IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System

• 8 recalls, same reason

  • Completed Z-0682-2021 FDA Class II ·initiated 18 Nov 2020
  • Completed Z-0660-2021 FDA Class II ·initiated 18 Nov 2020
  • Completed Z-0685-2021 FDA Class II ·initiated 18 Nov 2020
  • Completed Z-0683-2021 FDA Class II ·initiated 18 Nov 2020
  • Completed Z-0658-2021 FDA Class II ·initiated 18 Nov 2020
  • Completed Z-0684-2021 FDA Class II ·initiated 18 Nov 2020
  • Completed Z-0661-2021 FDA Class II ·initiated 18 Nov 2020
  • Completed Z-0657-2021 FDA Class II ·initiated 18 Nov 2020

  Complaint trend regarding needle shaft gas leaks.

• 10 recalls, same reason

  • Terminated Z-2676-2020 FDA Class II ·initiated 4 Jun 2020
  • Terminated Z-2683-2020 FDA Class II ·initiated 4 Jun 2020
  • Terminated Z-2677-2020 FDA Class II ·initiated 4 Jun 2020
  • Terminated Z-2678-2020 FDA Class II ·initiated 4 Jun 2020
  • Terminated Z-2681-2020 FDA Class II ·initiated 4 Jun 2020
  • Terminated Z-2679-2020 FDA Class II ·initiated 4 Jun 2020
  • Terminated Z-2682-2020 FDA Class II ·initiated 4 Jun 2020
  • Terminated Z-2680-2020 FDA Class II ·initiated 4 Jun 2020
  • Terminated Z-2674-2020 FDA Class II ·initiated 4 Jun 2020
  • Terminated Z-2675-2020 FDA Class II ·initiated 4 Jun 2020

  The needle surface deteriorated due to unexpected electrolysis during procedure.

510(k) Number

K152133 ↗

FDA Product Code

GEH

FDA applicant

Galil Medical , Ltd.

Device Class

Class II

Regulation

21 CFR Part 878.4350

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Cryo-Hit II, Models EP3T3, EP5T2, EP5T5, EP7T5, EP8T5

  Class II

  FDA 510(k) K991517 Active Cleared 27 Jul 1999

• Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch 2024 (Seednetgold)

  Class II

  FDA 510(k) K042667 Active Cleared 14 Oct 2004

• IceEdge 2.4 Cryoablation Needle

  Class II

  FDA 510(k) K111859 Active Cleared 7 Oct 2011

• Visual-Ice Cryoablation System

  Class II

  FDA 510(k) K123865 Active Cleared 6 Feb 2013

• Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3

  Class II

  FDA 510(k) K021261 Active Cleared 3 Jul 2002

• ICEfx Cryoablation System

  Class II

  FDA 510(k) K181153 Active Cleared 15 May 2018

See all devices from Galil Medical Ltd →

• What is the primary use case for the IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles, and how do they differ from standard cryosurgical tools?

  The IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles are specifically designed for prostate cryoablation, delivering controlled freezing to create a precise zone of coagulative necrosis in targeted tissue. Unlike standard cryosurgical tools, these needles feature a 2.1 mm shaft diameter and are paired with the Visual-ICE System, which enhances visualization and uniformity of the ablation zone. This makes them ideal for procedures requiring high precision, such as prostate cryotherapy, where accurate tissue destruction is critical.

• Are the IcePearl and IceFORCE kits single-use or reusable, and what does this mean for clinical workflow?

  The IcePearl 2.1 CX Prostate Cryoablation Kit and IceFORCE 2.1 CX Prostate Cryoablation Kit are single-use, sterile devices. This means each kit is intended for one procedure only, reducing the risk of cross-contamination and ensuring consistent performance. Clinically, this simplifies workflow by eliminating the need for reprocessing, but it does require proper inventory management to maintain availability for multiple cases.

• What storage and handling requirements should be followed for these cryoablation needles and kits?

  As sterile single-use devices, the IcePearl and IceFORCE kits must be stored according to standard sterile medical device protocols. This includes keeping them in their original packaging until immediately before use, protecting them from physical damage, and adhering to manufacturer guidelines for shelf life. There are no specific MRI safety restrictions noted, but standard electromagnetic interference precautions should still apply in MRI environments.

• What regulatory pathway was followed for FDA clearance of these devices, and what does that imply for their clinical application?

  The IcePearl and IceFORCE Cryoablation Needles were cleared via the FDA 510(k) pathway (K152133), with a decision of substantially equivalent (SESE) to existing cryosurgical accessories. This clearance was granted under the General and Plastic Surgery advisory committee, indicating their intended use aligns with procedures performed in those specialties. Clinically, this means the devices are considered safe and effective for their labeled use—cryoablation of prostate tissue—when used as instructed in the approved labeling.

• What needle sizes and models are available, and how might this affect procedure planning?

  The system offers two primary needle models: the IcePearl 2.1 CX Cryoablation Needle and the IceFORCE 2.1 CX Cryoablation Needle, both featuring a 2.1 mm shaft diameter. These are paired with their respective kits and the Visual-ICE System for enhanced visualization. The uniformity in shaft size ensures consistency in tissue ablation, which is particularly important for procedures like prostate cryoablation where precise targeting is essential. Clinicians should confirm compatibility with their specific cryoablation platform before use.