(316 days)
The device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.
The disposable rectal speculum is a non-metal (Polypropylene) device used to introduce water into the colon and dispose waste from the colon during a colonic irrigation procedure.
I apologize, but the provided text does not contain the information required to answer your request regarding the acceptance criteria and the study that proves the device meets those criteria.
The document is a 510(k) premarket notification for a colonic irrigation system. It details the device's indications for use, technological characteristics, and claims substantial equivalence to predicate devices. However, it does not describe any specific performance acceptance criteria or a study that directly tests and proves the device meets such criteria.
Instead, the document focuses on:
- Substantial Equivalence: The primary argument for market clearance is that the device is substantially equivalent to legally marketed predicate devices in terms of intended use, indications for use, design, and materials.
- Biocompatibility Testing: It mentions that the finished colonkit was tested for biocompatibility, indicating one type of non-clinical testing performed.
Therefore, I cannot populate the requested table or provide details on the study's methodology, sample size, expert involvement, or ground truth establishment because this information is not present in the provided text.
To answer your question, information about specific performance metrics (e.g., flow rate, safety pressure limits, material strength, etc.), the criteria set for these metrics, and the results of tests designed to meet these criteria would be needed. This depth of information is typically found in design verification and validation reports, which are part of the larger 510(k) submission but are not fully detailed in this summary letter.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 10, 2016
Colonplus Equipments & Speculums, S.L. % Solmarie Rivera Senior Medical Device Expert Business Excellence Consulting, Inc. City View Plaza Suite #802/ #48 Road 165 Km 1.2 Guaynabo, 00968 PR
Re: K152834
Trade/Device Name: Colonplus Colonkit Small / Colonplus Colonkit Large / Colonplus Colonkit Large with Stop Collar 6 / Colonplus Colonkit Large with Stop Collar 10 Regulation Number: 21 CFR§ 876.5220 Regulation Name: Colonic Irrigation System Regulatory Class: II Product Code: KPL Dated: June 29, 2016 Received: June 29, 2016
Dear Solmarie Rivera:
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.
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.
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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 (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 contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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 vours.
Douglas Silverstein -S 2016.08.10 11:24:57 -04'00'
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152834
Device Name
Device Name
Colonkit Small / Colonplus Colonkit Large / Colonplus Colonkit Large with Stop Collar 6 / Colonplus Colonkit Large with Stop Collar 10
Indications for Use (Describe)
Indications for Use (Describe)
The device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(k) Summary
| 510(k) Owner's Name: | Colonplus Equipments & Speculums, S.L. |
|---|---|
| Address: | C/Portuetxe 13, 1-C |
| 20.018 - San Sebastian (Guipuzcoa) | |
| Spain | |
| Phone: | +34 670556449 |
| Email: | jorge@colonplus.net |
| Website: | www.colonplus.net |
| Name of Contact Person: | Jorge Echevarría |
| Address/Contact: | C/Portuetxe 13, 1-C |
| 20.018 - San Sebastian | |
| Spain | |
| Date Prepared: | May 4, 2015 |
| Trade Name: | Colonplus Colonkit Small, Colonplus Colonkit Large, ColonplusColonkit Large with Stop Collar 6, and Colonplus Colonkit Largewith Stop Collar 10 |
| Common Name: | Colonic Irrigation System |
| Classification Name: | System, Irrigation, Colonic (per 21 CFR 876.5220) Class II |
| Product Code: | KPL |
| Predicate Devices: | Submission #: K050112Trade Name: Pro-Fit™ Disposable Speculum (Regular and SmallSize) |
| Submission #: K131852 - HydrokitTrade Name: Transcom Colon Hydrotherapy Models HC-1 andHC 1 Clessia And Hydrokit |
Legally Marketed Devices to Which your Firm is Claiming Equivalence: The Colonplus Colonkits (Small, Large, Large with Stop Collar 6 and Large with Stop Collar 10) are substantially equivalent in intended use, indications for use, and design to the Prime Pacific Health Innovations Corporation Pro-Fit™ disposable speculum (Regular and Small size) cleared on March 15, 2005 under Pre-market Notification 510(k) number K050112. In addition, it is substantially equivalent in intended use, indications, design, and materials to the Hydrokit from Transcendencias Comerciales, S.L cleared on April 17, 2014 under Pre-Market Notification 510(k) K131852.
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Description of the Device: The disposable rectal speculum is a non-metal (Polypropylene) device used to introduce water into the colon and dispose waste from the colon during a colonic irrigation procedure.
Intended Use of the Device: The device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.
Technological Characteristics Compared to Predicate Device:
The Colonplus Colonkits have the same technological characteristics as, and are substantially equivalent to the Pro-Fit™ Disposable Speculums (K050112), manufactured by Prime Pacific Health Innovations Corporation (See Figure 5A, 5B, and 5C). Both products are to be used with colon hydrotherapy equipment. The Colonplus Colonkit large was designed with two variations including a stop collar (insertion stopper) with an irrigation water entrance with diameter of 6 mm and 10 mm, respectively. The Pro-Fit™ speculum, released per 510(k) K050112, was designed with an insertion stopper to avoid over insertion, as well. The design of the Colonplus Colonkit cannula with obturator is also substantially equivalent to the speculum in the Hydrokit predicate with Pre-market Notification 510(k) K131852. Both have models with and without stop collar. Refer to Figures 5D and 5E below.
Image /page/4/Picture/4 description: The image shows a white plastic part with a stop collar. The stop collar is located near the middle of the part. The part has a pointed end and a cylindrical body. There is an arrow pointing to the stop collar with the text "Stop Collar".
Figure 5A Predicate Pro-Fit™ Disposable Speculum (with stop collar/limit)
Image /page/4/Picture/6 description: The image shows a medical device with an arrow pointing to the stop collar. The stop collar is a ring-shaped component that is part of the device. The device appears to be made of clear plastic and has a cylindrical shape. The text "Stop Collar" is written next to the arrow.
Figure 5B Colonplus Colonkit (cannula with stop collar)
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Image /page/5/Picture/0 description: The image shows a medical device, possibly a catheter or similar instrument, against a dark background. The device is translucent and cylindrical, with several attachments or ports along its length. It appears to be made of plastic or a similar material, and its design suggests it is intended for insertion into the body for medical purposes.
Figure 5C Colonplus Colonkit (cannula without stop collar)
Image /page/5/Picture/2 description: The image shows a medical device in a clear plastic bag. The device is white and has a cylindrical shape with a ring on one end. There are also a couple of tubes coming out of the side of the cylinder. The device appears to be a catheter or some other type of medical instrument.
Figure 5D Polypropylene Predicate Hydrokit (cannula without stop collar)
Image /page/5/Picture/4 description: The image shows medical tubing and equipment on a black background. There is a long, corrugated tube coiled on the left side of the image. There is also a smaller, clear tube coiled in a circle. A stop collar is labeled on the right side of the image.
Figure 5E Polypropylene Predicate Hydrokit (kit including cannula with stop collar)
The Colonplus Colonkit cannula and obturator are made out of polypropylene, in contrast to the ProFit™ which is made out of polyethylene. Polypropylene has good impact strength, surface hardness, dimensional stability and excellent abrasion resistance. The finished colonkit was tested for biocompatibility by Laboratorio BIOLAB S.L in Spain. When compared with predicate 510(k) K131852 Hydrokit from Transcendencias Comerciales S.L, both are made out of polypropylene and have the same intended use and indications for use, which supports the substantial equivalence of materials.
The kit components of the Colonkits (irrigation tube and evacuation tube) are also substantially equivalent to those included in the ProFit™ disposable speculum kit (water line and
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water hose) manufactured by Prime Pacific Health Innovations Company through 510(k) K050112.
Indications for use
The device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.
Summary and Conclusions from the Nonclinical Tests Submitted:
Substantial equivalence of the Colonplus Colonkit System is supported by a comparison of the intended use, indications for use, and design with the Pro-fit™(K050112) and by a comparison of the intended use, indications for use, design and materials to the Hydrokit (K131852), as well as acceptable results from biocompatibility test.
§ 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.