(48 days)
Not Found
No
The device description and summary of performance studies focus on mechanical components and physical properties, with no mention of AI or ML algorithms for analysis, decision-making, or image processing.
No.
The device is described as an accessory that prevents inadvertent removal or displacement of nasogastric/nasojejunal tubes, which functions as a retention system rather than providing a therapeutic effect itself.
No
The device's description and intended use clearly state it is for retaining nasogastric/nasointestinal tubes to prevent inadvertent removal or displacement and to secure the feeding tube. It does not mention any function related to diagnosing a disease or condition.
No
The device description clearly outlines physical components (insertion catheter, retrieval catheter, tube clamp) and their mechanical function in retaining a tube. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to physically retain nasogastric/nasointestinal tubes to prevent their displacement or removal. This is a mechanical function performed on the patient's body.
- Device Description: The description details a system of catheters, magnets, umbilical tape, and a clamp used for physical retention. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a physical accessory used to secure a medical tube within the patient's body. This falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CORGRIP Nasogastric/Nasointestinal (NG/NI) Tube Retention System is indicated for use with enteral feeding tubes of 8 FR and greater and NG decompression, suction and drainage tubes up to 18 FR to prevent inadvertent removal or displacement of the tubes for adult patients.
Product codes
KNT
Device Description
The CORGRIP NG/NI Tube Retention System is an accessary to prevent unwanted displacement or removal of nasogastric/nasojejunal tubes for adult patients by retaining the tube to the patient's nasal septum. The device consists of three main components: insertion (delivery) catheter, retrieval catheter, and tube clamp.
The catheters are placed in either nare of the patient and the clinician maneuvers the catheters to connect the magnets at the back of the patient's nasal septum. Both catheters have a flexible tip to aid in magnet connection. Once connection is made the magnet on the insertion catheter is pulled through the nare by the retrieval catheter. Both catheters are then removed from each nare until the ends of the umbilical tape are exiting either nare. The umbilical tape is then secured to the feeding tube with the provided clamp.
The proposed device adds the option of a 14, 16 and 18 Fr clamp.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal septum
Indicated Patient Age Range
adult patients
Intended User / Care Setting
clinician, Prescription Use
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 14, 16, and 18 Fr CORGRIP NG/NI Tube Retention System clamp testing was conducted in a laboratory setting to establish verification of design requirements. Testing found that all clamps and materials met or exceeded design requirements established for the components when used with Covidien Salem Sump Dual Lumen Stomach Tubes. The following tests showed that the additional clamp sizes are substantially equivalent to those of the predicate device:
- Visual inspections
- Tether grip strength
- Tube grip strength
- Tube occlusion
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2016
CORPAK MedSystems, Inc. A Division of Halyard Health Stephanie Wasielewski VP, RA/QA 1001 Asbury Drive Buffalo Grove, IL 60089
Re: K162110
Trade/Device Name: CORGRIP NG/NI Tube Retention System Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT Dated: July 27, 2016 Received: July 29, 2016
Dear Stephanie Wasielewski:
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. 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
1
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. 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 (OS) 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,
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) K162110
Device Name CORGRIP NG/NI Tube Retention System
Indications for Use (Describe)
The CORGRIP Nasogastric/Nasointestinal (NGNI) Tube Retention System is indicated for use with enteral feeding tubes of 8 FR and greater and NG decompression, suction and drainage tubes up to 18 FR to prevent inadvertent removal or displacement of the tubes for adult patients.
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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Image /page/3/Picture/1 description: The image is a logo for "CORPAK MEDSYSTEMS". The logo is set against a blue background with rounded corners. The word "CORPAK" is in large, bold, white letters, and there is a yellow line underneath it. Below the line, the word "MEDSYSTEMS" is written in smaller, white letters.
510(k) Summary
- l. SUBMITTER
CORPAK MedSystems, Inc. 1001 Asbury Dr. Buffalo Grove, IL 60089
P: 847 403-3400 Contact: Stephanie Wasielewski Date prepared: July 27, 2016
II. DEVICE
Trade name: CORGRIP NG/NI Tube Retention System Common name: Tube retention Classification name: Gastrointestinal tube and accessories (21 CFR 876.5980) Regulatory Class: II Product Code: KNT
III. PREDICATE DEVICE
CORGRIP NG/NI Tube Retention System (K133599)
IV. DEVICE DESCRIPTION
The CORGRIP NG/NI Tube Retention System is an accessary to prevent unwanted displacement or removal of nasogastric/nasojejunal tubes for adult patients by retaining the tube to the patient's nasal septum. The device consists of three main components: insertion (delivery) catheter, retrieval catheter, and tube clamp.
The catheters are placed in either nare of the patient and the clinician maneuvers the catheters to connect the magnets at the back of the patient's nasal septum. Both catheters have a flexible tip to aid in magnet connection. Once connection is made the magnet on the insertion catheter is pulled through the nare by the retrieval catheter. Both catheters are then removed from each nare until the ends of the umbilical tape are exiting either nare. The umbilical tape is then secured to the feeding tube with the provided clamp.
The proposed device adds the option of a 14, 16 and 18 Fr clamp.
V. INDICATIONS FOR USE
The CORGRIP Nasogastric/Nasointestinal (NG/NI) Tube Retention System is indicated for use with enteral feeding tubes of 8 FR and greater and NG decompression, suction and drainage tubes up to 18 FR to prevent inadvertent removal or displacement of the tubes for adult patients.
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VI. COMPARISON
The predicate device is identical to the proposed device with the exception of the additional clamp sizes (14,16 and 18Fr).
VII. Performance Data
The 14, 16, and 18 Fr CORGRIP NG/NI Tube Retention System clamp testing was conducted in a laboratory setting to establish verification of design requirements. Testing found that all clamps and materials met or exceeded design requirements established for the components when used with Covidien Salem Sump™ Dual Lumen Stomach Tubes. The following tests showed that the additional clamp sizes are substantially equivalent to those of the predicate device:
- . Visual inspections
- Tether grip strength
- Tube grip strength ●
- . Tube occlusion
Based upon the clamp test results, the proposed device design remains substantially equivalent to the predicate device.
VIII.Conclusions
There are no material or design changes being made to any components of the CORGRIP. In order to accommodate the larger suction tubes CORPAK has added three clamp sizes 14, 16 and 18 Fr.
The use, safety and effectiveness, of the proposed device clamps are substantially equivalent to the predicate device in terms of intended use, mode of operation, patient population, design, acceptance criteria, and biocompatibility.