GASTRO-INTESTINAL SYSTEM EN-410WM

K993704 · Fujinon, Inc. · FDA · Feb 11, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K993704
• Device Name: GASTRO-INTESTINAL SYSTEM EN-410WM
• Applicant: Fujinon, Inc.
• Product Code: FDA · Gastroenterology, Urology
• Decision Date: Feb 11, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This video enteroscope is for the optical visualization of the upper gastrointestinal tract. This includes the Esophagus, Stomach, Duodeum and Small Bowel. It is intended for observation, diagnosis and endoscopic treatment.

Device Story

The Fujinon EN-410WM is a video enteroscope designed for optical visualization of the upper gastrointestinal tract. It functions as an endoscopic imaging tool used by physicians in clinical settings to observe, diagnose, and perform endoscopic treatments within the esophagus, stomach, duodenum, and small bowel. The device captures visual data of the internal anatomy, which is transmitted to a video processor for display on a monitor, allowing the clinician to navigate the tract and identify pathologies or perform interventions. It facilitates minimally invasive diagnostic and therapeutic procedures, potentially reducing the need for more invasive surgical interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Video enteroscope for upper GI tract visualization. Consists of an insertion tube with an integrated imaging sensor (video endoscope). Operates via optical visualization transmitted to a compatible video processor. Sterilization is performed according to manufacturer instructions for reusable endoscopic equipment.

Indications for Use

Indicated for optical visualization, observation, diagnosis, and endoscopic treatment of the upper gastrointestinal tract, including the esophagus, stomach, duodenum, and small bowel in patients requiring endoscopic procedures.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2000

Fujinon, Inc. c/o Mr. Gary Adler Bingham Dana Murase Counselors at Law 399 Park Avenue New York, NY 10022-4689 Re: K993704 Gastro-Intestinal System EN-410WM Dated: January 12, 2000 Received: January 13, 2000 Regulatory Class: II Regulatory of 1500/Procode: 78 FDA

Dear Mr. Adler:

Bour and wed your Section 510(k) notification of intent to market the device referenced above and we have have have We have reviewed your Section 510(k) noticeations for use stated in the endosure) to legally
delemined the device is substantially equivals (for the indications for use the e delemined the device is substantialy equivalent (or toe states , to rast see and many , and the enation , and of the of the marketed predicate devices markets in high in they 20, 1070, movel the provisions of the provisions of the
Medical Device Amendments, or to devices that have been reviews, su Medical Device Amendments, or to devices hat have been estimation in the more of the consisted on the collections.
Federal Food, Drum and waters and the ecting market for ann Federal Food, Drug, and Cosmelic Act (Ad). You may, the Act include requirements for annual registration, listing of
provisions of the Act. The general controls provised mi provisions of the Act. The general controls provisions of the Accorner of the management of the manufaction.

If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), it may
n the Code of lf your device is classified (see above) into einer class in (species on be love (v r che invel in the Code of the Code of the Code of be subject to such additional controls. Existing major regulation assumes ompliance with
Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalion (OS) fo Fegulations, Title 21, Parts out o oss. A substantely cyterialth Cuality System Regulation (OS) for the Current Good Manufacturing Practice requirements as through periodic CS inspections, the Food and Medical Devices: General regulation (CFR Fall Dell the Comply with the GM regulation may result in
Drug Administration (FDA) will verify such assumply with the GM regulation Drug Administration (FDA) will vehily such assumplier in annumer oncerning your device in the Eederal
regulatory action. In addition, FDA may publish further announcement of regulatory action. In addition, FDA nier announcements on the onlines on offect any obligation your a
Register. Please note: this response to your premarke notiscination d Register. Please note: this response to your premarket nomically dos model the election of the may be of the provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 500(k) premately notification for I his letter will allow your nativeling your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your labeling regulation (21 CFR Pat 801 and additionally for not in il you desire specific dovice for your device of our aboung rance at [phone]. Additionally for questions on viro diagnosic devices), please contact the Office of Compliance at [phone]. Also, Also, Also, Also, Also, Also, Allas, the promotion and adventising of your defices, problem of the contriction" (21 CFR 807.97). Other please note tre regulation entiled, "Misfrancing of relating to potained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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S10(k) NUMBER (IF KNOWN): K993704

DEVICE NAME: GASTRO INTES TINALSYSTEM

INDICATIONS FOR USE: EN-410WM

This video enteroscope is for the optical visualization of the upper gastrointestinal tract. This includes the Esophagus, Stomach, Duodeum and Small Bowel. It is intended for observation, diagnosis and endoscopic treatment.

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

Concurrence of CDRH, Office of Device Evaluation (OI

Prescription Use
(Per 21 CFR 801.109)
OR

Over-The-Counte (Optional For

r

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K993704