Galil Medical Cryoablation Systems are intended for cryoablative destruction of tissue during surgical procedures. The cryoablation systems are 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 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.

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 hemanglomas, mucccele 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)
t 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)
t Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)

Device Description

The IceEDGE 2.4 Cryoablation Needle is a sterile, single use, disposable component used in conjunction with a Galil Medical Cryoablation System when performing cryoablative destruction of tissue. It is intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application. The disposable cryoablation needle has a sharp cutting tip, a 2.4 mm shaft, a color-coded handle, gas tubing, and a connector. Additionally, the needle shaft exhibits markings every 5 mm to aid in positioning the needle in tissue. The IceEDGE needle differs from the predicate devices in that it contains modified heat exchanger and a larger shaft diameter to enable the needle to produce a larger iceball size.

AI/ML Overview

This document is a 510(k) summary for the IceEDGE 2.4 Cryoablation Needle. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on performance testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Dimensional Specifications for needle	Met defined specifications (implies passing dimensional testing)
Functional Performance (e.g., gas flow, sealing)	Met defined specifications (implies passing functional testing)
Freezing Performance (e.g., iceball size, temperature)	Met defined specifications (implies passing freezing performance testing). Specific mention of "larger iceball size" compared to predicates due to design modifications.
Biocompatibility	Meets ISO 10993 requirements
Safety & Effectiveness (overall)	"Test results demonstrated that the IceEDG namedie meets defined specifications and does not raise any new safety or effectiveness issues."

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "Performance testing was conducted on IceEDGE Cryoablation Needle," but does not specify the sample size used for any of the tests (dimensional, functional, freezing performance, or in vivo ablation zone characterization).

The data provenance is not explicitly stated. However, the testing was conducted in-house by Galil Medical Ltd., and it is implied to be prospective as it was conducted specifically for this 510(k) submission. There is no mention of country of origin for the data beyond that it was conducted by the submitter (Galil Medical Ltd. in Israel).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. The document refers to "in vivo ablation zone characterization," which would typically involve expert interpretation (e.g., by pathologists or radiologists). However, the number and qualifications of such experts are not detailed.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This study was not done. The document describes performance testing of the device itself and compares its technical specifications and intended use to predicate devices, but it does not involve human readers for comparative effectiveness.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This concept does not apply to this device. The IceEDGE 2.4 Cryoablation Needle is a physical medical device (a cryoablation needle), not an algorithm or AI software. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used:

For the in vivo ablation zone characterization, the ground truth would likely be histopathological or imaging-based assessment by experts (e.g., pathology reports or radiological interpretations of ablation zones). However, the document only broadly states "in vivo ablation zone characterization" without specifying the precise method of ground truth establishment. For other tests (dimensional, functional, freezing), the "ground truth" would be the device specifications themselves (e.g., a specific length, a certain gas flow rate, a measured iceball diameter).

8. Sample Size for the Training Set:

This information is not applicable as this is a physical medical device and not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as this is a physical medical device and not an AI/ML algorithm.

Summary

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Section 5. 510(k) Summary

OCT - 7 2011

K111859

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 Ltd. Tavor 1 Building Shaar Yokneam Yokneam Industrial Park 20692 Israel

Company ContactPerson:	Ms. Amy McKinneyDirector, Regulatory AffairsGalil Medical Inc.
Phone:	651-287-5096
Fax:	651-287-5097
Email:	amy.mckinney@galilmedical.com
Device Name:	IceEDGE™ 2.4 Cryoablation Needle
Device ClassificationName:	Cryosurgical unit and accessories (GEH)21 CFR 878.4350
Predicate Devices:	IceRod 17G 90° Cryoablation Needle (K060144)IceRod PLUS 17G Cryoablation Needles (K110946)ENDOcare PerCryo Renal Cryoprobe, an accessory to theCRYOcare Cryosurgical System (K963826)

Device Description:

Intended Use:

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

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Galil Medical Cryoablation Systems have the following specific indications:

Ablation of prostate tissue in cases of prostate cancer and Benign Urology . Prostate Hyperplasia (BPH)
Ablation of cancerous or malignant tissue and benign tumors, and . Oncology palliative intervention
. Ablation or freezing of skin cancers and other cutaneous Dermatology disorders

Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the evelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cvsts, multiple warts, plantar warts, actinic and seborrheic keratosis, cavernous hemangiomas, perianal condylomata, and palliation of tumors of the skin

Gynecology Ablation of malignant neoplasia or benign dysplasia of the female genitalia
t 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
Ablation of benign or malignant growths of the anus or rectum, ● Proctology and hemorrhoids

Summary of Performance Data and Substantial Equivalence:

The IceEDGE 2.4 Cryoablation Needle uses the same technology and has the same intended use and method of operation as compared to the predicate devices. Both the new and predicate devices consist of a sharp cutting tip, a shaft, a color-coded handle, gas tubing, and a connector. Both the new and predicate devices are comprised of similar materials and serve as conduits for high pressure gas during a cryoablation procedure.

Performance testing was conducted on IceEDGE Cryoablation Needle to verify safety and performance characteristics and to establish substantial equivalence. Testing was conducted according to protocols based on international standards and in-house requirements and included dimensional testing, functional testing, freezing performance, and in vivo ablation zone characterization. Additionally, the needle meets the biocompatibility requirements outlined in ISO 10993. Test results demonstrated that the IceEDG namedie meets defined specifications and does not raise any new safety or effectiveness issues.

Conclusion:

The information and data provided in this 510(k) Notification establish that the IceEDGE 2.4 Cryoablation Needle is substantially equivalent to the legally marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms.

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

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

OCT - 7 2011

Re: K111859

Trade/Device Name: IceEDGE 2.4 Cryoablation Needle Regulation Number: 21 CFR 878.4350 Regulation Name: Cyrosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: August 26, 2011 Received: August 29, 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 aft the Act or any Federal statutes and regulations administered by other Federal agencies. Your must

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Page 2 - Ms. Amy McKinney

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 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.fdaggy/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/ReportalProblem/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,

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, uppercase letters. Below the company name is the tagline "A New Vision of Precision" in a smaller font size.

Indications for Use Statement

510(k) Number (if known): __ K11XXXXX |< || 859

Device Name: IceEDGE 2.4 Cryoablation Needle

Indications For Use:

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 hemanglomas, mucccele 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)
t 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)
t 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)
	for has

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K11185-9

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.