The ICEfx™ Cryoablation System 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. This System is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions) by the application of extremely cold temperatures.

The ICEfx Cryoablation System 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 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, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas
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

Device Description

The ICEfx™ Cryoablation System is a mobile system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The therapy delivered by the system is based on the Joule-Thomson effect displayed by compressed gases. The ICEfx System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by the use of Galil Medical CX technology in which a heating element inside the cryoablation needle can be energized to cause thawing.

AI/ML Overview

The provided document is a 510(k) Premarket Notification summary for the ICEfx Cryoablation System. It focuses on demonstrating substantial equivalence to a predicate device, the Visual-ICE Cryoablation System (K113860), rather than proving independent effectiveness through a clinical study with detailed acceptance criteria and performance metrics typically associated with AI/ML device submissions.

Therefore, the information required to populate the requested table and answer the detailed questions about acceptance criteria, study design (sample size, data provenance, ground truth establishment, expert adjudication, MRMC studies, training set details), and specific performance metrics is not present in this document.

This submission is for a medical device that achieves its therapeutic effect through the application of extremely cold temperatures via a physical system (Joule-Thomson effect with argon gas), not through an AI/ML algorithm that predicts or diagnoses based on data. The "performance data" mentioned in the summary refers to engineering and verification/validation testing of the physical system, electrical components, and software, ensuring it functions as intended and meets safety standards, rather than evaluating interpretive accuracy (like an AI model).

Here's what can be extracted and why the rest cannot be answered:

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

Acceptance Criteria (Implicit): The document states that "A full battery of verification and validation testing was conducted... to ensure that the design, functionality, and performance met all the specified requirements." These "specified requirements" are the implicit acceptance criteria, but no specific quantitative metrics (e.g., "Cryoprobe reaches -X degrees Celsius within Y seconds" or "Iceball diameter of Z mm after T minutes") are provided in this summary.
Reported Device Performance: The document generally states: "Test results demonstrated that the ICEfx Cryoablation System meets defined specifications..." It lists types of testing performed (system, electrical, mechanical, labeling, software, usability) but does not provide specific performance outcomes or values against defined criteria.

Acceptance Criteria (Inferred from document)	Reported Device Performance
System Functionality Requirements	Met defined specifications.
Electrical Safety Requirements	Met defined specifications.
Mechanical Safety Requirements	Met defined specifications.
Labeling Accuracy	Met defined specifications.
Software Functionality and Safety	Met defined specifications.
Usability	Met defined specifications.

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

Not applicable/Not provided. The "test set" here refers to the physical device undergoing engineering tests, not a dataset for an algorithm. There is no mention of "data provenance" in the context of clinical data for algorithmic evaluation.

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

Not applicable/Not provided. This type of information is relevant for AI/ML devices where human expert consensus often establishes ground truth for image interpretation or diagnosis. For a cryoablation system, "ground truth" would be related to physical properties (e.g., temperature attained, iceball size), established by instrumentation and calibration, not human interpretation.

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

Not applicable/Not provided. Adjudication is used for expert disagreements in clinical ground truth establishment, which isn't the focus of this device's testing.

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:

No. This is a physical cryoablation system, not an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant to its regulatory submission.

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

Not applicable/Not provided. There is no "algorithm only" performance reported as this device is a physical cryosurgical tool. Its software controls the system, but it doesn't provide diagnostic outputs or interpretations that would be evaluated in a standalone manner.

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

Not explicitly stated for the "test set" as it relates to performance; however, for a cryoablation system, ground truth for its physical performance would be based on instrumentation readings and measurements (e.g., temperature probes confirming freezing, imaging to measure iceball dimensions against known physical properties of ice formation).

8. The sample size for the training set:

Not applicable/Not provided. This device does not use an AI model that requires a training set in the conventional sense.

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

Not applicable/Not provided. Since there's no training set for an AI model, this question is not relevant.

In summary: The provided 510(k) summary is for a traditional medical device (cryoablation system) that demonstrates substantial equivalence through engineering verification and validation testing, not through a statistical evaluation of an AI algorithm's performance on clinical data or comparative effectiveness studies with human readers. Therefore, many of the questions asked, which are highly relevant to AI/ML device submissions, do not apply to this document.

Summary

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May 15, 2018

Galil Medical Inc. Ms. Rachel Owens Sr. Regulatory Affairs Specialist 4364 Round Lake Road Arden Hills, Minnesota 55112

Re: K181153

Trade/Device Name: ICEfx Cryoablation System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: April 30, 2018 Received: May 1, 2018

Dear Ms. Owens:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application(PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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Page 2 - Ms. Rachel Owens

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Jennifer R. Stevenson For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181153

Device Name ICEfx™ Cryoablation System

Indications for Use (Describe)

The ICEfx Cryoablation System 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, proctology and urology. This System is destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions) by the application of extremely cold temperatures.

The ICEfx Cryoablation System has the following specific indications:

· Urology Ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasja (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, 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, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas

· 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

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K181153 510(k) SUMMARY ICEfx™ Cryoablation System

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

Submitter:	Galil Medical Inc.4364 Round Lake RoadArden Hills, MN 55112
Company Contact Person:	Rachel OwensSr. Regulatory Affairs SpecialistGalil Medical Inc.
Phone:	651-287-5024
Fax:	651-203-7392
Email:	rachel.owens@btgplc.com
Alternate Contact Person:	Rebeka StoltmanDirector, Regulatory AffairsGalil Medical Inc.
Phone:	651-287-5020
Fax:	877-510-7757
Email:	Rebeka.stoltman@btgplc.com
Device Name:	ICEfx™ Cryoablation System
Device Classification Name:	Cryosurgical unit and accessories
Regulation Number:	21 CFR 878.4350
Product Code:	GEH
Predicate Device 510(k):	Visual-ICE Cryoablation System (K113860)
Date of Preparation:	April 30, 2018

Device Description:

The table below provides a summary comparison of the submitted device compared to the predicate device.

Description of SubmittedDevice:ICEfx Cryoablation System	Comments related to Predicate:Visual-ICE Cryoablation System (K113860)
Design and Construction
Console	Similar to predicate; ICEfx is smaller and lighter weight
Needle ports	ICEfx contains fewer needle ports
Channel Lock	Same as predicate

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Description of SubmittedDevice:ICEfx Cryoablation System	Comments related to Predicate:Visual-ICE Cryoablation System (K113860)
User interface	Similar to predicate; touchscreen with equivalentfunction and features
Needle Interface	Same as predicate
Performance and Function
Principles of Operation:Freezing / Thawing	Same as predicate; ICEfx does not support the optionfor helium thaw
CX Technology for ElectricalThawing	Same as predicate
Needle Compatibility	Same as predicate; ICEfx supports fewer needles

In summary, the submitted ICEfx Cryoablation System has the same technology and principle of operation as the predicate device.

Indications for Use / Intended Use:

The ICEfx Cryoablation System 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. This System is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions) by the application of extremely cold temperatures.

The ICEfx Cryoablation System 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 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, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas
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

The intended use and indications for use are the identical to the Visual-ICE predicate.

Summary of Performance Data and Substantial Equivalence:

A full battery of verification and validation testing was conducted on the ICEfx Cryoablation System to ensure that the design, functionality, and performance met all the specified requirements and that the features of the system satisfy its intended use. Testing was conducted according to protocols based on international standards and in-house requirements. Verification testing included system testing, electrical testing, mechanical

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testing, labeling testing, and software testing. System testing assessed whether the functional requirements of the system as a whole were satisfied by the design. Mechanical testing evaluated the mechanical robustness of the system and sub-systems, functional testing of the gas system, and tests of mechanical safety requirements. Electrical testing assessed the functional aspects of the circuit assemblies, tests of electromagnetic compatibility and immunity (EMC/EMI), and tests of electrical safety requirements. Labeling verification evaluated user manual and labeling accuracy with respect to design requirements and risk mitigations. Software testing exercised individual units of software as well as tests of the functionality of the entire software package. Validation testing included design and usability testing. Test results demonstrated that the ICEfx Cryoablation System meets defined specifications, is substantially equivalent to the predicate device, and does not raise any new issues of safety and effectiveness for its intended use.

Conclusion (Statement of Equivalence):

As the indications for use and fundamental scientific technology have not changed, the nonclinical performance data provided in this Special 510(k) Premarket Notification supports a determination that the ICEfx Cryoablation System is substantially equivalent to the legally marketed predicate device, with regard to performance, safety, and effectiveness for its intended use.

Regulation Number and Section

§ 878.4350 Cryosurgical unit and accessories.

(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.