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K Number
K040228
Device Name
MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122
Manufacturer
MEDI-STIM A/S
Date Cleared
2004-04-29

(87 days)

Product Code
DPW
Regulation Number
870.2100
Type
Traditional
Panel
CV
Reference & Predicate Devices
K992305,K010452,K903026
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Medi-Stim VeriQ System is an intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions. The clinical indications for the device are:

  • Accurate transit time blood volume and Doppler velocity flow measurements during cardiovascular-, vascular-, transplantation- and neuro-surgery.
  • Simultaneous measurements of blood pressure, vascular resistance, interfaced physiological signals and other derived parameters during these procedures.
  • Detection of normal and abnormal blood volume and Doppler velocity flow patterns during these procedures.
  • Provides guidance to prepare surgical plans at the initiation of surgery and to support the successful accomplishment of surgery including detection and location of vessels during surgical procedures.
  • Detection and quantification of the degree of stenosis in arteries by using the Doppler velocity profile.
Device Description

The Medi-Stim VeriQ System is used intraoperatively to measure blood volume and velocity waveforms in arteries and veins. Transit time and Doppler ultrasonography is used to obtain these measurements.

AI/ML Overview

The provided text does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding ground truth, sample sizes, or expert involvement as requested.

The document is a 510(k) summary for the Medi-Stim VeriQ System, submitted to the FDA in 2004. It describes the device, its intended use, and indicates the FDA's determination of substantial equivalence to predicate devices. However, it does not include data from performance studies with acceptance criteria.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided input.

§ 870.2100 Cardiovascular blood flowmeter.

(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).