(205 days)
No
The device description and performance studies focus on mechanical and safety features (pressure, temperature, flow regulation, electrical safety, leak resistance) and do not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended for colon cleansing when medically indicated (before radiological or endoscopic examination), which is a therapeutic purpose.
No
The device is intended for colon cleansing, which is a therapeutic or preparatory procedure, not a diagnostic one. It does not identify or analyze diseases or conditions.
No
The device description clearly outlines hardware components such as a pressure regulated safety system, self-contained cleaning system, flow regulator, and uses disposable rectal speculum kits, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The "Aqua Cleanse" device is used to physically cleanse the colon by introducing and removing water. It does not analyze any biological specimens taken from the body.
- Intended Use: The intended use is for colon cleansing before procedures, not for analyzing samples to diagnose or monitor a medical condition.
The device is a therapeutic or procedural device, not a diagnostic one.
N/A
Intended Use / Indications for Use
THIS DEVICE IS INTENDED FOR COLON CLEANSING WHEN MEDICALLY INDICATED, SUCH AS BEFORE RADIOLOGICAL OR ENDOSCOPIC EXAMINATION.
Product codes
KPL
Device Description
The proposed device "Aqua Cleanse" is for colon cleansing when medically indicated such as before radiological or endoscopic examination. It introduces water at a comfortable temperature into the large intestine. It fills and empties water into and out of the colon thus cleansing it of its contents. The device is equipped with a pressure regulated safety system; a self-contained cleaning system, and flow regulator. lt is used with the accessory, disposable rectal speculum kits.
The associated disposable kit is intended to introduce water into the colon through a speculum inserted into the rectum to assist with the evacuation of the contents of the lower colon. This is a single-use only kit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Colon / large intestine / rectum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The Aqua Cleanse device has been subjected to bench testing to determine conformance to performance specifications and requirements taking account of its intended use as a colon irrigation system.
Functional testing showed correct operation of the Aqua Cleanse as per its intended use, specifically including:
- Pressure Safety
- Temperature Safety
- . Electrical Safety
- . Leak Resistant
- . Colon hydrotherapy treatment in accordance with device performance specifications
Note: No animal or clinical testing was performed on the proposed device.
Bench test results proved safety and effectiveness when testing for accurate pressure and temperature range. The two devices are essentially the same when comparing: intended use, indications for use, safety, functionality, and operation of the legally marketed device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
HC-1 CLASSIC (K131852)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three human profiles facing right, stacked on top of each other, with flowing lines beneath them. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 11, 2015
Quality Medical Supply, Inc. Julie Solomon CEO 13174 W. Foxfire Drive, Suite B-132 Surprise, AZ 85378
Re: K150381
Trade/Device Name: Aqua Cleanse Regulation Number: 21 CFR§ 876.5220 Regulation Name: Colonic irrigation system Regulatory Class: II Product Code: KPL Dated: August 5. 2015 Received: August 7, 2015
Dear Julie Solomon,
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 (reporting of
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medical device-related 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely yours.
Herbert P. Lerner -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K150381
Device Name AQUA CLEANSE
Indications for Use (Describe) THIS DEVICE IS INTENDED FOR COLON CLEANSING WHEN MEDICALLY INDICATED. SUCH AS BEFORE RADIOLOGICAL OR ENDOSCOPIC EXAMINATION.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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Image /page/3/Picture/0 description: The image shows the logo for Quality Medical Supply. The logo features a green, rounded shape resembling a speech bubble or a stylized letter 'Q'. Below the shape, the text "Quality Medical Supply" is written in a simple, sans-serif font. The text is in a lighter shade of green, complementing the color of the shape above.
SECTION 5 510(k) SUMMARY
| DATE OF SUBMISSION: | JUNE 6, 2015 |
|---|---|
| SUBMITTER NAME: | QUALITY MEDICAL SUPPLY |
| SUBMITTER ADDRESS: | 13174 W. FOXFIRE DRIVE |
| SUITE B-132 | |
| SURPRISE, AZ 85378 | |
| CONTACT: | JULIE SOLOMON |
| TELEPHONE: | (623) 640-4646 |
| EMAIL: | JULIE@QMSAZ.COM |
| DEVICE TRADE NAME: | AQUA CLEANSE |
| COMMON NAME: | COLONIC IRRIGATION SYSTEM |
| DISPOSABLE RECTAL SPECULUM KITS | |
| CLASSIFICATION NAME: | COLONIC IRRIGATION SYSTEM (21 CFR 876.5220) |
| 510(K) SUBMISSION NUMBER: | K150381 |
| 510(k) TYPE: | TRADITIONAL |
| PREDICATE DEVICE: | HC-1 CLASSIC (K131852) |
| MANUFACTACTURER: TRANSCENDENCIAS COMERCIALES SL TRANSCOM |
DEVICE DESCRIPTION:
The proposed device "Aqua Cleanse" is for colon cleansing when medically indicated such as before radiological or endoscopic examination. It introduces water at a comfortable temperature into the large intestine. It fills and empties water into and out of the colon thus cleansing it of its contents. The device is equipped with a pressure regulated safety system; a self-contained cleaning system, and flow regulator. lt is used with the accessory, disposable rectal speculum kits.
The associated disposable kit is intended to introduce water into the colon through a speculum inserted into the rectum to assist with the evacuation of the contents of the lower colon. This is a single-use only kit.
NOTE: This is the first submission for the above mentioned device and disposable rectal speculum kits. There have been no prior submissions.
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Image /page/4/Picture/0 description: The image shows a logo for a company called Quality Medical Supply. The logo features a green letter Q with a rounded shape and a tail-like extension at the bottom. Below the Q, the words "Quality Medical Supply" are written in a small, light-colored font.
SUMMARY OF COMPARISON WITH PREDICATE DEVICE:
In the establishment of substantial equivalence, the Aqua Cleanse as compared to the previously cleared HC-1 (K131852), manufactured by Transcendencias Comerciales SL Transcom, in Spain.
The following table summarizes the similarities of the principal technological characteristics and features of both predicate and new devices. From this table, it can be established that the Aqua Cleanse device and the predicate device are very similar.
COMPRISON TABLE
| Characteristic/Feature | PROPOSED DEVICE | PREDICATE DEVICE | |
|---|---|---|---|
| AQUA CLEANSE | HC-1 CLASSIC (K131852) | ||
| 1 | Cabinet Construction | Aluminum | Steel |
| 2 | Dimensions | 21" X 17" X 4.5" | 38" X 23" X 4.7" |
| 3 | Installation Type | Fixed | Fixed |
| 4 | Filters | 3 Stage | 2X 5pm Stage |
| 5 | U.V. light | NO | YES |
| 6 | Cleaning System | Automatic | Automatic |
| 7 | Timer | Yes | Yes |
| 8 | Flow Control | Yes | Yes |
| 9 | Pressure Gauge | Yes 0 - 2 PSI | Yes 0 - 250 MBAR |
| 10 | Temperature Gauge | Yes 99 - 100 Fahrenheit | Yes 22 40 Celsius |
| 11 | Lighting | Yes – Waterproof LED | Yes – Fluorescent Protected |
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Image /page/5/Picture/0 description: The image features the logo for Quality Medical Supply. The logo consists of a green letter "Q" formed by a circle with a tail extending downwards. Below the "Q", the words "Quality Medical Supply" are written in a simple, sans-serif font, also in green. The overall design is clean and modern, suggesting a focus on quality and healthcare.
ACCESSORY, DISPOSABLE RECTAL SPECULUM KITS:
QMS kits are comprised of 1 rectal speculum, 1 inflow waterline, and 1 out-flow waste hose. They have the same technological characteristics as, and are substantially equivalent to, the predicate Hydro kits and use the same three component manufacturers as Specialty Health Products "Speculum Collection". Manufactured in the US by: Smooth-Bor Plastics, Icon Injection Molding, and Kelpac Medical.
Where applicable (with internal body contact) these materials have been tested for skin irritation and toxicity. Testing was conducted by Nelson Laboratories. Please note: the testing was completed at Nelson Laboratories where they are certified to ANSI/AAMI/ISO 10993-5. Quality Medical Supply does not carry these certifications nor does our application require us to do so.
INTENDED USE:
This device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examination.
SUMMARY DISCUSSION OF NON-CLINICAL DATA:
The Aqua Cleanse device has been subjected to bench testing to determine conformance to performance specifications and requirements taking account of its intended use as a colon irrigation system.
Functional testing showed correct operation of the Aqua Cleanse as per its intended use, specifically including:
- Pressure Safety
- Temperature Safety
- . Electrical Safety
- . Leak Resistant
- . Colon hydrotherapy treatment in accordance with device performance specifications
Note: No animal or clinical testing was performed on the proposed device.
CONCLUSIONS:
According to the bench test results and all of the above information we note a remarkable comparison between the Aqua Cleanse device and the predicate device HC-1 Classic (as well as the accessory, disposable speculum kits) Bench test results proved safety and effectiveness when testing for accurate pressure and temperature range. The two devices are essentially the same when comparing: intended use, indications for use, safety, functionality, and operation of the legally marketed device.