This product is intended to be used in combination with an endoscope to assist endoscopic insertion into the body. Never use this product for any other purpose. This product is intended for use in medical facilities by medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments.

Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter and its associated summary for a medical device called "Over-tube (TR-1108A)". This document describes the device, its intended use, and its substantial equivalence to a predicate device.

Crucially, this document is for an "Over-tube" which is a physical accessory used with an endoscope, not an AI/software-based medical device. Therefore, the concepts of acceptance criteria, study design (like MRMC, human-in-the-loop, standalone performance), data provenance, expert ground truth establishment for AI models, and training/test sets as commonly understood for AI/ML device clearances do not apply to this specific product.

The document discusses performance testing of the physical device to demonstrate that changes in size (outer diameter, maximum outer diameter) compared to the predicate device do not affect its safety or efficacy.

Here's how the information provided relates to the closest equivalent concepts for a physical device:

Acceptance Criteria and Reported Device Performance

The document states that "the subject device met performance specifications in the following additional testing." This implies that the 'acceptance criteria' were met if the device passed these tests. The reported performance is simply that it "passed all test objectives."

Table of "Acceptance Criteria" (Implied) and "Reported Device Performance" for an Over-tube (TR-1108A):

Performance Test	Acceptance Criteria (Implied: "Met Specifications")	Reported Device Performance
Insertion Force	Met predetermined specifications	Passed
Working Length	Met predetermined specifications	Passed
Flexibility	Met predetermined specifications	Passed
Maximum Diameter of Insertion Portion	Met predetermined specifications	Passed
Outer Diameter of Insertion Portion	Met predetermined specifications	Passed

Note: For a physical device, these are typically engineering specifications and not statistical performance metrics like sensitivity, specificity, AUC as seen in AI/ML devices.

Study Details (as applicable to a physical device)

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a 'sample size' of cases/patients in the context of a typical AI study. For a physical device, this refers to the number of units tested or the number of movements/stresses performed during testing. This information is not detailed in the provided summary.
- Data Provenance: Not applicable in the AI/ML sense. The testing is likely done in a lab or benchtop setting by the manufacturer, not with patient data from specific countries or in retrospective/prospective studies.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- Not Applicable. Ground truth, in the context of an AI/ML device, refers to a definitive diagnosis or annotation of medical images/data. For a physical device like an over-tube, performance is assessed against engineering specifications and functional requirements, not expert-labeled "ground truth."
Adjudication Method for the Test Set:
- Not Applicable. Adjudication is typically for expert disagreements on ground truth labels in AI studies. For a physical device, test results are typically objective measurements against specifications.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. MRMC studies are specific to evaluating how AI impacts human reader performance, primarily in image interpretation. This is a physical device, so such a study would not be performed.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not an algorithm.
The Type of Ground Truth Used:
- Engineering Specifications / Functional Requirements. The "ground truth" for a physical device's performance is whether it meets its designed specifications (e.g., minimum flexibility, maximum diameter, insertion force within limits). This is determined by direct measurement and testing, not by expert consensus or pathology on patient data.
The Sample Size for the Training Set:
- Not Applicable. "Training set" refers to data used to train an AI model. This is a physical device.
How the Ground Truth for the Training Set was Established:
- Not Applicable. As there's no training set for a physical device.

In summary, the provided document is for a conventional hardware medical device, not an AI/ML software device. Therefore, many of the questions related to AI/ML study design and ground truth establishment are not applicable. The manufacturer demonstrated "substantial equivalence" by showing that the physical changes (size) did not negatively impact the device's ability to meet its performance specifications.

Summary

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November 1, 2024

Fujifilm Corporation % Chaitrali Kulkarni Sr. Regulatory Affairs Specialist FUJIFILM Healthcare Americas Corporation 81 Hartwell Ave. Suite 300 Lexington, Massachusetts 02421

Re: K243091

Trade/Device Name: Over-tube (TR-1108A) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FED Dated: September 30, 2024 Received: September 30, 2024

Dear Chaitrali Kulkarni:

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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

Submission Number (if known)

K243091

Device Name

Over-tube (TR-1108A)

Indications for Use (Describe)

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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		510(k) Summary		Prepared on: 2024-09-27
Contact Details				21 CFR 807.92(a)(1)
Applicant Name	Fujifilm Corporation
Applicant Address	798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN KANAGAWA258-8538 Japan
Applicant Contact Telephone	704-517-4886
Applicant Contact	Ms. Chaitrali Kulkarni
Applicant Contact Email	hcusregulatoryaffairs@fujifilm.com
Correspondent Name	FUJIFILM Healthcare Americas Corporation
Correspondent Address	81 Hartwell Ave. Suite 300 Lexington MA 02421 United States
Correspondent Contact Telephone	704-517-4886
Correspondent Contact	Ms. Chaitrali Kulkarni
Correspondent Contact Email	hcusregulatoryaffairs@fujifilm.com
Device Name				21 CFR 807.92(a)(2)
Device Trade Name	Over-tube (TR-1108A)
Common Name	Endoscope and accessories
Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology
Regulation Number	876.1500
Product Code(s)	FED
Legally Marketed Predicate Devices				21 CFR 807.92(a)(3)
Predicate #		Predicate Trade Name (Primary Predicate is listed first)	Product Code
K230752		Over-tube (TR-1208A)	FED
Device Description Summary				21 CFR 807.92(a)(4)

A. Intended Use/indications for Use This product is intended to be used in combination with an endoscope to assist endoscopic insertion into the body. Never use this product for any other purpose. This product is intended for use in medical facilities by medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments.

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This product is intended to be used in combination with an endoscopic insertion into the body. Never use this product for any other purpose. This product is intended facilities by medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments.

Indications for Use Comparison

The indication for use for the proposed device and the predicate devices are same.

Technological Comparison

There are size differences in the outer diameter, and maximum outer diameter. The differences in size do not affect the safety or efficacy of the device.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The changes in the subject device from the predicate device are changed in outer diameter, Maximum outer diameter, insertion route, and combination endoscope. There were no changes to material, sterilization, or intended use. To determine if the changes would affect the safety or efficacy of the subject device, performance testing was conducted, and the subject device passed all test objectives. It was determined that the new Over-tube model is substantially equivalent to the predicate devices.

The subject device met performance specifications in the following additional testing:

Insertion Force
Working length
· Flexibility
Maximum diameter of insertion portion
· Outer diameter of insertion portion

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

K243091 Page 2 of 2

21 CFR 807.92(a)(6)

21 CFR 807.92(a)(5)

Regulation Number and Section

§ 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.