SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101

K991382 · Genicon, LC · GCJ · Jul 15, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K991382
• Device Name: SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101
• Applicant: Genicon, LC
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jul 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The intended use of this device is for laparoscopic surgery by general, thoracic, gynecologic and urological surgeons.

Device Story

GeniCon Trocar/Cannula System is a surgical instrument used to establish a port of entry for laparoscopic instrumentation. The device features a modified single-slit stainless steel tip for tissue incision, an enlarged handle for ergonomic grip, and a cannula with trapezoidal fascia threads for anchoring. It includes a CO2 port with a male luer cap and a double-wall valve lock to maintain valve position and prevent premature release. Used by general, thoracic, gynecologic, and urological surgeons in clinical settings to facilitate minimally invasive procedures. The device is manually operated; performance is assessed via pressure testing and ease of insertion compared to predicate systems.

Clinical Evidence

Bench testing only. Testing performed in a simulated human abdominal cavity compared the GeniCon system to LifeQuest and Core trocar valve assemblies. Metrics included pressure testing, ease of insertion, and ease of use with common laparoscopic instruments. Results indicated performance equal to or superior to predicate devices.

Technological Characteristics

Materials include stainless steel (tip). Features: modified single-slit tip, trapezoidal fascia threads on cannula, CO2 port with male luer cap, and double-wall valve lock. Available in 2.5, 5, 7/8, 10, and 12mm diameters. Manual operation; no energy source or software components.

Indications for Use

Indicated for use in gynecologic, general, thoracic, and urological endoscopic procedures to establish a port of entry for instrumentation. Available in 2.5, 5, 7/8, 10, and 12mm diameters.

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

• LifeQuest Point Gard
• Dexide trocars

Reference Devices

• Apple trocar

Submission Summary (Full Text)

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89914382

JUL 15 1999

Page: II-1

Section II. 510(k) Summary

GeniCon L.C. Contact: Gary Haberland 573 Waterscape Way Orlando, FL 32828 Phone: [phone] Fax: [phone]

Date Prepared: April 19, 1999

Trade Name: GeniCon Trocar/Cannula System Common Name: Trocar Classification Name: Trocar (per CFR 870.1390)

The intended use of this device is for laparoscopic surgery by general, thoracic, gynecologic and urological surgeons.

The legally marketed device to which we are claiming previous acceptance of predicate device is the LifeQuest Point Gard and Dexide trocars both in sizes 2.5,5, 7/8, 10, 12mm systems.

Engineering testing has demonstrated that the valve assembly performs better than that of the Life Quest and Core trocar valve assembly. This testing incorporated a simulated human abdominal cavity and the method of insertion of the device and use with various common laparoscopic instruments. In all areas of performance, this device performed equal to if not superior in pressure testing, ease of use and insertion.

This device incorporates several design features which facilitate the surgeons use both during insertion and while instrumentation is being inserted and manipulated.

Trocar Tip:

- A modified single slit tip to provide easier insertion for the surgeon by enabling the tip to . minimally incise the tissue while providing a lower profile transition from the stainless tip to the cannula.
Trocar Handle:

- Enlarged to provide a more positive fit in the surgeon's palm during insertion, and provides a . groove to provide a more positive fit for the thumb during removal or re-insertion.
Cannula:

- Trapezoidal fascia threads, they provide an easier insertion while a positive anchoring during . instrument use.
- CO2 port with male luer cap provides a "finger grip" during device insertion while the male luer . cap is easier to remove and replace than the Apple silicone cap.
- . Double wall valve lock, assists in maintaining the valve position and to alleviate the premature release sometimes experienced by the Apple product.

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Image /page/1/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings or feathers. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 15 1999

Mr. Gary Haberland Product Manager GeniCon, L.C. 573 Waterscape Way Orlando, Florida 32828

Re: K991382 Trade Name: GeniCon Trocar Cannula System Regulatory Class: II Product Code: GCJ Dated: April 19, 1999 Received: April 21, 1999

Dear Mr. Haberland:

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 (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 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.

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## Page 2 - Mr. Gary Haberland

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,

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

Enclosure

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K94/382

Section I. Indications for Use

510 (k) Number: unassigned

Device Name: Trocar

Indications for Use:

The GeniCon trocar is available in 2.5, 5, 7/8, 10 and 12mm diameter with a mono-slit stainless tip. This trocar has application in gynecologic, general, thoracic and urology endoscopic procedures to establish a port of entry for instrumentation.

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Prescription Use

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

D. O'Dell

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K991382

Page: I-I

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