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Galil Medical's IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures. The IcePearl 2.1 CX and lceFORCE 2.1 CX Cryoablation Needles are indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. The systems are designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.

The Galil Medical IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles have the following specific indications:

• . Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH")
• . Oncology (ablation of cancerous or malignant tissue and benign tumors, and palliative intervention)
• . Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cvsts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.)
• . Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)
• . General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma)
• . ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth)
• Thoracic surgery (with the exception of cardiac tissue)
• . Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)

Galil Medical's IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles are sterile, single use, disposable components, when used in conjunction with Galil Medical's Visual-ICE Cryoablation System Software Revision 1.4.0, to perform cryoablative destruction of tissue. The needles are intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application. The IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles are disposable 2.1 mm needles that have a sharp cutting tip, a color-coded handle, a gas tube, and a connector. Both IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles offer handles configured as straight and in a 90° angled configuration (to aid positioning of the needle within the CT imaging system gantry).

The IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles were designed to provide the same cryoablation functionality with similar iceball shapes on a 2.1 mm shaft as compared to Galil Medical's predicate needles, IceRod CX (1.5 mm) needle and IceEDGE 2.4 mm needle.

The IcePearl 2.1 CX and IceFORCE 2.1 CX Crvoablation Needles differ from the predicate devices in that the reconfigured heat exchanger has been relocated from the needle shaft to the needle handle and an additional vacuum insulated tube has been incorporated into the handle. The changes were made to ensure optimal freezing performance utilizing a 2.1 mm shaft.

This Special 510(k) also contains changes to the Visual-ICE System software denoted as Software Release 1.4.0. Software Release 1.4.0 is an updated version of the Visual-ICE software previously cleared. There are no changes to the system hardware required as a result of the changes being made in the software. The following modifications were incorporated based on the added software support of the proposed IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles as well as customer and sales feedback to enhance the robustness of the software programming.

The provided text describes a 510(k) premarket notification for Galil Medical's IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles. This document is a regulatory submission for a medical device and, therefore, focuses on demonstrating substantial equivalence to existing predicate devices rather than proving a device meets specific acceptance criteria through a clinical study as would be done for AI/ML devices.

The information provided does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or data provenance for such a test set.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• A multi-reader multi-case (MRMC) comparative effectiveness study, nor effects size of human readers with/without AI assistance.
• A standalone (algorithm only) performance study.
• The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. Here's what is reported about the device and its performance testing:

Device Description and Comparison to Predicates:

• Device Name: IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles
• Predicate Devices: IceRod CX Cryoablation Needles (K121251 and K140584), IceEDGE 2.4 Cryoablation Needle (K111859), Visual-ICE Cryoablation System (K113860, K123865, K143564).
• Key Differences of Submitted Device from Predicates:
  • Reconfigured heat exchanger relocated from the needle shaft to the needle handle.
  • Incorporation of an additional vacuum insulated tube in the handle.
  • Needle shaft size is in-between the shaft sizes of the predicates (IceRod CX is 1.5mm, IceEDGE 2.4mm).
• Similarities to Predicates: Needle tip, gas pathway tubing, needle connector, freezing/thawing technology, function, freezing parameters, thaw parameters, track ablation, and indications for use.
• Software Changes: Visual-ICE System Software Revision 1.4.0 (updated from previously cleared version) to support the new needles and enhance robustness based on customer feedback. Changes include user interface updates, service/maintenance features, functional changes (e.g., support for heated wire temperature info, 2.1 CX needles, timeline reporting, lowest temperature display), and combined UI/functional changes (e.g., real-time power consumption feedback, easier timer activation, streamlined channel controls, fast thaw direct access, save/load programmed cycles).

Study/Testing Information (Summary of Performance Data):

• Purpose of Testing: To verify safety and performance characteristics and to establish substantial equivalence.
• Type of Testing: Performance testing was conducted on the IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles with Visual-ICE Software Revision 1.4.0.
• Testing Methodologies: Testing was conducted according to protocols based on international standards and in-house requirements.
• Specific Tests Mentioned:
  • Dimensional testing
  • Functional testing
  • Freezing performance
  • In vivo needle track ablation, based on depth of tissue necrosis characterization.
• Results: "Test results demonstrated that the IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles when used with Visual-ICE Software Revision 1.4.0 meet defined specifications and do not raise any new safety or effectiveness issues."

In summary, the document states that performance testing was performed to demonstrate that the new needles, in conjunction with the updated software, meet defined specifications and are substantially equivalent to existing devices. However, it does not detail specific acceptance criteria or provide a table of performance metrics against those criteria. The focus is on verifying that the changes do not introduce new safety or effectiveness concerns compared to the already cleared predicate devices.

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