SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3

K021261 · Galil Medical , Ltd. · GEH · Jul 3, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021261
• Device Name: SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3
• Applicant: Galil Medical , Ltd.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Jul 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SeedNet™ System (SeedNet Gold™ System) is intended for cryogenic destruction of tissue during surgical procedures. It 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 SeedNet™ System (SeedNet Gold™ 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 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.) ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth). Thoracic surgery (ablation of arrhythmic cardiac tissue and cancerous lesions,) Proctology (ablation of benign or malignant growths of the anus or rectum and hemorrhoids) The SeedNet™ System (SeedNet Gold™ System) may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide real-time visualization of the cryosurgical procedure.

Device Story

Cryosurgical system for tissue destruction via extreme cold. Inputs: gas/refrigerant for probe cooling. Operation: application of extreme cold temperatures to target tissue; system supports 4.5 mm surface probe. Used in OR/clinical settings by physicians. Supports real-time visualization via integration with MRI or ultrasound devices. Output: localized tissue necrosis/ablation. Benefits: minimally invasive destruction of tumors, lesions, and diseased tissue; palliative intervention for various cancers and benign growths.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use comparisons.

Technological Characteristics

Cryosurgical unit; includes 4.5 mm surface probe; supports MRI and ultrasound integration for visualization. System is a modification of K011950. Class II device.

Indications for Use

Indicated for patients requiring tissue ablation across general surgery, dermatology, neurology (cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. Specific conditions include prostate cancer, BPH, malignant/benign tumors, skin lesions, warts, hemorrhoids, 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

• SeedNet™ (K011950)
• CRYO-HIT™

Submission Summary (Full Text)

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## SECTION 8-510(K) SUMMARY

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510(k) Summary

Galil Medical - SeedNet™ System

510(k) Number

Company Name:

Galil Medical Ltd.

### Contact Person:

Dr. Roni Zvuloni, Director of IP & Regulatory Affairs Telephone: [phone] Fax: [phone]

Trade Proprietary Name:

SeedNet™ System , SeedNetGold™ System

Classification Name:

## CRYOSURGICAL UNIT

Classification:

GEH

## Predicate Devices:

- 1. SeedNet™
- 2. CRYO-HIT™

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#### Indication for Use:

The modified SeedNet 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 modified SeedNet 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.)

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)

The Modified SeedNet System may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide real-time visualization of the cryosurgical procedure.

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#### Technological Characteristics:

The Galil Medical's SeedNet™ System is a modification of Galil Medical LTD's cleared SeedNet™ System (K011950). The SeedNet™ System is the exact same device as the SeedNet™ except for the following modifications to its technological characteristics:

- 1. The inclusion of cryoanalgesia as an example of the device's cleared neurology general indication.
- 2. The addition of a 4.5 mm surface probe.
- 3. Addition of trade name: SeedNetGold™ System.
- 4. Provision of the use of the modified SeedNet system together with magnetic resonance imaging (MRI) device.

#### Substantial Equivalence

The modified SeedNet has the same intended use as the cleared SeedNet™ and the Cryo-Hit™, the same general and specific indications as the Cryo-Hit™, the same general and specific indications as the cleared SeedNet, except for the provision of the cryoanalgesia example of a neurology indication, the same principles of operation as the cleared SeedNet™ and the Cryo-Hit™, and the same technological characteristics as a combination of the cleared Cryo-Hit and the cleared SeedNet™ The inclusion of the cryoanalgesia as an example of the device's cleared neurology general indication, the addition of the Cryo-Hit's cleared 4.5 mm surface probe, and the MRI option do not raise any question of safety and effectiveness. The use of the alternative SeedNet Gold™ System trade name does not affect the safety or effectiveness of the device. Thus, the modified SeedNet System is substantially equivalent to the predicate devices.

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FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Galil Medical Ltd. c/o Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004-1109

Re: K021261

Trade Name: SeedNet™ System (SeedNet Gold™ System) Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit Regulatory Class: Class II (two) Product Code: OLC, GEH Dated: April 17, 2002 Received: April 19, 2002

Dear Mr. Kahan:

This letter corrects our substantially equivalent letter of July 03, 2002.

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. Jonathan S. Kahan

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.

elmee

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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## INDICATIONS FOR USE

510(k) Number (if known):

# 12021261

Device Name:

SeedNet™ System (SeedNet Gold™ System)

Indications for Use:

The SeedNet™ System (SeedNet Gold™ System) is intended for cryogenic destruction of tissue during surgical procedures.

It 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 SeedNet™ System (SeedNet Gold™ 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

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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.)

ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth).

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

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

The SeedNet™ System (SeedNet Gold™ System) may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide real-time visualization of the cryosurgical procedure.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-off) Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices

Stye Rhodes

510(k) Number

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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Over the Counter
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