The modified SeedNet™ System is intended for cryogenic destruction of tissue during surgical procedures. is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology, 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 ablation of benign tumors, and palliative intervention)

Dermatology (ablation or freezing of skin cancers and other cutaneous disorders)

Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)

General surgery (destruction of warts or lesions, palliation of tumors of the oral cavity, rectum and skin, and ablation of leukoplakia of the mouth, 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, hemorroids, anal fissures, perianal conylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, and recurrent cancerous lesions)

Thoracic surgery (ablation of arrhythmic cardiac tissue, and ablation of cancerous lesions)

Proctology (ablation of benign or malignant growths of the anus or rectum, and ablation of hemorrhoids)

Device Description

The Galil Medical's SeedNet™ System is a modification of Galil Medical LTD's cleared SeedNet™ System with STPS (K010991). The SeedNet™ System is the exact same device as the SeedNet™ except for the following modifications to its technological characteristics:

Addition of 2 and 3 mm probes which are included in the previously cleared the Cryo-Hit™, to which the SeedNet™ is a modification.

Addition of flexible probes as an accessory to the SeedNet™

The systems computer screens, but not its software algorithm have slightly been modified.

AI/ML Overview

This document is a 510(k) summary for the Galil Medical SeedNet™ System, specifically focusing on modifications to an already cleared device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of typical AI/software device evaluation.

The provided text describes a medical device (cryosurgical unit) and its modifications, focusing on demonstrating substantial equivalence to predicate devices for regulatory approval. This type of submission (510(k)) for a physical medical device typically relies on demonstrating that the device is as safe and effective as a legally marketed predicate device, rather than providing the detailed performance studies with acceptance criteria, ground truth, and expert evaluation that are common for AI/software devices.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided document.

Here is what can be inferred or explicitly stated based on the text, with clear indications for what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable / Not present in this document. This document is a 510(k) summary for a physical cryosurgical unit, focused on demonstrating substantial equivalence to predicate devices. It does not define specific performance metrics or acceptance criteria for device output in the way a software or AI device might (e.g., sensitivity, specificity, accuracy thresholds). The "performance" being evaluated implicitly is its ability to perform cryoablation for the stated indications, similar to its predicates.

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

Not applicable / Not present in this document. As this is a submission for a physical medical device demonstrating substantial equivalence, there isn't a "test set" of data in the sense of an AI/software evaluation. There is no mention of a clinical study or specific data used to "test" the modified device's performance against a gold standard. The evaluation relies on the known performance and safety of the predicate devices and the minor nature of the modifications.

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

Not applicable / Not present in this document. There is no "test set" or ground truth established in the context of an AI/software evaluation.

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

Not applicable / Not present in this document. There is no "test set" requiring adjudication.

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

No, a MRMC comparative effectiveness study was not done. This is a physical cryosurgical unit, not an AI-assisted diagnostic or treatment planning system. Therefore, the concept of "human readers improve with AI assistance" does not apply.

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

Not applicable. The device is a cryosurgical unit; it is not an algorithm evaluated for standalone performance. While it has "computer screens" and "software algorithm" (mentioned as "slightly modified" but not the focus of the submission), the core intent is a physical procedure performed by a human.

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

Not applicable / Not present in this document. No ground truth is mentioned as being used for performance evaluation of this physical device in the manner typical for AI/software. The "truth" in this context is the established safety and efficacy of cryoablation devices for the indicated uses, as demonstrated by the predicate devices.

8. The sample size for the training set

Not applicable / Not present in this document. This is not an AI/machine learning model where a "training set" would be used.

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

Not applicable / Not present in this document.

Summary

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p.1/2 Galil Medical Proprietary Information

SECTION 8-510(K) SUMMARY

510(k) Summary

Galil Medical - SeedNet™ System

JAN 2 9 2002

510(k) Number

Kolly50

Company Name:

Galil Medical Ltd.

Contact Person:

Dr. Roni Zvuloni, Director of IP & Regulatory Affairs Telephone: +972-4-959 10 80 +972-4-959 10 77 Fax:

Trade Proprietary Name:

SeedNet™.

Classification Name:

CRYOSURGICAL UNIT

Classification:

GEH

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Predicate Devices:

1. SeedNet™
1. CRYO-HIT™
1. Cryo-Mono with TUF Probe

Indication for Use:

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 ablation of benign tumors, and palliative intervention)

Dermatology (ablation or freezing of skin cancers and other cutaneous disorders)

Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)

Thoracic surgery (ablation of arrhythmic cardiac tissue, and ablation of cancerous lesions)

Proctology (ablation of benign or malignant growths of the anus or rectum, and ablation of hemorrhoids)

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Technological Characteristics:

Addition of 2 and 3 mm probes which are included in the previously cleared the Cryo-Hit™, to which the SeedNet™ is a modification.

Addition of flexible probes as an accessory to the SeedNet™

The systems computer screens, but not its software algorithm have slightly been modified.

Substantial Equivalence

The modified SeedNet has the same intend use as the cleared SeedNet, Cryo-Hit, and Cryo-Mono with TUF Probe, the same general and specific indications as the Cryo-Hit, the same principles of operation as the cleared SeedNet, and very similar technological characteristics as the cleared SeedNet, Cryo-Hit and Cryo-Mono with TUF Probe. The minor difference in the diameter of the modified SeedNet's and Cryo-Mono's flexible probes and the modified SeedNet's computer screens does not raise any new questions of safety or effectiveness. Thus, the SeedNet™ System is substantially equivalent to these predicate devices.

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FEB 2 1 2008

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Galil Medical Ltd. c/o Mr. Jonathan S. Kahan Hogin & Hartson L.L.P. 555 Thirteenth Street, NW Washington, DC 20004-1109

Re: K011950

Trade/Device Name: SeedNet™ System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II (two) Product Code: OCL. GEH Dated: October 30, 2001 Received: October 31, 2001

Dear Mr. Kahan:

This letter corrects our substantially equivalent letter of January 29, 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

Sincerelv yours,

Q.M.a

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

JAN 2 9 2002

Koll1950 510(k) Number (if known):

Device Name:

SeedNet™ 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, 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 ablation of benign tumors, and palliative intervention)

Dermatology (ablation or freezing of skin cancers and other cutaneous disorders)

Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)

General surgery (destruction of warts or lesions, palliation of tumors of the oral cavity, rectum and skin, and ablation of leukoplakia of the mouth, angiomas,

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

sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorroids, anal fissures, perianal conylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, and recurrent cancerous lesions)

Thoracic surgery (ablation of arrhythmic cardiac tissue, and ablation of cancerous lesions)

Proctology (ablation of benign or malignant growths of the anus or rectum, and ablation of hemorrhoids)

(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

510(k) Number

Prescription Use 1 (Per 21 CFR 801.109)

Over the Counter Use

Muriam C. Provost

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

510(k) Number_Koll 950

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.