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Intra-Operative Positioning System (IOPS®) (MC-1) +4 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K230309

by Centerline Biomedical, Inc.

Identifiers

510(k) Number
K230309 FDA 510(k)
FDA Product Code
DQK FDA 510(k)
Models / Variants
Intra-Operative Positioning System (IOPS®) (MC-1) FDA 510(k)
IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1) FDA 510(k)
IOPS Guidewire (ATW-2) FDA 510(k)
IOPS Tracking Pad (TP-1) FDA 510(k)
IOPS Guidewire Handle (SSH-1) FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1425 FDA 510(k)
Regulation Number
870.1425 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Intra-Operative Positioning System (IOPS) is a suite of devices designed for real-time 3D visualization and navigation during endovascular procedures. It integrates catheters, guidewires, and tracking pads to align surgical instruments with pre-acquired 3D imaging data, enhancing precision and spatial awareness in vascular interventions. The system includes specialized catheters (Simple Curve and Reverse Curve), a guidewire, a tracking pad, and a guidewire handle, all engineered to work cohesively with intraoperative imaging systems. This aids clinicians in accurately positioning devices within complex vascular anatomies, reducing procedural uncertainty.

The IOPS system is supplied as a reusable set of components intended for use in sterile operating environments during endovascular procedures. Components are designed for compatibility with MRI-safe imaging systems and are intended for single-use per procedure, though the main console may be reusable. The system’s catheters, guidewire, and accessories are packaged sterilely and require no additional sterilization before use. Authorized for use in the United States under FDA 510(k) clearance (K230309), the system adheres to regulatory standards for cardiovascular devices, ensuring compliance with safety and performance requirements for intraoperative navigation tools.

Frequently asked questions

What is the IOPS® Intra-Operative Positioning System (MC-1) used for?

The IOPS® Intra-Operative Positioning System (MC-1) is designed for real-time 3D visualization and navigation during endovascular procedures. It integrates specialized catheters (Simple Curve and Reverse Curve), a guidewire, a tracking pad, and a guidewire handle to align surgical instruments with pre-acquired 3D imaging data. This enhances precision and spatial awareness, particularly in complex vascular anatomies, reducing procedural uncertainty.

How is the IOPS® system supplied, and is it sterile?

The IOPS® system is supplied as a reusable set of components, with individual catheters, guidewires, and accessories packaged sterilely for single-use per procedure. The system is engineered for sterile operating environments and does not require additional sterilization before use, ensuring readiness for immediate intraoperative application.

Are the catheters and guidewires reusable or single-use?

The catheters (Simple Curve and Reverse Curve), guidewire, and accessories in the IOPS® system are intended for single-use per procedure. While the main console may be reusable, the disposable components are designed to maintain sterility and performance for one use, reducing cross-contamination risks.

What models of catheters are included in the IOPS® system?

The IOPS® system includes two specialized catheters: the IOPS Simple Curve Catheter (SCC-1) and the IOPS Reverse Curve Catheter (RCC-1). These catheters are engineered to navigate complex vascular anatomies and work cohesively with the system’s tracking pad and guidewire for precise intraoperative positioning.

Is the IOPS® system compatible with MRI-safe imaging systems?

Yes, the IOPS® system is designed for compatibility with MRI-safe imaging systems. This ensures seamless integration with intraoperative imaging during endovascular procedures, allowing clinicians to leverage real-time 3D visualization without interference from non-MRI-safe components.

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: Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve ..., Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve ..., IOPS Technology | Centerline Biomedical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Centerline Biomedical, Inc.

Sources (1)

  • FDA 510(k) K230309 24 fields · synced Oct 1, 2026