SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM)

K051052 · Galil Medical , Ltd. · GEH · May 6, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051052
• Device Name: SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM)
• Applicant: Galil Medical , Ltd.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: May 6, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SeedNet System is intended for cryogenic destruction of tissue during surgical procedures. The SeedNet System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, (including cryoanalgesia), thoracic surgery, ENT. neurology 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 has the following specific indications: Urology (ablation of prostate tissue in cases of prostate cancer 피 and Benign Prostate Hyperplasia "BPH") Oncology (ablation of cancerous or malignant tissue and benign 미 tumors, and palliative intervention) Dermatology (ablation or freezing of skin cancers and other I cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, basal cell tumors, dermatofibromas small ulcerated 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 제 of the female genitalia) (palliation of tumors of the rectum, . General surgery hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions.) ENT (Palliation of tumors of the oral cavity and ablation of 트 leukoplakia of the mouth). (ablation of arrhythmic cardiac tissue · Thoracic surgery cancerous lesions) Proctology (ablation of benign or malignant growths of the anus 트 or rectum, and hemorrhoids) The 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.

Device Story

Cryosurgical system using argon-cooled probes to destroy tissue via extreme cold; used in various surgical specialties including urology, oncology, and dermatology. System includes console, cryoneedles/probes, and remote MRI-compatible Mobile Distribution Panel (MDP). Operated by physicians in clinical/surgical settings. Provides real-time visualization when integrated with MRI or ultrasound. Software monitors system operation and provides alerts if temperature sensors/thermocouples fail to detect signals. Enables precise tissue ablation for cancer treatment, BPH, and palliative care; benefits patients through minimally invasive destruction of targeted lesions.

Clinical Evidence

Bench testing only. Verification process included electrical, mechanical, and biocompatibility testing to support substantial equivalence.

Technological Characteristics

Argon-cooled cryosurgical unit. Includes console, cryoneedles, cryoprobes, and remote MRI-compatible Mobile Distribution Panel (MDP). Features temperature sensors/thermocouples for monitoring. Software-based monitoring for sensor signal loss. Compatible with MRI and ultrasound for visualization.

Indications for Use

Indicated for patients requiring tissue ablation in urology (prostate cancer, BPH), oncology (malignant/benign tumors, palliative care), dermatology (skin cancers, warts, lesions, angiomas, keratoses), gynecology (genital neoplasia/dysplasia), general surgery (rectal tumors, hemorrhoids, fissures, cysts), ENT (oral tumors, leukoplakia), thoracic surgery (arrhythmic cardiac 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

• SeedNet System (K031117)
• SeedNetGold System (K003065)
• Cryo-Hit System (K010991, K011950, K021261)

Submission Summary (Full Text)

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MAY - 6 2005

K05/052

Page 1 of 3

510(K) SUMMARY Galil Medical LTD. SeedNet System

# Applicant's Name:

Galil Medical Ltd. Tavor 1 Building Shaar Yokneam Yokneam Industrial Park 20692 ISRAEL Tel: [phone] ﻟﺴﻨﺔ Fax: [phone]

# Contact Person:

Sarit Gelbart VP Regulatory Affairs Galil Medical Ltd. Tel: [phone], Ext. 240 Fax: [phone] [e-mail]

Trade Name:

Classification:

SeedNet/SeedNetGold System, CryoThera System, Cryo-Hit System

Cryosurgical Unit

| Common/Usual Name: | Cryosurgical unit with argon-cooled probes |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code: | GEH |
| Regulation No.: | 878.4350 |
| Class: | II; FDA has not specifically classified cryosurgical<br>units with argon cooled cryoprobes as class II<br>devices under 21 C.F.R. § 878.4350. However, FDA<br>has cleared Galil Medical SeedNetTM and<br>SeedNetGoldTM, which are cryosurgical units with<br>argon-cooled Cryoprobes, as Class II devices<br>(K031117, K003065, K010991, K011950, and<br>K021261). Therefore, cryosurgical units with argon-<br>cooled probes are Class II medical devices. |

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K051052

Page 2 of 3

#### Predicate Devices:

Galil's SeedNet™ System and SeedNetGold™ System and Galil's Cryo-Hit™ System.

#### Intended Use:

The SeedNet System is intended for cryogenic destruction of tissue during surgical procedures. The SeedNet System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, (including cryoanalgesia), thoracic surgery, ENT. neurology 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 has the following specific indications:

- Urology (ablation of prostate tissue in cases of prostate cancer 피 and Benign Prostate Hyperplasia "BPH")
- Oncology (ablation of cancerous or malignant tissue and benign 미 tumors, and palliative intervention)
- Dermatology (ablation or freezing of skin cancers and other I cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, basal cell tumors, dermatofibromas small ulcerated 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 제 of the female genitalia)
- (palliation of tumors of the rectum, . General surgery hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions.)
- ENT (Palliation of tumors of the oral cavity and ablation of 트 leukoplakia of the mouth).
- (ablation of arrhythmic cardiac tissue · Thoracic surgery cancerous lesions)

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K05/052

Page 3 of 3

- Proctology (ablation of benign or malignant growths of the anus 트 or rectum, and hemorrhoids)
The 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.

## Performance Data & Substantial Equivalence:

The modified SeedNet System is substantially equivalent in all aspects, e.g., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available SeedNet System. The principle changes between the devices include:

- 1. Addition of the cryoneedles and cryoprobes that are different sizes, shapes, or made of different materials
- 2. The MRI compatible SeedNet System was modified to include a remote MRI Compatible Mobile Distribution Panel (MDP)
- က် Addition of functional features to the software that the operation of the system and indicate the user when no signal is detected from specific temperature sensors or thermocouples.
- Inclusion of New General Use Template for use with the IceRod™ 4. Cryoneedles
- 5. Provision of IceRod™ Prostate and Renal Kits.
- Addition of the trade name CryoThera in addition to Cryo-Hit and 6. SeedNet/SeedNetGold.

The modified SeedNet System and its modified accessories were subjected to a comprehensive testing process as part of the design verification process. This included electrical, mechanical and biocompatibility testing. The modified SeedNet System does not raise any new safety and/or effectiveness issues. Thus, the modified SeedNet System is substantially equivalent to the cleared SeedNet System (the SeedNet™; the SeedNetGold™ and the Cryo-Hit™).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple and monochromatic.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Galil Medical Ltd. c/o Mr. Jonathan S. Kahan Hogan and Hartson 555 13th Street, N.W. Washington, DC 20009

Re: K051052

Trade/Device Name: SeedNet System (SeedNet/SeedNetGold System, CyroThera System, Cyro-Hit System) Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II (two) Product Code: OCL, GEH Dated: April 19, 2005 Received: April 25, 2005

Dear Mr. Kahan:

This letter corrects our substantially equivalent letter of May 6, 2005.

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,

elgmal

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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K05/052

Page 1 of 2

## INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

SeedNet System (SeedNet/SeedNetGoId System, CryoThera System, Cryo- Hit System)

Indications for Use:

The SeedNet 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 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.)

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K05/052

Page 2 of 2

- 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 may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide realtime visualization of the cryosurgical procedure.

AND/OR Use Prescription X (Part 21 C.F.R. 801 Subpart D)

Over-The-Counter Use (PART 21 C.F.R. 801 Subpart C)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| | Restorative |
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| | Neurological |

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