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K Number
K973844
Device Name
GASTRIC AND RECTAL CATHETERS
Manufacturer
G & J ELECTRONICS, INC.
Date Cleared
1999-06-04

(604 days)

Product Code
FFX
Regulation Number
876.1725
Type
Traditional
Panel
Gastroenterology/Urology
Reference & Predicate Devices
N/A
Predicate For
K160287
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Mui Scientific Y-type Barostat Gastric Catheter is used as part of a barostat system to measure sensory pressures and volumes in the stomach.
The Mul Sclentific Y-type Barostat Rectal Catheter is used as part of a barostat system to measure sensory pressures and volumes in the anorectal region.

Device Description

Y-type Gastric Catheter; Y-type Rectal Catheter

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets specific criteria. The document is a 510(k) clearance letter from the FDA for a medical device (Mui Scientific Y-Type Gastric and Rectal Barostat Catheters), which confirms its substantial equivalence to legally marketed predicate devices.

The document only discusses the device's intended use and regulatory classification. It does not include details regarding:

  • A table of acceptance criteria or reported device performance.
  • Sample sizes for test sets, data provenance, or details of a study.
  • The number or qualifications of experts used to establish ground truth.
  • Adjudication methods.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies.
  • Standalone algorithm performance.
  • The type of ground truth used.
  • Sample size for training sets or how ground truth for training sets was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria using the provided text.

§ 876.1725 Gastrointestinal motility monitoring system.

(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).