OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS

K980465 · Olympus America, Inc. · FDT · Apr 21, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980465
• Device Name: OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS
• Applicant: Olympus America, Inc.
• Product Code: FDT · Gastroenterology, Urology
• Decision Date: Apr 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Olympus TJF-140R/JF-140R Duodenovideoscopes have been designed to be used with an Olympus EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy Accessories (Forceps, Brush, Electrosurgical Accessories, etc.), Electrosurgical Unit, and other Ancillary Equipment for endoscopy and endoscopic surgery within the duodenum. Olympus MAJ-311 Distal Cover is specifically designed to be attached to the Olympus TJF-140R Duodenovideoscope during an endoscopic procedure. Olympus MAJ-411 Distal Cover is specifically designed to be attached to the Olympus JF-140R Duodenovideoscope during an endoscopic procedure.

Device Story

Olympus TJF-140R/JF-140R are duodenovideoscopes used for visualization and endoscopic surgery within the duodenum. Devices connect to EVIS Video System Center, light source, monitor, and ancillary equipment (electrosurgical units, forceps, brushes). Distal covers (MAJ-311/MAJ-411) attach to the scope tip during procedures. Operated by physicians in clinical settings; output is real-time video displayed on a monitor to guide diagnostic or therapeutic interventions. Benefits include minimally invasive access to the duodenum for surgical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Flexible duodenovideoscopes with distal tip covers. Connects to EVIS video system. Class II device. No specific materials or software algorithms described.

Indications for Use

Indicated for use in endoscopy and endoscopic surgery within the duodenum. Intended for prescription use by trained clinicians.

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.

Predicate Devices

• Olympus TJF-140 EVIS Duodenovideoscope (K954451)
• Olympus JF-140 EVIS Duodenovideoscope (K954451)
• Olympus MH-880 Distal Cover (K954451)
• Olympus MH-975 Distal Cover (K954451)

Submission Summary (Full Text)

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

APR 2 1 1998

K 980465

11

# 510 (k) SUMMARY OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section 807.92.

| Device Name: | Olympus TJF-140R/JF-140R EVIS Duodenovideoscopes<br>Olympus MAJ-311/MAJ-411 Distal Covers. |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Olympus EVIS Duodenovideoscopes |
| Classification Name: | 21 CFR 876.1500, Class II<br>Endoscopes and Accessories. |
| Predicate Devices: | Olympus TJF-140 EVIS Duodenovideoscope (K954451)<br>Olympus JF-140 EVIS Duodenovideoscope (K954451)<br>Olympus MH-880 Distal Cover (K954451)<br>Olympus MH-975 Distal Cover (K954451) |
| Prepared & Submitted By:<br>(Contact Person) | Ms. Laura Storms-Tyler<br>Olympus America Inc.<br>Endoscope Division<br>Two Corporate Center Drive<br>Melville, New York 11747-3157<br>[phone] |
| Summary Preparation Date: | 10/31/97 |

Statement of Intended Use:

# TJF-140R/JF-140 R Duodenovideoscopes

Olympus TJF-140R Duodenovideoscopes have been designed to be used with an Olympus EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy Accessories (Forceps, Brush, Electrosurgical Accessories, etc.), Electrosurgical Unit, and other Ancillary Equipment for endoscopy and endoscopic surgery within the duodenum.

## MAJ-311/MAJ-411 Distal Covers

The Olympus MAJ-311 Distal Cover is designed to the Olympus TJF-140R Duodenovideoscope during an endoscopic procedure. The Olympus MAJ-411 Distal Cover is designed to be attached to the Olympus JF-140R Duodenovideoscope during an endoscopic procedure.

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

Image /page/1/Picture/0 description: The image shows a logo for the Department of Health. The logo is a stylized image of a human face in profile, with three wavy lines representing the hair and forehead. The words "DEPARTMENT OF HEALTH" are written in a circular pattern around the logo.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 21 1998

Ms. Laura Storms-Tyler Director, Regulatory Affairs Endoscope Division Olympus America, Inc. Two Corporate Center Drive Melville, NY 11747-3157

The End

Re: K980465

Olympus TJF-140R and JF-140R EVIS Duodenoscopes and MAJ 311-MAJ 411 Distal Tip Covers Dated: February 2, 1998 Received: February 5, 1998 Regulatory Class: II 21 CFR 876.1500/Procode: 78 FDT

#### Dear Ms. Storms-Tyler:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this resonse to your premarket notification submission does not affect any obligation vou might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510/k) premarket notification. The FDA finding of substantial equivalence of 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 device on our labeling regulation (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

K 980465

### Indications for Use Statement

510(k) Number (if known):

Not assigned yet

Device Name:

Olympus TJF-140R/JF-140R EVIS Duodenovideoscopes and accessories

Indications for Use:

## TJF-140R/JF-140R Duodenovideoscopes

Olympus TJF-140R/JF-140R Duodenovideoscopes have been designed to be used with an Olympus EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy Accessories (Forceps, Brush, Electrosurgical Accessories, etc.), Electrosurgical Unit, and other Ancillary Equipment for endoscopy and endoscopic surgery within the duodenum.

## MAJ-311/MAJ-411 Distal Covers

Olympus MAJ-311 Distal Cover is specifically designed to be attached to the Olympus TJF-140R Duodenovideoscope during an endoscopic procedure. Olympus MAJ-411 Distal Cover is specifically designed to be attached to the Olympus JF-140R Duodenovideoscope during an endoscopic procedure.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(per 21CFR 801.109) | <div style="text-align:center;">✓</div> | OR | Over-the Counter Use<br>(Optional Format 1-2-96) |
|-----------------------------------------|-----------------------------------------|----|--------------------------------------------------|
|-----------------------------------------|-----------------------------------------|----|--------------------------------------------------|

| (Division Sign-Off) | <i>Robert D. Ratliff</i> |
|-----------------------------------------------------------------------|--------------------------|
| Division of Reproductive, Abdominal, ENT,<br>and Radiological Devices | |
| 510(k) Number | K980465 |