The Visual-ICE Cryoablation System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, 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 Visual-ICE 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, 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 the rectum, hemorrhoids, 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: Ablation of arrhythmic cardiac tissue cancerous lesions
· Proctology: Ablation of benign or malignant growths of the anus or rectum, and hemorrhoids

Device Description

The Visual-ICE Cryoablation System is a mobile console 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 Visual-ICE System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or, alternatively, by the use of Galil Medical i-Thaw® technology in which a heating element inside the cryoablation needle can be energized to cause thawing.

This Special 510(k) is being submitted to modify the software with a variety of changes to enhance usability of the system. The functions of the system that users use to deliver the cryoablation treatment remain unchanged.

AI/ML Overview

The provided text is a 510(k) Summary for the Visual-ICE® Cryoablation System, Software Revision 1.3.1. It describes a medical device and its intended use, but it does not contain information about acceptance criteria, device performance metrics, sample sizes for test or training sets, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC or standalone).

The document is a regulatory submission demonstrating substantial equivalence to a predicate device, focusing on software changes and their impact on safety and effectiveness. It states that "Software Revision 1.3.1 passed all verification and validation testing," implying that it met internal development and regulatory requirements, but it does not detail those specific acceptance criteria or the study data that proves the device meets them in terms of clinical performance.

Therefore, many of the requested elements cannot be extracted from this document.

Here's what can be inferred and what is explicitly not present:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria: Not explicitly stated in terms of specific performance metrics or thresholds. The document implies an acceptance criterion of "passed all verification and validation testing" for the software changes, but no numerical or qualitative performance targets are provided.
Reported Device Performance: Not reported in terms of clinical outcomes or specific performance metrics. The document states "no new unacceptable risks were identified" and "no changes were made to the Visual-ICE System hardware," focusing on the safety and functional integrity of the software update rather than clinical performance data.

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

Sample Size for Test Set: Not specified. "Complete software verification and validation testing" was performed, but the size or nature of the test set (e.g., number of test cases, simulated procedures, or patient data if applicable) is not detailed.
Data Provenance: Not specified. Given it's a software update for an existing device, testing likely involved internal simulations, unit tests, integration tests, and system-level tests. There is no mention of patient data (retrospective or prospective, or country of origin) being used for this specific software revision's validation.

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

Not applicable/Not mentioned. The document describes software verification and validation, which typically involves engineering and quality assurance personnel, not clinical experts establishing ground truth for diagnostic or therapeutic accuracy in the same way an AI model for image interpretation would require.

4. Adjudication method for the test set:

Not applicable/Not mentioned. Adjudication is relevant when multiple experts interpret data to establish a consensus ground truth. This type of process is not described for software verification and validation.

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

No. This is not an AI-assisted diagnostic or therapeutic device that would involve human readers. The device is a cryoablation system, and this submission relates to a software update for its control system.

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

No. This device is a cryoablation system, which is inherently a human-in-the-loop interventional device. The software update affects its control and usability. Standalone algorithm performance is not applicable in this context.

7. The type of ground truth used:

Not explicitly defined in the context of clinical ground truth (e.g., pathology, outcomes data). For software verification, the "ground truth" would be the expected behavior/output as defined by the software requirements and design specifications. For example, if a timer should display "X" seconds, the ground truth is "X" seconds, and the test verifies that it does.

8. The sample size for the training set:

Not applicable/Not mentioned. This is not a machine learning or AI device that requires a training set in the conventional sense. The software was developed and verified, not "trained."

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

Not applicable/Not mentioned, as there is no training set for this type of device.

In summary: The provided document is a regulatory statement for a software update to a cryoablation system. It confirms that the software passed internal verification and validation, thus maintaining substantial equivalence to previously cleared devices. However, it does not include the detailed performance study information typically associated with AI/ML-based diagnostic or therapeutic devices such as acceptance criteria based on accuracy/sensitivity/specificity, clinical test sets, expert ground truth establishment, or comparative effectiveness studies.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 5, 2015

Galil Medical Incorporated Ms. Amy McKinney Vice President, Global Regulatory Affairs & Quality 6518 Tamarind Sky Lane Fulshear, Texas 77441

Re: K143564

Trade/Device Name: Visual-ICE® Cryoablation System, Software Revision 1.3.1 Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: February10, 2015 Received: February 11, 2015

Dear Ms. McKinney:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Jennifer R. Stevenson -S

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) K143564

Device Name

Visual-ICE Cryoablation System, Software Revision 1.3.1

Indications for Use (Describe)

· 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, 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 the rectum, hemorrhoids, 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: Ablation of arrhythmic cardiac tissue cancerous lesions
· Proctology: Ablation of benign or malignant growths of the anus or rectum, and hemorrhoids

Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Galil Medical. The logo consists of a stylized letter "G" in blue, with a green dot inside the "G". To the right of the "G" is the text "GALILMEDICAL" in blue. Below the logo is the text "Leading Through Innovation" in a smaller font size and also in blue.

Section 5. 510(k) Summary

510(k) SUMMARY

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 Road WArden Hills, MN 55112USA
Company Contact Person:Phone:Fax:Email:	Amy E. McKinneyVice President, Global Regulatory Affairs & QualityGalil Medical Inc.651-287-5096651-287-5097amy.mckinney@galilmedical.com
Alternate Contact Person:Phone:Email:	Lynne DaviesSr. Manager, Global Regulatory AffairsGalil Medical Inc.651-287-5098Lynne.davies@galilmedical.com
Device Name:	Visual-ICE® Cryoablation System, Software Revision 1.3.1IceRod 1.5 CX Cryoablation Needle
Device ClassificationName:	Cryosurgical unit and accessories (GEH)21 CFR 878.4350
Predicate Device:	Visual-ICE® Cryoablation System (K113860)Visual-ICE® Cryoablation System, Software Revision 1.2.2(K123865)IceRod CX Cryoablation Needle (K121251)
Date of Preparation:	March 3, 2015

Device Description:

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Image /page/4/Picture/0 description: The image is a logo for Galil Medical. The logo consists of a stylized letter "G" with a green dot inside, followed by the text "GALILMEDICAL" in a bold, sans-serif font. Below the company name is the tagline "Leading Through Innovation" in a smaller, lighter font.

energized to cause thawing.

User Interface Changes	Added information to be displayed on Big Timers and made timers movable Modified wording on all displayed messages for clarity Minor appearance modifications Minor bug fixes
Service andMaintenance Changes	Minor updates used only by service personnel
Functional Changes	Modified wording for clarity. Removed lockout for procedure at maintenance due and end of life; will display warning upon startup. Allow for user configurable time parameter for displayed low gas message. Removed restriction for programming up to three freeze thaw cycles. Added ability to load and save pre-programmed freeze-thaw cycles. Allow cautery and freeze in any order. Added a 30 second flush after a freeze. Added ability to display internal gas temperature of i-Thaw capable needles. Added gas line flush at start of every procedure Minor bug fixes

User Interface Changes

Added information to be displayed on Big Timers and made timers movable Modified wording on all displayed messages for clarity Minor appearance modifications Minor bug fixes

Service andMaintenance Changes

Minor updates used only by service personnel

Functional Changes

Modified wording for clarity. Removed lockout for procedure at maintenance due and end of life; will display warning upon startup. Allow for user configurable time parameter for displayed low gas message. Removed restriction for programming up to three freeze thaw cycles. Added ability to load and save pre-programmed freeze-thaw cycles. Allow cautery and freeze in any order. Added a 30 second flush after a freeze. Added ability to display internal gas temperature of i-Thaw capable needles. Added gas line flush at start of every procedure Minor bug fixes

Intended Use:

The Visual-ICE Cryoablation System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, 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 Visual-ICE 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

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Image /page/5/Picture/0 description: The image shows the logo for Galil Medical. The logo features a stylized letter "G" in blue, with a green circle inside the "G". To the right of the "G" is the text "GALIL MEDICAL" in blue, with "GALIL" being larger than "MEDICAL". Below the logo is the text "Leading Through Innovation" in a smaller font.

●	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, 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	Ablation of arrhythmic cardiac tissue cancerous lesions
●	Proctology	Ablation of benign or malignant growths of the anus or rectum, and hemorrhoids

Summary of Performance Data and Substantial Equivalence:

The Visual-ICE System and software were evaluated in accordance with Galil Medical's risk management plan. No new unacceptable risks were identified based on the changes incorporated into Software Revision 1.3.1. Complete software verification and validation testing was completed on the new software revision. Software Revision 1.3.1 passed all verification and validation testing. No changes were made to the Visual-ICE System hardware.

Conclusion:

The information and data provided in this Special 510(k) establish that the Visual-ICE Cryoablation System Software Revision 1.3.1 is substantially equivalent to the legally marketed predicate device.

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.