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

Device Description

This device is not a kit. This device is an instrument for hydrotherapy of the colon. It introduces filtered water at a confortable temperature into the large intestine. It is an automatic system for filling and emptying water into and out of the colon and thus cleansing the colon of its contents when medically indicated such as before radiological or endoscopic examination. It is hygienic, painless and odorless. The instrument has an automatic pressure safety system; automatic disinfection; a system for collection of samples for analysis; remote and frontal panel control; a counter for the number of liters of water used; a three-way faucet; flow regulator; thermostatic mixer and an automatic temperature safety feature. It contains disposable components for use only once in the therapy

AI/ML Overview

The provided document is a 510(k) Premarket Notification summary for the TRANSCOM Colon Hydrotherapy Model HC-2000. It focuses on demonstrating substantial equivalence to already marketed predicate devices rather than providing detailed acceptance criteria and a study proving performance against those criteria in the context of a new, quantifiable performance claim.

Here's a breakdown based on the request:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific "acceptance criteria" in terms of measurable performance thresholds. Instead, it relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. The table provided (pages 2-3) compares various parameters of the TRANSCOM device with three predicate devices.

Table: Comparative Technological Characteristics (as a proxy for acceptance and performance based on equivalence)

Parameter	TRANSCOM (Reported Performance)	Predicate Devices (Baseline/Acceptable Performance)
Water Source	Household/Commercial	Household/Commercial (Specialty Health, Clearwater, Dotolo Research)
Water Flow (Pressure)	Yes	Yes (All Predicates)
Water Flow Control Valve	Yes	Yes (All Predicates)
Drainage System (Gravity)	Yes	Yes (All Predicates)
Closed System Water	Yes	Yes (All Predicates)
Drainage	Yes	Yes (All Predicates)
Mixing Valve (Grohemix)	Yes	Yes (All Predicates)
Powers Hydroguard	N/A (Difference noted in text: Transcom uses a syringe, predicates use gravity flow or pump. This implies a different mechanism but must be functionally equivalent for therapy.)	Yes (Specialty Health, Clearwater, Dotolo Research)
Fittings (Brass/Stainless)	Yes	Yes (All Predicates)
Cabinet Composition (Stainless Steel/Sheet Metal)	N/A (Implied: Stainless Steel, as other options are N/A for Transcom)	Stainless Steel / Sheet Metal (Varies by predicate; for example, Specialty Health has both, Transcom only Stainless Steel appears to be listed)
Sink & Faucet	N/A (Difference noted in text: Clearwater needs a sink/faucet, Transcom is plumbed)	N/A (Specialty Health, Dotolo Research). Yes for Clearwater as part of Major Separate System Components.
Cabinet Design	Wall-Mount	Wall-Mount (Specialty Health, Dotolo Research), Portable (on-wheels) (Clearwater)
Weight	132.3 lbs.	Approx 40 lbs. (Specialty Health, Dotolo Research), 70 lbs. (Clearwater)
Physical Dimensions	1020 x 720 x 270 CM	20" w x 7" d x 20" h (Specialty Health, Dotolo Research), 19" w x 16" d x 41" h (Clearwater)
Sanitation System	None (as listed under "Sanitation System" property, but listed as "Sanitation System" component below)	None (All Predicates - under "Sanitation System" property). Yes (All Predicates - under "Major Separate System Components"). This appears to be an inconsistency in the table for "Sanitation System" property.
Pumps	(Implied: Not applicable as it uses a syringe)	(Clearwater uses a pump. Others gravity flow.)
Mode of Operation	Continuous Water Flow, Gravity Flow Drainage, Manual Operation	Continuous Water Flow, Gravity Flow Drainage, Manual Operation (All Predicates)
Major Separate System Components	Mixing Valve, Pressure Regulator, Water Manifold System, Relief Valve System, Monitoring System (Temp. Pressure), Viewing Assembly, Sanitation System, Lighting Assembly, Drainage Assembly, None (last "None" likely for Sink & Faucet difference)	Mixing Valve, Pressure Regulator, Water Manifold System, Relief Valve System, Monitoring System (Temp. Pressure), Viewing Assembly, Sanitation System, Lighting Assembly, Drainage Assembly, None (Specialty Health, Dotolo Research). For Clearwater: includes Sink & Faucet.
Intended Usage	Colonic Irrigator	Colonic Irrigator (All Predicates)
Monitoring Systems (Water Temperature/Pressure)	Yes	Yes (All Predicates)
View Tube Assembly (Fluid Discharge Path)	Yes	Yes (All Predicates)
Fluid Pathway	Disinfected, and disposable except the view tube assembly which must be cleaned & sterilized prior to each procedure	Disinfected, and disposable except the view tube assembly which must be cleaned & sterilized prior to each procedure (All Predicates)
Specimen Collection	Yes	Yes (Specialty Health, Dotolo Research), No (Clearwater)
Regulators (Water Pressure)	Norgren, Yes	Norgren, Yes (All Predicates)
Relief Valve (Water Pressure)	Norgren, Yes	Norgren, Yes (All Predicates)
Over Pressure Relief System	Yes	Yes (All Predicates)
Systems Check Valves	Yes	Yes (All Predicates)
Sanitation System (overall)	Yes	Yes (All Predicates)
Syringe/Pump	Yes (Syringe)	Gravity Flow System (Specialty Health, Dotolo Research), Yes (Pump for Clearwater)
Gauges (Water Temperature/Pressure)	Yes	Yes (All Predicates)
Electrical Requirements	110/120 VAC 50/60 Hz service, power outlet to be grounded and polarized and GFI, Yes	110/120 VAC 50/60 Hz service, power outlet to be grounded and polarized and GFI, Yes (All Predicates)
View Tube Assembly Rack Lighting	Yes	Yes (All Predicates)

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

The document explicitly states:

"Substantial equivalence is not based on an assessment of non-clinical performance data." (page 5, Section 7)
"Substantial equivalence is not based on an assessment of clinical performance data." (page 5, Section 8)

Therefore, no test set was used as no particular performance study was conducted to prove the device met acceptance criteria beyond demonstrating similar technological characteristics and intended use to predicate devices already on the market. There is no information on data provenance.

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

Not applicable, as no test set or clinical/non-clinical performance data was used in the assessment for substantial equivalence.

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

Not applicable, as no test set or performance evaluation requiring ground truth adjudication was conducted.

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. This is a medical device (colonic irrigation system), not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

Not applicable. This is a medical device, not an algorithm.

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

Not applicable, as no specific performance evaluation requiring ground truth was conducted. The ground for equivalence is the functional and technological similarity to legally marketed predicate devices.

8. The sample size for the training set

Not applicable, as this is a medical device for hydrotherapy, not a machine learning algorithm.

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

Not applicable, as this is a medical device for hydrotherapy, not a machine learning algorithm.

Summary

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SRS INTERNATIONAL CORPORATION

Suite 1000 • 1625 K Street, NW • Washington, DC 20006-1604 Telephone (202) 223-0157/0298 • Telecopy (202) 835-8970

OCT 31 1997

PREMARKET NOTIFICATION [510(K)] SUMMARY

1. Name/Address/Phone/Fax, Contact Person, Date:

Submitter's Name: SRS International Corporation 1625 K St., NW, Suite 1000 Washington, DC 20006 Address: 202-223-1057 Telephone: Fax: 202-835-8970 Michael G. Farrow, Ph.D. Contact Person: Date of Summary: February 8, 1997

2. Name of Device, Propietary Name, Common Name, Classification

Transcom Colon Hydrotherapy Name of Device: Proprietary Name: Transcom Colon Hydrotherapy Common Name: Colonic Irrigation System Irrigator, Colonic (Gastro/Urology) 78 KPL Classification:

3. Legally Marketed Predicate Devices of Substantial Equivalence

Specialty Health Models A&B Clearwater PPC-101 Doltolo Research Corp. Toxygen

4. Description of Device

5. Intended Use of Device

The indication for use of this device must be restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination. 41:

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6. Summary of Technological Characteristics Compared to Predicates

Program Bear 1, Willi, Burgh, Burnin 20f6

412

こ

Summaries between Transcom and three predicates manufactured by Specialty Health, Clearwater, and Dotolo Research, appear below.

Differences in technological characteristics between Transcom and the predicate devices include the following.

Between Transcom and Specialty Health

1. Specialty Health uses a gravity flow system, Transcom a syringe.
  Between Transcom and Clearwater
1. A sink and faucet are needed for the Clearwater unit; Transcom is plumbed.
1. Clearwater has no speculum collection; Transcom does.
1. Clearwater's unit is portable; Transcom is wall mounted
1. Clearwater uses a pump; Transcom uses a syringe

Between Transcom and Doltolo

1. Dotolo uses a gravity flow system. Transcom a syringe
  Details in the technological characteristics for Transcom and the predicates are itemized on the following pages.

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Parameter	TRANSCOM	SPECIALTY HEALTHHydro-San	CLEARWATERPPC-101	DOTOLO RESEARCHTOXYGEN
Water Source	Household/Commercial	Household/Commercial	Household/Commerical	Household/Commerical
Water Flow (Pressure)	Yes	Yes	Yes	Yes
Water Flow ControlValve	Yes	Yes	Yes	Yes
Drainage System(Gravity)	Yes	Yes	Yes	Yes
Closed SystemWater	Yes	Yes	Yes	Yes
Drainage	Yes	Yes	Yes	Yes
Mixing ValveGrohemix	Yes	Yes	Yes	Yes
Powers Hydroguard	N/A	Yes	Yes	Yes
FittingsBrassStainless	YesYesYes	YesYesYes	YesYesYes	YesYesYes
Cabinet CompositionStainless SteelSheet Metal (Painted)	YesN/AN/A	YesYesN/A	YesN/AN/A	YesN/AN/A
Sink & Faucet	N/A	N/A	N/A	N/A
Cabinet Design	Wall-Mount	Wall-Mount	Portable(on-wheels)	Wall-Mount
Weight	132.3 lbs.	Approx 40 lbs.	70 lbs.	Approx 40 lbs.
Physical Dimensions	1020 x 720 x 270 CM	20" w x 7" d x 20" h	19" w x 16" d x 41" h	20" w x 7" d x 20" h
Sanitation System	None	None	None	None
Pumps
Parameter	TRANSCOM	SPECIALTY HEALTHHydro-San	CLEARWATERPPC-101	DOTOLO RESEARCHTOXYGEN
Mode of Operation	Continuous Water FlowGravity Flow DrainageManual Operation	Continuous Water FlowGravity Flow DrainageManual Operation	Continuous Water FlowGravity Flow DrainageManual Operation	Continuous Water FlowGravity Flow DrainageManual Operation
Major Separate SystemComponents	Mixing ValvePressure RegulatorWater Manifold SystemRelief Valve SystemMonitoring System(Temp. Pressure)Viewing AssemblySanitation SystemLighting AssemblyDrainage AssemblyNone	Mixing ValvePressure RegulatorWater Manifold SystemRelief Valve SystemMonitoring System(Temp. Pressure)Viewing AssemblySanitation SystemLighting AssemblyDrainage AssemblyNone	Mixing ValvePressure RegulatorWater Manifold SystemRelief Valve SystemMonitering System(Temp. Pressure)Viewing AssemblySanitation SystemLighting AssemblyDrainage AssemblySink & Faucet	Mixing ValvePressure RegulatorWater Manifold SystemRelief Valve SystemMonitering System(Temp. Pressure)Viewing AssemblySanitation SystemLighting AssemblyDrainage AssemblyNone
Intended Usage	Colonic Irrigator	Colonic Irrigator	Colonic Irrigator	Colonic Irrigator
Monitoring SystemsWater Temperature	Yes	Yes	Yes	Yes
Pressure	Yes	Yes	Yes	Yes
View Tube Assembly(Fluid Discharge Path)	Yes	Yes	Yes	Yes
Fluid Pathway	Disinfected, and disposableexcept the view tubeassembly which mustbe cleaned & sterilizedprior to each procedure	Disinfected, and disposableexcept the view tubeassembly which mustbe cleaned & sterilizedprior to each procedure	Disinfected, and disposableexcept the view tubeassembly which mustbe cleaned & sterilizedprior to each procedure	Disinfected, and disposableexcept the view tubeassembly which mustbe cleaned & sterilizedprior to each procedure
pecimum Collection	Yes	Yes	No	Yes
Parameter	TRANSCOM	SPECIALTY HEALTHHydro-San	CLEARWATERPPC-101	DOTOLO RESEARCHTOXYGEN
Regulators(Water Pressure)	NorgrenYes	NorgrenYes	NorgrenYes	NorgrenYes
Relief Valve(Water Pressure)	NorgrenYes	NorgrenYes	NorgrenYes	NorgrenYes
Over Pressure ReliefSystem	Yes	Yes	Yes	Yes
Systems Check Valves	Yes	Yes	Yes	Yes
Sanitation System	Yes	Yes	Yes	Yes
SyringePump	Yes	Gravity Flow SystemYes	Gravity Flow SystemYes	Gravity Flow SystemYes
GaugesWater TemperatureWater Pressure	Yes	Yes	Yes	Yes
Electrical Requirements	110/120 VAC 50/60 Hzservice, power outletto be grounded andpolarized and GFIYes	110/120 VAC 50/60 Hzservice, power outletto be grounded andpolarized and GFIYes	110/120 VAC 50/60 Hzservice, power outletto be grounded andpolarized and GFIYes	110/120 VAC 50/60 Hzservice, power outletto be grounded andpolarized and GFIYes
View Tube AssemblyRack Lighting	Yes	Yes	Yes	Yes

100 - 100 -

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7. Non-Clinical Performance Data

Substantial equivalence is not based on an assessment of non-clinical performance data.

1 1 1 1 1 1 2 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 6 046

416

8. Clinical Performance Data

Substantial equivalence is not based on an assessment of clinical performance data.

9. Conclusions from Non-Clinical and Clinical

Not applicable

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Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its head facing left and its wings forming three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 31 p:r

TRANSCOM Transcendencias Comerciales, S.L. c/o Michael G. Farrow, Ph.D. SRS International Corporation 1625 K Street, N.W. Washington, D.C. 20006-1604

Re: K970482

TRANSCOM Colon Hydrotherapy Model HC-2000 Dated: September 10, 1997 Received: September 10, 1997 Regulatory class: II 21 CFR §876.5220/Product code: 78 KPL

Dear Dr. Farrow:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, 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.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely your

W.Liau Yu

Lillian Yin. Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_1__of_1_

510(k) Number (if known):____K_970482

Device Name: _ TRANSCOM COLON HYDROTHERAPY MODEL HC-2000

Indications For Use:

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K970482

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use
(Optional Format 1-2-96)

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.