(66 days)
No
The device description and performance studies focus on the physical properties and safety of a colonic irrigation system accessory, with no mention of AI or ML.
No.
The device is used for colon cleansing, specifically to evacuate the contents of the lower colon before examinations, which is not considered a therapeutic treatment for a disease or condition.
No
Explanation: The device is used for colon cleansing to evacuate contents, not to diagnose a condition or disease. Its purpose is preparatory for other examinations, not diagnostic in itself.
No
The device description explicitly states it is a "plastic, non-sterile, single use product colonic irrigation system" and describes physical components like a nozzle. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for colon cleansing before medical procedures like radiological or endoscopic examinations. This is a physical intervention to prepare the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a colonic irrigation system that instills water into the colon. This is a mechanical process for evacuation, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.).
- Detecting or measuring specific substances or markers.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. This device is used to physically cleanse the colon.
N/A
Intended Use / Indications for Use
The use of this device is 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)
KPL
Device Description
The Colonic Plus Regular, Small and Straight shape Hydrokits is a plastic, non-sterile, single use product colonic irrigation system that is used as an accessory with lower bowel Colonic irrigation systems intended to instill water into the colon through a nozzle inserted 2" 3" into the rectum to evacuate the contents of the lower colon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
colon, rectum
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)
No clinical studies are submitted to support this premarket notification. The water pressure leakage test and the Tensile & Compression tests performed on the finalized Colonic Plus Hydrokits were passed according to our acceptance criteria and were substantial equivalent to the predicate device. Biocompatability Testing on Cytotoxicity, Irritation and Sensitization have all passed.
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.
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.
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
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 1, 2018
Colonic Plus Rosa Alvarez Owner 73-925 Hwy. 111, Ste. L Palm Desert, CA 92260
Re: K180800
Trade/Device Name: Colonic Plus Regular, Small, and Straight Shape Hydrokits Regulation Number: 21 CFR& 876.5220 Regulation Name: Colonic Irrigation System Regulatory Class: II Product Code: KPL Dated: March 30, 2018 Received: April 4, 2018
Dear Rosa Alvarez:
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.
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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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Benjamin R. Fisher -S
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
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Indications for Use
510(k) Number (if known) K180800
Device Name
Colonic Plus Regular, Small, and Straight Shape Hydrokits
Indications for Use (Describe)
The use of this device is restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| Colonic Plus | Technical Evaluation
Documentation | # Document
Colonic Plus Hydrokits |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Section 05: | | |
| Traditional 510(k) Summary | | |
| DATE OF SUBMISSION: | 03/20/2018 | |
| SUBMITTER NAME: | Colonic Plus | |
| SUBMITTER ADDRESS: | 73-925 HWY 111, STE L
Palm Desert, CA 92260 | |
| CONTACT: | Rosa Alvarez | |
| TELEPHONE: | 760-340-0720 | |
| Fax: | 760-340-0189 | |
| E-mail: | Rosa.alvarez@yahoo.com | |
| DEVICE TRADE NAME: | Colonic Plus Regular, Small and Straight Shape Hydrokits | |
| COMMON NAME: | COLONIC IRRIGATION SYSTEM | |
| CLASSIFICATION NAME: | COLONIC IRRIGATION SYSTEM (21 CFR 876.5220) | |
| Procode: | KPL | |
| Regulatory Class: | II | |
| PREDICATE DEVICE: | Transcendencias Comerciales, S.L. K131852- Hydrokit
Trade Name: Transcom Colon Hydrotherapy Models HC-1
and HC-1 Classic And Hydrokit | |
Device Description: Colonic Plus Hydrokits
The Colonic Plus Regular, Small and Straight shape Hydrokits is a plastic, non-sterile, single use product colonic irrigation system that is used as an accessory with lower bowel Colonic irrigation systems intended to instill water into the colon through a nozzle inserted 2" 3" into the rectum to evacuate the contents of the lower colon.
Technical Characteristics Compared to the Predicate Device:
The proposed Colonic Plus Regular, Small and Straight shape Hydrokits (See Figues 3A-3C) are substantially equivalent in intended use, indications for use, design and material used in the Transcoms Hydrokit manufactured by Transcendenicas Comerciales, S.L.(K131852) (See figure 3D). The only differences between the new device and the predicate device is that the ring on the obturator is crescent and on the predicate device is round and that the tip of the obturator is slightly wider on the new device. Lastly on the Colonic Plus Straight shape speculum, it has no curve and is slightly thinner than the predicate device.
-
See diagrams below
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Proposed Devices:
Image /page/4/Figure/2 description: The image shows three different types of Colonic Plus Hydrokits, labeled as Figure 3A, 3B, and 3C. Figure 3A is the Regular Hydrokit, Figure 3B is the Small Hydrokit, and Figure 3C is the Straight Shape Hydrokit. The image uses arrows to point out features of each kit, such as the crescent ring, slightly wider insertion tip, and the absence of a bulb/curve in the straight shape kit. The straight shape kit is also noted to be slightly thinner.
Predicate Devices:
Image /page/4/Picture/4 description: The image shows a medical device inside of a clear plastic bag. The device is white and has a round ring on one end. An arrow points to the round ring and the text "Round ring" is next to the arrow.
Figure 3D: Transcom Hydrokit (K131852)
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Proposed Kit Components
Image /page/5/Picture/2 description: The image shows a collection of medical tubing and equipment on a dark surface. There are two corrugated tubes, one straight tube coiled with a label, and a plastic syringe-like device with a handle. The corrugated tubes appear to be connected by a metal piece in the center. The tubes are all clear and made of plastic.
Figure 4A: Colonic Plus Hydrokit (K163040)
Predicate device Kit Components
Image /page/5/Picture/5 description: The image shows a collection of medical supplies against a black background. There is a long, corrugated tube coiled on the left side of the image. To the right of the tube, there is a smaller, clear tube coiled in a circle, along with a small white packet. Below these items, there is a clear, cylindrical object and a long, thin tool with a loop at one end.
Figure 4B: Transcom (K131852)
Kit Components packaged with the proposed disposable Colonic Plus Regular, Small and straight shape Hydrokit (plastic water line, EVA corrugated and segmented waste hose, & surgical lubricant) are substantially equivalent to those included with the Transcom Hydrokit manufactured by Transcendencias Comerciales, S.L. (K131852) (See figure 4A above) Surgical Lubricant: Dynarex Sterile Lubricating Jelly K092488
INTENDED USE COMPARED TO THE PREDICATES DEVICE:
The device is intended for use to cleanse the colon when medically indicated, such as before radiological or endoscopic examination. It has the same intended use as predicate devices Transcom Hydrokit Manufactured by Trascendencias Comerciales, S.L. (K131852).
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SUMMARY DISCUSSION OF NON-CLINICAL DATA:
The Colonic Plus Regular, Small, and Straight Shape Hydrokits are substantially equivalent in indications for use, intended use, design and material as that of the Transcoms Hydrokit (K131852). The water pressure leakage test and the Tensile & Compression tests performed on the finalized Colonic Plus Hydrokits were passed according to our acceptance criteria and were substantial equivalent to the predicate device. We also submitted our finalized Colonic Plus hydrokits (Speculum, Obturator, and PVC water line) to American Preclinical Services for Biocompatability Testing on Cytotoxicity, Irritation and Sensitization which have all passed.
SUMMARY DISCUSSION OF CLINICAL DATA:
No clinical studies are submitted to support this premarket notification.
CONCLUSION:
We believe the intended use, the indications for use, the design, materials used, the functionality and the operation of the speculum kit is essentially the same as the predicate devices: Transcoms Hydrokit (K131852). Hence, substantial equivalence of the The Colonic Plus Regular, Small and Straight shape Hydrokits with the legally marketed device may be established.