Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical and automated features for colon hydrotherapy, with no mention of AI, ML, image processing, or data-driven decision making.

Therapeutic

Yes

The device is used for "colon cleansing when medically indicated" and involves "hydrotherapy of the colon" for therapeutic purposes before medical examinations.

Diagnostic

No

The device is described as an instrument for hydrotherapy of the colon, used for colon cleansing. Its function is to fill and empty water for cleansing, not to diagnose medical conditions or provide diagnostic information. While it mentions a "system for collection of samples for analysis," its primary intended use and mechanism are for cleansing, not diagnosis. The lack of performance study data for diagnosis also supports this.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical instrument with hardware components such as a pressure safety system, disinfection system, sample collection system, controls, flow regulator, thermostatic mixer, and disposable components. This is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "colon cleansing when medically indicated, such as before radiological or endoscopic examination." This is a therapeutic or preparatory procedure performed directly on the patient's body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
Device Description: The description details an instrument that introduces and removes water from the colon. This is a physical intervention, not a process of analyzing biological samples.
Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on laboratory testing.

Therefore, this device falls under the category of a medical device used for a procedure, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

78 KPL

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Colon

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)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

1-646

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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

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

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:

1

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.

2

| Parameter | TRANSCOM | SPECIALTY HEALTH
Hydro-San | CLEARWATER
PPC-101 | DOTOLO RESEARCH
TOXYGEN |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Water Source | Household/Commercial | Household/Commercial | Household/Commerical | Household/Commerical |
| 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 | Yes | Yes |
| Fittings
Brass
Stainless | Yes
Yes
Yes | Yes
Yes
Yes | Yes
Yes
Yes | Yes
Yes
Yes |
| Cabinet Composition
Stainless Steel
Sheet Metal (Painted) | Yes
N/A
N/A | Yes
Yes
N/A | Yes
N/A
N/A | Yes
N/A
N/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 HEALTH
Hydro-San | CLEARWATER
PPC-101 | DOTOLO 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
Monitering System
(Temp. Pressure)
Viewing Assembly
Sanitation System
Lighting Assembly
Drainage Assembly
Sink & Faucet | Mixing Valve
Pressure Regulator
Water Manifold System
Relief Valve System
Monitering 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 | Yes | Yes | Yes | Yes |
| Pressure | Yes | Yes | Yes | Yes |
| View Tube Assembly
(Fluid Discharge Path) | 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 |
| pecimum Collection | Yes | Yes | No | Yes |
| Parameter | TRANSCOM | SPECIALTY HEALTH
Hydro-San | CLEARWATER
PPC-101 | DOTOLO 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 | Yes | Yes | Yes | Yes |
| Syringe
Pump | Yes | Gravity Flow System
Yes | Gravity Flow System
Yes | Gravity Flow System
Yes |
| Gauges
Water Temperature
Water Pressure | Yes | Yes | Yes | Yes |
| 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 | 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 |
| View Tube Assembly
Rack Lighting | Yes | Yes | Yes | Yes |

100 - 100 -

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5

7. Non-Clinical Performance Data

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

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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

6

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

7

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)