The Galil Medical IceRod CX Cryoablation Needle is intended for cryoablative destruction of tissue during surgical procedures. The IceRod CX Cryoablation Needle is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), 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.

The Galil Medical IceRod CX Cryoablation Needle 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 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 (with the exception of cardiac tissue)
. Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)

Device Description

The IceRod CX Cryoablation Needle is a sterile, single use, disposable component used in conjunction with Galil Medical's Visual-ICE 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 IceRod CX disposable cryoablation needle has a 17G shaft, a sharp cutting tip, a color-coded handle, a gas tube, and a connector containing a small PCB board capable of relaying needle information such as needle type, lot number, and expiration date information to Galil's Visual-ICE Cryoablation System. Additionally, the needle exhibits markings to aid in positioning the needle in tissue. The IceRod CX needle differs from the predicate devices in that the distal shaft of the needle contains a non-stick coating and Galil's i-Thaw electrical thaw technology can be used for FastThaw and/or Track Ablation following a cryoablation procedure when used with Galil's Visual-ICE Cryoablation System.

AI/ML Overview

The provided text describes the IceRod CX Cryoablation Needle and its substantial equivalence to predicate devices, focusing on design differences and intended use rather than specific acceptance criteria or a detailed study plan to demonstrate device performance against such criteria. Therefore, much of the requested information cannot be extracted directly from the given document.

Here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a quantitative manner. It states that "Performance testing was conducted on IceRod CX 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 needle track ablation, based on depth of tissue necrosis characterization." It concludes that "Test results demonstrated that the IceRod CX needle meets defined specifications and does not raise any new safety or effectiveness issues."

However, specific acceptance criteria values (e.g., maximum freezing temperature, ice ball size, thaw rate) and the measured performance metrics are not provided.

Acceptance Criteria Category	Reported Device Performance
Dimensional Testing	Meets defined specifications
Functional Testing	Meets defined specifications
Freezing Performance	Meets defined specifications
In Vivo Needle Track Ablation (depth of tissue necrosis characterization)	Meets defined specifications
Biocompatibility	Meets requirements outlined in ISO 10993

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

Sample Size for Test Set: Not explicitly stated. The document mentions "in vivo needle track ablation" which implies an animal or cadaver study, but the number of needles or test subjects is not provided.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The in vivo nature suggests prospective experimental testing.

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

Not mentioned in the document.

4. Adjudication Method for the Test Set

Not mentioned in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned. This type of study is more relevant for diagnostic imaging devices where human readers interpret output, not for a cryoablation needle's performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the device is a cryoablation needle, not an algorithm or AI system. Its performance is related to its physical and thermodynamic properties, not an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing cited appears to be based on:

Defined specifications: For dimensional, functional, and freezing performance.
Depth of tissue necrosis characterization: For in vivo needle track ablation, likely determined through histological examination or similar scientific assessment in a lab setting.
ISO 10993 requirements: For biocompatibility, involving standardized tests.

8. The Sample Size for the Training Set

This question is not applicable as the device is a cryoablation needle, not an AI or machine learning model that requires a training set.

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

This question is not applicable as the device is a cryoablation needle, not an AI or machine learning model that requires a training set.

Summary

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K12(251

. . . .

510(k) Summary

Submitter:

510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

Galil Medical Ltd.

	Tavor 1 BuildingShaar YokneamYokneam Industrial Park 20692Israel
Company Contact Person:	Ms. Lynne A DaviesSr. Regulatory Affairs AdvisorGalil Medical Inc.
Phone:	651-287-5098
Fax:	651-287-5099
Email:	lynne.davies@galilmedical.com
Alternate Contact Person:	Ms. Amy E McKinneyDirector, Regulatory AffairsGalil Medical Inc.
Phone:	651-287-5096
Fax:	651-287-5097
Email:	amy.mckinney@galilmedical.com
Device Name:	IceRod CX Cryoablation Needle
Device ClassificationName:	Cryosurgical unit and accessories (GEH)21 CFR 878.4350
Predicate Devices /Referenced 510(k):	IceRod PLUS 17G Cryoablation Needles (K110946)IceRod i-Thaw 17G Cryoablation Needles (K060390)

Device Description:

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K12/251

Intended Use:

The Galil Medical IceRod CX Cryoablation Needle 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 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 (with the exception of cardiac tissue)
. Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)

Summary of Performance Data and Substantial Equivalence:

The IceRod CX 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 (with the exception of the PCB board). Both the new and predicate devices are comprised of similar materials (with the exception of the non-stick coating) and serve as conduits for high pressure gas during a cryoablation procedure.

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The following table provides a summary comparison of the submitted device compared to the predicate devices.

K121251

Description of SubmittedDevice:	Comments related to Predicates:
IceRod CX Cryoablation Needle	IceRod PLUS 17G Cryoablation Needles (K110946)IceRod i-Thaw 17G Cryoablation Needles (K060390)
Design and Construction
Needle Tip	Same as predicate
Needle Shaft	Same as predicate with the exception of the non-stickcoating
Gas Pathway Tubing	Same as predicate
Handle	Same as predicate
Needle Connector	Same as predicate with the exception of the PCB board
Performance and Function
Freezing/Thawing Technology	Same as predicate
Function	Same as predicate with the exception of the addition ofthe FastThaw and Track Ablation features.
Freezing Parameters	Same as predicate
Thaw Parameters	Same as predicate with the exception of the addition ofthe FastThaw feature
Track Ablation	New feature
Indications for Use	See below

Performance testing was conducted on IceRod CX 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 needle track ablation, based on depth of tissue necrosis characterization. Additionally, the needle meets the biocompatibility requirements outlined in ISO 10993. Test results demonstrated that the IceRod CX needle 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 IceRod CX Cryoablation Needle is substantially equivalent to the legally marketed predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract eagle-like symbol with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

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

Galil Medical Limited % Galil Medical Incorporation Ms. Lynne A. Davies Senior Regulatory Affairs Advisor 126 Mesquite Street Lake Jackson, Texas 77566

AUG 2 8 2012

Re: K121251

Trade/Device Name: IceRod CX Cryoablation Needle Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: August 17, 2012 Received: August 20, 2012

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.

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

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Page 2 - Ms. Lynne A. Davies

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.

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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K1212S(

Indications for Use Statement

510(k) Number (if known): K121251

Device Name: IceRod CX Cryoablation Needle

Indications For Use:

The Galil Medical IceRod CX Cryoablation Needle 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 tumors of the rectum, hemorrhoids, anal fissures, pilonidal cvsts, 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 (with the exception of cardiac tissue) .
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)

Nikh Oden for mxm

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K12125

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.