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K Number
K063061
Device Name
CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
Manufacturer
VIASYS MEDSYSTEMS
Date Cleared
2007-04-02

(179 days)

Product Code
KNT
Regulation Number
876.5980
Type
Traditional
Panel
GU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The CORTRAK™ System is an electrical device designed to aid qualified operators in the placement of VIASYS MedSystems feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding, Prior to commencing the delivery of food, confirmation of correct tube placement by X-ray or acceptable hospital protocol is required.

Device Description

The CORTRAK™ System is an electrical device designed to aid qualified operators in the placement of VIASYS MedSystems feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe a study proving such criteria are met. The document is an FDA 510(k) clearance letter for the CORTRAK™ Enteral Access Device, indicating that the device has been found substantially equivalent to a predicate device.

The letter discusses:

  • The device name and regulation details.
  • The FDA's determination of substantial equivalence.
  • General controls and regulations applicable to the device.
  • Contact information for further inquiries.
  • The "Indications for Use" for the CORTRAK™ System.

It does not include details about:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes, data provenance, or study types (retrospective/prospective).
  3. Number or qualifications of experts for ground truth.
  4. Adjudication methods.
  5. MRMC comparative effectiveness studies or effect sizes.
  6. Standalone algorithm performance.
  7. Type of ground truth used (e.g., pathology, outcomes data).
  8. Training set sample size.
  9. How ground truth for the training set was established.

§ 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.