Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell Reservoir

510(k) Number

K121536 ↗

FDA Product Code

DTZ

Device Class

Class II

Regulation

21 CFR Part 870.4350

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• XTRA Autotransfusion System (with XTRA Bowl sets)

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• Card 43 Cardiotomy Reservoir with Phosphorylcholine Coating

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

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  FDA 510(k) K010974 Active Cleared 18 Jun 2001

• PureFlex Arterial Cannulae

  Class II

  FDA 510(k) K180979 Active Cleared 16 Nov 2018

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

• What is the Inspire 8F Oxygenator designed for?

  The Inspire 8F Oxygenator is specifically designed for use during open-heart surgical procedures, functioning as a cardiopulmonary bypass oxygenator. It facilitates gas exchange by removing carbon dioxide and adding oxygen to venous blood, ensuring efficient oxygenation while the heart is temporarily stopped or bypassed. The integrated arterial filter further reduces the risk of emboli, and the hardshell reservoir manages venous return and cardiotomy suction blood, maintaining optimal processing and temperature control throughout the procedure.

• How is the Inspire 8F Oxygenator supplied and what are its sterility and reuse specifications?

  The Inspire 8F Oxygenator is supplied as a single-use, sterile device. This design ensures patient safety by eliminating the risk of cross-contamination between uses. Single-use devices are intended for one-time use in controlled surgical environments, adhering to strict sterility protocols to maintain integrity before and during use. Reuse is not recommended or approved for this device.

• What distinguishes the hardshell reservoir design in this oxygenator?

  The hardshell reservoir in the Inspire 8F Oxygenator is engineered to manage venous return and cardiotomy suction blood efficiently. This design enhances performance by providing better temperature control and stability within the cardiopulmonary bypass circuit, reducing the risk of air entrainment and ensuring smoother blood processing during surgery. The rigid structure also supports consistent oxygenation and filtration, contributing to overall surgical safety.

• How should the Inspire 8F Oxygenator be stored and handled?

  The Inspire 8F Oxygenator must be stored and handled according to sterile medical device protocols to preserve its integrity. It should be kept in its original, unopened packaging until immediately before use, in a clean, dry environment protected from contamination, moisture, and extreme temperatures. Proper storage ensures the device remains sterile and functional, ready for use in controlled surgical settings as intended.

• What regulatory classification does this device hold, and what standards does it adhere to?

  The Inspire 8F Oxygenator is classified as a Class II medical device under FDA regulations and has received 510(k) clearance (K121536). It adheres to cardiovascular-specific standards, ensuring compliance with rigorous safety and performance requirements for use in cardiopulmonary bypass procedures. The device’s design and functionality have been evaluated to meet these regulatory criteria, guaranteeing reliability in clinical settings.