(121 days)
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No
The 510(k) summary describes a mechanical tube retention system and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device's stated indication is to prevent inadvertent removal or displacement of tubes, which is a supportive function rather than a direct therapeutic intervention for disease or injury.
No
The device is described as a tube retention system to prevent inadvertent removal or displacement of feeding tubes, which is a therapeutic or supportive function, not a diagnostic one.
No
The description clearly states the device is a "Nasogastric/Nasointestinal (NG/NI) Tube Retention System" and is indicated for use with "CORPAK MedSystems enteral feeding tubes". This indicates a physical system designed to retain tubes, not a software-only device.
Based on the provided information, the CORGRIP Nasogastric/Nasointestinal (NG/NI) Tube Retention System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent inadvertent removal or displacement of enteral feeding tubes in adult patients. This is a mechanical function related to securing a medical device within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any interaction with bodily specimens or diagnostic purposes.
- Anatomical Site: The device is used with tubes placed in the nasogastric/nasointestinal tract, which is a physical location within the body, not a specimen source for in vitro testing.
Therefore, the CORGRIP system is a medical device used for patient care, but it does not fit the definition of 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 CORPAK MedSystems enteral feeding tubes of 8 Fr and greater to prevent inadvertent removal or displacement of the tubes for adult patients.
Product codes
KNT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adult patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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)
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§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing segments, representing the department's commitment to health, human services, and well-being. The eagle is positioned within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling it.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 26, 2014
CORPAK MedSystems, Inc. Stephanie Wasielewski VP, RA/QA 1001 Asbury Drive Buffalo Grove, IL 60089
K133599 Re:
Trade/Device Name: CORGRIP Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: February 24, 2014 Received: February 25, 2014
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. The I ou may a 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 r lease oc advised that i Driv issual.co evour device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies.
1
Page 2 – Stephanie Wasielewski
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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/6 description: The image shows the name "Benjamin Asher-S" in a bold, sans-serif font. The letters are black against a white background, and the name is written in a single line. The letters "DA" are stylized and appear to be part of a logo.
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
2
INDICATIONS FOR USE
510(k): K133599
Device Name: CORGRIP
Indications for use:
The CORGRIP Nasogastric/Nasointestinal (NG/NI) Tube Retention System is indicated for use with CORPAK MedSystems enteral feeding tubes of 8 Fr and greater to prevent inadvertent removal or displacement of the tubes for adult patients.
× Prescription Use __ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Per 21 CFR 801.109)
or Over-the-counter use ______________________________________________________________________________________________________________________________________________________
Concurrence of CDRH, Office of Device Evaluation (ODE)
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