SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD)

K042667 · Galil Medical , Ltd. · GEH · Oct 14, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042667
• Device Name: SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD)
• Applicant: Galil Medical , Ltd.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Oct 14, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SeedNetGold™ with Renal Kit is intended for cryogenic destruction of tissue during surgical procedures. The SeedNetGold™ with Renal Kit 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.

Device Story

SeedNetGold™ with Renal Kit is a cryosurgical system utilizing argon-cooled probes to destroy tissue via extreme cold. System includes cryoneedles and thermal monitoring; used in various surgical specialties including urology, oncology, and dermatology. Operates by applying cryogenic temperatures to target tissue (e.g., prostate, kidney, tumors, skin lesions). Used in clinical settings by physicians; may be used with MRI or ultrasound for real-time visualization of the procedure. Output is the physical destruction of targeted tissue. Benefits include minimally invasive tissue ablation for cancerous or benign conditions.

Clinical Evidence

Bench testing only. Data demonstrated that the SeedNetGold™ with Renal Kit is at least as safe and effective as the cleared SeedNetGold™ with Prostate Kit and Prostate Template in destroying tissue through the application of extreme cold temperatures.

Technological Characteristics

Cryosurgical unit with argon-cooled probes. Conforms to ASTM F 882-84 and ANSI/AAMI/ISO 11135. Compatible with MRI and ultrasound for visualization. System includes cryoneedles and thermal monitoring components. Class II device.

Indications for Use

Indicated for patients requiring tissue ablation in urology (prostate cancer, BPH), oncology (malignant/benign tumors, palliative), dermatology (skin cancers, warts, lesions, angiomas, keratoses), gynecology (malignant neoplasia, benign 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

• SeedNetGold™ (K042667)

Submission Summary (Full Text)

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| 510(k) Summary | K042667 |
|--------------------|---------------------------------------------------------------|
| Applicant's Name | Yoram Levy<br>Consultant |
| | Galil Medical Ltd. |
| | P.O. Box 224 |
| | Yokneam Industrial Park 20692 |
| | ISRAEL |
| Telephone: | 972-4-959 10 80 |
| Fax: | 972-4-959 10 77 |
| Contact Person: | Yoram Levy, QSite |
| | 31 Haavoda St. |
| | Binyamina, Israel 30500 |
| | Tel [phone]; Fax [phone] |
| | [e-mail] |
| B. Trade Name: | SeedNetGold ^TM with Renal Kit |
| E. Classification: | Classification name: Cryosurgical unit |
| | Common/usual name: Cryosurgical unit with argon-cooled probes |
| | Product Code: GEH |
| | Regulation No.: 878.4350 |

## F. Reason for the Premarket Notification Submission:

Galil Medical intends to market a Renal Kit that includes cryoneedles, thermal Galli Medical Intellus to market a Ronal The use with the SeedNet Gold during renal cryoablation.

# F. Identification of Legally Marketed Predicate Devices:

Galil's SeedNetGoldTM

No GM /F/7.3/ 03/01b

# F. Performance Standards or Special Controls:

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The SeedNet™ and the SeedNetGold™ conform to ASTM Designation F 882-84 (reapproved 1996).

The SeedNet™ and the SeedNetGold™ conform to ANSI/AAMI/ISO 11135.

#### Indications for Use:

The SeedNetGold™ with Renal Kit is intended for cryogenic destruction of tissue during surgical procedures. The SeedNetGold™ with Renal Kit 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 SeedNetGold™ with Renal Kit 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 sebortheic 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, t 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)

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The SeedNetGold™ System may be used with a magnetic resonance imaging (MRI) device The Securversiond - bystem mig-seal-time visualization of the cryosurgical procedure.

### Technological Characteristics:

The SeedNetGold™ with Renal Kit is the exact same device as the cleared SeedNetGold™ The Securier one - with Renal Kit, which is a modification to the SeedNet Gold's cleared Prostate Kit and Prostate Template.

#### Performance Testing

Bench testing demonstrated that the SeedNetGold™ with Renal Kit is at least as safe and Deneffective as the cleared SeedNetGold™ with the Prostate Kit and Prostate Template in destroying encedive as the application of extreme cold temperatures during cryosurgical procedures.

### Comparison to the Predicate Device

The SeedNetGold™ with Renal Kit has the same intended use, general and specific indications, The SecuretGold - with Achar In Has Seed NetGold™. In addition, the SeedNetGold™ with and principits of operation as the eleared bebared SeedNetGold™, except .
Renal Kit has the exact same technological characteristics as the cleared Seed Ki for their Renal Kit, which is an optional accessory. The minor differences between the Renal Kit and the Prostate Kit, which is and Prostate, do not raise new questions of safety or effectiveness. and the Prostate Kit and Trostate Tomplace, as TM with Renal Kit is as safe and effective as the Bench data demonstrates that the SeedNetGold™ with Renal Kit is substantially equivalent.
cleared SeedNetGold™; thus, the SeedNetGold™ with Renal Kit is substantially equival

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Image /page/3/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a human figure embracing a globe.

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 LLP 555 Thirteenth Street NW Washington, DC 20004

Re: K042667

Trade/Device Name: SeedNetGold™ with Renal Kit Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II (two) Product Code: OCL, GEH Dated: September 7, 2004 Received: September 29, 2004

Dear Mr. Kahan:

This letter corrects our substantially equivalent letter of October 14, 2004.

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 yours,

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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No GM /F/7.3/ 03/01b Revision: a

510(k) Number (if known):

KO4 3667

Device Name:

SeedNetGold™ with Renal Kit

Indications for Use:

The SeedNetGold™ with Renal Kit is intended for cryogenic destruction of tissue during surgical procedures.

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It is indicated for use as a cryosurgical tool in the fields of surgery, general cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy provedby the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.

- The SeedNetGold™ with Renal Kit System (SeedNetGoldTM . 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)

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| | K042667 |
|----------------------|-------------|
| No GM /F/7.3/ 03/01b | Revision: a |

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

______________________________________________________________________________________________________________________________________________________________________________ AND/OR Use Prescription (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-off) (Division Sigil-on)
Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices

510(k) Number

Muriam C. Provost

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

**510(k) Number** K042667