HC-1 AND HC-1 CLASSIC

{0}------------------------------------------------ APR 1 7 2014 #### K131852 Page 1 of 4 | TECHNICAL EVALUATION<br>DOCUMENTATION | | # Document:<br>HC-1/HC-1 CLASSIC<br>HYDROKIT | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------| | SECTION 5 - 510(k) SUMMARY | | | | DATE OF SUBMISSION: | 2014-02-13 | | | SUBMITTER NAME: | TRANSCENDENCIAS COMERCIALES, S.L. | | | SUBMITTER ADDRESS: | C/ Zubiberri, 31<br>EDIF. URUMEA<br>PARQUE EMPRESARIAL ZUATZU<br>20018 SAN SEBASTIAN<br>GUIPÚZCOA - SPAIN | | | CONTACT: | Ramon Echevarria | | | TELEPHONE: | + 34 943 224 360 | | | Fax: | + 34 943 224 275 | | | e-mail: | admon@transcomsl.com | | | DEVICE TRADE NAME: | TRANSCOM COLON HYDROTHERAPY<br>MODELS HC-1 and HC-1 CLASSIC<br>And 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 Classic<br>Stainless steel casing | HC-2000 (K970482)<br>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 x<br>600 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) OR Over-The-Counter Use (21 CFR 801 Subpart C)