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K Number
K990389
Device Name
MOSS GASTROSTOMY TUBE
Manufacturer
MOSS TUBES, INC.
Date Cleared
1999-03-22

(42 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

Used for gastric and proximal duodenal decompression plus duodenal feeding.

Device Description

Moss Gastrostomy Tube

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study proving the device meets them. The document is a 510(k) clearance letter from the FDA for a device called "Moss Gastrostomy Tube," dated March 22, 1999. It states that the device is substantially equivalent to legally marketed predicate devices.

The letter mentions:

  • Device Name: Moss Gastrostomy Tube
  • Indications for Use: Used for gastric and proximal duodenal decompression plus duodenal feeding.
  • Regulatory Class: II, 21 CFR 876.5980
  • Procode: 78 KNT

However, it does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes used for test sets, data provenance, or retrospective/prospective study details.
  3. Number of experts or their qualifications for establishing ground truth.
  4. Adjudication methods.
  5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human readers with/without AI assistance.
  6. Results of a standalone algorithm-only performance study.
  7. The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document serves as a regulatory clearance document based on substantial equivalence, not a detailed study report with performance metrics.

§ 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.