The CRYO-HITTM 200 System, like the already cleared CRYO-HITTM 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, tumor, lesions and warts.

In addition the CRYO-HIT™ 200 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, 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 hemangilomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, 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 CRYO-HIT™ 200 System is the exact same device as Galil Medical LTD's cleared CRYO-HIT™ System (K980913) except for the following tochnological modifications: (1) Additional accessories are made available (1.5 mm probe, multiprobe distribution panel). (2) disposable probes are added as an option; (3) an additional method of controlling the freeze process is offered; and (4) minor changes to the software that are necessary for the display of the screen information have been made: and (5) the probes are available in chrome-coated brass and the flexible hose is available in two additional materials.

AI/ML Overview

The provided text describes the Galil Medical CRYO-HIT™ 200 System, a cryosurgical tool, and its substantial equivalence to previously cleared devices. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any other details typically found in a study proving device meet acceptance criteria.

The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

To answer your request, I would need a document that describes:

Specific performance metrics (e.g., cooling rate, minimum temperature achieved, ice ball size, tissue necrosis depth).
Pre-defined acceptance criteria for these metrics.
A study protocol and results demonstrating how the CRYO-HIT™ 200 achieved these criteria.
Details on the study design, including sample sizes, data provenance, ground truth methods, and expert involvement.

Summary

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Galil Medical Proprietary Information

JUL 27 1999

1-411 P.03/08 JOB-555
K991517
Section 9

510(K) Summary Galil Medical - CRYO-HITTM 200 System 510(k) Number K991517

Galil Medical Ltd. Company Name: Shaike Schatzberger, President and CEO Contact Person: Telephone: 972-4-959 10 80 972-4-959 10 77 Fax: CRYO-HITTM 200 Trade Proprietary Name:

GEH

Classification:

Predicate Devices:

ENDOcare CRYO-HITTM System

Indication for Use:

In addition the CRYO-HIT™ 200 System has the following specific indications:

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Galil Medical Proprietary Information

Section 9

Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia ("BPH"))

Oncology (ablation of cancerous or malignant tissue, 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)

Device Description:

Substantial equivalence: The CRYO-HITTM 200 System has the same intended use, and very similar principle of operation and technological characteristic as the cleared ENDOcare and cleared CRYO-HITTM System, thus the CRYO-HITTM 200 System is substantially equivalent to these legally marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 27 1999

Galil Medical, Ltd. c/o Mr. Jonathan S. Kahan Hogan & Hartson L.L.P. Columbia Square 555 Thirteenth Street, N.W. Washington, D.C. 20004

K991517 Re: Trade Name: Cryo-Hit™ 200 Regulatory Class: II Product Code: GEH Dated: April 17, 1999 Received: April 30, 1999

Dear Mr. Kahan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 – Mr. Jonathan S. Kahan

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Numed. Sager

Celia M. Witten, Ph.D., M.D. for Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K991517

Device Name: Cryo-Hit™ 200

Indications for Use: The Cryo-Hit™ 200 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, 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.

In addition the Cryo-Hit 200 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, 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 tumore of the oral cavity, rectum and skin, and ablation of leukoplakia of the mouth, angiomas, sebacous hyperplaaia, basal coll tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangilomas, mucocele cyste, multiple warts, plantar warts, hemorrhoids, and 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)

Prescription Use I (Per 21 C.F.R. 801.109)

Over-The-Counter Use_

Henrik V. Hagen, Dr. Ing.

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.