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

K980668 · Cryomedical Sciences, Inc. · GEH · Jul 17, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980668
• Device Name: CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790
• Applicant: Cryomedical Sciences, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Jul 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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 Story

Cryosurgical unit for tissue destruction via extreme cold. Console holds cryogen packets (liquid nitrogen, nitrous oxide, carbon dioxide, argon, or krypton); connects to 3-9 individually controlled cryoprobes. Cryogen forced through probe under pressure to freeze target tissue. Warming fluid (circulated air) used for probe thawing. Operated by clinicians in various surgical/clinical settings. Provides localized tissue ablation; enables precise destruction of benign/malignant growths, lesions, and arrhythmic cardiac tissue. Benefits include minimally invasive tissue removal and palliative care options.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Console-based cryosurgical system; supports liquid nitrogen, CO2, nitrous oxide, argon, and krypton. Features 3-9 individually controlled cryoprobe ports. Includes thermocouple temperature displays and cryogen flow switches. Warming mechanism uses circulated air. Portable, wheel-mounted console design. Interchangeable cryoprobes.

Indications for Use

Indicated for destruction of unwanted tissue in patients requiring cryosurgical intervention across various medical specialties including dermatology, general surgery, neurosurgery, thoracic surgery, urology, proctology, oncology, gynecology, ENT, and veterinary medicine. Specific applications include ablation of benign/malignant tumors, prostate cancer, BPH, skin lesions, warts, cardiac tissue, and palliative tumor treatment.

Regulatory Classification

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.

Predicate Devices

• ENDOcare's CRYOcare System
• CMS AccuProbe® Systems
• CMS Cryo-lite™ System

Submission Summary (Full Text)

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## 510(K) SUMMARY

K980668

February 20, 1998

#### Submitted by:

Cryomedical Sciences, Inc. 1300 Piccard Drive Suite L105 Rockville, Maryland 20850 [phone] Fax [phone]

#### 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, 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.

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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.

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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,<br>740, 750, 760, 770, 780 &<br>790 |
|-------------------------|--------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Cyrogens | Argon | Choice of liquid nitrogen,<br>carbon dioxide, nitrous<br>oxide, argon, and krypton,<br>sequentially |
| Number of<br>Cryoprobes | Up to eight Individually<br>controlled cryoports | Depending on model, from<br>three to nine individually<br>controlled cryoports |
| Cryogen Containers | Commercial Cryogen Source | Cryogen packet and/or<br>transfer line to larger cryogen<br>source |
| Size | 46"x19"x25" on Wheels | See specification sheet in<br>Operation Manual |
| Cryoprobe<br>Warming | Helium | Warming fluid such as<br>circulated air |
| Cryoprobes Types | Two sizes, interchangeable | Various, interchangeable |

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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,<br>530/550 and 600 Series | CMS Blizzard Models 70,<br>740, 750, 760, 770, 780 &<br>790 |
|-------------------------|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Cyrogens | Liquid Nitrogen | Choice of liquid nitrogen,<br>carbon dioxide, nitrous<br>oxide, argon, and krypton |
| Number of<br>Cryoprobes | Depending on Models, up to<br>three, up to five or up to<br>eight individually controlled<br>cryoports | Depending on model, from<br>three to nine individually<br>controlled cryoports |
| Cryogen Containers | Commercial cryogen<br>sources | Cryogen packet and/or<br>transfer line to larger cryogen<br>source |
| Size | See Operations Manuals for<br>exact dimensions (Tab I, J , K)<br>- on Wheels | See Specification Sheet in<br>Operation Manual |
| Cryoprobe<br>Warming | Nitrogen gas | Warming fluid , such as<br>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,<br>740, 750, 760, 770, 780 &<br>790 |
| Cryogens | Choice of nitrous oxide and<br>carbon dioxide | Choice of liquid nitrogen,<br>carbon dioxide, nitrous<br>oxide, argon, and krypton |
| Number of<br>Cryoprobes | One cryoprobe | Depending on model, from<br>three to nine individually<br>controlled cryoports |
| Cryogen Containers | Cryogen packets or<br>commercial cryogen source<br>through transfer line | Cryogen packets or<br>commercial cryogen source<br>through transfer line |
| Size | Portable - Hand-held | Portable - See Specification<br>Sheet in Operation Manual |
| Cryoprobes Types | Various, interchangeable | Various, interchangeable |

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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 [phone]. 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 [phone] or [phone] 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

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# 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

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