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K Number
K984628
Device Name
MODIFICATION OF MOSS P.E.G. TRAY
Manufacturer
MOSS TUBES, INC.
Date Cleared
1999-03-17

(77 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 Moss P. E. G. Tray is used to place a tube through the abdominal wall and into the lumen of the stomach (and/or beyond) without open surgery. The procedure provides a channel for providing nourishment directly into the digestive system for patients who cannot swallow (e.g. after stroke). An independent channel can be suctioned to remove excess feedings, swallowed air, or other fluids that might distend the stomach and lead to vomiting.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the Moss P.E.G. Tray, indicating substantial equivalence to a predicate device.

It includes:

  • Device Name: Moss P.E.G. Tray (Percutaneous Endoscopic Gastrostomy Tray)
  • Regulatory Class: II, 21 CFR 876.5980/Procode: 78 KNT
  • Indications for Use: To place a tube through the abdominal wall into the stomach for nourishment, and to remove excess feedings, air, or fluids.
  • Date of Clearance: March 17, 1999

However, it does not provide details about:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size, data provenance, or details of a test set.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study or effect size.
  6. Standalone performance study.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document is a regulatory approval notice, not a study report or clinical trial summary.

§ 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.