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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the "Aqua Cleanse" colonic irrigation system. As such, it does not contain the acceptance criteria or results from a study proving device performance in the manner typically associated with clinical trials of diagnostic or therapeutic devices.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (HC-1 Classic, K131852) through non-clinical testing and comparison of technological characteristics.

Therefore, many of the requested sections about clinical study design (sample size, ground truth, expert adjudication, MRMC studies) are not applicable to this submission.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Bench Test Results)
Pressure Safety	Maintain pressure within safe limits for a colonic irrigation system.	"Proved safety": Accurate pressure range.
Temperature Safety	Maintain temperature within a safe and comfortable range for colon cleansing.	"Proved safety": Accurate temperature range.
Electrical Safety	Compliance with relevant electrical safety standards.	"Correct operation": Compliant.
Leak Resistance	No leaks during operation.	"Correct operation": Leak resistant.
Functionality	Introduction, filling, and emptying of water into and out of the colon for cleansing.	"Correct operation": Per intended use.
Colon Hydrotherapy Treatment	Perform treatment in accordance with device performance specifications.	"Correct operation": Per specifications.

Note: The document states that "Bench test results proved safety and effectiveness when testing for accurate pressure and temperature range." The specific numerical acceptance criteria (e.g., pressure range, temperature range) are not explicitly detailed in the summary provided.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. The document refers to "bench testing," which typically involves testing a limited number of manufactured units or prototypes to verify engineering specifications, not a clinical "test set" of patients.
Data Provenance: Not applicable. The data comes from the manufacturer's internal bench testing. No country of origin for clinical data is relevant as no clinical data was used.
Retrospective/Prospective: Not applicable, as no clinical study was performed.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth as typically understood for clinical studies (e.g., disease diagnosis) was not established for this non-clinical bench testing. The "ground truth" here would be adherence to engineering specifications and safety standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No animal or clinical testing was performed on the proposed device."
Effect Size: Not applicable, as no such study was conducted.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical medical device (colonic irrigation system), not an AI algorithm. Its performance is evaluated through bench testing of its mechanical and electrical functions, not algorithmic accuracy.

7. Type of Ground Truth Used

For the bench testing, the "ground truth" was adherence to established engineering and safety specifications, and proper mechanical/electrical function.
For the accessory kits, material biocompatibility was assessed against ANSI/AAMI/ISO 10993-5 standards by Nelson Laboratories ("certified to ANSI/AAMI/ISO 10993-5").

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of a physical device like this. The device is not based on a machine learning algorithm that requires training data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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 DRIVESUITE B-132SURPRISE, AZ 85378
CONTACT:	JULIE SOLOMON
TELEPHONE:	(623) 640-4646
EMAIL:	JULIE@QMSAZ.COM
DEVICE TRADE NAME:	AQUA CLEANSE
COMMON NAME:	COLONIC IRRIGATION SYSTEMDISPOSABLE 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:

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.

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.