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Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K223682

by Sirius Medical Systems B.V.

Identifiers

510(k) Number
K223682 FDA 510(k)
FDA Product Code
PBY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4300 FDA 510(k)
Regulation Number
878.4300 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Sirius Pintuition System is a Temporary Tissue Marker designed for percutaneous placement in soft tissue. It provides real-time localization and navigation feedback to surgeons, enabling precise targeting of biopsy sites or surgical removal areas. The system includes a seed marker, a reusable probe, and a base unit that delivers audio-visual guidance. Its wire-free design eliminates the need for external tracking systems, improving surgical workflow efficiency.

The system is intended for use in General, Plastic Surgery procedures and is reusable (resterilizable) per manufacturer specifications. The probe and base unit are non-sterile and require sterilization between uses, while the seed is single-use. Compliance with FDA 510(k) clearance (K223682) and EU MDR (as referenced in web context) ensures regulatory adherence. The system operates in non-MRI environments and is supplied as a modular kit for surgical navigation.

Frequently asked questions

What is the Sirius Pintuition System used for?

The Sirius Pintuition System is designed for percutaneous placement in soft tissue during surgical procedures, specifically in General and Plastic Surgery. It provides real-time audio-visual guidance to surgeons, enabling precise localization and navigation of biopsy sites or surgical removal areas. The wire-free design eliminates the need for external tracking systems, enhancing workflow efficiency.

How is the Sirius Pintuition System supplied?

The system is supplied as a modular kit, consisting of a single-use seed marker, a reusable probe, and a reusable base unit. The seed is intended for one-time use, while the probe and base unit are non-sterile and require sterilization between uses to maintain compliance with manufacturer specifications.

Is the seed marker reusable or single-use?

The seed marker in the Sirius Pintuition System is designed for single-use only. This ensures sterility and safety for each surgical procedure, as reusing the seed could compromise its integrity and introduce contamination risks.

Can the Sirius Pintuition System be used in MRI environments?

No, the Sirius Pintuition System is explicitly designed for use in non-MRI environments. Its components are not MRI-compatible, so it should only be used in settings where MRI imaging is not required or available.

What regulatory approvals does the Sirius Pintuition System hold?

The Sirius Pintuition System holds FDA 510(k) clearance under the reference number K223682, confirming it is deemed substantially equivalent to a legally marketed predicate device. Additionally, it complies with EU MDR requirements, though specific CE marking details would require verification from the manufacturer or regulatory databases.

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: Pintuition System — Surgical Marker Navigation - sirius-medical.com, Advance beyond localization to real-time navigation - Sirius Medical, Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sirius Medical Systems B.V.

Sources (1)

  • FDA 510(k) K223682 24 fields · synced Oct 1, 2026