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

Device Description

FUJILM Over-tube consists of an inserting through the body, a handle portion to be gripped by the operator, a water injection portion for injecting water onto the insertion part, a suction portion for suctioning air from the walls, thereby changing the rigidity of the insertion part, and a hook portion for the control part of the endoscope. The suction portion is formed by a three-way stopcock and can be connected to a suction machine and changing the position of the three-way stopcock lever, the insertion portion can be in the state of vacuum, thereby increasing the rigidty of the insertion portion. The rigid body of the insertion maintains the shape of Over-tube and allow the endoscope insertion to smoothly move back and forth and rotate while decreasing the adverse impact to the patient anatomy. In addition, when water is injected from the water inlet connected to the inside of Over-tube, water enters between the endoscope and Over-tube, reducing friction between the endoscope and the Over-tube.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "Over-tube." It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not include information about studies involving human readers or AI assistance.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a structured table format. However, it lists various non-clinical tests performed and implies that the device "demonstrated that the design requirements" were met and that there were "no new concerns for the safety and efficacy."

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Bench Testing	Device meets design requirements for safety and efficacy.	Insertion force, working length, flexibility, shape retention portion, and outer diameter of the insertion portion were evaluated. No new safety/efficacy concerns identified.
Durability (Main Body)	No adverse effects on appearance, insertion force, attachability, and durability under tension.	Evaluated with accelerated-aged TR-1208A. No adverse effects reported. It was confirmed that "there were no adverse effects on the appearance, insertion force, attachable to the operating portion, and durability under tension."
Sterilized Packaging Safety	No adverse effects on appearance, seal strength, and dye penetration.	Evaluated with accelerated-aged TR-1507A. No adverse effects reported. It was confirmed that "there were no adverse effects on the appearance, seal strength, and dye penetration."
Biocompatibility	Device is biocompatible.	Testing performed; "There remains no new concern for the safety and efficacy."
Long-term Stability	Device maintains performance and safety over a 3-year shelf life.	Accelerated-aged testing supports the 3-year shelf life.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document mentions that Over-tube models TR-1208A and TR-1507A were used as representative models for bench testing. TR-1504A's performance was adopted from TR-1507A because it only differs in working length. For durability and packaging safety, accelerated-aged versions of TR-1208A and TR-1507A were used, respectively. The exact number of units tested for each model is not specified, but it's implied that "models" refers to individual devices. The document does not provide information about the country of origin or whether the data was retrospective or prospective. This is a premarket notification for a device, and the testing described is typically conducted in a controlled lab environment.
Data Provenance: Not specified in terms of country of origin or retrospective/prospective. The tests conducted are non-clinical, likely laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this document. The device is an "Over-tube" (an endoscope accessory), and the testing described is non-clinical performance and safety testing. It does not involve diagnostic interpretations by experts or the establishment of a "ground truth" for a test set in the way an AI-powered diagnostic device would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable to this document. As mentioned above, the testing is non-clinical and does not involve adjudication of expert opinions.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable to this document. The device is a physical endoscope accessory, not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable to this document. The device is a physical endoscope accessory, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not applicable to this document. The "ground truth" for the non-clinical tests would be established through engineering specifications, material properties, and physical testing methodologies rather than clinical outcomes or expert consensus. For example, "insertion force" has a measurable target, not an expert consensus.

8. The sample size for the training set

This information is not applicable to this document. The device is a physical endoscope accessory and does not involve a "training set" in the context of machine learning or AI models.

9. How the ground truth for the training set was established

This information is not applicable to this document. There is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 15, 2023

Fujifilm Healthcare Americas Corporation Kotei Aoki Manager, Regulatory Affairs 81 Hartwell Avenue Suite 300 Lexington, MA 02421

Re: K230752

Trade/Device Name: Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FED Dated: March 17, 2023 Received: August 18, 2023

Dear Kotei Aoki:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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-devices/device-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shanil P. Haugen -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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230752

Device Name Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)

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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K230752 Page 1 of 2

510(k) #: K230752	510(k) Summary	K230752 Page 1 of 2Prepared on: 2023-08-17
Contact Details		21 CFR 807.92(a)(1)
Applicant Name	FUJIFILM Healthcare Americas Corporation
Applicant Address	81 Hartwell Avenue, Suite 300 Lexington MA 02421 United States
Applicant Contact Telephone	7652462931
Applicant Contact	Mr. Kotei Aoki
Applicant Contact Email	kotei.aoki@fujifilm.com
Device Name		21 CFR 807.92(a)(2)
Device Trade Name	Over-tube (TR-1208A);Over-tube (TR-1504A);Over-tube (TR-1507A)
Common Name	Endoscope and accessories
Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology
Regulation Number	876.1500
Product Code	FED
Legally Marketed Predicate Devices		21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K191415	Pathfinder™ Endoscope Overtube	FED
K091773	FUJINON STERILE OVERTUBES	FED

Device Description Summary

FUJIFLM Over-tube consists of an inserting through the body, a handle portion to be gripped by the operator, a water injection portion for injecting water onto the insertion part, a suction portion for suctioning air from the walls, thereby changing the rigidity of the insertion part, and a hook portion for the control part of the endoscope. The suction portion is formed by a three-way stopcock and can be connected to a suction machine and changing the position of the three-way stopcock lever, the insertion portion can be in the state of vacuum, thereby increasing the rigidty of the insertion portion. The rigid body of the insertion maintains the shape of Over-tube and allow the endoscope insertion to smoothly move back and forth and rotate while decreasing the adverse impact to the patient anatomy. In addition, when water is injected from the water inlet connected to the inside of Over-tube, water enters between the endoscope and Over-tube, reducing friction between the endoscope and the Over-tube.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(4)

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

21 CFR 807.92(a)(5)

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Both the proposed devices and the predicate device are combined with the compatible endoscope and assist the endoscope to be used in the patient's gastrointestinal tract. Both devices are indications only. The indications for use and intended use are the same in the proposed devices and the predicate device.

Technological Comparison

21 CFR 807.92(a)(6)

The inner diameters of the proposed devices are smaller than that of the predicate device. The insertion force of the compatible endoscope through the proposed devices has been evaluated through the bench testing. There is no new concern for the safety and efficacy of the proposed devices.

The maximum outer diameter of the predicate device is unknown. The working lengths of the proposed devices are different from that of the predicate device. Thus, the maximum outer diameters and the proposed devices have been evaluated through the bench testing. There is no new concern for the safety and efficacy of the proposed devices.

The compatible endoscopes are different the predicate device. The bench testing demonstrates that there is no new concern for the safety and efficacy of using the proposed devices with respective compatible endoscopes.

The connectors of the water and air inlets in the predicate device is unknown. However, the Luer connectors of the water and air inlets in the proposed device are the same as the Luer connection of the water and air inlets in the Reference Device FUJINON STERILE OVERTUBE TS-13101 (K091773). Therefore, there is no new concern for the safety and effectiveness regarding the connectors of the water and air inlets.

The transport and storage environment of the predicate device is unknown. The transport and storage environment of the proposed devices has been evaluated through the long-term stability testing. There is no new concern for the proposed devices when they are properly transported and stored.

The material construction of the predicate device is unknown. The proposed devices has been evaluated through the biocompatibility testing. There remains no new concern for the safety and efficacy.

The proposed Over-tubes and the predicate device, Pathfinder™ Endoscope Overtube Gl 085160-2 (K191415), share intended use and indications. The proposed device and the predicate device share some technological characteristics and principles of operation. The biocompatibility testing and bench testing demonstrate that the proposed devices remain as safe and effective as the predicate device. The proposed Over-tubes are substantially equivalent to the predicate Overtube.

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

Insertion force, working length, flexibility, shape retention portion, and outer diameter of insertion portion were tested on Over-tube models TR-1208A and TR-1507A as the representative model. TR-1504A only differs from TR-1507A in working length only (see "bench testing.pdf"). Since TR-1504A, TR-1504A can adopt the performance of TR-1507A.

The durability of the main body of the proposed device was evaluated with the accelerated-aged Over-tube TR-1208A to ensure there were no adverse effects on the appearance, insertion force, attachable to the operating portion, and durability under tension (see "Long-term Stability Test Rep.pdf").

The safety of sterilized packaging was evaluated with the accelerated-aged device Over-tube TR-1507 A to ensure there were no adverse effects on the appearance, seal strength, and dye penetration (see "Long-term Stability Test Rep.pdf").

Not Applicable

The testing demonstrated that the design requirements. Furthermore, the accelerated-aged testing supports the 3-year shelf life of the devices.

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.