(163 days)
No
The device description and performance studies focus on mechanical and temperature control mechanisms, with no mention of AI or ML.
Yes
The device is described as a professional colon hydrotherapy system used for colon cleansing when medically indicated, addressing a medical condition (colon contents) and preparing for medical procedures like radiological or endoscopic examinations.
No
The device is indicated for colon cleansing, a therapeutic procedure, not for diagnosing medical conditions. Its function is to introduce water into the colon to cleanse it, not to detect, monitor, or identify diseases or conditions.
No
The device description clearly outlines a physical system with hardware components like a mixing valve, switches, tubing, and a rectal nozzle, indicating it is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Water Lily 10 Function: The Water Lily 10 is a colon hydrotherapy system. It introduces water into the body (the large intestine) to cleanse it. It does not analyze any specimens taken from the body.
The device's purpose is a physical cleansing procedure performed on the body, not a diagnostic test performed on a sample from the body.
N/A
Intended Use / Indications for Use
The Water Lily The is indicated for colon cleansing when medically indicated, such as before radiological or endoscopic examination.
Product codes (comma separated list FDA assigned to the subject device)
KPL
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large intestine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Testing
Test Parameter: Ensure pressure inside patient's colon will not exceed 2 psi
Results: 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
Test Parameter: Demonstrate that the device will shut down when the water temperature exceeds 104° F
Results: When water temperature reaches 104°F the controller sets off an audible alarm and sends a signal to the solenoid valve that closes water flow to the client. The therapist will cool down the system to 104°F and reset the unit.
Test Parameter: Electrical Safety - UV filtration system
Results: Approved by UL and CSA
Test Parameter: Electrical safety - Controller-thermocouple and solenoid valve
Results: Approved by UL and CSA
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Colon | |
| 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
(727) 842-1700
(727) 842-1700
Telephone:
Telephone:
Fax:
1
| Parameters | The Water Lily™ | Angel of Water™ |
|---|---|---|
| 510(k) Number | K003720 | |
| Indications for Use | The Water Lily™ Colonic | |
| Hydrotherapy System is | ||
| indicated for colon . | ||
| cleansing when medically | ||
| indicated, such as before | ||
| radiological or endoscopic | ||
| examination. | Colon cleansing when | |
| medically indicated such as | ||
| before radiological or | ||
| endoscopic examination. | ||
| Controlled by patient | Yes | Yes |
| Temperature Range | 99°-103° F | 99°-103° F |
| Temperature cannot rise | ||
| above 103° F | Yes | Yes |
| Water flow controlled by | ||
| mixing valve | Yes | Yes |
| Single-use sterile disposable | ||
| 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 | |
| patient's colon will not | |
| exceed 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 the | |
| device will shut down | |
| when the water | |
| temperature exceeds | |
| 104° F | When water temperature reaches 104°F the controller sets off |
| an audible alarm and sends a signal to the solenoid valve | |
| that closes water flow to the client. The therapist will cool | |
| down the system to 104°F and reset the unit. | |
| Electrical Safety - UV | |
| filtration system | Approved by UL and CSA |
| Electrical safety - | |
| Controller-thermocouple | |
| and solenoid valve | Approved by UL and CSA |
2
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.
3
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
4
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
5
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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