VISUAL-ICE CRYOABLATION SYSTEM

K113860 · Galil Medical, Inc. · GEH · Mar 12, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K113860
• Device Name: VISUAL-ICE CRYOABLATION SYSTEM
• Applicant: Galil Medical, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Mar 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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 Story

Mobile, computer-controlled cryoablation console; utilizes Joule-Thomson effect via high-pressure argon gas circulating through closed-tip needles to induce tissue freezing; active thawing via helium gas circulation or internal heating element (i-Thaw technology). Operated by clinicians in surgical settings; touch screen interface allows procedure control and monitoring. System destroys targeted tissue (prostate, kidney, liver metastases, skin lesions) via extreme cold. Output provides real-time procedural monitoring to assist clinician in tissue ablation; facilitates minimally invasive surgical intervention; benefits patients by enabling precise, localized tissue destruction.

Clinical Evidence

Bench testing only. Verification and validation included system, electrical, mechanical, packaging, labeling, software, design/usability, and animal/cadaver testing. No clinical trial data presented.

Technological Characteristics

Mobile console; Joule-Thomson effect cooling; argon/helium gas source; closed-tip cryoablation needles; i-Thaw heating element; touch screen interface; computer-controlled; software-based monitoring.

Indications for Use

Indicated for cryoablative tissue destruction in general surgery, dermatology, neurology (cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. Patient populations include those with prostate cancer, BPH, malignant/benign tumors, skin cancers, cutaneous disorders, warts, lesions, female genital dysplasia, breast fibroadenomas, and arrhythmic cardiac tissue.

Regulatory Classification

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.

Predicate Devices

• Presice Cryosurgical System (K060390)

Submission Summary (Full Text)

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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: [phone] Fax: Email: [e-mail]

Sr. Regulatory Affairs Advisor

Alternate Contact:

- Galil Medical Inc. 651-287-5098 Phone: Fax: [phone] Email: [e-mail]

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

Lynne Davies

#### 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.

#### Intended 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

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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 Benign<br>Prostate Hyperplasia (BPH) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • Oncology | Ablation of cancerous or malignant tissue and benign tumors, and<br>palliative intervention |
| • Dermatology | Ablation or freezing of skin cancers and other cutaneous disorders |
| | Destruction of warts or lesions, angiomas, sebaceous hyperplasia,<br>basal cell tumors of the eyelid or canthus area, ulcerated basal cell<br>tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple<br>warts, plantar warts, actinic and seborrheic keratosis, cavernous<br>hemangiomas, peri-anal condylomata, and palliation of tumors of the<br>skin |
| • Gynecology | Ablation of malignant neoplasia or benign dysplasia of the female<br>genitalia |
| • General surgery | Palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal<br>cysts, and recurrent cancerous lesions, ablation of breast<br>fibroadenomas |
| • ENT | Palliation of tumors of the oral cavity and ablation of leukoplakia of the<br>mouth |
| • Thoracic surgery | Ablation of arrhythmic cardiac tissue cancerous lesions |
| • Proctology | Ablation of benign or malignant growths of the anus or rectum, and<br>hemorrhoids |

#### 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 [phone] or [phone] 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