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 Description

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:

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

AI/ML Overview

The provided text is a 510(k) summary for the Galil Medical - SeedNet™ System, a cryosurgical unit. It describes the device, its indications for use, technological characteristics, and substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, I cannot fulfill your request for that specific information based on the provided text. The document focuses on regulatory approval based on demonstrating equivalence, not on detailed performance study results.

Here's what I can extract from the provided text, but it will be very limited given the absence of the requested information:

1. A table of acceptance criteria and the reported device performance:

Cannot be provided. The document does not mention any acceptance criteria or report specific device performance metrics (e.g., sensitivity, specificity, accuracy, precision). It primarily focuses on the device's intended use and technological characteristics in comparison to predicate devices.

2. Sample size used for the test set and the data provenance:

Cannot be provided. No test set, data provenance, or sample sizes for any studies are mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Cannot be provided. No information about experts or ground truth establishment for a test set is present.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Cannot be provided. No mention of adjudication methods.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Cannot be provided. This document is for a cryosurgical unit, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance is discussed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Cannot be provided. The device is a cryosurgical tool, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Cannot be provided. No ground truth for any study is mentioned.

8. The sample size for the training set:

Cannot be provided. No training set is mentioned as this device is a physical cryosurgical unit, not an AI model.

9. How the ground truth for the training set was established:

Cannot be provided. No ground truth for a training set is mentioned.

Summary

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SECTION 8-510(K) SUMMARY

Image /page/0/Picture/3 description: The image contains a sequence of characters that appear to be handwritten. The characters are 'K', 'O', '2', '1', 'a', and 'b', followed by the number '1'. The characters are written in a casual, slightly slanted style, and they are all connected to each other. The image has a simple, unadorned look, with the focus solely on the handwritten characters.

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: +972-4-959 10 80 Fax: +972-4-959 10 77

Trade Proprietary Name:

SeedNet™ System , SeedNetGold™ System

Classification Name:

CRYOSURGICAL UNIT

Classification:

GEH

Predicate Devices:

1. SeedNet™
1. CRYO-HIT™

\\DC - 67930/1 - #1514804 v1

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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)

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:

1. The inclusion of cryoanalgesia as an example of the device's cleared neurology general indication.
1. The addition of a 4.5 mm surface probe.
1. Addition of trade name: SeedNetGold™ System.
1. 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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Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract human figure.

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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.

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

{6}------------------------------------------------

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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Page 3 of 3

X Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR ·

、、、

Over the Counter
Use__________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 878.4350 Cryosurgical unit and accessories.

(a)
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.(b)
Classification. Class II.