SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS

K060144 · Galil Medical , Ltd. · GEH · Feb 13, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060144
• Device Name: SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS
• Applicant: Galil Medical , Ltd.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Feb 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SeedNet Family is intended for cryogenic destruction of tissue during surgical procedures. The SeedNet Family 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 Family 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 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

SeedNet Family is a cryosurgical unit using argon-cooled probes to destroy tissue via extreme cold. System includes console, cryoneedles (including 17G and 90° variants), and needle/TS holder stand. Used in clinical settings by physicians across multiple specialties (urology, oncology, dermatology, etc.). Device supports image-guided procedures using CT, MRI, or ultrasound. Physician operates system to apply cryo-ablation to target tissue; output is physical tissue destruction. Benefits include minimally invasive treatment of tumors, lesions, and other specified pathologies.

Clinical Evidence

Bench testing only. No clinical data presented. Verification included electrical, mechanical, and biocompatibility testing to support modifications to needle geometry and imaging modality compatibility.

Technological Characteristics

Cryosurgical unit using argon-cooled probes. Materials include stainless steel cryoneedles. System supports CT, MRI, and ultrasound imaging modalities. Modifications include 17G (1.5mm) needle and 90° needle geometry. Device is a console-based system.

Indications for Use

Indicated for patients requiring tissue ablation or cryosurgical intervention across urology (prostate cancer, BPH), oncology (malignant/benign tumors), dermatology (skin cancers, warts, lesions), gynecology (genital neoplasia/dysplasia), general surgery (tumors, hemorrhoids, fibroadenomas), ENT (oral tumors, leukoplakia), thoracic surgery (arrhythmic tissue, lesions), and proctology (anal/rectal growths).

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 (K980913, K991272, K991517, K993965, K003065, K010991, K012497, K011950, K021261, K031117, K042667, K051052, K052530)
• SeedNetGold® System
• CryoThera® System
• Cryo-Hit® System
• Endocare CryoCare surgical system

Submission Summary (Full Text)

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#### Attachment 8

## 510(k) SUMMARY

# 次 060144

#### Galil Medical Ltd.

### SeedNet® Family System

| Applicant's Name: | Galil Medical Ltd.<br>Tavor 1 Building<br>Shaar Yokneam<br>Yokneam Industrial Park 20692<br>Israel<br>Tel: [phone]<br>Fax: [phone] |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sarit Gelbart<br>VP Regulatory Affairs<br>Galil Medical Ltd.<br>Tel: [phone], Ext. 240<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name: | SeedNet®/SeedNetGold® System, CryoThera® System,<br>Cryo-Hit® System (for ease of use, all those systems will<br>be called in this submission the "SeedNet Family" |
| Classification: | 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 units<br>with argon-cooled cryoprobes as class II devices under 21<br>C.F.R. § 878.4350. However, FDA has cleared Galil<br>Medical's Cryo-Hit®, SeedNet® SeedNetGold® and<br>CryoThera® which are cryosurgical units with argon-<br>cooled cryoprobes, as Class II devices (K980913, K991272,<br>K991517, K993965, K003065, K010991, K012497,<br>KO11950, K021261, K031117, K042667, K051052,<br>K052530). Therefore, cryosurgical units with argon-<br>cooled probes are Class II medical devices. |

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#### Predicate Devices:

Galil's SeedNet® System and SeedNetGold® System, CryoThera® and Galil's Cryo-Hit® System. The Endocare CryoCare surgical system and accessories also served as predicate.

#### 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, 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 t Benign Prostate Hyperplasia "BPH")
- Oncology (ablation of cancerous or malignant tissue and benign I 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 I the female genitalia)
- General surgery (palliation of tumors of the rectum, hemorrhoids, ı 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)

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#### Performance Data & Substantial Equivalence:

The modified SeedNet Family is substantially equivalent in all aspects, e.g., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available SeedNet Family. In addition, the device is also substantially equivalent to the EndoCare CryoCare system and accessories. The principle changes between the devices include:

- 1. Addition of a longer 17G (1.5mm) needle which is a modification to the cleared 1.5 mm stainless steel crvoneedle.
- 2. Addition of 90° needle, which is a modification to the cleared 1.5 mm stainless steel cryoneedle (the "SeedNet Cryoncedle"),
- 3. Addition of a needle/TS holder stand, and
- 4. Addition of CT as imaging modality to the device labeling, in addition to MRI and ultrasound.

The modified SeedNet Family 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 Family does not raise any new safety and/or effectiveness issues. Thus, the modified SeedNet Family is substantially equivalent to the cleared SeedNet Family (the SeedNet®; the SeedNetGold®; the Cryo-Hit® and the CryoThera® System) and to the Endocare CryoCare system and accessories.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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 caduceus, a symbol often associated with medicine and healthcare, in the center. Encircling the caduceus are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The seal is presented in black and white.

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: K060144

Trade/Device Name: SeedNet Family Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II (two) Product Code: OCL, GEH Dated: January 19, 2006 Received: January 19, 2006

Dear Mr. Kahan:

This letter corrects our substantially equivalent letter of February 13, 2006.

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 (OS) 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 vours.

eemell.

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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Attachment 9

#### Indications for Use Statement

510(k) Number (if known): KO 60144

#### Intended Use:

The SeedNet Family is intended for cryogenic destruction of tissue during surgical procedures. The SeedNet Family 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 Family 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 cutancous 지 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 I the female genitalia)
- General surgery (palliation of tumors of the rectum, hemorrhoids, 트 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) 1910 11

vision Sign-Off Division of General, Restorative. and Neurological Devices

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- Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous 피 lesions)
- Proctology (ablation of benign or malignant growths of the anus or . rectum, and hemorrhoids)

Prescription Use _ X (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use_ (Per 21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suval Paver

(Division Sign-C Division of General, Reand Neurological Device.

Number KO(a) 44

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