The Visual-ICE™ Cryoablation System is intended for cryoablative destruction of tissue during surgical procedures. The Visual-ICE 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. 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.

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 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 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 (ablation of arrhythmic cardiac tissue cancerous lesions) .
. Proctology (ablation of benign or malignant growths of the anus or rectum, and hemomhoids)

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. These changes are primary being made to the user interface and the service and maintenance screens. Basic functionality of the system remains unchanged, however, the following functional modifications have been made:

. Organ map display has been modified to allow users to place MTS needles on the Organ Мар,
When all channels are locked and linked together the Test All button icon state identifies the . state for all channels.
The software defaults all needles to the first 1-wire needle that was attached. .
User interface can display up to three large timers instead of two. .
Freeze-thaw cycles can now be programmed for all channels using the All button, .
The software wams the user of low gas when the remaining gas time reaches 10 minutes . instead of 5 minutes,
"Stick" intensity has been changed from 20% to 5%, .
Helium low-pressure warning was reduced to 1800 PSI from 2100 PSI. .

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Visual-ICE® Cryoablation System, Software Revision 1.2.2:

This submission is a Special 510(k) for software modifications to an existing device (Visual-ICE® Cryoablation System, K113860). Special 510(k)s are for well-established devices where changes do not alter the fundamental scientific technology or intended use, and where performance can be verified through existing test methods. This typically means a full clinical study with acceptance criteria for the device's diagnostic performance (e.g., sensitivity, specificity) against a ground truth would not be required or presented in this type of submission. Instead, the focus is on verification and validation of the software changes to ensure they did not introduce new risks or negatively impact existing functionality.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by changes)	Reported Device Performance
User can place MTS needles on the Organ Map.	Organ map display has been modified to allow users to place MTS needles on the Organ Map.
Test All button icon accurately identifies the state for all channels when locked and linked.	When all channels are locked and linked together the Test All button icon state identifies the state for all channels.
Software defaults all needles to the first 1-wire needle attached.	The software defaults all needles to the first 1-wire needle that was attached.
User interface can display up to three large timers.	User interface can display up to three large timers instead of two.
Freeze-thaw cycles can be programmed for all channels using the All button.	Freeze-thaw cycles can now be programmed for all channels using the All button.
Software warns of low gas when remaining gas time reaches 10 minutes.	The software warns the user of low gas when the remaining gas time reaches 10 minutes instead of 5 minutes.
"Stick" intensity is changed from 20% to 5%.	"Stick" intensity has been changed from 20% to 5%.
Helium low-pressure warning is reduced to 1800 PSI.	Helium low-pressure warning was reduced to 1800 PSI from 2100 PSI.
No new risks identified from software changes.	No new risks were identified based on the changes incorporated into Software Revision 1.2.2.
Software Revision 1.2.2 passes all verification testing.	Software Revision 1.2.2 passed all verification testing.
No performance degradation of basic system functionality.	Basic functionality of the system remains unchanged.

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

Sample Size: Not applicable in the context of a diagnostic performance study, as this is a software update for a cryoablation system, not a diagnostic device. The "test set" here refers to the software verification and validation tests. The document states a "complete software verification test was conducted" but does not specify the number of individual test cases or scenarios.
Data Provenance: Not applicable for a software verification study. The tests would have been performed by the manufacturer (Galil Medical Inc.) in a testing environment.

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

Number of experts: Not applicable. The "ground truth" for a software verification study involves comparing the software's behavior against its functional specifications and requirements. This is typically established by software engineers and quality assurance personnel, not medical experts for a diagnostic assessment.

4. Adjudication method for the test set

Adjudication method: Not applicable. Software verification involves testing against defined specifications. Test failures would be reported and addressed, but there isn't a "consensus" or "adjudication" process in the medical expert sense.

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

MRMC Study: No. This is not a diagnostic device with an AI component that assists human readers.

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

Standalone Performance: Not applicable. This is a cryoablation system where the software controls the hardware and user interface for a medical procedure performed by a clinician. It's not an algorithm that performs a task autonomously in a "standalone" fashion such as diagnosing an image.

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

Type of Ground Truth: The "ground truth" for this software update is the software requirements specification and design documentation. The verification testing confirms that the software's behavior matches these predefined requirements.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is not a machine learning or AI-driven system that requires a "training set."

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

Ground Truth for Training Set: Not applicable, as there is no training set for this type of software update.

Summary

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GGALILMEDICAL

Leading Through Innovation

K123865

Page 1 of 2

Section 5. 510(k) Summary

FEB 6 2013

510(k) SUMMARY TEMPLATE

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 Arden Hills, MN 55112 USA

Company Contact Person:	Amy E. McKinneyDirector, Regulatory Affairs
Phone:Fax:	Galil Medical Inc.651-287-5096
Email:	651-287-5097amy.mckinney@galilmedical.com
Device Name:	Visual-ICE® Cryoablation System, Software Revision 1.2.2
Device ClassificationName:	Cryosurgical unit and accessories (GEH)21 CFR 878.4350
Predicate Device:	Visual-ICE® Cryoablation System (K113860)

Device Description:

. Organ map display has been modified to allow users to place MTS needles on the Organ Мар,
When all channels are locked and linked together the Test All button icon state identifies the . state for all channels.
The software defaults all needles to the first 1-wire needle that was attached. .

Page 10 of 46

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K123865

Image /page/1/Picture/1 description: The image shows the logo for Galil Medical. The logo consists of a stylized letter "G" with a small circle inside, followed by the text "GALILMEDICAL" in bold, sans-serif font. Below the company name is the tagline "Leading Through Innovation" in a smaller font size.

Page 2 of (2)

User interface can display up to three large timers instead of two. .
Freeze-thaw cycles can now be programmed for all channels using the All button, .
The software wams the user of low gas when the remaining gas time reaches 10 minutes . instead of 5 minutes,
"Stick" intensity has been changed from 20% to 5%, .
Helium low-pressure warning was reduced to 1800 PSI from 2100 PSI. .

Intended Use:

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 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 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 (ablation of arrhythmic cardiac tissue cancerous lesions) .
. Proctology (ablation of benign or malignant growths of the anus or rectum, and hemomhoids)

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 risks were identified based on the changes incorporated into Software Revision 1.2.2. A complete software verification test was conducted based on the originally approved protocol and test methods. Software Revision 1.2.2 passed all verification testing. Additional validation testing was not required based on the changes made to the software. No changes were made to the Visual-ICE System hardware.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved shapes that resemble a person embracing or being embraced.

Public Health Service

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

February 6, 2013

Galil Medical, Incorporated % Ms. Amy McKinney Director, Regulatory Affairs 6518 Tamarind Sky Lane Fulshear, Texas 77441

Re: K123865

Trade/Device Name: Visual-ICE Cryoablation System, Software Revision 1.2.2 Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: January 08, 2013 Received: January 11, 2013

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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Page 2 - Ms. Amy McKinney

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours, For

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K123865

Device Name: Visual-ICE Cryoablation System, Software Revision 1.2.2

Indications For Use:

The Visual-ICE™ Cryoablation System is intended for cryoablative destruction of tissue during surgical procedures. The Visual-ICE 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. 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.

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 evelid or canthus area, ulcerated basal cell turnors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemangiomas, 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 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 (ablation of arrhythmic cardiac tissue cancerous lesions) .
Proctology (ablation of benign or malignant growths of the anus or rectum, and . hemorrhoids)

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Surgical Devices 510(k) Number __K123865 ・

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.