Xtra

Model / Reference

04364CN

Primary DI / UDI-DI

08033178115032

Basic UDI-DI

8033178CARDATSPROCFZ

510(k) Number

K112245 ↗

FDA Product Code

CAC

EMDN Code

B0401 Intra- and postoperative blood collection, washing and reinfusion devices and kits

Device Class

Class IIb EUDAMED

Class II 510(k)

Regulation

21 CFR Part 868.5830

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Cardioplegia Adapters, Vessel Canulae, and Aortic Root Cannulae

  Class II

  FDA 510(k) K972503 Active Cleared 26 Aug 1997

• XTRA Autotransfusion System (with XTRA Bowl sets)

  Class II

  FDA 510(k) K240584 Active Cleared 29 Apr 2024

• Card 43 Cardiotomy Reservoir with Phosphorylcholine Coating

  Class II

  FDA 510(k) K061527 Active Cleared 27 Jun 2006

• Retrograde Cardioplegia Cannula, Manual-Inflating, with Malleable or Guidwire Stylet

  Class II

  FDA 510(k) K010974 Active Cleared 18 Jun 2001

• PureFlex Arterial Cannulae

  Class II

  FDA 510(k) K180979 Active Cleared 16 Nov 2018

• Revolution Centrifugal Blood Pump

  Class II

  FDA 510(k) K190650 Active Cleared 7 Aug 2019

See all devices from Sorin Group Italia S.R.L. →

• What is the primary purpose of the XTRA Autotransfusion System, and how does it reduce reliance on blood transfusions during surgery?

  The XTRA Autotransfusion System is designed for intraoperative and postoperative cell salvage, meaning it collects, processes, and reinfuses a patient’s own blood (autologous blood) during surgery. By doing so, it helps minimize the need for allogeneic blood transfusions—blood donated by others—which can reduce risks like infections, immune reactions, and complications from foreign blood products. This system is specifically intended for use in anesthesiology settings to support surgical procedures where blood loss is anticipated.

• Is the XTRA collection set reusable, or is it intended for single-use only? How does this affect its sterility?

  The XTRA collection set is intended for single-use only. This design ensures sterility is maintained throughout its use, as reuse could compromise the integrity of the plastic materials (including PVC) and introduce contamination risks. Since it’s sterile upon packaging, it must be handled according to the manufacturer’s instructions to preserve sterility until use.

• What materials is the XTRA collection set primarily made of, and are there any considerations for patients with material sensitivities?

  The XTRA collection set is primarily composed of plastic materials, including PVC. While PVC is commonly used in medical devices, patients with known sensitivities to plastics or PVC should be evaluated by their healthcare provider before use. The system is not designed to accommodate alternative materials, so compatibility with the patient’s medical history is a clinical consideration.

• How should the XTRA Autotransfusion System be stored to ensure it remains effective and sterile?

  The XTRA collection set must be stored according to the manufacturer’s instructions to maintain sterility and functionality. This typically includes keeping it in its original packaging, away from direct sunlight or extreme temperatures, and protecting it from physical damage. Improper storage could compromise the device’s integrity, potentially affecting its performance during use.

• What regulatory pathways has the XTRA Autotransfusion System followed, and how does this classify its use in clinical settings?

  The XTRA Autotransfusion System has undergone FDA 510(k) clearance (K112245) and MDR compliance, classifying it as a Class II medical device under regulation 868.5830. This designation means it has been evaluated for safety and effectiveness through a structured regulatory process, ensuring it meets standards for autologous blood salvage in surgical settings. The system is not intended for any other clinical use beyond what’s specified in its regulatory filings.