THE WATER LILY

K094022 · Clearwater Products, LLC · KPL · Jun 11, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K094022
• Device Name: THE WATER LILY
• Applicant: Clearwater Products, LLC
• Product Code: KPL · Gastroenterology, Urology
• Decision Date: Jun 11, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5220
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Water Lily™ Colonic Hydrotherapy System is indicated for colon cleansing when medically indicated, such as before radiological or endoscopic examination.

Device Story

Professional colon hydrotherapy system; introduces filtered water into large intestine for cleansing. System utilizes mixing valve for temperature control (99°-103° F); flow controlled by user-operated switch. Includes ultraviolet and carbon filtration. Uses disposable tubing and sterile, single-use rectal nozzle. Operated by clinician/therapist in clinical setting. Safety features include pressure limitation (gravity-fed, max 2 psi) and automatic thermal shutdown (audible alarm and solenoid valve closure if temperature exceeds 104° F). Benefits patient by facilitating bowel preparation for diagnostic procedures.

Clinical Evidence

Bench testing only. Testing confirmed pressure regulation (gravity-fed system ensures <2 psi) and thermal safety (automatic shutdown at 104° F). Electrical safety verified via UL and CSA standards.

Technological Characteristics

Colonic irrigation system; gravity-fed. Materials include disposable tubing and sterile rectal nozzle. Features UV and carbon water filtration. Temperature control via mixing valve; thermal safety via thermocouple and solenoid valve. Pressure control via gravity-fed design. Electrical components UL/CSA approved.

Indications for Use

Indicated for colon cleansing in patients requiring bowel preparation for 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).

Predicate Devices

• Angel of Water Colon Hydrotherapy System (K003720)

Reference Devices

• ConMed Corporation rectal nozzle (K050992)

Submission Summary (Full Text)

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## K094022

# 510(k) Summary

## JUN 1 1 2010

#### SPONSOR

807.92(a)(1)

Fax:

Contact Person: Robert Bolden

Summary Preparation Date: May 18, 2010

### DEVICE NAME

Trade Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class: Panel:

## PREDICATE DEVICE

86. m, n ∈ {1, 2}

Water LilyTM Colon Hydrotherapy System Colonic Irrigation System 876.5220 KPL Class II Gastroenterology/Urology

#### 807.92(a)(3)

| Company | Product | 510(k) # |
|---------------------------------|---------------------------------------------|----------|
| Lifestream Purification Systems | Angel of Water Colon<br>Hydrotherapy System | K003720 |

## DEVICE DESCRIPTION

The Water Lily 10 is a professional colon hydrotherapy system for use when medically indicated. It introduces filtered water at a comfortable temperature into the large intestine, thus cleansing the colon of its contents. Water temperature is controlled by means of a mixing valve; flow is controlled by one switch operated by the user. The system is manually sanitized prior to each use with a suitable broad spectrum disinfectant (not included). The system includes disposable tubing and a sterile, disposable rectal nozzle intended for single use only (ConMed Corporation K050992).

## DEVICE INDICATIONS FOR USE

The Water Lily "M Colonic Hydrotherapy System is indicated for colon cleansing when medically indicated, such as before radiological or endoscopic examination.

807.92(a)(5)

#### 807.92(a)(4)

# 807.92(a)(2)

ly
Hydrotherapy System
Irrigation System
0

Company Name: Clearwater Products LLC Company Address 5910 Pine Hill Road, Unit 9 Port Richey, FL 34668

[phone]

[phone]

Telephone:

Telephone:
Fax:

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| Parameters | The Water Lily™ | Angel of Water™ |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K003720 |
| Indications for Use | The Water Lily™ Colonic<br>Hydrotherapy System is<br>indicated for colon .<br>cleansing when medically<br>indicated, such as before<br>radiological or endoscopic<br>examination. | Colon cleansing when<br>medically indicated such as<br>before radiological or<br>endoscopic examination. |
| Controlled by patient | Yes | Yes |
| Temperature Range | 99°-103° F | 99°-103° F |
| Temperature cannot rise<br>above 103° F | Yes | Yes |
| Water flow controlled by<br>mixing valve | Yes | Yes |
| Single-use sterile disposable<br>nozzle | Yes | Yes |
| Sprayer | Yes | Yes |
| Filtration: | | |
| Ultraviolet | Yes | Yes |
| Carbon Filtration | Yes | Yes |

#### COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6) 12.3 Predicate Product Comparison Table

## NONCLINICAL AND CLINICAL TEST

## 807.92(b)

Summary of Non-Clinical Testing

| Test Parameter | Results |
|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ensure pressure inside<br>patient's colon will not<br>exceed 2 psi | Formula for PSI-On a gravity fed line is 100 ft. drop = 43 psi.<br>Therefore a 2.5 Ft drop =1.07 psi (.43 x 2.5 = 1.075)<br>Confirmed by 0-3 psi gage |
| Demonstrate that the<br>device will shut down<br>when the water<br>temperature exceeds<br>104° F | When water temperature reaches 104°F the controller sets off<br>an audible alarm and sends a signal to the solenoid valve<br>that closes water flow to the client. The therapist will cool<br>down the system to 104°F and reset the unit. |
| Electrical Safety - UV<br>filtration system | Approved by UL and CSA |
| Electrical safety -<br>Controller-thermocouple<br>and solenoid valve | Approved by UL and CSA |

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The Angel of Water, K003720 and the Water Lily were compared in the following areas and found to have similar technological characteristics and to be equivalent:

> Intended Use Target Population Design Performance Materials Used Where Used

## SAFETY and EFFECTIVENESS

The Water Lily "M uses the same principles of operation as the Angle of Water™. The water temperature range of 99°-103° is the exact same for both devices. All other aspects of the two devices are simple plumbing using tubes and valves. This 510(k) does not raise any new issues effecting safety and effectiveness.

#### Biocompatibility and Sterilization:

ConMed rectal nozzle (K050992)

#### CONCLUSION

### 807.92(b)(3)

The Water Lily and the predicate device (Angel of Water K003720) were compared in the following areas and found to have similar technological characteristics and to be equivalent:

- Intended Use Target Population Design Performance Materials Used Where Used
The Water Lily" uses the same principles of operation as the Angel of Water™. The water temperature range of 99°-103° is the exact same for both devices. All other aspects of the two devices are simple plumbing using tubes and valves. This 510(k) does not raise any new issues effecting safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002

Clearwater Products, LLC c/o Mr. E. J. Smith Consultant Smith Associates 1468 Harwell Avenue CROFTON MD 21114

## JUN 1 1 2010

· Re: K094022

Trade/Device Name: Water Lily™ Regulation Number: 21 CFR §876.5220 Regulation Name: Colonic irrigation system Regulatory Class: II Product Code: KPL Dated: June 7, 2010 Received: June 7, 2010

Dear Mr. Smith:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting of medical device-related

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#### Page 2 -

adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K 09 402 2

Device Name: Water Lily™

Indications for Use:

The Water Lily The is indicated for colon cleansing when medically indicated, such as before radiological or endoscopic examination.

## (Check appropriate designation below)

Prescription Use r (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

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