(60 days)
Not Found
No
The device description focuses on mechanical components and physical properties, with no mention of AI/ML capabilities or data processing beyond basic flow and resistance.
Yes.
The device is used for treatment of acute non-toxic megacolon and colonic strictures, which indicates a therapeutic purpose.
No
The device is described as being used for the "treatment of acute non-toxic megacolon... and colonic strictures" and its design facilitates "colon decompression," indicating its therapeutic rather than diagnostic purpose.
No
The device description clearly outlines physical components such as a colon decompression tube, guiding catheter, and wire guide, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of acute non-toxic megacolon and colonic strictures. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is designed for decompression and drainage of the colon. It's a tool used in a medical procedure to alleviate a condition, not to analyze a sample from the body to diagnose a disease or condition.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to directly intervene in a physical condition within the body.
N/A
Intended Use / Indications for Use
This device is used for treatment of acute non-toxic megacolon, (Ogilvie's syndrome) and colonic strictures.
Product codes (comma separated list FDA assigned to the subject device)
FEG
Device Description
14Fr Colon Decompression Set (CDSG)
The CDSG device consists of a colon decompression tube, guiding catheter and wire guide. The colon decompression tube is 14Fr in diameter with a length of 175cm. The device design includes side ports which allow for colon decompression. The device has connections to allow attachment to drainage collection bag or for the device to be flushed. The colon decompression tube, guiding catheter and wire guide can be observed fluoroscopically. The device is supplied sterile, intended for single use only. Use of this device is restricted to a trained healthcare professional.
Marcon Colon Decompression Set (CDSM)
The CDSM device consists of a colon decompression tube and wire guide. The colon decompression tube is supplied in a range of diameter options, 7Fr. 8.5Fr and 10Fr. The colon decompression tube has a length of 350cm. The device design includes side ports which allow for colon decompression. The device has connections to allow attachment to drainage collection bag or for the device to be flushed. The colon decompression tube and wireguide can be observed fluoroscopically. The colon decompression tube has a design feature (pigtail) at the distal end of the device which helps reduce migration. The device is supplied sterile, intended for single use only. Use of this device is restricted to a trained healthcare professional.
Wire Guide
The same wire guide is supplied with both the CDSG and CDSM devices; the wire guide has a flexible distal ball tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopically
Anatomical Site
colon
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professional.
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)
The biocompatibility evaluation for the Colon Decompression Sets, was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" (June 16, 2016). Performance testing included simulated use, dimensional testing, resistance to collapse, flow rate, tensile strength testing, dimensional and leakage tests, MR safety testing, radiopacity and shelf life testing. The results of the non-clinical testing demonstrates that the Colon decompression sets met the design input requirements based on the intended use, and do not raise new questions of safety or effectiveness.
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.
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
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1, 2017
Cook Ireland Ltd Laura Graham Regulatory Affairs Specialist O'Halloran Road, National Technology Park Limerick Ireland
Re: K171619 Trade/Device Name: 14Fr Colon Decompression Set (CDSG) Marcon Colon Decompression Set (CDSM) Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: FEG Dated: May 31, 2017 Received: June 2, 2017
Dear Laura Graham:
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.
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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 (reporting of medical devicerelated 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,
Charles Viviano -S
Benjamin R. Fisher, Ph.D. For 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) K171619
Device Name
14Fr Colon Decompression Set (CDSG) Marcon Colon Decompression Set (CDSM)
Indications for Use (Describe)
This device is used for treatment of acute non-toxic megacolon, (Ogilvie's syndrome) and colonic strictures.
| 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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I. SUBMITTER
Cook Ireland Ltd. O' Halloran Road National Technology Park Limerick Ireland
Phone: +353 61 334440 Fax: +353 61 239293
Contact Persons: Laura Graham, Regulatory Affairs Specialist Jacinta Kilmartin, Regulatory Affairs Manager
Phone: +353 61 334440 Fax: +353 61 239293
Date Prepared: May 31, 2017
II. DEVICE
Trade Name of Device:
- . 14Fr Colon Decompression Set (CDSG)
- . Marcon Colon Decompression Set (CDSM)
The model numbers are CDSG-14-175, CDSM-7, CDSM-8.5 and CDSM-10.
Common or Usual Name: Colon Decompression Set
Classification Name: Gastrointestinal Tubes and Accessories (21 CFR 876.5980)
Regulatory Class: II
Product Code: FEG
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III. PREDICATE DEVICE
Predicate: Cook Colon Decompression Set, K900035 cleared on March 07, 1990.
IV. DEVICE DESCRIPTION
14Fr Colon Decompression Set (CDSG)
The CDSG device consists of a colon decompression tube, guiding catheter and wire guide. The colon decompression tube is 14Fr in diameter with a length of 175cm. The device design includes side ports which allow for colon decompression. The device has connections to allow attachment to drainage collection bag or for the device to be flushed. The colon decompression tube, guiding catheter and wire guide can be observed fluoroscopically. The device is supplied sterile, intended for single use only. Use of this device is restricted to a trained healthcare professional.
Marcon Colon Decompression Set (CDSM)
The CDSM device consists of a colon decompression tube and wire guide. The colon decompression tube is supplied in a range of diameter options, 7Fr. 8.5Fr and 10Fr. The colon decompression tube has a length of 350cm. The device design includes side ports which allow for colon decompression. The device has connections to allow attachment to drainage collection bag or for the device to be flushed. The colon decompression tube and wireguide can be observed fluoroscopically. The colon decompression tube has a design feature (pigtail) at the distal end of the device which helps reduce migration. The device is supplied sterile, intended for single use only. Use of this device is restricted to a trained healthcare professional.
Wire Guide
The same wire guide is supplied with both the CDSG and CDSM devices; the wire guide has a flexible distal ball tip.
INDICATIONS FOR USE V.
This device is used for treatment of acute non-toxic megacolon, pseudo-obstruction (Ogilvie's syndrome) and colonic strictures.
The subject and predicate device are intended to be used for colon decompression.
The intended use is identical; however, the indications for use (patient population) are limited for the subject device compared to the original clearance for the predicate device.
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH A PREDICATE DEVICE
The subject device is substantially equivalent to the currently marketed device, Colon Decompression Sets, K900035 cleared on March 07, 1990.
In brief, the subject device has the same technological characteristics as the predicate Colon Decompression Sets, with respect to the following:
- Both devices have the same intended use for colon decompression. —
- | Both devices are for use in the colon.
- -Both devices are intended for single use only.
- -Both devices are sold sterile and are sterilised using ethylene oxide.
- -Both devices are visible under fluoroscopy (radiopaque).
- Both devices have side ports. -
- Both devices are placed over the 0.035in wire guide. -
- -Both devices are supplied with a wire guide with the same material and dimensions.
The following technological differences exist between the subject device and the predicate device, Cook Colon Decompression Sets;
- Method of placement (Via a Colonoscope) and supplied with of guiding catheter. |
- । Colon decompression tube dimensions (Diameter and Length) and sideport configuration
- Pigtail (For CDSM models only) |
- | Material
PERFORMANCE DATA VII.
The biocompatibility evaluation for the Colon Decompression Sets, was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" (June 16, 2016). Performance testing included simulated use, dimensional testing, resistance to collapse, flow rate, tensile strength testing, dimensional and leakage tests, MR safety testing, radiopacity and shelf life testing.
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VIII. CONCLUSIONS
The subject device has indications for use and technological characteristics that are similar to the predicate device. The results of the non-clinical testing demonstrates that the Colon decompression sets met the design input requirements based on the intended use, and do not raise new questions of safety or effectiveness. The results of these tests support a determination of substantial equivalence of the colon decompression sets to the predicate device.