CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND E

K991272 · Galil Medical , Ltd. · GEH · Jul 12, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991272
• Device Name: CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND E
• Applicant: Galil Medical , Ltd.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Jul 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The modified CRYO-HIT™ System, like the already cleared CRYO-HIT™ System is intended for cryogene ablation of tissue during surgical procedures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology, 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. In addition the modified CRYO-HIT™ 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 ablation of benign tumors, and palliative intervention) Dermatology (ablation or freezing of skin cancers and other cutaneous disorders) Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia) General surgery (destruction of warts or lesions, palliation of tumors of the oral cavity, rectum and skin, and ablation of leukoplakia of the mouth, 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, hemorrhoids, anal fissures, perianal conylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, and recurrent cancerous lesions) Thoracic surgery (ablation of arrhythmic cardiac tissue, and ablation of cancerous lesions) Proctology (ablation of benign or malignant growths of the anus or rectum, and ablation of hemorrhoids)

Device Story

CRYO-HIT™ is a cryosurgical unit for tissue ablation via extreme cold. System utilizes multiple probes (1-8 configurations) and external thermocouples to monitor and control freeze process. Operated by physicians in surgical settings; includes optional foot pedal for control. Device transforms gas/refrigerant flow into localized freezing at probe tip; software manages display of temperature and process information. Output allows clinicians to visualize and control ablation of prostate, kidney, liver, and various cutaneous/internal lesions. Benefits include precise destruction of diseased tissue while sparing surrounding structures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Cryosurgical unit; utilizes multiple probe configurations (1-8) and external thermocouples for temperature monitoring. Features include foot pedal control, single-use probe options, and software for display of process information. Operates via extreme cold application for tissue destruction.

Indications for Use

Indicated for patients requiring cryosurgical ablation of tissue in urology (prostate cancer, BPH), oncology (malignant/benign tumors, palliative care), dermatology (skin cancers, cutaneous disorders), gynecology (malignant/benign dysplasia), general surgery (warts, lesions, tumors, various cysts/hemangiomas), thoracic surgery (arrhythmic tissue, cancerous lesions), and proctology (anal/rectal growths, hemorrhoids).

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

• ENDOcare CRYO-HIT™ System
• CRYO-HIT™ System (K980913)

Submission Summary (Full Text)

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## Galil Medical Proprietary Information

JUL 1 2 1999

ﺗﻤ

510(k) Summary

Galil Medical - CRYO-HIT™ System

Company Name:

Galil Medical Ltd.

Contact Person:

Shaike Schatzberger, President and CEO Telephone: [phone] [phone] Fax:

Trade Proprietary Name:

CRYO-HIT™.

CRYOSURGICAL UNIT

Classification Name:

Classification:

GEH

Predicate Devices:

ENDOcare CRYO-HITTM System

Indication for Use:

The modified CRYO-HIT™ System, like the already cleared CRYO-HIT™ The modilled CKYO-HIT™ System, inst agtion of tissue during surgical System is intended for cryogene as a cryosurgical tool in the fields of general surgery, dermatology, neurology, thoracic surgery, ENT, general surgery, oncology, and urology, and urology, The system is designed to gynecology, oncology, proctorogy, and aronegy of temperatures including prostate and kidney tissue, liver metastascs, turnors, skin lesions, and warts.

In addition the modified CRYO-HIT™ System has the following specific indications:

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Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hynernlasia "BPH")

Oncology (ablation of cancerous or malignant tissue, and ablation of benign tumors, and palliative intervention)

Dermatology (ablation or freezing of skin cancers and other cutaneous disorders)

Gynecology (ablation of malignant neoplasia or benign dysplasia of the fomale genitalia)

General surgery (destruction of warts or lesions, palliation of tumors of the oral cavity, rectum and skin, and ablation of leukoplakia of the mouth, 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, hemorroids, anal fissures, perianal conylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, and recurrent cancerous lesions)

Thoracic surgery (ablation of arrhythmic cardiac tissue, and ablation of cancerous lesions)

Proctology (ablation of benign or malignant growths of the anus or recturn, and ablation of hemorrhoids)

## Device Description:

The different CRYO-HIT™ models have the same performance, technology and intended use. The only difference between them are the number of probe got a available in each model (1-probe, 2-probe, 3-probe, 4-probe, 5-probe, 5-probe, 7-probe and 8-probe configurations) and the number of temperature sensor ports, to meet the needs of different customers.

The probes that can be used in the different configurations are exactly the same. The modified CRYO-HIT™ System is the exact same device as Galil Medical I.TD's cleared CRYO-HIT™ System (K980913) except for the following technological modifications: (1) Additional probes are made available; (2) single use probes are added as an option; (3) a foot pedal is added as an operating option; (4) the number of probes and external thermocouples is more varied; (5) the modified CRYO-HIT™ System allows an additional method of controlling the freeze process; and (6) minor changes to the software that are necessary for the display of the screen informations

Substantial Equivalence: The modified CRYO-HIT™ System has the same intended use, and very similar principle of operation and technological characteristic as the cleared ENDOcare and cleared CRYO-HIT™ System, thus the modified CRYO-HIT™ System is substantial equivalent to these legally marketed predicate devices.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2008

Galil Medical Ltd. c/o Mr. Howard M. Holstein Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004

Re: K991272 Trade Name: Cryo-Hit™ System Regulatory Class: II (two) Product Code: OCL, GEH Dated: February 17, 1999 Received: April 13, 1999

Dear Mr. Holstein:

This letter corrects our substantially equivalent letter of July 12, 1999.

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 (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.

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.

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Page 2 - Mr. Howard M. Holstein

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); 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

elma
Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 9

Galil Medical Proprietary Information

## INDICATIONS FOR USE

CRYO-HIT'" System

510(k) Number (if known):

Device Name:

Indications for Use:

The modified CRYO-HIT™ System. like the already cicared CRYO-HIT™ System is imended for exposence desouction of
CRYO-HIT™ System is incendures It is indicated for use as a tissue during surgical procedures. It is indicated for use as a cryosurgical tool in the fictios of general surgery, demandology, neurology, thoracie surgery, ENT, gystem is designed to designed to destroy proctology. and urology. The system is designed to designed to destroy tissue by the application of extreme of extreme cold temperatures, including prostate and kidney tissue, liver metastases, tumors,
including prostation and kidney tissue, liver metastases, tumors,
including prostationers

skin lesions, and warts. skin lesions, and wards.
In addition the modified CRYO-HIT™ System has the

following specific indications: following specific indications:
Urology (ablation of prostate tissue in cases of prostate cancer
Urology (ablack and themalesia "BPH") Urology (ablation of prosuate Hyperplassia "BPH")
and Benign Prosuate Hyperplassia "BPH")

Oncalogy (ablation of cancerous or malignant ticsuo, and Oncalors (ablation of benign lumors, and palliative intervention) Dermatology (ablation or freezing of skin cancers and other

curaneous disorders) Gynecology (ablation of malignant neoplasia or benign
Grandogy (ablation of malignant neoplasia or benign

dysplasia of the famale genitalia) dysplasia of the female genitalia)
General surgery (destruction of wars or lesions, palliation of
General surgery (destruction of wars or lesions, and ablation of General surgery (desiration of warts of restum and skins, and ablation of
tumors of the other mayer, enchomas, sebaceous nyperplast leukoplakia of the mouth, anglomas, sebacaus nyperplastis, basal cell tumors of the eyelid or canthus area, ulcerated basal
basal cell tumors of the cyclid or canthus area, ulcerated basal cell tumors, dermatofibromes small hemanglomas, muchocole cysis, multiple warts, plantar wars, hemorroids, and fissures,
cysis, multiple warts, plantar wars, hemorroids, and fissures, perianal conylomata, pilonidal cysts, actinic and seborthere perianal conylomata, pilonidal cysts, actinto and 100%.
Keratoses, cavernous hemangiomas, and recurrent cancerous

lesions)
Thoracic surgery (ablation of arrhythmic cardiac tissuc, and lesions) ablation of cancerous lesions) ablation of cancerous iesions)
Proctology (ablation of benign of malignant growths of the

Proctology (ablation of occition of hemorrhoids)

## (PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Collier. Sign-off)
Division of Reproff)
Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices

510(k) Number K 971137

Prescription Use
(Per 21 CFR 801.109)

OR

Over the Counter Use_

Ronald Lyons Jr.

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