SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA

K052530 · Galil Medical , Ltd. · GEH · Nov 18, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052530
• Device Name: SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA
• Applicant: Galil Medical , Ltd.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Nov 18, 2005
• Decision: SESE
• Submission Type: Traditional
• 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, l hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas.) ENT (Palliation of tumors of the oral cavity and ablation of u 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 (SeedNet, SeedNetGold, CryoThera, Cryo-Hit) functions as a cryosurgical unit using argon-cooled cryoprobes to destroy tissue via extreme cold. System operates by circulating argon gas through probes to induce localized tissue necrosis. Used by physicians in clinical settings (OR/clinic) for ablation of tumors, lesions, and specific tissue types (prostate, kidney, breast, skin). Can be integrated with MRI or ultrasound for real-time procedural visualization. Output is physical tissue destruction; healthcare providers monitor procedure via imaging to guide probe placement and ensure adequate treatment margins. Benefits include minimally invasive tissue destruction for various oncological and benign conditions.

Clinical Evidence

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

Technological Characteristics

Cryosurgical unit utilizing argon-cooled cryoprobes. System includes console and probes for extreme cold application. Compatible with MRI and ultrasound for visualization. Software-controlled operation. Class II device under 21 CFR 878.4350.

Indications for Use

Indicated for patients requiring tissue ablation across general surgery, dermatology, neurology, thoracic, ENT, gynecology, oncology, proctology, and urology. Specific conditions include prostate cancer, BPH, malignant/benign tumors, skin lesions/cancers, warts, gynecological dysplasia, breast fibroadenomas, hemorrhoids, and cardiac arrhythmias.

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 Family (Galil Medical)
• CryoCare CS system
• Visica system

Submission Summary (Full Text)

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510(K) SUMMARY Galil Medical LTD.

# SeedNet Family

K052530

#### Applicant's Name:

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

#### Contact Person:

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

#### Trade Name:

SeedNet/SeedNetGold System, CryoThera System, Cryo-Hit System (for ease of reference, the CryoThera, Cryo-Hit, SeedNet, and SeedNetGold are collectively being called the "SeedNet Family" in this 510(k) notice except when there is a need to distinguish between the devices).

| 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<br>cryosurgical units with argon cooled cryoprobes<br>as class II devices under 21 C.F.R. § 878.4350.<br>However, FDA has cleared Galil Medical<br>SeedNet™ and SeedNetGold™, which are<br>cryosurgical units with argon-cooled Cryoprobes,<br>as Class II devices. Therefore, cryosurgical units<br>with argon-cooled probes are Class II medical<br>devices. |

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### Predicate Devices:

Galil Medical Ltd. believes that the current SeedNet Family with the expanded Indications for Use is substantially equivalent to the combination of the following predicate devices, all classified under product code GEH:

- SeedNet Family, Galil Medical.
- 『 CryoCare CS system.
- E Visica system.

## 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:

- I Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH")
- 트 Oncology (ablation of cancerous or malignant tissue and benign tumors, and palliative intervention).
- 트 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)

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- General surgery (palliation of tumors of the rectum, l hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas.)
- ENT (Palliation of tumors of the oral cavity and ablation of u leukoplakia of the mouth).
- . Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous lesions)
- 트 Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)

The SeedNet Family 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 Indications for Use of the current SeedNet Family is expanded to include the specific indication of ablation of breast fibroadenomas. The only change between the current and the cleared indications of the SeedNet Family is the addition of this indication to the cleared General Surgery specific indications. This indication of breast fibroadenomas is claimed by both the 510(k)-cleared CryoCare CS system and Visica system. All systems are cryo-surgery systems, which employ similar performance characteristics. In all other aspects including technological characteristics, software, user interface and principles of operation, the SeedNet Family described in this submission is substantially equivalent to the cleared SeedNet Family.

Therefore, Galil Medical Ltd. believes that the SeedNet Family described in this submission is substantially equivalent to the combination of its predicate devices; the cleared SeedNet Family (the SeedNet™; the SeedNetGold™ , the CryoThera™ and the Cryo-Hit™), the CryoCare CS and the Visica systems, and does not raise any new questions of safety and/or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with outstretched wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.

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

Re: K052530

Trade/Device Name: SeedNet Family (SeedNet/SeedNetGold System, CryoThera System, Cryo- Hit System) Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II (two) Product Code: OCL, GEH Dated: September 6, 2005 Received: September 14, 2005

Dear Mr. Kahan:

This letter corrects our substantially equivalent letter of November 18, 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 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.

elgmee

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

KOS2520

510(k) Number (if known):

Device Name:

SeedNet Family (SeedNet/SeedNetGold System, CryoThera System, Cryo- Hit System)

Indications for Use:

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

It is indicated for use as a cryosurgical tool in the fields of surgery, dermatology, neurology (including general 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 recturn, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas.)

Mark

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

510(k) Number

KOS-2530

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- ENT (Palliation of tumors of the oral cavity and t 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 Family may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide realtime visualization of the cryosurgical procedure.

Prescription Use x (Part 21 C.F.R. 801 Subpart D)

AND/OR

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

Mark H. Milliken

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
K05253

510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)