JIMMY JOHN III RECTAL NOZZLE

K973256 · Colon Therapeutics · KPL · Sep 29, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K973256
• Device Name: JIMMY JOHN III RECTAL NOZZLE
• Applicant: Colon Therapeutics
• Product Code: KPL · Gastroenterology, Urology
• Decision Date: Sep 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5220
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for use in Colon Irrigation with any colon irrigation system. Class II - These devices are intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.

Device Story

Jimmy John III Rectal Nozzle is a device used for colon irrigation. It functions as an interface component for colon irrigation systems to facilitate colon cleansing. The device is intended for use in clinical settings where colon cleansing is medically indicated, such as prior to diagnostic procedures like radiological or endoscopic examinations. It is operated by healthcare professionals as part of a broader colon irrigation system.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device classification and intended use.

Technological Characteristics

Rectal nozzle for colon irrigation systems; classified as Class II under 21 CFR 876.5220 (Product code: 78 KPL).

Indications for Use

Indicated for patients requiring colon cleansing for medical indications, including preparation for radiological or endoscopic examinations.

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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 1997

Mr. Jim Girouard President Colon Therapeutics 2909 Main Avenue Groves, Texas 77619 Re: K973256

Jimmy John III Rectal Nozzle Dated: August 22, 1997 Received: August 25, 1997 Regulatory class: II 21 CFR §876.5220/Product code: 78 KPL

Dear Mr. Girouard:

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, 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 OS 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 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/dsmamain.html".

Sincerely yours,

William Yu

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

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| 510(k) Number (if known): | K973256 |
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| Device Name: | JIMMY JOHN III RECTAL NOZZLE |

Indications For Use:

PACKAGE LABEL

Indications For Use

Intended for use in Colon Irrigation with any colon irrigation system.

Class II - These devices are intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.

(PLEASE IN) NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACIE IF NUELEID)

Concurrence of CDRH, Ollice of Device Evaluation (ODE)

Robert Q. Rathbun

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 16473256 510(k) Number _

Prescription Use
(Per 21 CFR 801.109)

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Over-The-Counter Use

(Uplivini Forust 1-2-90)

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