and large intestine. | The new PUMA-G system<br>is an accessory to enteral<br>feeding tubes that enables<br>ultrasound-based<br>placement of<br>percutaneous gastrostomy<br>feeding tubes.<br>(N/A) |
| Indications for Use | ENDORAIL is an<br>accessory indicated for a<br>fast and easy colonoscopy | The NaviAid BGC is an<br>accessory indicated for fast<br>and easy colonoscopy,<br>ileoscopy and upper | The new PUMA-G system<br>is an accessory to enteral<br>feeding tubes that enables<br>ultrasound-based |
| Comparison<br>Elements | Subject Device: | Primary Predicate Device<br>(#1): (K111760) | Reference Device (#2):<br>(K183057) |
| | ENDORAIL | NaviAid BGC<br>(renamed "NaviAid ABC") | PUMA-G System |
| | procedure with a standard<br>endoscope. | enteroscopy procedures<br>with a standard endoscope. | placement of<br>percutaneous gastrostomy<br>feeding tubes.<br>(N/A) |
| | The device allows keeping<br>all the advantages of an<br>endoscopic procedure, such<br>as back-and-forth<br>navigation, real-time<br>operation, video imaging, or<br>the capability to stop<br>propagation if needed, and<br>to use an instrument<br>channel for patient<br>treatment as necessary. | The device allows keeping<br>all the advantages of an<br>endoscopic procedure,<br>such as back-and-forth<br>navigation, real-time<br>operation, video imaging,<br>or the capability to stop<br>propagation if needed, and<br>to use an instrument<br>channel for patient<br>treatment as necessary. | |
| Sterility and<br>Reusability | The Balloon Catheter<br>component of ENDORAIL is<br>supplied as "non-sterile"<br>and for "single-use". | The NaviAid BGC system is<br>supplied as "non-Sterile"<br>and for "single use". | The procedural kit<br>(guidewire, balloon<br>catheter and other<br>accessories) is supplied as<br>"sterile" and for "single-<br>use". |
| Comparison<br>Elements | Subject Device: | Primary Predicate Device<br>(#1): (K111760) | Reference Device (#2):<br>(K183057) |
| | ENDORAIL | NaviAid BGC<br>(renamed "NaviAid ABC") | PUMA-G System |
| | The ENDORAIL Handpiece<br>(external magnet) is<br>supplied as "non-sterile"<br>and "re-usable". | | The External Magnet<br>component is supplied as<br>"non-sterile" and "re-<br>usable". |
| Environment of<br>Use | ENDORAIL is intended for<br>use in hospitals or clinics by<br>specialized medical staff. | The NaviAid BGC is for use<br>in hospitals or clinics by<br>specialized medical staff. | The PUMA-G system is for<br>use in hospitals or clinics<br>by specialized medical<br>staff. |
| Limitations of Use | To be used during<br>endoscopy of the large<br>intestine only. | To be used during<br>endoscopy of the small and<br>large intestine. | None known. |
| Principles of<br>Operation | ENDORAIL facilitates the<br>advancement and<br>placement of an intestinal<br>endoscope. | The NaviAid BGC facilitates<br>the advancement and<br>placement of an intestinal<br>endoscope. | The PUMA-G System<br>facilitates feeding tube<br>insertion that can be<br>performed at a patient's<br>bedside. |
| | The system utilizes a<br>specialized balloon, inserted<br>in the endoscope using an<br>inflation tube catheter,<br>which is alternately inflated<br>and deflated in order to | The system utilizes a<br>specialized balloon,<br>inserted in the endoscope<br>using an inflation tube<br>catheter, which is<br>alternately inflated and | The system relies on a<br>balloon catheter<br>containing a small<br>magnetic needle that is fed<br>through a patient's mouth<br>and guided into the |
| Comparison<br>Elements | Subject Device: | Primary Predicate Device<br>(#1): (K111760) | Reference Device (#2):<br>(K183057) |
| | ENDORAIL | NaviAid BGC<br>(renamed "NaviAid ABC") | PUMA-G System |
| | allow the proper<br>progression and to ensure a<br>suitable positioning of the<br>endoscope in the intestine. | deflated in order to allow<br>the proper progression and<br>to ensure a suitable<br>positioning of the<br>endoscope in the intestine. | stomach using an external<br>magnet. The balloon is<br>made to be "grabbed" by<br>an external magnet placed<br>over the patient stomach. |
| | ENDORAIL uses a single<br>disposable balloon. The<br>balloon traverses ahead of<br>the endoscope through the<br>endoscope's instrument<br>channel and thus it can be<br>applied on demand without<br>the need for a pre-<br>procedure preparation of<br>the device. | The NaviAid BGC uses a<br>single disposable balloon.<br>The balloon traverses ahead<br>of the endoscope through<br>the endoscope's instrument<br>channel and thus it can be<br>applied on demand without<br>the need for a pre-<br>procedure preparation of<br>the device. | The balloon is inflated with<br>saline and ultrasound<br>guides the treating<br>physician as they insert a<br>needle through the<br>stomach and into the<br>balloon. The balloon<br>catches a wire that is then<br>pulled back up and out the<br>mouth as the balloon is<br>removed. A feeding tube |
| | The balloon is connected to<br>a dedicated inflation tube<br>that runs inside the<br>instrument channel of the<br>endoscope and is connected<br>at its proximal (user) end to | The balloon is connected to<br>a dedicated inflation tube<br>that runs inside the<br>instrument channel of the<br>endoscope and is<br>connected at its proximal | can then be pushed back<br>down over the wire and<br>safely out the stomach. |
| Comparison<br>Elements | Subject Device: | Primary Predicate Device<br>(#1): (K111760) | Reference Device (#2):<br>(K183057) |
| | ENDORAIL | NaviAid BGC<br>(renamed "NaviAid ABC") | PUMA-G System |
| | an inflation/deflation<br>system. | (user) end to an<br>inflation/deflation system. | |
| | The user manually operates<br>and controls the inflation<br>and deflation of the balloon<br>through the<br>inflation/deflation system. | The user manually operates<br>and controls the inflation<br>and deflation of the balloon<br>through the<br>inflation/deflation system. | |
| | The balloon can be<br>advanced ahead of the<br>endoscope tip or pulled<br>back through a<br>pushing/pulling action on<br>the inflation tube at its<br>proximal end, outside the<br>patient's body. | The balloon can be<br>advanced ahead of the<br>endoscope tip or pulled<br>back through a<br>pushing/pulling action on<br>the inflation tube at its<br>proximal end, outside the<br>patient's body. | |
| | The balloon and inflation<br>tube do not compromise in<br>a significant way the<br>endoscope's flexibility, its<br>field of view or the | The balloon and inflation<br>tube do not compromise in<br>a significant way the<br>endoscope's flexibility, its<br>field of view or the | |
| Comparison<br>Elements | Subject Device: | Primary Predicate Device<br>(#1): (K111760) | Reference Device (#2):<br>(K183057) |
| | ENDORAIL | NaviAid BGC<br>(renamed "NaviAid ABC") | PUMA-G System |
| | manoeuvrability of its tip,<br>and do not limit the usage<br>of any standard endoscopy<br>tools such as biopsy forceps,<br>snare, needle etc. The<br>balloon catheter system can<br>be pulled back at any time<br>during the procedure in<br>order to allow use of<br>therapy tools. | manoeuvrability of its tip,<br>and do not limit the usage<br>of any standard endoscopy<br>tools such as biopsy<br>forceps, snare, needle etc.<br>The balloon catheter<br>system can be pulled back<br>at any time during the<br>procedure in order to allow<br>use of therapy tools. | |
| | When the balloon is<br>advanced beyond the<br>endoscope distal end,<br>inflated and anchored, it<br>behaves as a distal "anchor"<br>towards which the<br>endoscope tip is advanced.<br>Endoscope advancement is<br>thus performed using the<br>inflation tube as a guide<br>wire, allowing the<br>endoscope to be more | When the balloon is<br>advanced beyond the<br>endoscope distal end,<br>inflated and anchored, it<br>behaves as a distal<br>"anchor" towards which<br>the endoscope tip is<br>advanced. Endoscope<br>advancement is thus<br>performed using the<br>inflation tube as a guide<br>wire, allowing the | |
| Comparison<br>Elements | Subject Device:<br>ENDORAIL | Primary Predicate Device<br>(#1): (K111760) | Reference Device (#2):<br>(K183057) |
| | | NaviAid BGC<br>(renamed "NaviAid ABC") | PUMA-G System |
| | easily guided through the<br>straightened curves and<br>loops of the colon. | endoscope to be more<br>easily guided through the<br>straightened curves and<br>loops of the colon. | |
| | The ENDORAIL balloon is<br>filled with a<br>magnetorheological<br>ferromagnetic fluid<br>composed of solid<br>micrometric carbonyl iron<br>powder dispersed in a water<br>solution of Sodium Chloride<br>and Sodium Citrate, by<br>means of a syringe. | The NaviAid BGC balloon is<br>filled with ambient air using<br>an air supply unit and<br>control pump. | The PUMA-G balloon is<br>filled with saline solution<br>using a syringe. |
| | The balloon is inflated with<br>a ferromagnetic fluid and<br>"anchored" to the colon<br>wall. | The balloon is inflated with<br>air increasing the balloon<br>volume until its diameter is<br>enough large to fill the<br>entire intestine lumen. | The balloon is inflated with<br>saline solution and<br>"anchored" to the stomach<br>wall. |
| | | | |
| Comparison<br>Elements | Subject Device:<br>ENDORAIL | Primary Predicate Device<br>(#1): (K111760)<br>NaviAid BGC<br>(renamed "NaviAid ABC") | Reference Device (#2):<br>(K183057)<br>PUMA-G System |
| | The "anchoring" of the<br>balloon is ensured by<br>magnetic force using an<br>external magnet over the<br>patient abdomen in<br>correspondence of the<br>balloon.<br><br>The anchoring of the<br>balloon allows the<br>straightening of the colon<br>curves and loops, facilitating<br>the endoscope progression. | The "anchoring" of the<br>balloon is ensured by the<br>friction force exerted by the<br>filled balloon against the<br>intestine wall.<br><br>The anchoring of the<br>balloon allows the<br>straightening of the colon<br>curves and loops,<br>facilitating the endoscope<br>progression. | The "anchoring" of the<br>balloon is ensured by<br>magnetic force using an<br>external magnet over the<br>patient abdomen in<br>correspondence of the<br>balloon. |
| Orifice of Use | The ENDORAIL catheter is<br>passed via the colonoscope<br>through anus into the<br>colon. | The NaviAid BGC catheter is<br>passed via the colonoscope<br>through anus into the<br>colon. | The PUMA-G catheter is<br>passed through the mouth<br>into the stomach of the<br>patient.<br>(N/A) |
| Balloon<br>Inflation/Deflation<br>Mechanism | The user may manually<br>operate and control the<br>inflation and deflation of | The user may manually<br>operate and control the<br>inflation and deflation of | The user may manually<br>operate and control the<br>inflation and deflation of |
| Comparison<br>Elements | Subject Device: | Primary Predicate Device (#1): (K111760) | Reference Device (#2): (K183057) |
| | ENDORAIL | NaviAid BGC<br>(renamed “NaviAid ABC”) | PUMA-G System |
| | the balloon through the<br>syringe. | the balloon through the<br>power air supply/foot<br>pedal control system.<br>(N/A) | the balloon through the<br>syringe. |
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#### VII. Non-Clinical Performance Data
Endostart s.r.l. has conducted extensive verification and validation testing of ENDORAIL, as an accessory for colonoscopy capable of facilitating progression of the endoscope in the large intestine. The subject device was tested to ensure that it can provide all the capabilities necessary to operate safely and effectively.
Acceptance criteria have been established to ensure that the subject device performs in a manner that is substantially equivalent to the cited predicate devices. Testing was conducted to verify the safety and performance requirements of the subject device and the test results support substantial equivalence to the predicate devices. The following table lists the nonclinical tests performed on the subject ENDORAIL for a determination of substantial equivalence.
| ENDORAIL - Non-Clinical Tests Performed |
|-------------------------------------------------|
| Biocompatibility Testing |
| Electrical Safety Testing |
| Electromagnetic Compatibility Testing |
| Software Verification and Validation Testing |
| Mechanical Testing |
| Components Testing |
| Human Factors Validation Testing |
| Microbiological Bioburden Testing |
| Shelf Life and Stability Testing |
| Packaging Testing |
| Environmental Conditioning and Shipping Testing |
| Characterization and Functional Testing |
ENDORAIL complies with all the applicable voluntary recognized standards related to its regulations and product code and successfully passed all respective testing.
The following quidance documents and standards were followed to determine appropriate methods for evaluating the performance of the subject device.
| Guidance Documents and Recognized Standards Applicable to ENDORAIL | | | |
|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Standard/Guidance | Title | | |
| FDA Guidance | Design Control Guidance for Medical Device Manufacturers | | |
| FDA Guidance | Format for Traditional and Abbreviated 510(k)s | | |
| FDA Guidance | The 510(k) Program: Evaluating Substantial Equivalence in<br>Premarket Notifications [510(k)] | | |
| FDA Guidance | Recommended Content and Format of Non-Clinical Bench<br>Performance Testing Information in Premarket Submissions | | |
| Guidance Documents and Recognized Standards Applicable to ENDORAIL | | | |
| Standard/Guidance | Title | | |
| FDA Guidance | Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" | | |
| FDA Guidance | General Principles of Software Validation | | |
| FDA Guidance | Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices | | |
| FDA Guidance | Content of Premarket Submissions for Device Software Functions | | |
| FDA Guidance | Applying Human Factors and Usability Engineering to Medical Devices | | |
| FDA Guidance | Content of Human Factors Information in Medical Device Marketing Submissions [Draft] | | |
| FDA Guidance | Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions | | |
| FDA Guidance | Shelf-life of Medical Devices | | |
| FDA Guidance | Device Labeling Guidance #G91-1 (Blue Book Memo) | | |
| FDA Guidance | Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment | | |
| FDA Guidance | Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex | | |
| FDA Guidance | Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices | | |
| FDA Guidance | Refuse to Accept Policy for 510(k)s | | |
| FDA Guidance | Financial Disclosure by Clinical Investigators | | |
| FDA Guidance | eCopy Program for Medical Device Submissions | | |
| ANSI AAMI ES60601-<br>1:2005/(R)2012 &<br>A1:2012,<br>C1:2009/(R)2012 &<br>A2:2010/(R)2012 | Medical Electrical Equipment - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance | | |
| ANSI AAMI IEC 60601-<br>1-2:2014 | Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests | | |
| IEC/TR 60601-4-2<br>Edition 1.0 2016-05 | Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems | | |
| IEC 60601-1-6 Edition<br>3.2 2020-07 | Medical Electrical Equipment-Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability | | |
| ANSI AAMI IEC<br>62304:2006/A1:2016 | Medical device software - Software Life Cycle Processes | | |
| ANSI AAMI IEC 62366-<br>1:2015+AMD1:2020<br>(Consolidated Text) | Medical Devices - Part 1: Application of Usability Engineering to Medical Devices | | |
| ISO 10993-1 Fifth<br>edition 2018-08 | Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process | | |
| Guidance Documents and Recognized Standards Applicable to ENDORAIL | | | |
| Standard/Guidance | Title | | |
| ISO 10993-2 Second<br>edition 2006-07-15 | Biological evaluation of Medical devices Part 2: Animal welfare<br>requirements | | |
| ISO 10993-5 Third<br>edition 2009-06-01 | Biological evaluation of medical devices - Part 5: Tests for in vitro<br>cytotoxicity | | |
| ISO 10993-10 Fourth<br>edition 2021-11 | Biological evaluation of medical devices - Part 10: Tests for skin<br>sensitization | | |
| ISO 10993-11 Third<br>edition 2017-09 | Biological evaluation of medical devices - Part 11: Tests for<br>systemic toxicity | | |
| ISO 10993-12 Fifth<br>edition 2021-01 | Biological evaluation of medical devices - Part 12: Sample<br>preparation and reference materials | | |
| ISO 10993-23 First<br>edition 2021-01 | Biological evaluation of medical devices - Part 23: Tests for<br>irritation | | |
| ISO 20695 First edition<br>2020-03 | Enteral feeding systems - Design and testing | | |
| ASTM F2528-06<br>(Reapproved 2014) | Standard Test Methods for Enteral Feeding Devices with a<br>Retention Balloon | | |
| ISO 80369-7 Second<br>edition 2021-05 | Small-bore connectors for liquids and gases in healthcare<br>applications - Part 7: Connectors for intravascular or hypodermic<br>applications | | |
| ISO 11737-1 Third<br>edition 2018-01 | Sterilization of health care products - Microbiological methods -<br>Part 1: Determination of a population of microorganisms on<br>product | | |
| ISO 7886-1 Second<br>edition 2017-05 | Sterile hypodermic syringes for single use - Part 1: Syringes for<br>manual use | | |
| ISO 20696 First edition<br>2018-06; Corrected<br>2019-12 | Sterile urethral catheters for single use | | |
| ASTM F1886/F1886M-<br>16 | Standard Test Method for Determining Integrity of Seals for<br>Flexible Packaging by Visual Inspection | | |
| ASTM F1929-15 | Standard Test Method for Detecting Seal Leaks in Porous Medical<br>Packaging by Dye Penetration – Method B | | |
| ASTM F88/F88M-21 | Standard Test Method for Seal Strength of Flexible Barrier<br>Materials | | |
| ASTM D4332-14 | Standard Practice for Conditioning Containers, Packages, Or<br>Packaging Components For Testing | | |
| ASTM F1980-21 | Standard Guide for Accelerated Aging of Sterile Barrier Systems<br>for Medical Devices | | |
| ASTM D4169-22 | Standard Practice for Performance Testing of Shipping Containers<br>and Systems | | |
| The United States<br>Pharmacopeia (USP)<br>and National Formulary<br>(NF) USP 42–NF 37;<br>M98900_01_01 | <151> Pyrogen Test (USP Rabbit Test) | | |
| ISO 14155 Third edition<br>2020-07…
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
