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K Number
K972655
Device Name
CONTROL SYRINGE
Manufacturer
MEDICAL SPECIALTIES INTL., INC.
Date Cleared
1997-11-04

(112 days)

Product Code
IZI
Regulation Number
892.1600
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This device is used when viscous liquid needs to be hand-force injected into a manifold or tubing set. The polycarbonate housing enables pressure to be exerted without fear of breakage. nowsing charice problams of so so catheterization procedure.

Device Description

Control Syringe Models 10200, 10201, 10202, 10203, 10204 and 10205

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria. The documents are a regulatory approval letter (K972655) for "Control Syringe Models 10200, 10201, 10202, 10203, 10204 and 10205" and an "Indications For Use" statement.

Specifically, the text is missing:

  1. A table of acceptance criteria and reported device performance: This information is not present. The letter only states that the device is "substantially equivalent" to predicate devices.
  2. Sample size used for the test set and data provenance: No details about a test set or its characteristics are provided.
  3. Number of experts and their qualifications for ground truth: No mention of experts or ground truth establishment for a test set.
  4. Adjudication method: Not discussed in the provided documents.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study: No information on such a study.
  6. Standalone performance study: No details about an algorithm-only performance study.
  7. Type of ground truth used: Not specified, as no study details are given.
  8. Sample size for the training set: Not mentioned.
  9. How ground truth for the training set was established: Not mentioned.

The documents focus solely on the regulatory approval process based on "substantial equivalence" to a predicate device, as opposed to a detailed performance study with specific acceptance criteria.

§ 892.1600 Angiographic x-ray system.

(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.