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).

AI/ML Overview

The provided document describes the K094022 510(k) submission for the Water Lily™ Colon Hydrotherapy System. This device is a colonic irrigation system and its acceptance criteria and the study proving it meets them are detailed primarily through a comparison to a predicate device, the Angel of Water™ Colon Hydrotherapy System (K003720), and non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

This device is cleared based on demonstrating substantial equivalence to a predicate device. The acceptance criteria are implicitly met by showing similar technical characteristics and performance to the predicate. The "reported device performance" below refers to the results of non-clinical testing for specific safety parameters.

Acceptance Criteria (Inferred from Predicate Equivalence and Safety Tests)	Reported Device Performance (Water Lily™)
Intended Use	Colon cleansing when medically indicated, such as before radiological or endoscopic examination.
Target Population	Same as predicate
Design	Same principles of operation as predicate
Performance	Similar to predicate
Materials Used	Similar to predicate (e.g., single-use sterile disposable nozzle, ConMed K050992)
Where Used	Similar to predicate
Patient Control	Yes
Temperature Range	99°-103° F
Temperature cannot rise above 103° F (safety mechanism)	Yes. When water temperature reaches 104°F, an audible alarm sounds, and a solenoid valve closes water flow to the client. The therapist then cools the system to 104°F and resets the unit.
Water flow controlled by mixing valve	Yes
Filtration: Ultraviolet	Yes
Filtration: Carbon Filtration	Yes
Pressure inside patient's colon will not exceed 2 psi (safety mechanism)	Formula for PSI: 2.5 Ft drop = 1.075 psi. Confirmed by 0-3 psi gage.
Electrical Safety - UV filtration system	Approved by UL and CSA
Electrical Safety - Controller-thermocouple and solenoid valve	Approved by UL and CSA

2. Sample size used for the test set and the data provenance

The document does not detail a "test set" in the traditional sense involving human subjects or clinical data for evaluating the device's performance against the acceptance criteria. Instead, the evaluation is based on:

Non-clinical bench testing: This was used to verify specific safety parameters (pressure, temperature shutdown, electrical safety). There is no "sample size" indicated for these tests, as they are typically performed on a limited number of manufactured units to confirm design specifications.
Comparison to a predicate device: The Water Lily™ was compared to the Angel of Water™ (K003720) based on shared technical characteristics. This is a design and functional comparison, not a data-driven clinical comparison.
Data provenance: Not applicable in the context of clinical trials as no clinical trials were performed. The testing described is bench testing.

Therefore, there is no explicit sample size for a "test set" or data provenance information (country of origin, retrospective/prospective) because the submission focuses on substantial equivalence through design and non-clinical engineering verification rather than clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device's clearance is based on substantial equivalence to a predicate device and non-clinical bench testing. There was no "ground truth" derived from expert consensus for a test set as would be found in a clinical study for diagnostic accuracy or efficacy.

4. Adjudication method for the test set

Not applicable. As no clinical "test set" was described requiring expert assessment or ground truth establishment, no adjudication method was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No. The document does not mention any clinical studies, including MRMC comparative effectiveness studies, demonstrating how human readers (or users in this context) improve with or without AI assistance. This device is a physical medical device, not an AI-driven diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This device is a colon hydrotherapy system and does not involve any algorithms or AI, thus rendering "standalone performance" (in the context of AI) irrelevant.

7. The type of ground truth used

Not applicable in the sense of clinical "ground truth." For the non-clinical tests, the "ground truth" equates to engineering specifications and safety standards (e.g., pressure not exceeding 2 psi, temperature shutdown at 104°F, UL/CSA electrical safety approvals). The primary ground for clearance is substantial equivalence to the legally marketed predicate device.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable, as no training set was used.

Summary

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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

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 ColonHydrotherapy System	K003720

DEVICE DESCRIPTION

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

(727) 842-1700

Telephone:

Telephone:
Fax:

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Parameters	The Water Lily™	Angel of Water™
510(k) Number		K003720
Indications for Use	The Water Lily™ ColonicHydrotherapy System isindicated for colon .cleansing when medicallyindicated, such as beforeradiological or endoscopicexamination.	Colon cleansing whenmedically indicated such asbefore radiological orendoscopic examination.
Controlled by patient	Yes	Yes
Temperature Range	99°-103° F	99°-103° F
Temperature cannot riseabove 103° F	Yes	Yes
Water flow controlled bymixing valve	Yes	Yes
Single-use sterile disposablenozzle	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 insidepatient's colon will notexceed 2 psi	Formula for PSI-On a gravity fed line is 100 ft. drop = 43 psi.Therefore a 2.5 Ft drop =1.07 psi (.43 x 2.5 = 1.075)Confirmed by 0-3 psi gage
Demonstrate that thedevice will shut downwhen the watertemperature exceeds104° F	When water temperature reaches 104°F the controller sets offan audible alarm and sends a signal to the solenoid valvethat closes water flow to the client. The therapist will cooldown the system to 104°F and reset the unit.
Electrical Safety - UVfiltration system	Approved by UL and CSA
Electrical safety -Controller-thermocoupleand 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 (800) 638-2041 or (301) 796-7100 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

Page of

Regulation Number and Section

§ 876.5220 Colonic irrigation system.

(a)
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).(b)
Classification. (1) Class II (performance standards) when the device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.(2) Class III (premarket approval) when the device is intended for other uses, including colon cleansing routinely for general well being.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any colonic irrigation system described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a colonic irrigation system described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other colonic irrigation system shall have an approved PMA in effect before being placed in commercial distribution.