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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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Galil Medical Cryoablation Systems are intended for cryoablative destruction of tissue during surgical procedures. The cryoablation systems is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.

Galil Medical Cryoablation Systems 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 hemangiomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal 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, recurrent cancerous lesions, ablation of breast fibroadenomas
• ENT Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth
• Thoracic surgery Ablation of arrhythmic cardiac tissue cancerous lesions
• Proctology Ablation of benign or malignant growths of the anus or rectum, and hemorrhoids

Galil Medical's predicate IceSphere needles and Galil's proposed IceSphere needles are sterile, single use, disposable devices used in conjunction with Gali! Medical's cleared cryoablation systems (SeedNet, SeedNet Gold; Presice; Visual-ICE) for cryoablative destruction of tissue during surgical procedures. The needles have a sharp cutting tip, a 1.5mm (17G) shaft, a color-coded handle, gas tubing, and a connector. Galil's predicate and proposed iceSphere needles are available in 2 handle configurations: straight and 90°. The needles contain shaft markings to aid the physician in needle placement.

Galil is requesting clearance of the proposed vacuum insulated IceSphere needles. The vacuum insulated modification represents a one-for-one component exchange within the internal non-patient contacting lumen of the cryoablation needle shaft.

The provided text is a 510(k) summary for the Galil Medical IceSphere Cryoablation Needle. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information regarding traditional acceptance criteria, a test set with ground truth, or details of a study with human readers or standalone AI performance.

Instead, the performance data discussed pertains to engineering verification testing to demonstrate that the modified device (with vacuum insulation) meets design specifications compared to the predicate non-insulated device.

Therefore, many of the requested fields cannot be filled based on the provided document.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document states: "The insulated IceSphere successfully passed all the design properties testing in accordance with the established acceptance criteria compared to the non-insulated IceSphere predicate. Test results demonstrated that the proposed insulated IceSphere needles meet defined specifications and do not raise any new safety or effectiveness issues as compared to the predicate."

This implies that the acceptance criteria were defined as the modified device performing equivalently to the predicate device in design properties testing. Specific numerical acceptance criteria or performance metrics are not provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes engineering verification tests on the device itself, not a clinical study on patient data. Therefore, typical "test set" and "data provenance" as applied to AI/diagnostic devices are not applicable and not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not a diagnostic device or a study requiring expert readers for ground truth. This information is not applicable and not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not a diagnostic device or a study requiring adjudication. This information is not applicable and not provided.

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

This is not a diagnostic device or a study involving human readers or AI assistance. This information is not applicable and not provided.

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

This is not an algorithm or AI device. This information is not applicable and not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Given this is an engineering verification of a physical medical device (cryoablation needle), the "ground truth" would be objective engineering measurements and comparisons to design specifications and the predicate device's measured performance. No clinical "ground truth" like pathology or outcomes data is relevant for the reported testing. This information is not applicable in the traditional sense of diagnostic AI.

8. The sample size for the training set

This document does not describe the development of an AI algorithm with a training set. This information is not applicable and not provided.

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

This document does not describe the development of an AI algorithm with a training set. This information is not applicable and not provided.

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The Galil Medical IceRod CX Cryoablation Needle is intended for cryoablative destruction of tissue during surgical procedures. The IceRod CX Cryoablation Needle is 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 IceRod CX Cryoablation Needle has 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, 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 is requesting clearance of a laser marking process improvement technique used to create the "markings" on the needle shaft of the previously cleared IceRod CX Needle (K121251). Galil's IceRod CX Needle (K121251) is a sterile, single use, disposable component used in conjunction with Galil Medical's Visual-ICE Cryoablation System (K113860, K123865) when performing cryoablative destruction of tissue. The needle has a sharp cutting tip, a 1.5mm (17G) shaft, a color-coded handle, gas tubing, and a connector. The handle is in a 90° configuration to aid positioning of the needle within the CT imaging system gantry. The IceRod CX needle contains shaft markings to aid the physician in needle placement. There are no changes to the marking dimensions on the needle. Only the marking technique has been modified.

Since Galil is requesting clearance for a revised shaft marking process improvement technique for the IceRod CX Cryoablation Needle design itself (with the exception of the shaft marking method) has not changed. There are no other design, specification, process, or material changes to the needle; additionally, the model number of the needle is unchanged.

This document is a 510(k) summary for the IceRod CX Cryoablation Needle, focusing on an improved laser marking process for the needle shaft. It primarily establishes substantial equivalence to a previously cleared device (K121251) rather than presenting a detailed clinical study with acceptance criteria in the typical sense for a brand new device or algorithm.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, ground truth for training set) are not applicable to the type of submission described. This submission is for a process improvement to an existing device, not a new diagnostic or therapeutic algorithm.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in the typical format of a new medical device submission (e.g., sensitivity, specificity, accuracy thresholds). Instead, the acceptance criteria are implicit in demonstrating that the new laser marking process does not negatively impact the needle's integrity, safety, or performance characteristics compared to the predicate device.

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

• Sample Size: Not explicitly stated as a "test set" in the context of clinical performance. The document describes "shaft qualification testing," "heat affected zone measurements," and "shaft marking quality and adherence to specifications." The specific number of needles tested for these engineering/bench tests is not provided.
• Data Provenance: Not applicable in the context of clinical data. It's bench testing data conducted by Galil Medical.

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

Not applicable. Ground truth, in the sense of expert consensus on medical findings, is not relevant for this engineering-focused submission. The "ground truth" here is adherence to engineering specifications and performance parameters.

4. Adjudication method for the test set

Not applicable. No expert adjudication process is described.

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 submission is for a medical device (cryoablation needle), not an AI/CAD device, and therefore, an MRMC study is not relevant.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is based on engineering specifications, performance metrics, and safety standards derived from the predicate device and established manufacturing/quality control processes. This involves physical measurements, stress tests, and evaluations against pre-defined limits for mechanical integrity, thermal properties, and visual quality of the markings.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

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