The sterile overtubes are intended to be used as accessories with the Fujinon Enteroscopes and Colonoscopes cleared for use with overtubes. The overtubes are used to assist with the movement of the scopes inside the upper or lower digestive tract.

The sterile overtubes are intended to be used as accessories with the Fujinon Double Balloon Enteroscopy system, which is used for the optical visualization of the gastrointestinal tract

Device Description

The Fujinon double balloon enteroscopy system (K040048) and EC-450B15 (K090116) utilize specialized overtubes to ensure complete positioning of the enteroscope or colonoscope in the digestive tract and to ensure the tip of the scope can be smoothly inserted to reach the area of diagnosis.

The overtube (TS-12140) was included in the original 510(k) K040048 and the overtube (TS-13101) was included in 510(k) K090116 with the EC-450BI5.

This submission includes the following items:
TS-12140 Over Tube Originally included in the K040048 as non-sterile.
TS-13140 Over Tube
TS-13101 Over Tube Including in K090016.

AI/ML Overview

{
  "acceptance_criteria_and_performance_table": {
    "title": "Acceptance Criteria for Fujinon Sterile Overtubes",
    "headers": ["Acceptance Criteria (Performance Standard)", "Reported Device Performance"],
    "rows": [
      ["Biocompatibility requirements (per ISO standards)", "Passed"],
      ["Sterilization process validation (per ISO standards)", "Validated"],
      ["Same indications for use as predicate devices", "Met"],
      ["Same dimensions as predicate devices", "Met"],
      ["Same material composition as predicate devices", "Met"]
    ]
  },
  "study_details": {
    "sample_size_test_set": "Not applicable, as the submission describes a change to a sterile version of an existing device, not a new diagnostic algorithm using a test set.",
    "data_provenance": "Not applicable.",
    "number_of_experts_ground_truth_test_set": "Not applicable.",
    "qualifications_of_experts": "Not applicable.",
    "adjudication_method": "Not applicable.",
    "mrmc_comparative_effectiveness_study": false,
    "effect_size_human_readers_ai_vs_without_ai": "Not applicable.",
    "standalone_performance_study": false,
    "type_of_ground_truth_used": "Not applicable. The study focuses on demonstrating sterility and biocompatibility, not diagnostic accuracy requiring a ground truth.",
    "sample_size_training_set": "Not applicable.",
    "ground_truth_for_training_set_establishment": "Not applicable."
  },
  "additional_information": "This 510(k) submission ([K091773](https://510k.innolitics.com/search/K091773)) is for Fujinon Sterile Overtubes, which are a sterile version of previously cleared non-sterile overtubes ([K040048](https://510k.innolitics.com/search/K040048) and [K090116](https://510k.innolitics.com/search/K090116)). The submission aims to establish substantial equivalence by demonstrating that the sterile devices meet biocompatibility and sterilization standards, and maintain the same intended use, dimensions, and material composition as their non-sterile predicates. The document does not describe a study involving diagnostic performance, AI algorithms, or human readers, but rather focuses on the safety and effectiveness aspects related to the sterilization of the device."
}

Summary

{0}------------------------------------------------

510(k) SUMMARY

510(k) SUMMARY K091773 pg 1 of 2

Submission Type: Special 510(k)

Date Prepared [21 CFR 807.92(a)(1)]: June 10, 2009

AUG 0 7 2009

Submitter's Information [21 CFR 807.92(a)(1)]

This 510(k) is being submitted by Joseph Azary on behalf of Fujinon Inc.

Contact: Joseph Azary Orchid Design 80 Shelton Technology Center Shelton, CT 06484 Tel: (203) 922-0105 Fax: (203) 922-0130

Sponsor / U.S. Distributor: Fujinon Inc. 10 High Point Drive Wayne, NJ 07470 FDA Establishment Registration# 2431293.

Manufacturer: FujiFilm Corporation 1-324 Uetake-Cho Kita-Ku. Saitama-Shi Saitama 331-9624, Japan FDA Establishment Registration# 9610875

Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Device Trade Name: Fujinon Sterile Overtubes Device Common, Usual, or Classification Names: Endoscope Accessories Classification: Class II, 21 CFR 876.1500, FDS and KOG

Predicate Device [21 CFR 807.92(a)(3)]

Fujinon Overtubes included with Double Balloon Enteroscopy - K040048 Fujinon Overtubes included with EC-450BI5 - K090116

Page 112

{1}------------------------------------------------

FUJIFILM

510(k) SUMMARY

Kog1773 pg 20

Description of the Device [21 CFR 807.92(a)(4)]

The overtube (TS-12140) was included in the original 510(k) K040048 and the overtube (TS-13101) was included in 510(k) K090116 with the EC-450BI5.

This submission includes the following items:

Product	Product Name	Comments
TS-12140	Over Tube	Originally included inthe K040048 as non-sterile.
TS-13140	Over Tube
TS-13101	Over Tube	Including inK090016.

Intended Use [21 CFR 807.92(a)(5)]

Technological Characteristics [21 CFR 807.92(a)(6)]

Fujinon, Inc. believes that the subject device is substantially equivalent to the predicate device. The subject devices have the same indications for use, dimensions, and material composition as the predicate. The only difference is the subject devices are offered as sterile devices.

Performance Data [21 CFR 807.92(b)(1)]

The subject device has been subjected to and passed biocompatibility requirements and the sterilization process has been validated per ISO standards.

Conclusion [21 CFR 807.92(b)(3)]

We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a black and white logo. The logo consists of three stylized lines that appear to be stacked on top of each other. The lines are thicker at the top and taper down towards the bottom, with a slight curve at the end of each line. To the left of the stacked lines, there is some text that is oriented vertically, but the text is too blurry to read.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Fujinon, Inc. % Mr. Joseph M. Azary Senior Regulatory Consultant Orchid Design 80 Shelton Technology Center SHELTON CT 06484

Re: K091773

Trade/Device Name: Fujinon Sterile Over Tubes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: July 17, 2009 Received: July 22, 2009

Dear Mr. Azary:

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. 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.

AUG 0 7 2009

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 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

{3}------------------------------------------------

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Lamme M. Mouk

Larry M. Moore

Janine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

091173

Device Name: Fujinon Sterile Over Tubes

Indications For Use:

The sterile overtubes are intended to be used as accessories with the Fujinon Double Balloon Enteroscopy system, which is used for the optical visualization of the gastrointestinal tract

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Here is the JSON requested:

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Page 1 of 1

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.