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, 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 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

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.

AI/ML Overview

The provided document is a 510(k) summary for the Visual-ICE™ Cryoablation System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study results proving a device meets acceptance criteria, or information on AI/standalone performance. It primarily focuses on the device's technical specifications and intended clinical applications.

Therefore, I cannot provide the requested information about acceptance criteria and detailed study results from the provided text. The document states a "full battery of verification and validation testing was conducted" and that "Test results demonstrated that the Visual-ICE Cryoablation System meets defined specifications," but it does not explicitly list those specifications or provide the data from those tests.

Here's a breakdown of what can and cannot be extracted based directly on your request:

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

Cannot provide. The document states that testing demonstrated the system "meets defined specifications" but does not enumerate these specifications or the exact performance results against them.

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

Cannot provide concrete details. The document mentions "animal cadaver testing" but does not specify the sample size, type of animals, or provenance. It does not mention any human data or the specifics of other testing (system, electrical, mechanical, etc.).

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)

Not applicable/Cannot provide. The document does not describe the establishment of a "ground truth" for a test set in the context of diagnostic or AI performance evaluation. This device is a cryoablation system, a therapeutic device, not a diagnostic one.

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

Not applicable/Cannot provide. No mention of an adjudication process for a test set is made, as this is not a diagnostic device involving expert review of results.

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, not applicable. The document describes a cryoablation system, which is a therapeutic device rather than an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and no such study is mentioned.

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

No, not applicable. This is a hardware cryoablation system, not an algorithm or AI.

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

Not applicable. See points 3 and 4. The "ground truth" for a therapeutic device's performance would typically relate to its physical functionality (e.g., cooling efficacy, temperature control, mechanical reliability), not diagnostic interpretation.

8. The sample size for the training set

Not applicable. No mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable. No mention of a "training set" or its ground truth.

Summary of what the document does state regarding testing:

Testing Conducted: A "full battery of verification and validation testing" including system testing, electrical testing, mechanical testing, packaging and labeling testing, software testing, design and usability testing, and animal cadaver testing.
Outcome: "Test results demonstrated that the Visual-ICE Cryoablation System meets defined specifications, is substantially equivalent to the predicate device, and does not raise any new issues of safety and effectiveness."
Predicate Device: Galil Medical's Presice Cryoablation System (K060390). The Visual-ICE System is stated to use "the same technology and has the same intended use and indications for use as the predicate."

In essence, the document confirms that testing was done to ensure the device met its requirements and was substantially equivalent, but it does not provide the granular details of those tests, specific acceptance criteria, or the results in a quantifiable manner as you've requested.

Summary

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GALILMEDICAL
A New Vision of Precision

Section 5. 510(k) Summary J

Page 1 of ②

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 Arden Hills, MN 55112

Company Contact Person:

Ms. Amy McKinney Director, Regulatory Affairs Galil Medical Inc. 651-287-5096 Phone: 651-287-5097 Fax: Email: amy.mckinney@galilmedical.com

Sr. Regulatory Affairs Advisor

Alternate Contact:

Galil Medical Inc. 651-287-5098 Phone: Fax: 651-287-5099 Email: lynne.davies@galilmedical.com

Device Name:	Visual-ICE™ Cryoablation System
Device Classification Name:	Cryosurgical unit and accessories (GEH)21 CFR 878.4350
Predicate Devices:	Presice Cryosurgical System (K060390)

Lynne Davies

Device Description:

Intended Use:

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A New Vision of Precision

CONFIDENTIAL

extreme cold temperatures including prostate and kidney tissue, liver metastases, lesions, and warts.

The Visual-ICE Cryoablation System has the following specific indications:

• Urology	Ablation of prostate tissue in cases of prostate cancer and BenignProstate Hyperplasia (BPH)
• Oncology	Ablation of cancerous or malignant tissue and benign tumors, andpalliative 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 celltumors, dermatofibromas, small hemangiomas, mucocele cysts, multiplewarts, plantar warts, actinic and seborrheic keratosis, cavernoushemangiomas, peri-anal condylomata, and palliation of tumors of theskin
• Gynecology	Ablation of malignant neoplasia or benign dysplasia of the femalegenitalia
• General surgery	Palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidalcysts, and recurrent cancerous lesions, ablation of breastfibroadenomas
• ENT	Palliation of tumors of the oral cavity and ablation of leukoplakia of themouth
• Thoracic surgery	Ablation of arrhythmic cardiac tissue cancerous lesions
• Proctology	Ablation of benign or malignant growths of the anus or rectum, andhemorrhoids

Summary of Performance Data and Substantial Equivalence:

The Visual-ICE System uses the same technology and has the same intended use and indications for use as the predicate, Galil Medical's Presice Cryoablation System (K060390).

A full battery of verification and validation testing was conducted on the Visual-ICE Cyroablation System to ensure that the design, functionality, and performance met the requirements. Testing was conducted according to protocols based on international standards and in-house requirements. Testing included system testing, electrical testing, mechanical testing, packaging and labeling testing, software testing, design and usability testing, and animal cadaver testing. Test results demonstrated that the Visual-ICE Cryoablation System meets defined specifications, is substantially equivalent to the predicate device, and does not raise any new issues of safety and effectiveness.

Conclusion:

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

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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 and Human Services. The logo consists of a stylized eagle or bird-like figure with three distinct lines forming its body and wings. The bird is oriented diagonally, facing towards the upper right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

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

Galil Medical, Inc. % Ms. Amy McKinney Director, Regulatory Affairs 63 Chicory Court Lake Jackson, Texas 77566

MAR 1 2 2012

Re: K113860

Trade/Device Name: Visual-ICE Cryoablation System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: December 29, 2011 Received: December 30, 2011

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

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Page 2 - Ms. Amy McKinney

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 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.

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

Sincerely yours,

Mark A. Mcllvaine

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

Enclosure

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Image /page/4/Picture/0 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 "A New Vision of Precision" in a smaller, lighter font.

Indications for Use Statement

K12XXXXX 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Visual-ICE Cryoablation System

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 cryssurgical 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, turnors, 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 turnors 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 (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)

Neil P. O'Brien for mka

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113860

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.