ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM

K033149 · Ultimate Concepts, Inc. · KPL · Mar 23, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K033149
• Device Name: ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM
• Applicant: Ultimate Concepts, Inc.
• Product Code: KPL · Gastroenterology, Urology
• Decision Date: Mar 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5220
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.

Device Story

Colonic irrigation system; instills water into colon via rectal nozzle to cleanse/evacuate lower colon contents. Device comprises fluid container, tubing, nozzle, and console-type toilet; connects to household hot/cold water and sewer lines. Enables control of water temperature and gravity-induced flow. Used in clinical settings for colon cleansing when medically indicated. Facilitates bowel preparation for diagnostic procedures; benefits patient by ensuring clear colon for examination.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparison to the predicate device.

Technological Characteristics

Colonic irrigation system; console-type design with fluid container, tubing, and rectal nozzle. Connects to standard household hot/cold water and sewer plumbing. Operates via gravity-induced flow with temperature control. No software or electronic components described.

Indications for Use

Indicated for patients requiring colon cleansing prior to 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).

Predicate Devices

• Angel of Water, Colon Hydrotherapy System (K003720)

Submission Summary (Full Text)

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K033 49 Premarket Notification - Ultimate Conce

MAR 2 3 2004

## Ultimate Concepts Inc.

7835 South 1300 East Sandy, Utah 84094 Phone [phone] or 801-566-3214

SUMMARY

| Submitter's name:<br>Address: | Ultimate Concepts, Inc.<br>7835 South 1300 East<br>Sandy, Utah 84094 |
|-------------------------------|----------------------------------------------------------------------|
| Phone:<br>Fax number: | 800-632-3241<br>801-566-7152 |
| Name of contact person: | Grace Holland<br>Regulatory Specialists, Inc<br>3722 Ave, Sausalito |

Date the summary was prepared: September 8, 2003

| Name of the device: | Ultimate Professional Continuous Flow<br>Colonic System |
|----------------------------|---------------------------------------------------------|
| Trade or proprietary name: | Ultimate Professional Continuous Flow<br>Colonic System |
| Common or usual name: | Colonic Irrigation System |
| Classification name: | Colonic Irrigation System |

Irvine, CA 92606

Phone: [phone] fax: [phone]

The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:

> Angel of Water, Colon Hydrotherapy System, manufactured by Lifestream Purification Systems. Reference K003720

Description of the device:

This 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 temperature, and gravity induced flow of water through the nozzle to be controlled. The device includes a console-type toilet and

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necessary fittings to allow the device to be connected to water and sewer pipes. This device uses water that comes from household type hot and cold outlets.

Indications:

This device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.

Summary of the technological characteristics of our device compared to the predicate device:

The Angel of Water, K003720 and Ultimate Professional Continuous Flow Colonic System were compared in the following areas and found to have similar technological characteristics and to be equivalent.

Intended use Target Population Design Performance Where Used

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three overlapping wings, representing the department's mission to protect and promote the health and well-being of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2004

Ultimate Concepts, Inc. c/o Ms. Grace Holland Regulatory Consultant Regulatory Specialists, Inc. 3722 Ave. Sausalito IRVINE CA 92606

Re: K033149

Trade/Device Name: Ultimate Professional Continuous Flow Colonic System Regulation Number: 21 CFR §876.5220 Regulation Name: Colonic irrigation system Regulatory Class; II Product Code: 76 KPL Dated: January 29, 2004 Received: February 2, 2004

·Dear Ms. Holland:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with 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,

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ough finding of substantial equivalence of your device to a legally prematication: "Privation: "Privesults 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), please If you desire spositiv acceptiance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. Ixxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Other or complanos as (2005) was a mart 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small miconnation on your volumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html.

Sincerely yours,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of of __

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Ultimate Professional Continuous Flow Colonic System

Indications For Use:

This device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

David G. Seymann
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number