Search Results

Galil Medical's IcePearl 2.1 CX L and IceFORCE 2.1 CX L Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures. The IcePearl 2.1 CX L and IceFORCE 2.1 CX L Cryoablation Needles are indicated for use as a cryosurgical tool in the fields of general surgery, dermatology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, 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 L and IceFORCE 2.1 CX L 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 cysts, multiple 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 L and IceFORCE 2.1 CX L Cryoablation Needles are sterile, single use, disposable components, when used in conjunction with Galil Medical's Visual-ICE Cryoablation System 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 L and IceFORCE 2.1 CX L Cryoablation Needles are disposable 2.1 mm needles that have a sharp cutting tip, a color-coded handle, a gas tube, and a connector. The IcePearl 2.1 CX L and IceFORCE 2.1 CX L Cryoablation Needles offer handles configured in a 90° angled configuration.

The IcePearl 2.1 CX L and IceFORCE 2.1 CX L Cryoablation Needles were designed to provide the same cryoablation functionality with the same iceball shapes as compared to Galil Medical's predicate needles, IcePearl 2.1 CX and IceFORCE 2.1 CX (K152133).

The new devices differ from the predicate devices in that the needle shaft is 55 mm longer than the needle shaft of the predicate devices. The longer shaft length was incorporated into the needles to treat deep-seated tumors in patients with a larger body habitus, while still allowing for CT gantry clearance using a 2.1 CX type needle.

The provided text describes the 510(k) summary for the IcePearl 2.1 CX L and IceFORCE 2.1 CX L Cryoablation Needles. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove performance against those criteria in the way one might expect for a novel device or a standalone AI algorithm.

Based on the provided text, the device itself is a physical medical instrument (cryoablation needles), not an AI-powered diagnostic or treatment planning system. Therefore, many of the requested points regarding AI device studies (e.g., sample size for test set, data provenance, ground truth experts, MRMC studies, standalone performance, training set details) are not directly applicable in the context of this 510(k) submission.

However, I can extract information related to the device and its performance testing as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance values in the way you might see for an AI algorithm (e.g., sensitivity, specificity thresholds). Instead, for a medical device like a cryoablation needle, acceptance is demonstrated by showing "same as predicate" or "meets defined specifications" through performance testing.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is detailed as "Performance testing... with the previously cleared Visual-ICE System Software to verify safety and performance characteristics and to establish substantial equivalence." This testing included "freezing and in vivo performance." The outcome was that "Test results demonstrated that the IcePearl 2.1 CX L and IceFORCE 2.1 CX L Cryoablation Needles meet defined specifications and do not raise any new safety or effectiveness issues."

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified in the provided text. The testing conducted included "freezing and in vivo performance," implying physical or biological testing, but the number of units tested or subjects in vivo is not given.
• Data Provenance: Not explicitly stated. The testing was described as "in-house requirements" and "according to protocols based on international standards," which suggests laboratory and potentially animal or human (if "in vivo" refers to human trials, which is unlikely for a 510(k) for a device modification of this nature) testing. Given Galil Medical Ltd. is based in Israel, some testing might have been conducted there.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable as the device is a physical cryoablation needle, not a diagnostic or AI device that requires expert ground truth for interpretation. Ground truth for its performance would be physical measurements of iceball size, temperature, consistency, and in vivo effects, not expert medical opinion on images or data.

4. Adjudication method for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth from multiple human readers for AI diagnostic studies. The performance of a physical device like a cryoablation needle is evaluated by direct measurement and observation, not by adjudicating expert opinions.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI device.

7. The type of ground truth used:

For a physical medical device like this, the "ground truth" would be the direct physical and biological effects observed during testing. This would include:

• Physical measurements of iceball dimensions, temperatures, and freezing/thawing parameters in simulated environments.
• Histopathological (pathology) assessment of ablated tissue in in vivo studies.
• Direct observation of device function and integrity.

The text vaguely refers to "freezing and in vivo performance," which would be assessed against established physical or biological metrics.

8. The sample size for the training set:

Not applicable. This is not an AI device that requires a training set in the sense of machine learning.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI device.

In summary, the document describes a 510(k) clearance for cryoablation needles that are substantially equivalent to a predicate device, with the primary difference being a longer needle shaft. The "study"
referred to is performance testing (including freezing and in vivo performance) to confirm that the longer needles maintain the same functional characteristics and safety profile as the predicate. The criteria are largely based on equivalence to the predicate and meeting defined internal specifications.

Ask a specific question about this device