Liquid Nitrogen:
For use as a cryosurgical tool for destruction of unwanted tissue in the fields of dermatology, general surgery, neurosurgery, thoracic surgery, urology, proctology, oncology, gynecology and ENT.

May be used to ablate prostatic tissue.
May be used for the ablation of prostatic tissue in cases of prostate cancer and benign prostatic hyperplasia.
May be used for ablation of cancerous or malignant tissue.
May be used for ablation of benign tumors.
May be used for palliative intervention.
May be used for ablation or freezing of skin cancers and other cutaneous disorders.
May be used for the ablation of malignant neoplasia or benign dysplasia of the female genitalia.
May be used for ablation of leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid and canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, and fissures, peri-anal condylomata, pilonidal cysts. actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions.
May be used for the destruction of warts or lesions.
May be used for the palliation of tumors of the oral cavity, rectum, and skin.
May be used for ablation of arrhythmic cardiac tissue.
May be used for the ablation of benign or malignant growths of the anus and rectum.
May be used for the ablation of hemorrhoids.

Nitrous Oxide:
For use as a tool in the destruction of unwanted tissue in the fields of dermatology, gynecology, general surgery, urology, and veterinary medicine.

Carbon Dioxide:
For used as a tool in the destruction of unwanted tissue in the fields of dermatology, gynecology, and general surgery.

Argon and Krypton:
For use as a cryosurgical tool in general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology for the ablation of tissue including liver metastass, skin lesions, warts and prostate tissue.

Device Description

The CMS Blizzard 700 Series Models 730, 740, 750, 760, 770, 780 & 790 are made up of two components: 1) a console which holds up to two cryogen packets of varving sizes and 2) depending on the model, can employ from three to nine individually controlled cryoprobes. The consoles includes a power switch, individually controlled cryogen flow switches, thermocouple temperature displays and, depending on the model between three and nine cryoprobe ports. The devices are used to destroy unwanted tissue by the application of cold to the selected site. The cryogen is forced through the cryoprobe under pressure. The cryoprobe, having been placed in the appropriate position, then becomes cold and freezes the tissue.

AI/ML Overview

The provided text is a 510(k) summary for the CMS Blizzard 700 Series cryosurgical units. It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) summary is a regulatory document used to demonstrate substantial equivalence to a legally marketed predicate device, primarily focusing on similarities in intended use, technology, and safety/effectiveness. It is not a clinical study report or a detailed performance validation report.

Therefore, for your request, I must report that the requested information is not present in the provided text.

Specifically:

A table of acceptance criteria and the reported device performance: Not present. The document focuses on comparing features with predicate devices, not on quantitative performance metrics or acceptance criteria for those metrics.
Sample size used for the test set and the data provenance: Not present. No test set or study data is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. There is no mention of ground truth establishment.
Adjudication method for the test set: Not present.
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: Not present. This document describes a cryosurgical unit, not an AI-assisted diagnostic or therapeutic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not present. This is a physical medical device, not an algorithm.
The type of ground truth used: Not present.
The sample size for the training set: Not present.
How the ground truth for the training set was established: Not present.

Summary

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510(K) SUMMARY

K980668

February 20, 1998

Submitted by:

Cryomedical Sciences, Inc. 1300 Piccard Drive Suite L105 Rockville, Maryland 20850 (301) 417-7070 Fax (310) 417-7077

Contact:

Richard J. Reinhart, Ph.D. President and CEO or Susan Hayes Regulatory Affairs

Proprietary name: CMS Blizzard 700 Series Models 730, 740, 750, 760, 770, 780 & 790

Common name: Cryosurgical unit and accessories

A cryosurgical unit with liquid nitrogen nitrous oxide, or Classification: carbon dioxide cooled cryoprobe and accessories is classified in Class II under CFR § 878.4350. Under CFR § 882.4250, a cryogenic surgical device is also classified in Class II.

The devices are used to destroy unwanted tissue by the application of cold to the selected site. The cryogen is forced through the cryoprobe under pressure. The cryoprobe, having been placed in the appropriate position, then becomes cold and freezes the tissue.

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The CMS Blizzard 700 Series Models 730, 740, 770, 780 & 790 cre similar in form and function to ENDOcare's CRYOcare System, as well as the CMS's own AccuProbe® Systems and its Cryo-lite™ System.

ﻤﻴﺘﺎﺑﻌﺎ

Comparison of Features Between the CMS Blizzard 700 Series Models730, 740, 750 , 760, 770, 780 and 790 AND ENDOcare's CRYOcare System

FEATURES	ENDOcare's CRYOcare	CMS Blizzard Models 70,740, 750, 760, 770, 780 &790
Cyrogens	Argon	Choice of liquid nitrogen,carbon dioxide, nitrousoxide, argon, and krypton,sequentially
Number ofCryoprobes	Up to eight Individuallycontrolled cryoports	Depending on model, fromthree to nine individuallycontrolled cryoports
Cryogen Containers	Commercial Cryogen Source	Cryogen packet and/ortransfer line to larger cryogensource
Size	46"x19"x25" on Wheels	See specification sheet inOperation Manual
CryoprobeWarming	Helium	Warming fluid such ascirculated air
Cryoprobes Types	Two sizes, interchangeable	Various, interchangeable

Page 2 of 3

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Comparison of Features Between the CMS Blizzard 700 Series Models730, 740, 750 , 760, 770, 780 and The CMS AccuProbe® Systems

FEATURES	CMS AccuProbe® 450,530/550 and 600 Series	CMS Blizzard Models 70,740, 750, 760, 770, 780 &790
Cyrogens	Liquid Nitrogen	Choice of liquid nitrogen,carbon dioxide, nitrousoxide, argon, and krypton
Number ofCryoprobes	Depending on Models, up tothree, up to five or up toeight individually controlledcryoports	Depending on model, fromthree to nine individuallycontrolled cryoports
Cryogen Containers	Commercial cryogensources	Cryogen packet and/ortransfer line to larger cryogensource
Size	See Operations Manuals forexact dimensions (Tab I, J , K)- on Wheels	See Specification Sheet inOperation Manual
CryoprobeWarming	Nitrogen gas	Warming fluid , such ascirculated air
Cryoprobes Types	Various, interchangeable	Various, interchangeable

Comparison of Features Between the CMS Blizzard 700 Series Models730, 740, 750 , 760, 770, 780 and 790 and CMS's Cryo-lite™ Svstem

System
FEATURES	CMS Cryo-lite™	CMS Blizzard Models 70,740, 750, 760, 770, 780 &790
Cryogens	Choice of nitrous oxide andcarbon dioxide	Choice of liquid nitrogen,carbon dioxide, nitrousoxide, argon, and krypton
Number ofCryoprobes	One cryoprobe	Depending on model, fromthree to nine individuallycontrolled cryoports
Cryogen Containers	Cryogen packets orcommercial cryogen sourcethrough transfer line	Cryogen packets orcommercial cryogen sourcethrough transfer line
Size	Portable - Hand-held	Portable - See SpecificationSheet in Operation Manual
Cryoprobes Types	Various, interchangeable	Various, interchangeable

Page 3 of 3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cryomedical Sciences, Inc. c/o Mr. Richard J. Reinhart, Ph.D. President and CEO 1300 Piccard Drive, Suite L105 Rockville, MD 20850

Re: K980668 Trade Name: CMS Blizzard 700 Series Models 730, 740, 750, 760, 770, 780 & 790 Regulatory Class: II (two) Product Code: OCL, GEH Dated: June 2, 1998 Received June 2, 1998

Dear Dr. Reinhart:

This letter corrects our substantially equivalent letter of July 17 1998.

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. Richard J. Reinhart, Ph.D.

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 vours.

O'Mallè

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

Depending on the cryogen used, the following are indications for use:

Liquid Nitrogen:

For use as a cryosurgical tool for destruction of unwanted tissue in the fields of dermatology, general surgery, neurosurgery, thoracic surgery, urology, proctology, oncology, gynecology and ENT.

May be used to ablate prostatic tissue. .
May be used for the ablation of prostatic tissue in cases of prostate . cancer and benign prostatic hyperplasia.
May be used for ablation of cancerous or malignant tissue. .
May be used for ablation of benign tumors. .
May be used for palliative intervention. .
May be used for ablation or freezing of skin cancers and other . cutaneous disorders.
. May be used for the ablation of malignant neoplasia or benign dysplasia of the female genitalia.
. May be used for ablation of leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid and canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, and fissures, peri-anal condylomata, pilonidal cysts. actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions.
May be used for the destruction of warts or lesions. ●
May be used for the palliation of tumors of the oral cavity, rectum, . and skin.
. May be used for ablation of arrhythmic cardiac tissue.
. May be used for the ablation of benign or malignant growths of the anus and rectum.
May be used for the ablation of hemorrhoids. ●

Padeep
-O(f)

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-C Division of General Restorative Devices 510(k) Number

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

Indications for Use (continued)

Nitrous Oxide:

For use as a tool in the destruction of unwanted tissue in the fields of dermatology, gynecology, general surgery, urology, and veterinary medicine.

Carbon Dioxide:

For used as a tool in the destruction of unwanted tissue in the fields of dermatology, gynecology, and general surgery.

Argon and Krypton:

For use as a cryosurgical tool in general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology for the ablation of tissue including liver metastass, skin lesions, warts and prostate tissue.

Prescription Use
(Per 21 CFR 801.109)

Division of G eral Restorative Devices 510(k) Number 12980H

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.