The device is intended for the optical visualization of the gastrointestinal tract. This includes the rectum, large and small intestine. It is intended for observation, diagnosis, and endoscopic treatment.

Device Description

The device is intended for the optical visualization of the gastrointestinal tract. This includes the recturn, large and small intestine. It is intended for observation, diagnosis, and endoscopic treatment.

The Fujinon double balloon enteroscopy system utilizes specialized balloons and over-tube to ensure complete positioning of the colonoscope. The tip of the scope can be smoothly inserted to reach the area of diagnosis. This allows for access to hard to reach areas within the bottom portion of the small intestine.

The EC-450B15 consists of the following portions / parts:

. Control portion - to provide grip for holding the endoscope and for the operation of the endoscope.
LG Flexible Portion Contains the light guide, air/water supply tube, suction tube, . and cables.
Bending Portion .
Distal End Contains objective lens, air/water nozzles, forceps channel. .

The EC-450Bl5 is used with balloons (BS-1 or BS-2) and an Over-Tube (TS-13101), as well as the balloon pump. The balloon pump, balloons and over-tube were introduced and included as part of the Double Balloon Enteroscopy 510(k).

The EC-450BI5 is used with a Processor (4400) and other peripheral items such as VCR, Television Monitor, and Printers.

AI/ML Overview

The provided text is a 510(k) summary for the Fujinon EC-450BI5 Colonoscope. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than conducting a de novo study to establish new acceptance criteria and prove performance against them.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not directly applicable or present in this specific 510(k) summary.

Here's an analysis based on the provided text:

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

Acceptance Criteria: Not explicitly stated as this is a substantial equivalence submission. The implicit acceptance criterion is that the new device is "as safe and effective as the predicate device" and shares "the same indications for use, material composition, characteristics, reprocessing/sterilization method."
Reported Device Performance: The document states, "The materials in the endoscope are identical to the materials used in the predicate device. Additionally, the device contains the same electrical configurations as the predicate devices." This implies that the performance is expected to be identical to the predicate given the design similarities. No specific performance metrics (e.g., sensitivity, specificity, accuracy) are provided, as would be expected for a de novo device.

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

Not Applicable. No test set or performance study data with human subjects or cases is mentioned. The submission relies on the established safety and effectiveness of the predicate devices and the similarity of the new device's design.

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)

Not Applicable. No ground truth establishment by experts is described as no new performance study was performed.

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

Not Applicable. No test set or adjudication method is described.

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

Not Applicable. This is a medical device (colonoscope), not an AI-based diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or described.

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

Not Applicable. This is a physical medical device; there is no standalone algorithm performance to evaluate.

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

Not Applicable. No ground truth is established for a new clinical performance claim. The basis for approval is substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device, and no training set is mentioned or implied.

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

Not Applicable. As above, no training set or ground truth establishment for a training set is described.

Summary of what the document DOES state regarding performance:

The basis for the Fujinon EC-450BI5 Colonoscope's approval relies on its substantial equivalence to two predicate devices: Fujinon EG-450HL5 (K041903) and Fujinon EN-450P5/20 (K040048).

The key performance claims and rationale for substantial equivalence are:

Same Indications for Use: "The device is intended for the optical visualization of the gastrointestinal tract... It is intended for observation, diagnosis, and endoscopic treatment." This is identical to the predicates.
Identical Materials: "The materials in the endoscope are identical to the materials used in the predicate device."
Same Electrical Configurations: "the device contains the same electrical configurations as the predicate devices."
Same Processor and Peripherals: "The subject device uses the same processor and peripherals as the predicate device."
Minor Changes: The main difference mentioned is the "use of a colonoscope for with the double balloon enteroscopy accessories or retrograde application of the double balloon enteroscopy system." The submitter concludes these changes are minor and do not alter the safety or effectiveness.

In the context of a 510(k) for a physical medical device demonstrating substantial equivalence, the "acceptance criteria" are effectively that the device functions as intended (optical visualization, diagnosis, treatment within the GI tract) and is as safe and effective as its predicates, primarily due to shared design characteristics and materials. No specific quantitative performance study is typically required or presented for such a submission if the changes are deemed minor and do not raise new questions of safety or effectiveness.

Summary

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FUJI:FILM

Image /page/0/Picture/1 description: The image shows the word "FUJINON" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The text is black against a white background, creating a high contrast and making the word easily readable.

K 090116

p.g. 1 of 3

510 (k) Summary

APR 2 2 2009

Date Prepared [21 CFR 807.92(a)(1)]

1/16/2009

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

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

Contact / Submitter: 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 Contact: Gina Walljasper Telephone: 973-633-5600 FDA Establishment Registration# 2431293

Manufacturer: Fujinon Corporation 1-324 Uetake-Cho Kita-Ku, Saitama-Shi Saitama 331-9624, Japan Contact: Masayuji Ooyatsu

FDA Establishment Registration# 9610875

ﯩﺮ

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K090116

Pg 2 of 3

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

Device Trade or Proprietary Name: Common, Usual, or Classification Name: Classification:

Fujinon EC-450BI5 Colonoscope Class II, 21 CFR 876.1500, FDF

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

Fujinon EG-450HL5 (K041903) .
Fujinon EN-450P5/20 (K040048) .

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

The EC-450B15 consists of the following portions / parts:

. Control portion - to provide grip for holding the endoscope and for the operation of the endoscope.
LG Flexible Portion Contains the light guide, air/water supply tube, suction tube, . and cables.
Bending Portion .
Distal End Contains objective lens, air/water nozzles, forceps channel. .

The EC-450BI5 is used with a Processor (4400) and other peripheral items such as VCR, Television Monitor, and Printers.

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

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K090116

pg 3 of 3

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

Fujinon, Inc. believes that the subject device is substantially equivalent to the predicate device. The subject device has the same indications for use, material composition, characteristics, reprocessing/sterilization method as the predicate. The subject device uses the same processor and peripherals as the predicate device.

The main difference is the use of a colonoscope for with the double balloon enteroscopy accessories or retrograde application of the double balloon enteroscopy system.

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

The materials in the endoscope are identical to the materials used in the predicate device. Additionally, the device contains the same electrical configurations as the predicate devices.

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.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three horizontal lines representing its wings or feathers. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 2009

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

Re: K090116

Trade/Device Name: Fujinon EC-450B15 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF, FED Dated: January 16, 2009 Received: January 23, 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.

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 (reporting of medical 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.

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx 21 CFR 884.xxx 21 CFR 892.xxx Other

(Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology)

(240) 276-0115 (240) 276-0115 (240) 276-0120 (240) 276-0100

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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

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

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ 090116

Device Name: Fujinon EC-450BI5

The device is intended for the optical visualization of the gastrointestinal tract. This includes the rectum, large and small intestines. It is intended for observation, diagnosis, and endoscopic treatment.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Arsmi Th. Threz

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

Page 11

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.