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

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 turnors, 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)

Device Description

The IceRod Plus 17G Cryoablation Needles are sterile, single use, disposable components used in conjunction with a Galil Medical Cryoablation System when performing cryoablative destruction of tissue. They are intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application. The IceRod Plus needles are available in two configurations, straight and angled 90°. Each 17-gauge (17G) disposable cryoablation needle has a sharp cutting tip, a shaft, a color-coded handle, a gas tube, and a connector. Additionally, each needle exhibits markings every 5 mm to aid in positioning the needle in tissue. The IceRod Plus needles differ from the predicate device in that they contain an inner vacuum insulated tube to provide additional shaft insulation during a cryoablation procedure.

AI/ML Overview

The provided text describes a 510(k) summary for the "IceRod Plus 17G Cryoablation Needles" and a letter from the FDA. This document is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific acceptance criteria and detailed performance metrics as might be found for novel devices or software.

Based on the information provided, here's a breakdown:

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

The document does not explicitly present a table of acceptance criteria with numerical targets and corresponding device performance data in the typical sense of a clinical trial or performance study for a diagnostic device. Instead, it describes various types of testing conducted to ensure the device meets specifications and is substantially equivalent to predicate devices. The "reported device performance" is a general statement that the device met these specifications, rather than a specific metric.

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Dimensional Testing	Adherence to specified dimensions for the needles (e.g., length, diameter, markings every 5mm).	"Test results demonstrated that the IceRod Plus needles meet defined specifications."
Functional Testing	Proper operation of the device as intended for cryoablation (e.g., gas flow, freezing/thawing application).	"Test results demonstrated that the IceRod Plus needles meet defined specifications."
Freezing Performance	Ability to achieve and maintain appropriate cold temperatures for tissue destruction.	"Test results demonstrated that the IceRod Plus needles meet defined specifications."
Stability	Maintenance of performance over time and under various conditions.	"Test results demonstrated that the IceRod Plus needles meet defined specifications."
Biocompatibility	Compliance with ISO 10993 standards for biological evaluation of medical devices.	"Additionally, the needles meet the biocompatibility requirements outlined in ISO 10993."
Overall Safety and Effectiveness	Not raising any new safety or effectiveness issues compared to predicate devices.	"Test results demonstrated that the IceRod Plus needles meet defined specifications and do not raise any new safety or effectiveness issues."

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

The document does not specify exact sample sizes for the testing set beyond implying that "performance testing was conducted on the IceRod Plus Cryoablation Needles" (plural, suggesting more than one, but not a defined number). There is no information provided about the data provenance (e.g., country of origin, retrospective or prospective) for these performance tests. This typically involves in-house laboratory testing rather than human subject data for this type of device.

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)

This information is not applicable to the type of device and testing described. The "ground truth" for cryoablation needles would be their physical and functional characteristics (e.g., dimensions, temperature output, biocompatibility), which are evaluated against engineering specifications and international standards, not typically established by clinical experts in the way ground truth is for diagnostic AI.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human reviewers independently assess data and resolve discrepancies, typically for diagnostic or clinical outcome measures. The testing described for the IceRod Plus is product performance testing against engineering and regulatory standards.

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

There is no indication that an MRMC comparative effectiveness study was conducted, nor is this type of study typically expected for a cryoablation needle. MRMC studies primarily evaluate the impact of a diagnostic AI system on human reader performance. The IceRod Plus is a medical device (a needle) used by a clinician during a procedure, not a diagnostic AI.

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

This information is not applicable. The IceRod Plus is a physical medical device, not an algorithm.

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

The "ground truth" for the performance testing mentioned (dimensional, functional, freezing performance, stability, biocompatibility) would be defined by engineering specifications, international standards (e.g., ISO 10993 for biocompatibility), and in-house requirements. It is not derived from expert consensus, pathology, or outcomes data in the clinical sense, but rather from measurable physical and performance characteristics.

8. The sample size for the training set

This information is not applicable. The IceRod Plus 17G Cryoablation Needle is a physical medical device, not an AI or machine learning model that requires a training set.

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

This information is not applicable for the same reason as point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Galil Medical. The logo consists of a stylized letter "G" with a circle at the end of one of its arms, followed by the text "GALIL MEDICAL" in bold, sans-serif font. Below the company name is the tagline "A New Vision of Precision" in a smaller, regular font.

Section 5. 510(k) Summary JUN 2 1 2011

K110946

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 Ltd.Tavor 1 BuildingShaar YokneamYokneam Industrial Park 20692Israel
------------	----------------------------------------------------------------------------------------------------

Company ContactPerson:	Ms. Lynne DaviesSr. Regulatory Affairs AdvisorGalil Medical Inc.Phone: 651-287-5098
Fax:Email:	651-287-5099lynne.davies@galilmedical.com
Device Name:	IceRod Plus 17G Cryoablation Needles
Device ClassificationName:	Cryosurgical unit and accessories (GEH)21 CFR 878.4350
Predicate Device:	IceRod 17G Cryoablation Needle (K051052)IceRod 17G 90° Cryoablation Needle (K060144)

Device Description:

Intended Use:

Special 510(k) - IceRod™ Plus Cryoablation Needles

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for Galil Medical. The logo features 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 font size.

designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.

I Cruschlation Systems have the following oppositions:

•	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 disordersDestruction 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 IceRod Plus Cryoablation Needles have the same intended use and method of operation as compared to the predicate devices. The IceRod Plus needles differ in design in that they contain an inner vacuum insulated tube to enhance shaft insulation during the cryoablation procedure. Both the new and predicate devices consist of a sharp cutting tip, a shaft, a color-coded handle, a gas tube, 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 the IceRod Plus Cryoablation Needles 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

Special 510(k) - IceRod™ Plus Cryoablation Needles

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for Galil Medical. The logo features 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.

and stability. Additionally, the needles meet the biocompatibility requirements outlined in ISO 10993. Test results demonstrated that the IceRod Plus needles meet defined specifications and do not raise any new safety or effectiveness issues.

Conclusion:

The information and data provided in this 510(k) Notification establish that the IceRod Plus 17G Cryoablation Needles are substantially equivalent to the legally marketed predicate devices.

Special 510(k) - IceRod™ Plus Cryoablation Needles

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like strokes. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the bird.

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

Galil Medical Ltd. % Ms. Lynne Davies Sr. Regulatory Affairs Advisor Tavor 1 Building, Shaar Yokneam Yokneam Industrial Park 20692 Israel

JUN 2 1 2011

Re: K110946

Trade/Device Name: IceRod™ Plus Cryoablation Needles Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: May 21, 2011 Received: May 25, 2011

Dear Ms. Davies:

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.

{4}------------------------------------------------

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Eric Keith

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

Enclosure

{5}------------------------------------------------

Indications for Use Statement

510(k) Number (if known):

Device Name: IceRodTM Plus Cryoablation Needles

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 turnors, 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 8 (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)

Nailre Ogle for nkn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

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.