GENICON SUCTION IRRIGATION SYSTEM

K041967 · Genicon · GCJ · Nov 12, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K041967
• Device Name: GENICON SUCTION IRRIGATION SYSTEM
• Applicant: Genicon
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Nov 12, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The GeniCon Laparoscopic Suction/Irrigation System is available with an array of probe designs to facilitate lavage during laparoscopic surgery. This device has applications in laparoscopic gynecologic, general, thoracic and urology procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.

Device Story

Laparoscopic suction/irrigation system; consists of handpiece with two trumpet-style valves, probe, and connecting tubing. Handpiece connects to external irrigation fluid supply and aspiration pump. Physician operates device during laparoscopic surgery to deliver sterile irrigation fluid and evacuate blood, tissue debris, and smoke from surgical site. Handpiece design allows introduction of various instruments through probe. Single-use, disposable device; probes available as single-use or reusable. Facilitates visualization of operative site; aids in surgical site management.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical suction/irrigation system; handpiece with two trumpet-style valves; probe; connecting tubing. Single-use, disposable device; probes available as single-use or reusable. Sterile. No electronic or software components.

Indications for Use

Indicated for patients undergoing laparoscopic gynecologic, general, thoracic, and urology surgical procedures requiring suction and irrigation to flush blood and tissue debris from the operative site to aid visualization.

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

• Stryker (K963646)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the word "GENICON" in large, bold, black letters. Below the word "GENICON" is the phrase "NEW IDEAS FOR MODERN HEALTH CARE" in smaller, thinner, black letters. The word "GENICON" is the most prominent feature of the image.

K041967

## Section 2 – 510K Summary

Date Prepared - October 24, 2004

Trade Name – Genicon Laparoscopic Suction Irrigation

Common Name – Suction Irrigation

Classification - Class II -- CFR 878.4400

Predicate Device – Stryker (K963646)

Product Description – The Genicon Laparoscopic Suction Irrigator
Product Description – The Genicon Laparoscopic Product Description - The Genieon andergoing a laparoscopic system is indicated for use in patients and sterile irrigation fluids to
surgical procedure. It is designed to deliver sterile in ovacuate blood surgical procedure. It is designed to deliver s
surgical sites during laparoscopic procedures and to evacuate blood,
surgical sites during laparoscopic procedures and to eva surgledi sites and smoke from the surgical site.

The system consists of a hand piece equipped with two trumpet style
s and consists of a hand piece and set docigned to The system consists of a nand pice of fubing, one set designed to valves, a probe, and connecting lines of tables designed to attach to
attach to a supply of irrigation fluid, and the direction and attach to a supply of inigation frails,
an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure.

The hand piece of the suction irrigator is designed to allow instruments The nand piece of the suction imgation probe to reach the to be introduced through the Saction inguilers (1) and own a variety of instruments and diameters.

It is a single use, disposable device and is sold sterile, and the probes it is a single use, unsposable device arra to s
may be available as single use or reusable depending on the purpose.

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

Image /page/1/Picture/0 description: The image shows the word "GENICON" in bold, black letters. Below the word "GENICON" is the phrase "NEW IDEAS FOR MODERN HEALTH CARE" in a smaller font. The word "GENICON" is the main focus of the image.

Indications for Use – The GeniCon Laparoscopic Suction/lrigation Indications for Use = The Genicon Eaper cape designs to facilitate lavage
System is available with an array of probe designs in lanarosco System is available with an array of probe assigned on the laparoscopic
during laparoscopic surgery. This device has applications in provide during laparoscopic surgery. "This defice we we colores to provide
gynecologic, general, thoracic and urboffees blood and tissue deb gynecologic, general, thoracic and arology h blood and tissue debris
suction and irrigation functions to help finalization suction and imgation runetions to half
from the operative site during laparoscopy to aid visualization.
Trom the operative site during laparoscopy to aid visualization.
Trom

Performance – There are no performance standards for this product.

Conclusion – Based on the indications for use and technological Conclusion – based on the muleations for as shown to be
characteristics, the Genicon Suction Irrigation system is a characteristics, the Genicon Suction ingution of
safe and effective for its intended use and substantially equivalent to the predicate devices.

Regards,
Gary W. Haberland

Product Manager

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

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird symbol, with three curved lines representing the wings or body of the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 2004

Mr. Gary W. Haberland Product Manager GeniCon 427 Lake Howell Maitland, Florida 32751

Re: K041967

Trade/Device Name: GeniCon Laparoscopic Suction Irrigation Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: September 20, 2004 Received: October 5, 2004

Dear:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave reviewed your becament be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encrease - 776, the enactment date of the Medical Device Amendments, or to commerce pror to they 2017 11:12 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 r ou may, dicrororo, marret of the Act include requirements for annual registration, listing of general oonline proficiouring 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 such additional controls. Existing major regulations affecting your device can may or subject to basil at all 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 f hat FDA has made a determination that your device complies with other requirements of the Act that 1197 how intatutes and regulations administered by other Federal agencies. You must or any reaturer all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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

Page 2 - Gary W. Haberland

This letter will allow you to begin marketing your device as described in your Section 510(k) This iciter will anow you to organization of substantial equivalence of your device to a legally premarket hotification. The President 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), please rryou desire of Compliance at [phone]. Also, please note the regulation entitled, Connect the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

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

## Indications for Use

510(k) Number (if known): K041967

Device Name: GeniCon Laparoscopic Irrigation System

Indications For Use:

The GeniCon Laparoscopic Suction/Irrigation System is available with an array of 1110 Genioch Lapage during laparoscopic surgery. This device has applications in laparoscopic gynecologic, general, thoracic and urology approcedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.

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)

Myriam C. Provost
Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

510(k) Number K64/967