The SeedNetGold™ with Renal Kit 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 (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)

Device Description

The SeedNetGold™ with Renal Kit is the exact same device as the cleared SeedNetGold™, which is a modification to the SeedNet Gold's cleared Prostate Kit and Prostate Template. The Renal Kit includes cryoneedles and thermal Galli Medical Intellus for use with the SeedNet Gold during renal cryoablation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the SeedNetGold™ with Renal Kit, and does not contain specific acceptance criteria, a detailed study proving performance, sample sizes, information about adjudicated ground truth, or MRMC study results as requested.

The document is a submission for a cryosurgical unit and primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (Galil's SeedNetGold™) rather than providing a detailed performance study with quantitative acceptance criteria.

Here's an analysis based only on the provided text, highlighting what's missing:

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

Acceptance Criteria: Not explicitly stated in the document. The submission appears to rely on demonstrating that the new "Renal Kit" modification for the SeedNetGold™ system is "at least as safe and effective" as the previously cleared SeedNetGold™ with Prostate Kit and Prostate Template.
Reported Device Performance: The document only makes a general statement: "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." No specific performance metrics (e.g., freezing temperatures achieved, lesion size, ablation efficiency, time to freeze/thaw, etc.) are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not mentioned. The document refers to "Bench testing," which typically involves laboratory experiments rather than human or animal subjects, but no specifics are given.
Data Provenance: Not mentioned. It's bench testing, so "country of origin" of data would refer to the lab location, which is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study involving human interpretation or diagnosis where expert ground truth would be established. The "ground truth" for cryoablation devices typically involves physical measurements of freezing parameters in a controlled environment or tissue models.

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

Not applicable for this type of bench testing.

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 MRMC study was done. This device is a cryosurgical unit, not an AI-powered diagnostic tool for human readers.

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

Not applicable. This is a hardware device for surgical procedures, not an algorithm.

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

The ground truth for "bench testing" would likely be based on physical measurements and engineering specifications related to cryoablation performance (e.g., temperature probes confirming achieve freezing temperatures, imaging (ultrasound/MRI) confirming ice ball formation/size, tissue damage assessments in ex-vivo models). The document doesn't detail these specifics.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device.

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

Not applicable. This is not a machine learning or AI device.

Summary of the Study (as described in the document):

The "study" described is primarily focused on demonstrating substantial equivalence for a modification (the Renal Kit) to an already cleared cryosurgical system (SeedNetGold™).

Objective: To show that the SeedNetGold™ with Renal Kit is "at least as safe and effective" as the predicate device (SeedNetGold™ with Prostate Kit and Prostate Template).
Methodology: "Bench testing" was performed.
Findings: The bench testing "demonstrated that the SeedNetGold™ with Renal Kit is at least as safe and effective... in destroying tissue by the application of extreme cold temperatures during cryosurgical procedures."
Conclusion: Based on the bench data, the device is considered substantially equivalent to the cleared predicate.

In essence, the provided 510(k) summary is a regulatory document arguing for substantial equivalence through bench testing, not a detailed clinical or performance study with quantified acceptance criteria as typically seen for novel devices or AI/diagnostic tools.

Summary

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510(k) Summary	K042667
Applicant's Name	Yoram LevyConsultant
	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 (972)4-638-8837; Fax (972)4-638-0510
	Yoram@qsitemed.com
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 (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,

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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(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) and the same of the same of the same of the same of the same of the same of the same of the same of the same of the same of the same of the states of the states and the state

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

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.