TRANSCOM COLON HYDROTHERAPY MODEL HC-2000

K970482 · Srs Intl. · KPL · Oct 31, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970482
• Device Name: TRANSCOM COLON HYDROTHERAPY MODEL HC-2000
• Applicant: Srs Intl.
• Product Code: KPL · Gastroenterology, Urology
• Decision Date: Oct 31, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5220
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Transcom Colon Hydrotherapy (Model HC-2000) is a wall-mounted instrument for colonic irrigation. It introduces filtered water at controlled temperatures into the large intestine to cleanse contents. System components include a mixing valve, pressure regulator, water manifold, relief valve, monitoring system (temperature/pressure), viewing assembly, sanitation system, and lighting assembly. Operation is manual, utilizing a syringe-based flow mechanism and gravity drainage. The device features automatic pressure safety, disinfection, and temperature regulation. It includes disposable components for single-use therapy. Used in clinical settings by healthcare providers to prepare patients for medical procedures. Output consists of visual monitoring of fluid discharge via a view tube assembly, allowing the clinician to observe the cleansing process. Benefits include hygienic, painless, and odorless colon preparation.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Wall-mounted colonic irrigator. Materials include brass and stainless steel. Features include thermostatic mixing valve (Grohemix), Norgren pressure regulators and relief valves, and manual flow control. Operates on 110/120 VAC 50/60 Hz. Includes automatic pressure safety, disinfection system, and temperature monitoring. Fluid pathway utilizes disposable components except for the view tube assembly. Dimensions: 1020 x 720 x 270 CM. Weight: 132.3 lbs.

Indications for Use

Indicated for colon cleansing in patients requiring bowel preparation for radiological or endoscopic examination.

Regulatory Classification

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).

Predicate Devices

• Specialty Health Hydro-San
• Clearwater PPC-101
• Doltolo Research Corp. Toxygen

Submission Summary (Full Text)

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41

# SRS INTERNATIONAL CORPORATION

Suite 1000 • 1625 K Street, NW • Washington, DC 20006-1604
Telephone [phone] • Telecopy [phone]

OCT 31 1997

## PREMARKET NOTIFICATION [510(K)] SUMMARY

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

Submitter's Name: SRS International Corporation
Address: 1625 K St., NW, Suite 1000 Washington, DC 20006
Telephone: [phone]
Fax: [phone]
Contact Person: Michael G. Farrow, Ph.D.
Date of Summary: February 8, 1997

### 2. Name of Device, Proprietary Name, Common Name, Classification

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

### 3. Legally Marketed Predicate Devices of Substantial Equivalence

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

### 4. Description of Device

This device is not a kit. This device is an instrument for hydrotherapy of the colon. It introduces filtered water at a comfortable 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

### 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.

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# 6. Summary of Technological Characteristics Compared to Predicates

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.
2. Clearwater has no speculum collection; Transcom does.
3. Clearwater's unit is portable; Transcom is wall mounted
4. 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 HEALTH
Hydro-San | CLEARWATER
PPC-101 | DOTLO RESEARCH
TOXYGEN |
| --- | --- | --- | --- | --- |
| Water Source | Household/Commercial | Household/Commercial | Household/Commercial | Household/Commercial |
| Water Flow (Pressure) | Yes | Yes | Yes | Yes |
| Water Flow Control Valve | Yes | Yes | Yes | Yes |
| Drainage System (Gravity) | Yes | Yes | Yes | Yes |
| Closed System | | | | |
| Water | Yes | Yes | Yes | Yes |
| Drainage | Yes | Yes | Yes | Yes |
| Mixing Valve | | | | |
| Grohemix | Yes | Yes | Yes | Yes |
| Powers Hydroguard | N/A | | Yes | |
| Fittings | | | | |
| Brass | Yes | Yes | Yes | Yes |
| Stainless | Yes | Yes | Yes | Yes |
| Cabinet Composition | | | | |
| Stainless Steel | Yes | N/A | Yes | N/A |
| Sheet Metal (Painted) | N/A | Yes | N/A | Yes |
| Sink & Faucet | N/A | N/A | Yes | 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 |
| Pumps | None | None | Sanitation System | None |

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| Parameter | TRANSCOM | SPECIALTY HEALTH
Hydro-San | CLEARWATER
PPC-101 | DOTLO RESEARCH
TOXYGEN |
| --- | --- | --- | --- | --- |
| Mode of Operation | Continuous Water Flow
Gravity Flow Drainage
Manual Operation | Continuous Water Flow
Gravity Flow Drainage
Manual Operation | Continuous Water Flow
Gravity Flow Drainage
Manual Operation | Continuous Water Flow
Gravity Flow Drainage
Manual Operation |
| 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 | Mixing Valve
Pressure Regulator
Water Manifold System
Relief Valve System
Monitoring System
(Temp. Pressure)
Viewing Assembly
Sanitation System
Lighting Assembly
Drainage Assembly
None | Mixing Valve
Pressure Regulator
Water Manifold System
Relief Valve System
Monitoring System
(Temp. Pressure)
Viewing Assembly
Sanitation System
Lighting Assembly
Drainage Assembly
Sink & Faucet | Mixing Valve
Pressure Regulator
Water Manifold System
Relief Valve System
Monitoring System
(Temp. Pressure)
Viewing Assembly
Sanitation System
Lighting Assembly
Drainage Assembly
None |
| Intended Usage | Colonic Irrigator | Colonic Irrigator | Colonic Irrigator | Colonic Irrigator |
| Monitoring Systems
Water Temperature
Pressure
View Tube Assembly
(Fluid Discharge Path) | Yes
Yes
Yes | Yes
Yes
Yes | Yes
Yes
Yes | Yes
Yes
Yes |
| 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 | 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 |
| Specimum Collection | Yes | Yes | No | Yes |

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| Parameter | TRANSCOM | SPECIALTY HEALTH
Hydro-San | CLEARWATER
PPC-101 | DOTLO RESEARCH
TOXYGEN |
| --- | --- | --- | --- | --- |
| Regulators
(Water Pressure) | Norgren
Yes | Norgren
Yes | Norgren
Yes | Norgren
Yes |
| Relief Valve
(Water Pressure) | Norgren
Yes | Norgren
Yes | Norgren
Yes | Norgren
Yes |
| Over Pressure Relief System | Yes | Yes | Yes | Yes |
| Systems Check Valves | Yes | Yes | Yes | Yes |
| Sanitation System Pump | Yes
Syringe | Yes
Gravity Flow System | Yes
Yes | Yes
Gravity Flow System |
| Gauges
Water Temperature
Water Pressure | Yes
Yes | Yes
Yes | Yes
Yes | Yes
Yes |
| Electrical Requirements | 110/120 VAC 50/60 Hz service, power outlet to be grounded and polarized and GFI | 110/120 VAC 50/60 Hz service, power outlet to be grounded and polarized and GFI | 110/120 VAC 50/60 Hz service, power outlet to be grounded and polarized and GFI | 110/120 VAC 50/60 Hz service, power outlet to be grounded and polarized and GFI |
| View Tube Assembly
Back Lighting | Yes | Yes | Yes | Yes |

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## 7. Non-Clinical Performance Data

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

## 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

OCT 31

TRANSCQM 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, 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.

If your device is classified (see above) into either class II (Special Controls) or 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 the Electronic Product 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 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


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)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)