GIBBONS STERILE TROCAR KITS

K012198 · Gibbons Surgical Corp. · FBQ · Aug 9, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K012198
• Device Name: GIBBONS STERILE TROCAR KITS
• Applicant: Gibbons Surgical Corp.
• Product Code: FBQ · Gastroenterology, Urology
• Decision Date: Aug 9, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5090
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gibbons' Surgical Corporation Sterile Trocar Kits contain devices intended for use during laparoscopic/ endoscopic surgery under the guidance of a physician.

Device Story

Gibbons' Sterile Trocar Kit consists of surgical instruments used during laparoscopic or endoscopic procedures. Device used by physicians in clinical/surgical settings to facilitate access to body cavities. Kit provides necessary tools for trocar placement; supports surgical access. Benefits include standardized, sterile components for endoscopic surgery. Output is physical access to surgical site; assists physician in performing minimally invasive procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile trocar kit for laparoscopic/endoscopic use. Class II device (Product Code FBQ). No specific materials, dimensions, or software characteristics described.

Indications for Use

Indicated for use during laparoscopic or endoscopic surgery under physician guidance. No specific patient population, age, or gender restrictions provided.

Regulatory Classification

Identification

A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.

Submission Summary (Full Text)

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AUG - 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa Crisson Director of Quality Assurance/ Regulatory Affairs Gibbons Surgical Corporation 1112 Jensen Drive, Suite 101 Virginia Beach, Virginia 23451

Re: K012198

Trade/Device Name: Gibbons' Sterile Trocar Kit Regulation Number: 876.5090 Regulatory Class: II Product Code: FBQ Dated: July 5, 2001 Received: July 13, 2001

Dear Ms. Crisson:

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 legally marketed predicate 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 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 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 - Ms. Lisa Crisson

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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

for Mark N. Milhusan

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

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## K012198

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510(k) Number (if known): Not Known Device Name: Gibbons' Sterile Trocar Kit FDA's Statement of the Indications For Use for device:

The Gibbons' Surgical Corporation Sterile Trocar Kits contain devices intended for use during laparoscopic/ endoscopic surgery under the guidance of a physician.

Prescription Use_ X OR (Per 21 CFR 801.109)

Over-The-Counter Use_

fo Mark N Millheuser

sion of General. " estorative and Neurological Devices KOI 2198

510(k) Number -