(225 days)
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.
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 guide 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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Primary Endpoints) | Reported Device Performance (ENDORAIL) |
|---|---|
| Efficacy: Colonoscopy incompletion rate ≤ 10% in long-lasting colonoscopies. | 0% colonoscopy incompletion rate. All 100% of patients successfully completed the colonoscopy. |
| Safety: No increase in colonoscopy serious adverse events (SAEs) (i.e., absence of any device-related SAEs). | No AE/SAE, no abnormal findings, and no overall change in the health status of any patient undergoing colonoscopy with ENDORAIL were observed in the study. |
Study Details
2. Sample Size and Data Provenance
- Test Set Sample Size: 38 patients were enrolled and included in the statistical analysis.
- Data Provenance: Prospective, multi-center clinical trial conducted in Italy, Germany, and Belgium.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
The document does not explicitly state the number of experts used to establish the ground truth for the test set cases or their specific qualifications beyond being "specialized medical staff" and "Principal Investigators" at the trial centers. However, the study involved:
- Principal Investigator: Prof. Alessandro Repici (IRCCS Humanitas Research Hospital, Milan, Italy)
- Principal Investigator: Prof. Helmut Neumann (GastroZentrum Lippe, Germany, affiliated with Universität Mainz)
- Principal Investigator: Prof. Raf Bisschops (University Hospitals Leuwen, Belgium)
These individuals are implied to be highly qualified gastroenterologists or endoscopists.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method for the test set cases, such as "2+1" or "3+1." The evaluation of outcomes (completion rate, adverse events) was directly reported as observed during the clinical study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study was a single-arm interventional study.
6. Standalone Algorithm Performance
This section is not applicable as ENDORAIL is a physical accessory to an endoscope, not a software algorithm or AI-driven device intended for standalone performance.
7. Type of Ground Truth Used
The ground truth for the acceptance criteria (colonoscopy completion and adverse events) was based on clinical observation and outcomes data from the prospective clinical trial. Colonoscopy completion was defined as caecal intubation being achieved. Adverse events were observed and classified by medical staff.
8. Sample Size for the Training Set
This section is not applicable. As ENDORAIL is a physical medical device accessory and not a machine learning algorithm, there is no "training set" in the context of AI/ML. The device's design and functionality were developed and validated through non-clinical testing and then evaluated in a clinical trial.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no training set for a physical device.
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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"
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ 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
| ComparisonElements | 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 anaccessory to an endoscopeand is intended to ensurepositioning of a standardendoscope (i.e., anendoscope that has aninstrument channel that isat least 3.7mm diameterand is used for standardendoscopic visualization)during endoscopy of thelarge intestine. | The NaviAid BGC is anaccessory to an endoscopeand is intended to ensurepositioning of a standardendoscope (i.e., anendoscope that has aninstrument channel that isat least 3.7mm diameterand is used for standardendoscopic visualization)during endoscopy of thesmall and large intestine. | The new PUMA-G systemis an accessory to enteralfeeding tubes that enablesultrasound-basedplacement ofpercutaneous gastrostomyfeeding tubes.(N/A) |
| Indications for Use | ENDORAIL is anaccessory indicated for afast and easy colonoscopy | The NaviAid BGC is anaccessory indicated for fastand easy colonoscopy,ileoscopy and upper | The new PUMA-G systemis an accessory to enteralfeeding tubes that enablesultrasound-based |
| ComparisonElements | Subject Device: | Primary Predicate Device(#1): (K111760) | Reference Device (#2):(K183057) |
| ENDORAIL | NaviAid BGC(renamed "NaviAid ABC") | PUMA-G System | |
| procedure with a standardendoscope. | enteroscopy procedureswith a standard endoscope. | placement ofpercutaneous gastrostomyfeeding tubes.(N/A) | |
| The device allows keepingall the advantages of anendoscopic procedure, suchas back-and-forthnavigation, real-timeoperation, video imaging, orthe capability to stoppropagation if needed, andto use an instrumentchannel for patienttreatment as necessary. | The device allows keepingall the advantages of anendoscopic procedure,such as back-and-forthnavigation, real-timeoperation, video imaging,or the capability to stoppropagation if needed, andto use an instrumentchannel for patienttreatment as necessary. | ||
| Sterility andReusability | The Balloon Cathetercomponent of ENDORAIL issupplied as "non-sterile"and for "single-use". | The NaviAid BGC system issupplied as "non-Sterile"and for "single use". | The procedural kit(guidewire, ballooncatheter and otheraccessories) is supplied as"sterile" and for "single-use". |
| ComparisonElements | 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) issupplied as "non-sterile"and "re-usable". | The External Magnetcomponent is supplied as"non-sterile" and "re-usable". | ||
| Environment ofUse | ENDORAIL is intended foruse in hospitals or clinics byspecialized medical staff. | The NaviAid BGC is for usein hospitals or clinics byspecialized medical staff. | The PUMA-G system is foruse in hospitals or clinicsby specialized medicalstaff. |
| Limitations of Use | To be used duringendoscopy of the largeintestine only. | To be used duringendoscopy of the small andlarge intestine. | None known. |
| Principles ofOperation | ENDORAIL facilitates theadvancement andplacement of an intestinalendoscope. | The NaviAid BGC facilitatesthe advancement andplacement of an intestinalendoscope. | The PUMA-G Systemfacilitates feeding tubeinsertion that can beperformed at a patient'sbedside. |
| The system utilizes aspecialized balloon, insertedin the endoscope using aninflation tube catheter,which is alternately inflatedand deflated in order to | The system utilizes aspecialized balloon,inserted in the endoscopeusing an inflation tubecatheter, which isalternately inflated and | The system relies on aballoon cathetercontaining a smallmagnetic needle that is fedthrough a patient's mouthand guided into the | |
| ComparisonElements | Subject Device: | Primary Predicate Device(#1): (K111760) | Reference Device (#2):(K183057) |
| ENDORAIL | NaviAid BGC(renamed "NaviAid ABC") | PUMA-G System | |
| allow the properprogression and to ensure asuitable positioning of theendoscope in the intestine. | deflated in order to allowthe proper progression andto ensure a suitablepositioning of theendoscope in the intestine. | stomach using an externalmagnet. The balloon ismade to be "grabbed" byan external magnet placedover the patient stomach. | |
| ENDORAIL uses a singledisposable balloon. Theballoon traverses ahead ofthe endoscope through theendoscope's instrumentchannel and thus it can beapplied on demand withoutthe need for a pre-procedure preparation ofthe device. | The NaviAid BGC uses asingle disposable balloon.The balloon traverses aheadof the endoscope throughthe endoscope's instrumentchannel and thus it can beapplied on demand withoutthe need for a pre-procedure preparation ofthe device. | The balloon is inflated withsaline and ultrasoundguides the treatingphysician as they insert aneedle through thestomach and into theballoon. The ballooncatches a wire that is thenpulled back up and out themouth as the balloon isremoved. A feeding tube | |
| The balloon is connected toa dedicated inflation tubethat runs inside theinstrument channel of theendoscope and is connectedat its proximal (user) end to | The balloon is connected toa dedicated inflation tubethat runs inside theinstrument channel of theendoscope and isconnected at its proximal | can then be pushed backdown over the wire andsafely out the stomach. | |
| ComparisonElements | Subject Device: | Primary Predicate Device(#1): (K111760) | Reference Device (#2):(K183057) |
| ENDORAIL | NaviAid BGC(renamed "NaviAid ABC") | PUMA-G System | |
| an inflation/deflationsystem. | (user) end to aninflation/deflation system. | ||
| The user manually operatesand controls the inflationand deflation of the balloonthrough theinflation/deflation system. | The user manually operatesand controls the inflationand deflation of the balloonthrough theinflation/deflation system. | ||
| The balloon can beadvanced ahead of theendoscope tip or pulledback through apushing/pulling action onthe inflation tube at itsproximal end, outside thepatient's body. | The balloon can beadvanced ahead of theendoscope tip or pulledback through apushing/pulling action onthe inflation tube at itsproximal end, outside thepatient's body. | ||
| The balloon and inflationtube do not compromise ina significant way theendoscope's flexibility, itsfield of view or the | The balloon and inflationtube do not compromise ina significant way theendoscope's flexibility, itsfield of view or the | ||
| ComparisonElements | 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 usageof any standard endoscopytools such as biopsy forceps,snare, needle etc. Theballoon catheter system canbe pulled back at any timeduring the procedure inorder to allow use oftherapy tools. | manoeuvrability of its tip,and do not limit the usageof any standard endoscopytools such as biopsyforceps, snare, needle etc.The balloon cathetersystem can be pulled backat any time during theprocedure in order to allowuse of therapy tools. | ||
| When the balloon isadvanced beyond theendoscope distal end,inflated and anchored, itbehaves as a distal "anchor"towards which theendoscope tip is advanced.Endoscope advancement isthus performed using theinflation tube as a guidewire, allowing theendoscope to be more | When the balloon isadvanced beyond theendoscope distal end,inflated and anchored, itbehaves as a distal"anchor" towards whichthe endoscope tip isadvanced. Endoscopeadvancement is thusperformed using theinflation tube as a guidewire, allowing the | ||
| ComparisonElements | Subject Device:ENDORAIL | Primary Predicate Device(#1): (K111760) | Reference Device (#2):(K183057) |
| NaviAid BGC(renamed "NaviAid ABC") | PUMA-G System | ||
| easily guided through thestraightened curves andloops of the colon. | endoscope to be moreeasily guided through thestraightened curves andloops of the colon. | ||
| The ENDORAIL balloon isfilled with amagnetorheologicalferromagnetic fluidcomposed of solidmicrometric carbonyl ironpowder dispersed in a watersolution of Sodium Chlorideand Sodium Citrate, bymeans of a syringe. | The NaviAid BGC balloon isfilled with ambient air usingan air supply unit andcontrol pump. | The PUMA-G balloon isfilled with saline solutionusing a syringe. | |
| The balloon is inflated witha ferromagnetic fluid and"anchored" to the colonwall. | The balloon is inflated withair increasing the balloonvolume until its diameter isenough large to fill theentire intestine lumen. | The balloon is inflated withsaline solution and"anchored" to the stomachwall. | |
| ComparisonElements | Subject Device:ENDORAIL | Primary Predicate Device(#1): (K111760)NaviAid BGC(renamed "NaviAid ABC") | Reference Device (#2):(K183057)PUMA-G System |
| The "anchoring" of theballoon is ensured bymagnetic force using anexternal magnet over thepatient abdomen incorrespondence of theballoon.The anchoring of theballoon allows thestraightening of the coloncurves and loops, facilitatingthe endoscope progression. | The "anchoring" of theballoon is ensured by thefriction force exerted by thefilled balloon against theintestine wall.The anchoring of theballoon allows thestraightening of the coloncurves and loops,facilitating the endoscopeprogression. | The "anchoring" of theballoon is ensured bymagnetic force using anexternal magnet over thepatient abdomen incorrespondence of theballoon. | |
| Orifice of Use | The ENDORAIL catheter ispassed via the colonoscopethrough anus into thecolon. | The NaviAid BGC catheter ispassed via the colonoscopethrough anus into thecolon. | The PUMA-G catheter ispassed through the mouthinto the stomach of thepatient.(N/A) |
| BalloonInflation/DeflationMechanism | The user may manuallyoperate and control theinflation and deflation of | The user may manuallyoperate and control theinflation and deflation of | The user may manuallyoperate and control theinflation and deflation of |
| ComparisonElements | Subject Device: | Primary Predicate Device (#1): (K111760) | Reference Device (#2): (K183057) |
| ENDORAIL | NaviAid BGC(renamed “NaviAid ABC”) | PUMA-G System | |
| the balloon through thesyringe. | the balloon through thepower air supply/footpedal control system.(N/A) | the balloon through thesyringe. |
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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 inPremarket Notifications [510(k)] | ||
| FDA Guidance | Recommended Content and Format of Non-Clinical BenchPerformance 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 60601-4-2Edition 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 Edition3.2 2020-07 | Medical Electrical Equipment-Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability | ||
| ANSI AAMI IEC62304:2006/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 Fifthedition 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 Secondedition 2006-07-15 | Biological evaluation of Medical devices Part 2: Animal welfarerequirements | ||
| ISO 10993-5 Thirdedition 2009-06-01 | Biological evaluation of medical devices - Part 5: Tests for in vitrocytotoxicity | ||
| ISO 10993-10 Fourthedition 2021-11 | Biological evaluation of medical devices - Part 10: Tests for skinsensitization | ||
| ISO 10993-11 Thirdedition 2017-09 | Biological evaluation of medical devices - Part 11: Tests forsystemic toxicity | ||
| ISO 10993-12 Fifthedition 2021-01 | Biological evaluation of medical devices - Part 12: Samplepreparation and reference materials | ||
| ISO 10993-23 Firstedition 2021-01 | Biological evaluation of medical devices - Part 23: Tests forirritation | ||
| ISO 20695 First edition2020-03 | Enteral feeding systems - Design and testing | ||
| ASTM F2528-06(Reapproved 2014) | Standard Test Methods for Enteral Feeding Devices with aRetention Balloon | ||
| ISO 80369-7 Secondedition 2021-05 | Small-bore connectors for liquids and gases in healthcareapplications - Part 7: Connectors for intravascular or hypodermicapplications | ||
| ISO 11737-1 Thirdedition 2018-01 | Sterilization of health care products - Microbiological methods -Part 1: Determination of a population of microorganisms onproduct | ||
| ISO 7886-1 Secondedition 2017-05 | Sterile hypodermic syringes for single use - Part 1: Syringes formanual use | ||
| ISO 20696 First edition2018-06; Corrected2019-12 | Sterile urethral catheters for single use | ||
| ASTM F1886/F1886M-16 | Standard Test Method for Determining Integrity of Seals forFlexible Packaging by Visual Inspection | ||
| ASTM F1929-15 | Standard Test Method for Detecting Seal Leaks in Porous MedicalPackaging by Dye Penetration – Method B | ||
| ASTM F88/F88M-21 | Standard Test Method for Seal Strength of Flexible BarrierMaterials | ||
| ASTM D4332-14 | Standard Practice for Conditioning Containers, Packages, OrPackaging Components For Testing | ||
| ASTM F1980-21 | Standard Guide for Accelerated Aging of Sterile Barrier Systemsfor Medical Devices | ||
| ASTM D4169-22 | Standard Practice for Performance Testing of Shipping Containersand Systems | ||
| The United StatesPharmacopeia (USP)and National Formulary(NF) USP 42–NF 37;M98900_01_01 | <151> Pyrogen Test (USP Rabbit Test) | ||
| ISO 14155 Third edition2020-07 | Clinical investigation of medical devices for human subjects - Goodclinical practice | ||
| Guidance Documents and Recognized Standards Applicable to ENDORAIL | |||
| Standard/Guidance | Title | ||
| ISO 15223-1 Fourthedition 2021-07 | Medical Devices - Symbols To Be Used With Medical DeviceLabels, Labelling, And Information To Be Supplied - Part 1:General Requirements | ||
| ISO 20417 First edition2021-04 Correctedversion 2021-12 | Medical devices - Information to be supplied by the manufacturer | ||
| ISO 14971 Third Edition2019-12 | Medical Devices - Application of Risk Management To MedicalDevices |
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VIII. Clinical Performance Data
Clinical validation testing was conducted with ENDORAIL to confirm the safety and effectiveness of the device. A summary of the design of the Multicenter Post-Market Single Arm Open Label Interventional Study performed, together with a summary of the key results, are provided below. The following table summarizes the main elements of the study.
| Title | Multicentre Clinical Trial for the evaluation of thesafety and effectiveness of ENDORAIL in patientswith long-lasting colonoscopy |
|---|---|
| Short Title | ENDORAIL Clinical Study |
| Study Type | Multicentre post-market single arm open labelinterventional study |
| Trial centres | 1. IRCCS Humanitas Research HospitalVia Manzoni 56, I-20089 Rozzano (Milan, Italy)(Principal Investigator: Prof. Alessandro Repici)2. GastroZentrum LippeLange Str 55 32105 Bad Salzuflen (Germany)affiliated with Universit\u00e4t MainzLangenbeck Street 1, D-55131 Mainz (Germany)(Principal Investigator: Prof. Helmut Neumann)3. University Hospitals LeuwenHerestraat 49, B-3000 Leuwen (Belgium)(Principal Investigator: Prof. Raf Bisschops) |
| Sponsor / Manufacturer | Endostart s.r.l., Via delle Regioni 265, 50052Certaldo (FI), ITALY |
| Trial period(first subject in-last subject out) | First Patient In: 24 January 2023;Last Patient In: 17 May 2023;Last Patient Last Visit: 24 May 2023. |
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Background
This Multicenter Post-Market Single Arm Open Label Interventional Study was intended to expand the clinical knowledge in support of the safety and efficacy of the ENDORAIL device.
Reported incomplete colonoscopy rates range from 4% to 25% of all screened patients. However, while international guidelines recommend a rate of less than 10% for diagnostic colonoscopies, the risk is at least 20% in the more challenging subset of patients characterized by long-lasting procedures.
A colonoscopy can be defined as "long-lasting" when caecal intubation time is longer than 10 minutes. As data from literature shows that about 80% of all diagnostic colonoscopies are typically completed in less than 10 minutes, the long-lasting colonoscopy subset represents approx. 20% of the total procedures. Indeed, since virtually all incomplete colonoscopies are also long-lasting, the risk of incompleteness in this subset of patients increases nearly fivefold (i.e., for a 5X increase, the lower bound of the rate increases from 4% to 20%).
ENDORAIL is intended to facilitate the positioning of a standard colonoscope. One of the main advantages of this system is that it can be used "as needed" during the procedure to prevent incomplete procedures without requiring any "preloading" ahead of time. This makes ENDORAIL particularly indicated for patients in which caecal intubation time gets longer and the risk of incompletion increases.
The aim of this study is to test the efficacy of ENDORAIL in ensuring low incompletion rate in long-lasting colonoscopies.
Primary Objectives
Efficacy (Timeframe: day 1)
To validate the efficacy of ENDORAIL in long-lasting colonoscopies by reaching a colonoscopy incompletion rate ≤ 10%.
Safety (Timeframe: day 1 to day 7)
To validate the safety of ENDORAIL in long-lasting colonoscopies, by demonstrating that colonoscopy serious adverse events (SAEs) are not increased using the device (i.e., absence of any device-related SAEs).
Methodology
Multicentre, post-marketing, single-arm, open-label, interventional study: Outpatients of either sex aged between 22-75 years (inclusive), undergoing elective colonoscopy for diagnostic or surveillance procedure, who signed a written ICF and presenting caecal intubation time greater than 10 minutes, took part in the study.
The study plan included: a Screening/Baseline/Treatment visit (Visit 1/Day 1), during which colonoscopy with ENDORAIL was performed; and a phone follow-up visit (Visit 2), scheduled at 7 (± 1) days post-treatment with ENDORAIL.
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Sample Size Determination
Efficacy (first primary objective) is assessed by measuring the colonoscopy completion rate in long-lasting procedures, which is a measurable parameter of clinical value recognized by international medical societies. Safety (second primary objective) is assessed by measuring the rate of adverse events. Adverse events are classified into four groups: serious gastrointestinal events; myocardial infarction; stroke; and pneumonia. Based on the data from the literature; the adverse events occurrence rates for those 4 groups, for screening or surveillance colonoscopy, are 47, 4, 7 and 10 patients per 100,000, respectively.
These two objectives are merged in one indicator for each subject, which is either equal to 1 if the procedure is incomplete or an adverse event occurs, or equal to 0 otherwise.
The non-completion rate of long-lasting colonoscopies conducted with ENDORAIL is expected to be around 10%. This will be compared to the above-mentioned threshold of 20% for incomplete procedures. It should be noted that this threshold is conservative and represents the most critical setting for comparison with respect to the art, as it is derived from the lower bound of the range from the literature.
When including the safety to provide the expected value of the indicator for ENDORAIL and the corresponding threshold, the above values of 10% minimally change, as the adverse event occurrence rate is 0.068% (given by the sum of the occurrence of the 4 events reported above per 100,000 persons, expressed in percentage).
With a significance level a of 5%, assuming a proportion of outcome of 10.1%, 85 patients allow to test with a power of 80% the H0: p ≥ 20%, where 20%, where 20% is the estimated percentage of incomplete procedure from literature.
The chosen number is then increased by the 10% to account for possible drop-out (e.g., cases to be discarded, losses to follow-up, etc.), resulting in 85/0.90 = 95 patients to be actually enrolled.
Inclusion and Exclusion Criteria
Inclusion Criteria
-
- Patients of both sexes aged between 22 75 years (inclusive).
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- Outpatients undergoing long-lasting diagnostic or surveillance colonoscopy. A longlasting colonoscopy is defined as follows: colonoscopy completion (caecal intubation) not achieved after 10 minutes from endoscope insertion through the anal.
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- Patients have signed a written informed consent form (ICF) for participation in the study at the time of enrolment or before.
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- Patients able to understand the full nature and the purpose of the investigation, including possible risks and side effects, able to cooperate with the Investigator and to
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comply with the requirements of the entire investigation based on Investigator's judgement.
Exclusion Criteria
-
- Body mass index (BMI) > 30 kg/m².
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- Outpatients undergoing colonoscopy for colorectal cancer screening or therapeutic indication.
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- Patients in class >2 physical status of the classification system of American Society of Anaesthesiologists.
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- Any contraindication to colonoscopy.
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- Any contraindication to sedation.
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- Known allergy or hypersensitivity to any of the elements of the Endorail Set (e.g.: iron).
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- Patients with permanently or semi-permanently implanted medical devices (e.g., orthopaedic implants, trauma fixation devices, cardiac pacemakers, implantable cardioverter defibrillator, drug pumps, neurostimulators, vascular stents, cochlear implants, aneurysm clip).
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- Presence of dense diverticulosis.
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- Presence of diverticulitis.
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- Presence of ferromagnetic foreign body.
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- Presence of large abdominal hernias.
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- Urgent colonoscopy.
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- Presence of severe thrombocytopenia.
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- Presence of severe granulocytopenia.
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- Presence of severe coagulopathy.
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- Presence of peritonitis.
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- Presence of colonic wall ischemia or necrosis or injured mucosa.
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- Presence of peritoneal carcinomatosis.
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- Boston Bowel Preparation Scale <2 in at least one of the colonic segments.
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- Presence of obstructing masses and strictures of the colon.
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- History of total or subtotal colectomy.
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- Presence of angulated and fixed colon curves.
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- Pregnant or breast-feeding women.
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- Patient unable to provide the signed ICF, uncooperative patient unlikely to comply with the protocol or unable to understand the nature, scope, and possible consequences of the study.
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- Presence of any other reason that, in the opinion of the Investigator, could prevent the subject from participating in the study or compromise the subject safety.
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- Concomitant participation in other clinical investigations or participation in the evaluation of any investigational product/device in the 30 days before this study or previous participation in the same investigation.
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Test Device
ENDORAIL (Endostart s.r.l., Certaldo, Firenze, Italy).
Duration of Treatment
One single procedure (long-lasting diagnostic or surveillance colonoscopy).
Concomitant Treatments
Permitted Treatments:
Participants were allowed to use any concomitant medication necessary for the treatment of pre-existing concomitant pathologies or for intercurrent diseases, if they do not interfere with the parameters under investigation. Sedation was performed by an anaesthesiologist or an endoscopist according to standard of care.
Non-Permitted Treatments:
No prohibited concomitant treatments were defined.
Endpoints
Primary Efficacy Endpoint:
The primary efficacy endpoint was ≤ 10% of incomplete long-lasting colonoscopies (colonoscopy was defined as complete when caecal intubation was achieved).
Primary Safety Endpoint:
The primary safety objective was to validate the safety of ENDORAIL in long-lasting colonoscopies by demonstrating that colonoscopy SAEs are not increased using the device (i.e., the lack of any device-related SAEs). The assessed AEs were:
- general AEs and medical device incidents, and
- specific AEs: gastrointestinal (GI) bleedings, intestinal perforation, mucosal petechiae ● and abdominal pain.
Secondary Endpoints:
None defined.
Statistical Analysis
A total of thirty-eight (38) patients were enrolled into the study, underwent the colonoscopy procedure with ENDORAIL, and were included in the statistical analysis. As discussed in the Sample Size Determination section, a first interim analysis was planned once 40% of the total sample size (i.e., 38 patients) was reached. At this first interim analysis, the statistical significance of sample was tested and was found to be sufficient, at which, time per protocol, the trial was terminated. A total of 38 patients was therefore considered for the interim analysis.
Thirty-six (36) out of thirty-eight (38) enrolled patients (94.7%) were successfully contacted for
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a phone follow-up visit, which was scheduled 7 ± 1 days after treatment. The remaining two (2) patients (i.e., 5.3%) resulted unreachable and were considered lost to follow-up. A total of 38 patients were therefore considered for the interim analysis.
The great majority of patients was enrolled in two (2) out of the three (3) study sites, as follows: 21 patients (55.3%) were enrolled at the Italian site (Milan) managed by Prof. Alessandro Repici, and 15 patients (39.5%) were enrolled at the German site (Bad Salzuflen) managed by Prof. Helmut Neumann. The remaining 2 patients (5.3%) were enrolled at the Belgian site (Leuwen) managed by Prof. Raf Bisschops.
The populations included in the analysis were the following:
Screening Set -The screening set included all patients who had signed the ICF and had been screened for inclusion in the study. Thirty-eight (38) patients were included in this population.
Intent-to-Treat (ITT) – The ITT population included all enrolled patients who underwent treatment with ENDORAIL. All 38 patients were included in this population.
Per-Protocol (PP) – The PP population included all patients of the ITT population who also met all inclusion/exclusion criteria. Again, all 38 enrolled patients were included in the PP population.
In conclusion, the three populations defined above resulted to be identical.
Analyses
The statistical analysis plan was finalized before the Data Base Lock and it included a more technical and detailed description of the statistical analyses summarized in this section.
All data collected in this study, and documented in the eCRFs, were listed and summarized (as appropriate):
- for quantitative variables: standard quantitative statistics (N, mean, standard deviation, median, interquartile range, minimum and maximum)
- . for qualitative variables: frequency distribution [number of non-missing observations (N) and percentages (%)].
The analysis plan provided:
- Analysis of baseline characteristics for all population. Baseline characteristics included demographic data, medical history, vital signs, and physical examination.
- . Analysis of endpoints for all population. This analysis included:
- analysis of the efficacy of ENDORAIL, considering the successful completion o of the colonoscopy; and
- analysis of the safety of ENDORAIL regarding intraprocedural adverse events. O
- Analysis of follow-up data for all population, regarding adverse events (AEs) and device deficiencies.
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A statistical test was planned to assess the significant difference of the indicator with respect to the threshold and statistically prove efficacy of ENDORAIL in long-lasting procedures. Due to the type of variable, the exact binomial test was adopted. Additionally, considering as alternative hypothesis that the rate observed in the analysed population is less than the respective threshold, the one-tailed test was adopted.
Medical AEs and medical device AEs were collected during the study.
The number of AEs – related or not-related to the medical device – and the number and proportion of patients with at least one AE were assessed.
All AEs were tabulated by System Organ Class (SOC) and Preferred Term (PT) after medical coding using the Medical Dictionary for Regulatory Activities (MedDRA) thesaurus version 24.1. The primary SOC and the PT were used for the analysis of the frequency distribution.
The frequency of occurrence of specific AEs (gastrointestinal bleedings, intestinal perforation, mucosal petechiae, abdominal pain) were assessed by means of default descriptive statistics.
The statistical analyses were carried out using R Statistical Software (Foundation for Statistical Computing, Vienna, Austria).
Conclusions about the Study Hypothesis
This study was designed to test the null hypothesis that the proportion of "event" (intended as procedure incomplete or serious adverse event) is equal or greater than 20%. The alternative hypothesis is that the proportion of "event" is less than 20%.
The interim analysis was performed to allow the termination of the study in advance if significance was found for the first 38 enrolled patients.
The observed events were 0 out of 38 patients: the exact binomial one-tailed test shows a 95% confidence interval of 0% (95%C1: 0% - 7.6%) with a p-value <0.001. The observed percentage of events was significantly under the pre-specified threshold of 20%.
Results: The principal safety and effectiveness results from the Multicenter clinical trial for the evaluation of safety and effectiveness of ENDORAIL in patients with long-lasting colonoscopy are presented below.
Efficacy Results: all patients enrolled into the clinical study successfully completed the colonoscopy with ENDORAIL and no patient needed to interrupt the diagnostic procedure or to be withdrawn from the study for any reason. More importantly, in all the patients (100%) the endoscopist could reach and fully inspect the last segment of the colon called caecum. In conclusion, the study results have achieved the primary efficacy endpoint, which was to validate the efficacy of ENDORAIL in long-lasting colonoscopies by reaching a colonoscopy incompletion rate ≤ 10%. In fact, the recorded coloscopy incompletion rate over the entire ENDORAIL study was 0%.
Safety Results: this clinical study was also conducted to assess the safety of ENDORAIL in long-lasting colonoscopies. No AE/SAE, no abnormal findings,
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and no overall change in the health status of any patient undergoing the colonoscopy with ENDORAIL were observed in the course of the clinical study. The study has therefore successfully achieved the primary safety objective, which was to validate the safety of ENDORAIL in long-lasting colonoscopies by demonstrating that colonoscopy SAEs are not increased by using this investigational device (i.e., absence of any device-related SAEs).
Conclusions: The ENDORAIL study was aimed at testing the safety and efficacy of the device in ensuring a low incompletion rate in long-lasting colonoscopies. The multicenter clinical trial for the evaluation of safety and effectiveness of ENDORAIL in patients with long-lasting colonoscopy confirmed that ENDORAIL is safe and effective for its intended use.
IX. Statement of Substantial Equivalence
Based on substantially equivalent intended use, technological characteristics and the safety and performance of non-clinical and clinical testing, the ENDORAIL is deemed to be substantially equivalent to its primary predicate device, the NaviAid BGC (subsequently renamed as "NaviAid ABC") cleared under K111760.
The ENDORAIL, as designed and manufactured, does not raise new questions reqarding safety and effectiveness as compared to its predicate device and is concluded to be substantially equivalent to its predicate device.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.