GC IRRIGATOR

K980868 · Gentle Colonics, Inc. · KPL · Aug 6, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980868
• Device Name: GC IRRIGATOR
• Applicant: Gentle Colonics, Inc.
• Product Code: KPL · Gastroenterology, Urology
• Decision Date: Aug 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5220
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The GC Irrigator is intended for use for colon cleansing when medically indicated, such as before radiological or endoscopic examination. To be used with commercially available gravity flow colonic irrigation units.

Device Story

GC Irrigator is a colon cleansing device designed for use with commercially available gravity flow colonic irrigation units. It facilitates bowel preparation for patients undergoing radiological or endoscopic examinations. The device is intended for clinical use under medical indication. It functions as an accessory to existing gravity-fed irrigation systems to assist in the cleansing process.

Clinical Evidence

No clinical data provided; substantial equivalence determined via 510(k) regulatory pathway.

Technological Characteristics

Gravity flow colonic irrigation accessory. Mechanical device; no electronic or software components described.

Indications for Use

Indicated for colon cleansing in patients requiring bowel preparation prior to radiological or endoscopic examination.

Regulatory Classification

Identification

A colonic irrigation system is a device intended to instill water into the colon through a nozzle inserted into the rectum to cleanse (evacuate) the contents of the lower colon. The system is designed to allow evacuation of the contents of the colon during the administration of the colonic irrigation. The device consists of a container for fluid connected to the nozzle via tubing and includes a system which enables the pressure, temperature, or flow of water through the nozzle to be controlled. The device may include a console-type toilet and necessary fittings to allow the device to be connected to water and sewer pipes. The device may use electrical power to heat the water. The device does not include the enema kit (§ 876.5210).

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged in a circular fashion around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 6 1998

Ms. Karen U. Salinas Regulatory Consultant Gentle Colonics, Inc. 6530 La Manga Dallas, TX 75248

Re: K980868 GC Irrigator Dated: May 29, 1998 Received: June 1, 1998 Regulatory Class: II 21 CFR 876.5220/Procode: 78 KPL

Dear Ms. Salinas:

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 (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 (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.

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/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

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

Enclosure

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

Page_1 __of__1

510(k) Number (if known): ___K980868

Device Name:__ GC Irrigator

Indications For Use:

The GC Irrigator is intended for use for colon cleansing when medically indicated, such as before radiological or endoscopic examination. To be used with commercially available gravity flow colonic irrigation units.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Colis h. Pollard

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K980868

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use