FUJINON EVL-F VIDEO LAPROSCOPE

K983561 · Fujinon, Inc. · GCJ · Dec 16, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K983561
• Device Name: FUJINON EVL-F VIDEO LAPROSCOPE
• Applicant: Fujinon, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Dec 16, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The flexible laproscope can be used to view complete therapeutic procedures using approved laproscopic instrumentation. The laproscope is used as a viewing device to complete procedures such as Laprosopic Cholecystectomy: Separation of Adhesions: Tubal Pregnancy: Uterine Hypoplasia: Infertilization: Mtritus: Cervical Myoma. Also procedures within the Thoracic Cavity such as the diagnosis and staging of Intrathoracic disease, therapeutic thoracic procedures, wedge resections, tube toracistomy pierodesis, thoracoscopy pleurodesis.

Device Story

EL2-TF410 Video Laproscope; flexible endoscope for visualization during surgical procedures. Input: optical image data from internal body cavities. Transformation: optical signal transmission to video processor for display on external monitor. Output: real-time video feed. Used in OR by surgeons/physicians. Facilitates minimally invasive surgery; enables visualization of therapeutic instruments; assists in diagnosis and staging of thoracic/abdominal conditions. Benefits: reduced invasiveness compared to open surgery; improved surgical precision via visual guidance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Flexible video laparoscope; optical imaging system; video output for external display. Device is a reusable surgical instrument. Sterilization method not specified in document.

Indications for Use

Indicated for patients undergoing laparoscopic or thoracoscopic procedures, including cholecystectomy, adhesion separation, treatment of tubal pregnancy, uterine hypoplasia, infertility, metritis, cervical myoma, and thoracic cavity procedures such as diagnosis/staging of intrathoracic disease, wedge resections, and pleurodesis.

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)

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

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

DEC 1 6 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Fujinon, Incorporated C/O Mr. Gary A. Adler Bingham Dana Murase 399 Park Avenue New York, New York 10022

K983561 Re:

Trade Name: EL2-TF410 Video Laproscope Regulatory Class: II Product Code: GCJ Dated: November 30, 1998 Received: December 1, 1998

Dear Mr. Adler:

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, and prohibitions 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 equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Page 2 - Mr. Gary A. Adler

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 (21 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/dsmamain.html".

Sincerely yours,

fCelia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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

of Page__________________________________________________________________________________________________________________________________________________________________________

K983561 510(k) Number (if known):

EL2-TF410 Video Laproscope Device Name:

Indications For Use:

i

Indications for Use:

The flexible laproscope can be used to view complete therapeutic procedures using approved laproscopic instrumentation. The laproscope is used as a viewing device to complete procedures such as Laprosopic Cholecystectomy: Separation of Adhesions: Tubal Pregnancy: Uterine Hypoplasia: Infertilization: Mtritus: Cervical Myoma.

Also procedures within the Thoracic Cavity such as the diagnosis and staging of Intrathoracic disease, therapeutic thoracic procedures, wedge resections, tube toracistomy pierodesis, thoracoscopy pleurodesis.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|


| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K983561 |

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use -----

(Optional Formal 1-2-9G)