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Cardiac Trigger CTM300

FDA 510(k)

Class II (US FDA 510(k))

510(k) K083854

by Ivy Biomedical Systems, Inc.

Identifiers

510(k) Number
K083854 FDA 510(k)
FDA Product Code
DRT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2300 FDA 510(k)
Regulation Number
870.2300 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Cardiac Trigger CTM300 is a cardiac synchronization device classified as a Monitor, Cardiac (Including Cardiotachometer & Rate Alarm). It generates precise timing signals aligned with the patient’s R-wave to enable synchronized imaging and diagnostic procedures. The device ensures accurate cardiac gating for modalities such as nuclear medicine, computed tomography (CT), magnetic resonance (MR), positron emission tomography (PET), and single photon emission computed tomography (SPECT).

The CTM300 is designed for use in clinical settings requiring precise cardiac synchronization, such as radiography, lithotripsy, and heart rate variability studies. It is a reusable device, supplied sterile or non-sterile as specified by the manufacturer, and operates in non-MRI environments. The model is authorized under FDA 510K clearance (K083854) and adheres to regulatory standards for Class II devices (D0RT). Storage and handling follow manufacturer guidelines to maintain functionality.

Frequently asked questions

What clinical procedures does the Cardiac Trigger CTM300 synchronize with, and why is this important for imaging accuracy?

The Cardiac Trigger CTM300 generates precise timing signals aligned with the patient’s R-wave to enable synchronized imaging for modalities like nuclear medicine, CT, MR, PET, and SPECT. This synchronization is critical because it reduces motion artifacts caused by the heartbeat, improving image clarity and diagnostic accuracy in procedures requiring high-resolution cardiac visualization.

Is the CTM300 designed for single-use or reusable applications, and how does this affect its maintenance?

The CTM300 is a reusable device, which means it can be used across multiple patients after proper cleaning, disinfection, and maintenance as outlined by the manufacturer’s guidelines. This design reduces waste and cost over time but requires adherence to strict protocols to ensure functionality and sterility when needed for sterile procedures.

Can the CTM300 be used in MRI environments, and if not, what are the implications for its placement in a clinical setting?

The CTM300 is explicitly designed for use in non-MRI environments, meaning it should not be placed inside or near an MRI scanner. Clinicians must ensure it is positioned outside the MRI bore to avoid interference with magnetic fields, which could compromise both the device’s performance and the safety of MRI procedures.

What regulatory pathway was followed for FDA clearance of the CTM300, and what does this mean for its safety and equivalence?

The CTM300 received FDA clearance through a 510(k) Special Review under the Cardiovascular (CV) Advisory Committee, with a decision code of SESE (Substantially Equivalent). This indicates the device was determined to be at least as safe and effective as a legally marketed predicate device, meeting Class II regulatory standards for cardiac monitors. The clearance number is K083854.

How should the CTM300 be stored, and does sterility play a role in its supply configuration?

The CTM300 can be supplied either sterile or non-sterile, depending on the manufacturer’s specifications for a given order. Sterility is relevant for procedures requiring aseptic conditions, such as certain cardiac interventions. Storage and handling must follow manufacturer instructions to preserve functionality, whether the device is sterile-packaged or intended for reprocessing.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF CTM-300 - Ivy Biomedical Systems, CARDIAC TRIGGER, MODEL: CTM300 by IVY BIOMEDICAL SYSTEMS, INC. | FDA ..., Ivy Data Sheets - Ivy Biomedical Systems

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ivy Biomedical Systems, Inc.

Sources (1)

  • FDA 510(k) K083854 24 fields · synced Sep 20, 2026