← Product Code [ODC](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/ODC) · K232327 # Endorail (K232327) _Endostart S.R.L. · ODC · Mar 15, 2024 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/ODC/K232327 ## Device Facts - **Applicant:** Endostart S.R.L. - **Product Code:** [ODC](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/ODC.md) - **Decision Date:** Mar 15, 2024 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## 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. ## 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). ## Regulatory 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. ## Predicate Devices - NaviAid BGC (later renamed "NaviAid ABC") ([K111760](/device/K111760.md)) ## Reference Devices - PUMA-G System ([K183057](/device/K183057.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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" {1}------------------------------------------------ (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). {2}------------------------------------------------ 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 {3}------------------------------------------------ # 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) | | |--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 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. {5}------------------------------------------------ # 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. {6}------------------------------------------------ #### 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. {7}------------------------------------------------ # Substantial Equivalence Comparison Table | Comparison
Elements | Subject Device: | Primary Predicate Device
(#1): (K111760) | Reference Device (#2):
(K183057) | |---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | ENDORAIL | NaviAid BGC
(renamed "NaviAid ABC") | PUMA-G System | | Product Code | ODC | ODC | KGC
(N/A) | | Regulation # | 876.1500 | 876.1500 | 876.5980
(N/A) | | Class | II | II | II | | Intended Use | ENDORAIL is an
accessory to an endoscope
and is intended to ensure
positioning of a standard
endoscope (i.e., an
endoscope that has an
instrument channel that is
at least 3.7mm diameter
and is used for standard
endoscopic visualization)
during endoscopy of the
large intestine. | The NaviAid BGC is an
accessory to an endoscope
and is intended to ensure
positioning of a standard
endoscope (i.e., an
endoscope that has an
instrument channel that is
at least 3.7mm diameter
and is used for standard
endoscopic visualization)
during endoscopy of the
small and large intestine. | The new PUMA-G system
is an accessory to enteral
feeding tubes that enables
ultrasound-based
placement of
percutaneous gastrostomy
feeding tubes.
(N/A) | | Indications for Use | ENDORAIL is an
accessory indicated for a
fast and easy colonoscopy | The NaviAid BGC is an
accessory indicated for fast
and easy colonoscopy,
ileoscopy and upper | The new PUMA-G system
is an accessory to enteral
feeding tubes that enables
ultrasound-based | | Comparison
Elements | Subject Device: | Primary Predicate Device
(#1): (K111760) | Reference Device (#2):
(K183057) | | | ENDORAIL | NaviAid BGC
(renamed "NaviAid ABC") | PUMA-G System | | | procedure with a standard
endoscope. | enteroscopy procedures
with a standard endoscope. | placement of
percutaneous gastrostomy
feeding tubes.
(N/A) | | | The device allows keeping
all the advantages of an
endoscopic procedure, such
as back-and-forth
navigation, real-time
operation, video imaging, or
the capability to stop
propagation if needed, and
to use an instrument
channel for patient
treatment as necessary. | The device allows keeping
all the advantages of an
endoscopic procedure,
such as back-and-forth
navigation, real-time
operation, video imaging,
or the capability to stop
propagation if needed, and
to use an instrument
channel for patient
treatment as necessary. | | | Sterility and
Reusability | The Balloon Catheter
component of ENDORAIL is
supplied as "non-sterile"
and for "single-use". | The NaviAid BGC system is
supplied as "non-Sterile"
and for "single use". | The procedural kit
(guidewire, balloon
catheter and other
accessories) is supplied as
"sterile" and for "single-
use". | | Comparison
Elements | Subject Device: | Primary Predicate Device
(#1): (K111760) | Reference Device (#2):
(K183057) | | | ENDORAIL | NaviAid BGC
(renamed "NaviAid ABC") | PUMA-G System | | | The ENDORAIL Handpiece
(external magnet) is
supplied as "non-sterile"
and "re-usable". | | The External Magnet
component is supplied as
"non-sterile" and "re-
usable". | | Environment of
Use | ENDORAIL is intended for
use in hospitals or clinics by
specialized medical staff. | The NaviAid BGC is for use
in hospitals or clinics by
specialized medical staff. | The PUMA-G system is for
use in hospitals or clinics
by specialized medical
staff. | | Limitations of Use | To be used during
endoscopy of the large
intestine only. | To be used during
endoscopy of the small and
large intestine. | None known. | | Principles of
Operation | ENDORAIL facilitates the
advancement and
placement of an intestinal
endoscope. | The NaviAid BGC facilitates
the advancement and
placement of an intestinal
endoscope. | The PUMA-G System
facilitates feeding tube
insertion that can be
performed at a patient's
bedside. | | | The system utilizes a
specialized balloon, inserted
in the endoscope using an
inflation tube catheter,
which is alternately inflated
and deflated in order to | The system utilizes a
specialized balloon,
inserted in the endoscope
using an inflation tube
catheter, which is
alternately inflated and | The system relies on a
balloon catheter
containing a small
magnetic needle that is fed
through a patient's mouth
and guided into the | | Comparison
Elements | Subject Device: | Primary Predicate Device
(#1): (K111760) | Reference Device (#2):
(K183057) | | | ENDORAIL | NaviAid BGC
(renamed "NaviAid ABC") | PUMA-G System | | | allow the proper
progression and to ensure a
suitable positioning of the
endoscope in the intestine. | deflated in order to allow
the proper progression and
to ensure a suitable
positioning of the
endoscope in the intestine. | stomach using an external
magnet. The balloon is
made to be "grabbed" by
an external magnet placed
over the patient stomach. | | | ENDORAIL uses a single
disposable balloon. The
balloon traverses ahead of
the endoscope through the
endoscope's instrument
channel and thus it can be
applied on demand without
the need for a pre-
procedure preparation of
the device. | The NaviAid BGC uses a
single disposable balloon.
The balloon traverses ahead
of the endoscope through
the endoscope's instrument
channel and thus it can be
applied on demand without
the need for a pre-
procedure preparation of
the device. | The balloon is inflated with
saline and ultrasound
guides the treating
physician as they insert a
needle through the
stomach and into the
balloon. The balloon
catches a wire that is then
pulled back up and out the
mouth as the balloon is
removed. A feeding tube | | | The balloon is connected to
a dedicated inflation tube
that runs inside the
instrument channel of the
endoscope and is connected
at its proximal (user) end to | The balloon is connected to
a dedicated inflation tube
that runs inside the
instrument channel of the
endoscope and is
connected at its proximal | can then be pushed back
down over the wire and
safely out the stomach. | | Comparison
Elements | Subject Device: | Primary Predicate Device
(#1): (K111760) | Reference Device (#2):
(K183057) | | | ENDORAIL | NaviAid BGC
(renamed "NaviAid ABC") | PUMA-G System | | | an inflation/deflation
system. | (user) end to an
inflation/deflation system. | | | | The user manually operates
and controls the inflation
and deflation of the balloon
through the
inflation/deflation system. | The user manually operates
and controls the inflation
and deflation of the balloon
through the
inflation/deflation system. | | | | The balloon can be
advanced ahead of the
endoscope tip or pulled
back through a
pushing/pulling action on
the inflation tube at its
proximal end, outside the
patient's body. | The balloon can be
advanced ahead of the
endoscope tip or pulled
back through a
pushing/pulling action on
the inflation tube at its
proximal end, outside the
patient's body. | | | | The balloon and inflation
tube do not compromise in
a significant way the
endoscope's flexibility, its
field of view or the | The balloon and inflation
tube do not compromise in
a significant way the
endoscope's flexibility, its
field of view or the | | | Comparison
Elements | Subject Device: | Primary Predicate Device
(#1): (K111760) | Reference Device (#2):
(K183057) | | | ENDORAIL | NaviAid BGC
(renamed "NaviAid ABC") | PUMA-G System | | | manoeuvrability of its tip,
and do not limit the usage
of any standard endoscopy
tools such as biopsy forceps,
snare, needle etc. The
balloon catheter system can
be pulled back at any time
during the procedure in
order to allow use of
therapy tools. | manoeuvrability of its tip,
and do not limit the usage
of any standard endoscopy
tools such as biopsy
forceps, snare, needle etc.
The balloon catheter
system can be pulled back
at any time during the
procedure in order to allow
use of therapy tools. | | | | When the balloon is
advanced beyond the
endoscope distal end,
inflated and anchored, it
behaves as a distal "anchor"
towards which the
endoscope tip is advanced.
Endoscope advancement is
thus performed using the
inflation tube as a guide
wire, allowing the
endoscope to be more | When the balloon is
advanced beyond the
endoscope distal end,
inflated and anchored, it
behaves as a distal
"anchor" towards which
the endoscope tip is
advanced. Endoscope
advancement is thus
performed using the
inflation tube as a guide
wire, allowing the | | | Comparison
Elements | Subject Device:
ENDORAIL | Primary Predicate Device
(#1): (K111760) | Reference Device (#2):
(K183057) | | | | NaviAid BGC
(renamed "NaviAid ABC") | PUMA-G System | | | easily guided through the
straightened curves and
loops of the colon. | endoscope to be more
easily guided through the
straightened curves and
loops of the colon. | | | | The ENDORAIL balloon is
filled with a
magnetorheological
ferromagnetic fluid
composed of solid
micrometric carbonyl iron
powder dispersed in a water
solution of Sodium Chloride
and Sodium Citrate, by
means of a syringe. | The NaviAid BGC balloon is
filled with ambient air using
an air supply unit and
control pump. | The PUMA-G balloon is
filled with saline solution
using a syringe. | | | The balloon is inflated with
a ferromagnetic fluid and
"anchored" to the colon
wall. | The balloon is inflated with
air increasing the balloon
volume until its diameter is
enough large to fill the
entire intestine lumen. | The balloon is inflated with
saline solution and
"anchored" to the stomach
wall. | | | | | | | Comparison
Elements | Subject Device:
ENDORAIL | Primary Predicate Device
(#1): (K111760)
NaviAid BGC
(renamed "NaviAid ABC") | Reference Device (#2):
(K183057)
PUMA-G System | | | The "anchoring" of the
balloon is ensured by
magnetic force using an
external magnet over the
patient abdomen in
correspondence of the
balloon.

The anchoring of the
balloon allows the
straightening of the colon
curves and loops, facilitating
the endoscope progression. | The "anchoring" of the
balloon is ensured by the
friction force exerted by the
filled balloon against the
intestine wall.

The anchoring of the
balloon allows the
straightening of the colon
curves and loops,
facilitating the endoscope
progression. | The "anchoring" of the
balloon is ensured by
magnetic force using an
external magnet over the
patient abdomen in
correspondence of the
balloon. | | Orifice of Use | The ENDORAIL catheter is
passed via the colonoscope
through anus into the
colon. | The NaviAid BGC catheter is
passed via the colonoscope
through anus into the
colon. | The PUMA-G catheter is
passed through the mouth
into the stomach of the
patient.
(N/A) | | Balloon
Inflation/Deflation
Mechanism | The user may manually
operate and control the
inflation and deflation of | The user may manually
operate and control the
inflation and deflation of | The user may manually
operate and control the
inflation and deflation of | | Comparison
Elements | Subject Device: | Primary Predicate Device (#1): (K111760) | Reference Device (#2): (K183057) | | | ENDORAIL | NaviAid BGC
(renamed “NaviAid ABC”) | PUMA-G System | | | the balloon through the
syringe. | the balloon through the
power air supply/foot
pedal control system.
(N/A) | the balloon through the
syringe. | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ {13}------------------------------------------------ {14}------------------------------------------------ {15}------------------------------------------------ {16}------------------------------------------------ #### 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
Premarket Notifications [510(k)] | | | | FDA Guidance | Recommended Content and Format of Non-Clinical Bench
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-
1:2005/(R)2012 &
A1:2012,
C1:2009/(R)2012 &
A2:2010/(R)2012 | Medical Electrical Equipment - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance | | | | ANSI AAMI IEC 60601-
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
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
3.2 2020-07 | Medical Electrical Equipment-Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability | | | | ANSI AAMI IEC
62304:2006/A1:2016 | Medical device software - Software Life Cycle Processes | | | | ANSI AAMI IEC 62366-
1:2015+AMD1:2020
(Consolidated Text) | Medical Devices - Part 1: Application of Usability Engineering to Medical Devices | | | | ISO 10993-1 Fifth
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
edition 2006-07-15 | Biological evaluation of Medical devices Part 2: Animal welfare
requirements | | | | ISO 10993-5 Third
edition 2009-06-01 | Biological evaluation of medical devices - Part 5: Tests for in vitro
cytotoxicity | | | | ISO 10993-10 Fourth
edition 2021-11 | Biological evaluation of medical devices - Part 10: Tests for skin
sensitization | | | | ISO 10993-11 Third
edition 2017-09 | Biological evaluation of medical devices - Part 11: Tests for
systemic toxicity | | | | ISO 10993-12 Fifth
edition 2021-01 | Biological evaluation of medical devices - Part 12: Sample
preparation and reference materials | | | | ISO 10993-23 First
edition 2021-01 | Biological evaluation of medical devices - Part 23: Tests for
irritation | | | | ISO 20695 First edition
2020-03 | Enteral feeding systems - Design and testing | | | | ASTM F2528-06
(Reapproved 2014) | Standard Test Methods for Enteral Feeding Devices with a
Retention Balloon | | | | ISO 80369-7 Second
edition 2021-05 | Small-bore connectors for liquids and gases in healthcare
applications - Part 7: Connectors for intravascular or hypodermic
applications | | | | ISO 11737-1 Third
edition 2018-01 | Sterilization of health care products - Microbiological methods -
Part 1: Determination of a population of microorganisms on
product | | | | ISO 7886-1 Second
edition 2017-05 | Sterile hypodermic syringes for single use - Part 1: Syringes for
manual use | | | | ISO 20696 First edition
2018-06; Corrected
2019-12 | Sterile urethral catheters for single use | | | | ASTM F1886/F1886M-
16 | Standard Test Method for Determining Integrity of Seals for
Flexible Packaging by Visual Inspection | | | | ASTM F1929-15 | Standard Test Method for Detecting Seal Leaks in Porous Medical
Packaging by Dye Penetration – Method B | | | | ASTM F88/F88M-21 | Standard Test Method for Seal Strength of Flexible Barrier
Materials | | | | ASTM D4332-14 | Standard Practice for Conditioning Containers, Packages, Or
Packaging Components For Testing | | | | ASTM F1980-21 | Standard Guide for Accelerated Aging of Sterile Barrier Systems
for Medical Devices | | | | ASTM D4169-22 | Standard Practice for Performance Testing of Shipping Containers
and Systems | | | | The United States
Pharmacopeia (USP)
and National Formulary
(NF) USP 42–NF 37;
M98900_01_01 | <151> Pyrogen Test (USP Rabbit Test) | | | | ISO 14155 Third edition
2020-07… --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/ODC/K232327](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/ODC/K232327) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com