The HC-1 and HC-1 Classic proposed device is a device for colon cleaning. It introduces water at a comfortable temperature into the large intestine. It automatically fills and empties water into and out of the colon thus cleansing it of its contents when medically indicated such as before radiological or endoscopic examination. It is hygienic, painless and odorless. The device is equipped with an automatic pressure safety system; integrated disinfectant container, flow regulator and a 3-way manifold. It is supplied with disposable probe/hose assemblies for single-use during colonic hydrotherapy.

The HYDROKIT is a colonic irrigation system intended to instill water into the colon through a nozzle inserted into the rectum to evacuate the contents of the lower colon.

AI/ML Overview

Here's an analysis of the provided documentation regarding the acceptance criteria and study for the TRANSCOM COLON HYDROTHERAPY MODELS HC-1 and HC-1 Classic, and HYDROKITS:

This device did not undergo a study to prove it met specific quantitative acceptance criteria related to its clinical efficacy or performance in a traditional sense. Instead, the FDA clearance via a 510(k) pathway was based on demonstrating substantial equivalence to a predicate device. This means the manufacturer argued the new device is as safe and effective as a legally marketed device (the predicate).

Therefore, many of the typical study-related questions (sample size, ground truth, MRMC, etc.) are not applicable in this context.

Here's the information based on your request:

1. A table of acceptance criteria and the reported device performance

Since this was a substantial equivalence submission, there aren't explicit quantitative "acceptance criteria" for clinical performance in the document beyond meeting the functional specifications of a colon irrigation system comparable to the predicate. The "performance" is implicitly deemed equivalent to the predicate device.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (Summary of Comparison)
HC-1 and HC-1 Classic:
Equivalent intended use	Yes, intended use is "colon cleansing when medically indicated, such as before radiological or endoscopic examination" - same as predicate.
Equivalent indications for use	Yes.
Equivalent functionality	Yes, based on technological characteristics listed below.
Equivalent operation	Yes, based on technological characteristics listed below.
Key Technological Characteristics:
Chassis material	HC-1 / HC-1 Classic: Stainless steel casing
	Predicate HC-2000: Steel casing with zinc additive for anti-corrosion
Dimensions	HC-1: 530 x 600 x 1020 mm
	HC-1 Classic: 610 x 230 x 600 mm
	Predicate HC-2000: 970 x 600 x 120 mm
Installation type	Mobile (HC-1) / Fixed (HC-1 Classic)
	Predicate HC-2000: Fixed
Pre-installation requirements	Similar (Cold/hot water, pressure regulator, syphon, electrical water heater, waste output tube)
Filters	2 x 5μm filters (same as predicate)
UV light	YES (same as predicate)
Water heating	Needs electric heater (same as predicate)
Flow meter	0 - 100 liter/hour (same as predicate)
Manometer	250 mbar (Predicate: 200 mbar)
Presostat setting	Cuts out at 150 mbar (Predicate: 100 mbar)
Features / Functions (e.g., process display, session time, counters, remote control, sample collection)	Proposed device is a simpler version with fewer automated features than the predicate HC-2000. (e.g., NO process display, NO session time counter, NO irrigation liter/time counter, NO front panel/remote control, NO sample collection on proposed device).
Cleaning system (water/disinfectant)	Manual (Proposed) vs. Automatic (Predicate)
Hydrokits:
Equivalent intended use	Yes.
Equivalent indications for use	Yes.
Equivalent functionality	Yes.
Equivalent operation	Yes.
(Substantially equivalent to SPO1 and SP02 disposable speculums K000388)	Material: SASOL HNR100 polypropylene copolymer (meets FDA 21CFR 177.1520). Biocompatibility and mechanical testing performed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not applicable. No clinical test set data was provided.
Data Provenance: Not applicable for clinical testing. Bench testing was performed but details on sample size for components or systems are not specified in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No establishment of ground truth by experts in a clinical study was performed or documented here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. No MRMC study was performed as this is a medical device (colon irrigation system), not an AI diagnostic tool involving human readers.

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

Not applicable. This is not an algorithm-based device. Functional laboratory bench testing was performed to ensure correct operation of the device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable for clinical ground truth. For the device itself, the "ground truth" for demonstrating substantial equivalence rested on:

Bench testing: Verifying electrical safety, electromagnetic compatibility, and delivery of colon hydrotherapy according to specifications.
Biocompatibility testing: For the Hydrokits (cytotoxicity, sensitization, irritation/intracutaneous toxicity).
Mechanical testing: For the Hydrokits (tensile, compression).
Comparison to Predicate Device: Architectural and functional similarities to the legally marketed predicates.

8. The sample size for the training set

Not applicable. This device does not use an "algorithm" in a machine learning sense, so there is no training set.

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

Not applicable. See above.

Summary of the Study:

The "study" presented here is a pre-market notification (510(k)) for substantial equivalence.

For the HC-1 and HC-1 Classic colon hydrotherapy units: The study primarily involved a comparison of technological characteristics and features to a previously cleared predicate device (TRANSCOM COLON HYDROTHERAPY MODEL HC-2000, K970482). Bench testing confirmed basic functional aspects like electrical safety, EMC, and operational specifications. No animal or clinical testing was performed. The conclusion was that the new devices' intended use, indications for use, functionality, and operation are essentially the same as the predicate, making them substantially equivalent.
For the HYDROKITS (disposable speculums and associated components): The study involved a comparison to a predicate device (SPO1 and SP02 disposable speculums, K000388). Bench testing included biocompatibility tests (cytotoxicity, sensitization, irritation or intracutaneous toxicity) and mechanical tests (tensile, compression) of the material (SASOL HNR100 polypropylene copolymer). No clinical data was submitted. The conclusion was substantial equivalence to the predicate disposable speculums.

Summary

{0}------------------------------------------------

APR 1 7 2014

K131852 Page 1 of 4

TECHNICAL EVALUATIONDOCUMENTATION		# Document:HC-1/HC-1 CLASSICHYDROKIT
SECTION 5 - 510(k) SUMMARY
DATE OF SUBMISSION:	2014-02-13
SUBMITTER NAME:	TRANSCENDENCIAS COMERCIALES, S.L.
SUBMITTER ADDRESS:	C/ Zubiberri, 31EDIF. URUMEAPARQUE EMPRESARIAL ZUATZU20018 SAN SEBASTIANGUIPÚZCOA - SPAIN
CONTACT:	Ramon Echevarria
TELEPHONE:	+ 34 943 224 360
Fax:	+ 34 943 224 275
e-mail:	admon@transcomsl.com
DEVICE TRADE NAME:	TRANSCOM COLON HYDROTHERAPYMODELS HC-1 and HC-1 CLASSICAnd HYDROKIT
COMMON NAME:	COLONIC IRRIGATION SYSTEM
CLASSIFICATION NAME:	COLONIC IRRIGATION SYSTEM (21 CFR 876.5220)
PREDICATE DEVICE:	TRANSCOM COLON HYDROTHERAPY MODEL HC-2000 (K970482)
DEVICE DESCRIPTION:	The HC-1 and HC-1 Classic proposed device is a device for colon cleaning. It introduces water at a comfortable temperature into the large intestine Itautomatically fills and empties water into and out of the

comfortable temperature into the large intestine. It automatically fills and empties water into and out of the colon thus cleansing it of its contents when medically indicated such as before radiological or endoscopic examination. It is hygienic, painless and odorless. The device is equipped with an automatic pressure safety system; integrated disinfectant container, flow regulator and a 3-way manifold. It is supplied with disposable probe/hose assemblies for single-use during colonic hydrotherapy.

The HYDROKIT is a colonic irrigation system intended to instill water into the colon through a nozzle inserted into the rectum to evacuate the contents of the lower colon.

SUMMARY OF COMPARISON WITH PREDICATE DEVICE:

In the establishment of substantial equivalence, The HC-1 model is compared with the previously cleared Transcom HC-2000 model for colonic irrigation (K970482).

The following table summarizes the similarities of the principal technological characteristics and features of both predicate and new devices.

#	Characteristic / Feature	PROPOSED DEVICE	PREDICATE DEVICE
1.	Chassis material	HC-1 / HC-1 ClassicStainless steel casing	HC-2000 (K970482)Steel casing with zinc additive for anti-corrosion

5-1

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image contains a logo with a stylized globe on the left and the word "Transcom" on the right. The globe is depicted with curved lines suggesting continents and oceans. The word "Transcom" is written in a bold, sans-serif font, with the letters closely spaced together. The overall design is simple and modern, conveying a sense of global reach or international communication.

Document: TECHNICAL EVALUATION DOCUMENTATION

HC-1/HC-1 CLASSIC HYDROKIT

SECTION 5 - 510(k) SUMMARY

2.	Dimensions	530 x 600 x 1020 (HC-1) / 610 x 230 x600 mm (HC-1 Classic)	970 x 600 x 120 mm
3.	Installation type	Mobile (HC-1) / Fixed (HC-1 Classic)	Fixed
4.	Pre-installation requirements	Cold and hot water	Cold and hot water
		Pressure regulator 2 bar	Pressure regulator 2 bar
		Syphon as low as possible	Syphon as low as possible
		Electrical water heater 60 liters	Electrical water heater 60 liters
		Waste output tube	Waste output tube
5.	Filters	2 x 5μm filters	2 x 5μm filters
6.	U.V. light	YES	YES
7.	Water heating	Needs electric heater	Needs electric heater
8.	Features / Functions
	- process display	NO	NO
	- flow meter	0 - 100 liter/hour	0 - 100 liter / hour
	- manometer	250 mbar	200 mbar
	- session time	NO	Automatic, programmable
	- fluorescent light	Static, protected	Static, protected
	- irrigation liter counter	NO	YES
	- irrigation time counter	NO	YES
	- front panel control	NO	YES
	- remote control	NO	YES
	- digital thermostat	YES, 2 alarms	YES, 2 alarms
	- sample collection	NO	YES
	- visor	Protected	Protected
	- syphon	External	External
9.	Cleaning system
	water	Manual	Automatic
	disinfectant	Manual	Automatic
10.	Presostat setting	Cuts out at 150 mbar	Cuts out at 100 mbar

From the above table, it can be established that the new device and the predicate device are very similar. In fact, the proposed device is a simpler version of the HC-2000 model.

About the Hydrokits:

The Hydrokits have the same technological characteristics as, and are substantially equivalent to the SPO1 and SP02 disposable speculums (K000388), manufactured by Clearwater Colon Hydrotherapy Inc. The only difference is the insertion stopper present on one of the models of Hydrokits.

The material used to manufacture the speculum & obturator is SASOL HNR100 polypropylene copolymer which meets FDA requirements 21CFR 177.1520. The finished Hydrokit Speculum was tested for biocompatibility by BIOLAB Laboratory in Spain

Kit components packaged with the Hydrokit disposable speculum (water line, waste hose, & surgical lubricant) are substantially equivalent to those included with the SP01 and SP02 disposable speculums, manufactured by Clearwater Colon Hydrotherapy Inc.

{2}------------------------------------------------

BARRON

# Document: TECHNICAL EVALUATION DOCUMENTATION

HC-1/HC-1 CLASSIC HYDROKIT

SECTION 5 - 510(k) SUMMARY

INTENDED USE:

The device is intended for use to cleanse the colon when medically indicated, such as before radiological or endoscopic examination

SUMMARY DISCUSSION OF NON-CLINICAL DATA:

HC-1 and HC-1 Classic:

The proposed device has been subject to bench testing to determine to performance specifications and requirements taking account of its intended use as a colon irrigation system.

Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use, specifically including:

Correct electrical safety -
Electromagnetic compatibility -
Delivery of colon hydrotherapy in accordance with device performance specifications -

No animal or clinical testing was performed on the proposed device

Hydrokits:

The proposed device has been subject to bench testing to determine to performance specifications and requirements taking account of its intended use as a colon irrigation system.

The bench tests performed are biocompatibility testings and mechanical testings:

Biocompatibility .
- Cytotoxicity o
- o Sensitization
- Irritation or intracutaneous toxicity O
Mechanical t
- Tensile o
- Compresion o

SUMMARY DISCUSSION OF CLINICAL DATA:

No clinical studies are submitted to support this premarket notification.

CONCLUSIONS:

HC-1 and HC-1 Classic:

We believe the intended use, the indications for use, the functionality and the operation of both HC-1 and HC-1 Classic variants are essentially the same as the predicate HC-2000 device. Hence, substantial equivalence of the TRANSCOM COLON HYDROTHERAPY MODEL HC-1 / HC-1 CLASSIC with the legally marketed device may be established.

{3}------------------------------------------------

ર-વ

	TECHNICAL EVALUATION	# Document:
	DOCUMENTATION	HC-1/HC-1 CLASSIC
		HYDROKIT
SECTION 5 - 510(k) SUMMARY

Hydrokits:

We believe the intended use, the indications for use, the functionality and the operation of Hydrokit is essentially the same as the predicate Clearwater Colon Hydrotherapy, Inc. Disposable Speculum. Hence, substantial equivalence of the Hydrokit with the legally marketed device may be established.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an abstract human figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 17, 2014

Transcendencias Comerciales SL TRANSCOM Ramon Echevarria General Manager C/ZUBIBERRI 31 - PLANTA BAJA LOCAL 1 San Sebastian, Guipuzcoa 20018 Spain

K131852 Re:

Trade/Device Name: TRANSCOM COLON HYDROTHERAPY MODELS HC-1 and HC-1 Classic And HYDROKITS Regulation Number: 21 CFR§ 876.5220 Regulation Name: Colonic irrigation system Regulatory Class: II Product Code: KPL Dated: February 13, 2014 Received: February 20, 2014

Dear Ramon Echevarria,

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.

{5}------------------------------------------------

Page 2 - Ramon Echevarria

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for

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

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image is a document header with the title "TECHNICAL EVALUATION DOCUMENTATION" in bold, black letters. Below this is the text "SECTION 04 -: INDICATIONS FOR USE STATEMENT". To the left of the title is the "trensecom" logo. To the right of the title is the text "#Document: HC-1/HC-1 CLASSIC HYDROKIT".

PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT (as required by ODE for all 510(k) received after Jan. 1, 1996)

510(k) Number: K131852

Device Name:

TRANSCOM COLON HYDROTHERAPY MODELS HC-1 and HC-1 Classic And HYDROKITS

Indications for Use:

The use of this device is restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.

(Do not write below this line. Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerne 2014.04.17 12 20

Prescription Use J (21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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.