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)
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 u ablation of 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.

Device Description

Cryosurgical unit with argon-cooled probes

AI/ML Overview

Acceptance Criteria and Device Performance for SeedNet Family Cryosurgical System

This document outlines the acceptance criteria and the study proving the SeedNet Family cryosurgical system meets these criteria, based on the provided 510(k) summary (K052530).

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the SeedNet Family (SeedNet/SeedNetGold System, CryoThera System, Cryo-Hit System) does not explicitly list distinct "acceptance criteria" in a quantitative or pass/fail format typical for performance studies of diagnostic devices. Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices (SeedNet Family, CryoCare CS system, and Visica system) for its expanded indications for use, particularly the addition of "ablation of breast fibroadenomas."

The "performance" is implicitly demonstrated through this claim of substantial equivalence. The core argument is that since the existing predicate devices are already cleared for the expanded indication and operate on similar principles, the SeedNet Family, with effectively identical technological characteristics and principles of operation, also meets the necessary performance for this expanded use.

Therefore, the "acceptance criteria" and "reported device performance" in this context are primarily qualitative and based on the established safety and effectiveness of the predicate devices for the specified indications.

Acceptance Criterion (Implicit)	Reported Device Performance
Safety and Effectiveness for Cryogenic Destruction of Tissue: The device must safely and effectively destroy target tissue through cryoablation for the specified indications.	The SeedNet Family operates on the same principles of cryosurgery as the predicate devices. The predicate devices (CryoCare CS system and Visica system) are already cleared for the ablation of breast fibroadenomas, and the existing SeedNet Family is cleared for a wide range of cryosurgical applications.
Technological Characteristics: The device's technological characteristics (software, user interface, principles of operation) must be substantially equivalent to predicate devices.	The submission explicitly states: "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."
Expanded Indication for Ablation of Breast Fibroadenomas: The device must be suitable for this specific procedure.	This indication is already claimed by the 510(k)-cleared CryoCare CS system and Visica system, establishing a precedent for its safety and effectiveness using similar cryo-surgery technology.
No New Questions of Safety and/or Effectiveness: The device, with its expanded indications, should not introduce any new safety or effectiveness concerns compared to predicate devices.	The submission explicitly states: "Galil Medical Ltd. believes that the SeedNet Family described in this submission is substantially equivalent to the combination of its predicate devices... and does not raise any new questions of safety and/or effectiveness."

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not describe a specific clinical "test set" or a new clinical study with a defined sample size for the expanded indication of breast fibroadenomas. The approach taken is substantial equivalence based on previously cleared devices.

Therefore, there is no direct information provided regarding:

Sample size used for the test set: Not applicable as no new clinical test set was conducted for this specific submission to demonstrate performance against explicit acceptance criteria.
Data provenance (country of origin, retrospective/prospective): Not applicable as the submission relies on the existing clearance and presumed data supporting the predicate devices, rather than new data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since no new clinical test set was conducted for this 510(k) submission, there is no information provided regarding:

Number of experts used to establish ground truth: Not applicable.
Qualifications of those experts: Not applicable.

4. Adjudication Method for the Test Set

As no specific test set was used for this expanded indication, there is no adjudication method provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this 510(k) submission. The submission is focused on substantial equivalence to predicate devices, not on comparing performance with and without AI assistance or human readers. The device described is a cryosurgical unit, a therapeutic device, not a diagnostic AI tool that would typically involve MRMC studies.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study for an algorithm was not performed or reported. The SeedNet Family is a hardware-based cryosurgical system, not an AI algorithm. While it may be used with visualization tools (MRI or ultrasound), the core device itself is not a standalone algorithm requiring such a study.

7. Type of Ground Truth Used

The ground truth for the expanded indication, by virtue of substantial equivalence, would be based on the established clinical outcomes and effectiveness of the predicate devices for breast fibroadenoma ablation, which would involve:

Pathology: Confirmation of successful tissue destruction or removal.
Imaging: Evidence from MRI or ultrasound that the target tissue was ablated as intended.
Clinical Outcomes Data: Patient follow-up to assess the success of the treatment and absence of recurrence.

However, these are inferences based on the nature of the device and its intended use, not explicitly stated as "ground truth used" for a new study within this 510(k) summary.

8. Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning algorithms. The SeedNet Family is a hardware-based cryosurgical unit, not an AI or machine learning device. Therefore, a training set is not applicable, and no sample size for a training set is provided.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set for an AI algorithm, the question of how its ground truth was established is not applicable.

Summary

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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: 972-4-9591080 Fax: 972-4-9591077

Contact Person:

Sarit Gelbart VP Regulatory Affairs Galil Medical Ltd. Tel: +972-4-9591080, Ext. 240 Fax: +972-4-9591077 sarit@galil-medical.co.il

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 classifiedcryosurgical units with argon cooled cryoprobesas class II devices under 21 C.F.R. § 878.4350.However, FDA has cleared Galil MedicalSeedNet™ and SeedNetGold™, which arecryosurgical units with argon-cooled Cryoprobes,as Class II devices. Therefore, cryosurgical unitswith argon-cooled probes are Class II medicaldevices.

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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 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 (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 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)

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.