K Number

Device Name

CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790

Manufacturer

CRYOMEDICAL SCIENCES, INC.

Date Cleared

1998-07-17

(147 days)

Product Code

GEH OCL

Regulation Number

878.4350

Intended 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. 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a cryosurgical device that uses cryogens to freeze tissue. The description focuses on the mechanical components (console, cryogen packets, cryoprobes) and the physical process of freezing. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".

Therapeutic

Yes

The device is intended for the destruction of unwanted tissue for various medical conditions and fields of medicine, which falls under the definition of a therapeutic device.

Diagnostic

The device is described as a "cryosurgical tool" for the "destruction of unwanted tissue" by "application of cold to the selected site," indicating a therapeutic rather than diagnostic function.

SaMD (Software as a Medical Device)

The device description clearly outlines hardware components including a console, cryogen packets, cryoprobes, power switch, flow switches, and temperature displays. This is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this device is a cryosurgical tool used to destroy unwanted tissue directly on the patient's body. It does not involve the analysis of samples taken from the body.
The device description focuses on the physical mechanism of tissue destruction through freezing. It describes a console, cryogen packets, and cryoprobes that apply cold to the target tissue. This is a direct therapeutic intervention, not a diagnostic test performed on a sample.

Therefore, this device falls under the category of a surgical tool or therapeutic device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

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.

Product codes (comma separated list FDA assigned to the subject device)

OCL, GEH

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

prostatic tissue, cancerous or malignant tissue, benign tumors, skin, cutaneous, malignant neoplasia, benign dysplasia of the female genitalia, 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, fissures, peri-anal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions, warts, lesions, tumors of the oral cavity, rectum, skin, arrhythmic cardiac tissue, benign or malignant growths of the anus and rectum, hemorrhoids, liver metastass

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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 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, nitrous
oxide, argon, and krypton,
sequentially |
| Number of
Cryoprobes | Up to eight Individually
controlled cryoports | Depending on model, from
three to nine individually
controlled cryoports |
| Cryogen Containers | Commercial Cryogen Source | Cryogen packet and/or
transfer line to larger cryogen
source |
| Size | 46"x19"x25" on Wheels | See specification sheet in
Operation Manual |
| Cryoprobe
Warming | Helium | Warming fluid such as
circulated air |
| Cryoprobes Types | Two sizes, interchangeable | Various, interchangeable |

Page 2 of 3

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, nitrous
oxide, argon, and krypton |
| Number of
Cryoprobes | Depending on Models, up to
three, up to five or up to
eight individually controlled
cryoports | Depending on model, from
three to nine individually
controlled cryoports |
| Cryogen Containers | Commercial cryogen
sources | Cryogen packet and/or
transfer line to larger cryogen
source |
| Size | See Operations Manuals for
exact dimensions (Tab I, J , K)

on Wheels | See Specification Sheet in
Operation Manual |
| Cryoprobe
Warming | Nitrogen gas | Warming fluid , such as
circulated 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 and
carbon dioxide	Choice of liquid nitrogen,
carbon dioxide, nitrous
oxide, argon, and krypton
Number of
Cryoprobes	One cryoprobe	Depending on model, from
three to nine individually
controlled cryoports
Cryogen Containers	Cryogen packets or
commercial cryogen source
through transfer line	Cryogen packets or
commercial cryogen source
through transfer line
Size	Portable - Hand-held	Portable - See Specification
Sheet in Operation Manual
Cryoprobes Types	Various, interchangeable	Various, interchangeable

Page 3 of 3

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.

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

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

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:

Prescription Use
(Per 21 CFR 801.109)

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