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K Number
K973230
Device Name
MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)
Manufacturer
MERIT MEDICAL SYSTEMS, INC.
Date Cleared
1997-11-25

(90 days)

Product Code
DXT
Regulation Number
870.1650
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Universal Fluid Dispensing Syringe is Merit Medical's Monarch Syringe and Intellisystem Syringe intended to be used by healthcare professionals to inject fluids into the body and monitor the pressure of that fluid.

Device Description

This is a general purpose syringe and inflation device with pressure monitoring capability.

AI/ML Overview

This document is a 510(k) summary for a Universal Fluid Dispensing Syringe (Merit Medical's Monarch Syringe and Intellisystem Syringe) and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria related to AI/ML performance.

The document discusses:

  • Device Name: Universal Fluid Dispensing Syringe
  • Common Name: Piston Syringe
  • Trade Name: Intellisystem Inflation Device and Fluid Dispensing Syringe, Monarch Inflation Device and Fluid Dispensing Syringe
  • Intended Use: To be used by healthcare professionals to dispense fluids to the body and monitor the pressure of that fluid.
  • Technological Characteristics: Describes two models (Monarch and Intellisystem) which are 20ml volume syringes with electronic pressure monitoring capabilities and fluid dispensing mechanisms.
  • Predicate Device: Merit Medical Medallion Syringe
  • Regulatory Classification: Class II (Product Code: DXT)
  • FDA Decision: Found substantially equivalent to pre-amendment devices, allowing market entry.

Therefore, I cannot provide the requested information as it is not present in the given text. The questions you posed are typically relevant for AI/ML-based medical devices, which this document does not describe.

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.