CRYOCARE CS SURGICAL SYSTEM

K032333 · Endocare, Inc. · GEH · Aug 12, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032333
• Device Name: CRYOCARE CS SURGICAL SYSTEM
• Applicant: Endocare, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Aug 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Cryocare CS Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition, the system is intended for use in the following indications: General Surgery - Destruction of warts or lesions . - Palliation of tumors of the oral cavity, rectum and skin . - Ablation of leukoplakia of the mouth, 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, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, recurrent cancerous lesions Urology - Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia . Gynecology - Ablation of malignant neoplasia or benign dysplasia of the female genitalia . Oncology - Ablation of cancerous or malignant tissue ● - Ablation of benign tumors ● - Palliative intervention ● Neurology - Freezing of nerve tissue in pain management/cryoanalgesia ● Dermatology - Ablation or freezing of skin cancers and other cutaneous disorders . Proctology - Ablation of benign or malignant growths of the anus or rectum . - Ablation of hemorrhoids ● Thoracic Surgery - Ablation of arrhythmic cardiac tissue . - Ablation of cancerous lesions ●

Device Story

Cryocare CS Surgical System is a console-based cryosurgical unit; delivers cold temperatures to tissue via disposable CryoProbes; monitors tissue temperature via TempProbes. Integrates Terason 2000 ultrasound module for real-time prostate imaging/guidance. Console features 19" LCD, video printer, CD-R/W drive, alphanumeric/remote keypads. Operates using argon/helium gas. Used in OR/clinic settings by physicians. Provides real-time ultrasound and treatment screens; displays prostagraph for probe placement. AutoFreeze mode allows pre-programmed treatment parameters. Benefits include precise tissue ablation/freezing for various surgical specialties.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design similarity to previously cleared predicate devices.

Technological Characteristics

Console-based cryosurgical unit; utilizes argon and helium gas for cooling. Supports up to 8 CryoProbes and 8 TempProbes. Integrated Terason 2000 ultrasound module (Model 8EC4 Endocavity Smart Probe) for B-mode, Power/Color Doppler, and Harmonic Imaging. 19" LCD display. IBM-compatible microprocessor, Windows-based environment. Standard 120/230 VAC power. Disposable, single-use probes.

Indications for Use

Indicated for patients requiring tissue ablation via cryosurgery in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary, and thoracic surgery. Specific conditions include prostate cancer, BPH, tumors, skin lesions, warts, and cardiac arrhythmias. No specific age or gender contraindications listed.

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 Cryocare Surgical System (K023757)
• Endocare Cryocare Surgical System with CryoGuide (K002615)
• Terason Model 2000/BAS Portable Ultrasound System (K030191)

Submission Summary (Full Text)

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Endocare, Inc. Traditional 510(k): Cryocare CS Surgical System

K 032333

Image /page/0/Picture/3 description: The image shows the logo for Endocare. The logo consists of a stylized graphic to the left of the word "endocare" in a bold, slightly italicized font. Below "endocare" is the tagline "extending life everyday" in a smaller, less bold font. The overall design is simple and professional.

# 510(K) SUMMARY

Prepared May 7, 2003

| TRADE NAME | Cryocare CS Surgical System | | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------------------------------------------------------------|
| COMMON NAME | Cryosurgical unit and accessories | | |
| CLASSIFICATION | Class II (21 CFR 878.4350) | | |
| SUBMITTED BY | Endocare, Inc.<br>201 Technology<br>Irvine, CA 92618 | CONTACT | Eben Gordon<br>Regulatory Affairs<br>949.450.5424<br>949.450.5300 |
| PREDICATE DEVICE | K023757 - Endocare Cryocare Surgical System<br>Decision date: 12/5/2002 | | |
| | K002615 - Endocare Cryocare Surgical System with CryoGuide<br>Decision date: 11/13/2000 | | |
| | K030191 - Terason Model 2000/BAS Portable Ultrasound System<br>Decision date: 1/29/2003 | | |
| DEVICE<br>DESCRIPTION | The Cryocare CS (Combo System) Surgical System consists of a compact, easy-to-<br>operate console that delivers cold temperatures to targeted tissue (via connected<br>CryoProbes) and monitors temperatures in the surrounding tissue (via connected<br>TempProbes).<br>The Cryocare CS Surgical System has a fold-down 19" LCD high-resolution<br>display screen, a video printer for hard copy prints of the captured images and<br>patient information, a CD-R/W drive for data storage and retrieval, an<br>alphanumeric keypad and a remote keypad.<br>The Cryocare CS unit integrates the functions of the existing Cryocare surgical<br>system and the CryoGuide system into one console. The CryoGuide software is an<br>optional brachy-like intraoperative real-time guidance and planning system, which<br>identifies and guides CryoProbe placement for prostate procedures.<br>An added feature to the Cryocare CS Surgical System is integration of the Terason<br>2000 ultrasound trans-rectal probe for dedicated prostate imaging. The ultrasound<br>module utilizes the Terason Model 2000 Handheld Ultrasound System using<br>Model 8EC4 Endocavity Smart Probe. It is capable of transverse and sagital<br>views, and operates in B, Power Doppler, Color Doppler (including directional and<br>non-directional Power Doppler), and Harmonic Imaging. This use includes<br>ultrasound guidance for placement of needles, cryosurgery, and brachytherapy.<br>Ultrasound images may be obtained either from an external ultrasound (via video<br>connection) or from the integrated Terason 2000 ultrasound module. The user<br>screen simultaneously displays the real-time ultrasound image along with the<br>treatment screen. For prostate procedures, the treatment screen displays the | | |
| | prostagraph showing the anatomical CryoProbe and TempProbe placements and | | |

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associated temperature readings.

| | The Cryocare CS Surgical System can control up to eight, single-use, disposable<br>CryoProbes and monitor up to eight independent TempProbes. The console<br>operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon<br>and helium gas. An IBM-compatible microprocessor serves as the host computer<br>operating in a Windows environment. CryoProbe control can also be achieved via<br>the remote control keypad. The CryoProbes can be operated manually or using the<br>AutoFreeze mode, which allows users to pre-program specific prostate treatment<br>parameters. |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INDICATIONS FOR<br>USE | The Cryocare CS Surgical System has the same intended use as previously<br>cleared for the Cryocare CS Surgical System - K023757. |
| | The Cryocare CS Surgical System is intended for use in open, minimally invasive<br>or endoscopic surgical procedures in the areas in general surgery, urology,<br>gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary<br>surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the<br>application of extreme cold temperatures including prostate and kidney tissue, liver<br>metastases, tumors, skin lesions, and warts. |
| | The intended uses of the Terason 2000 Ultrasound System, when used as a part of<br>the Cryocare CS Surgical System, are a subset of the uses cleared under K030191,<br>and are documented in section 4.3 of this submission. |
| SUMMARY OF<br>SUBSTANTIAL<br>EQUIVALENCE | The Cryocare CS Surgical System has the following similarities to that of the<br>previously cleared predicate devices:<br>Has the same intended use, Use the same operating principle and has not altered the fundamental technology, Incorporate the same CryoProbe, Incorporate the same system design, Incorporate the same patient contacting materials, Same manufacturing materials, and Packaged and sterilized using the same materials and processes. |
| | In summary, the modified Cryocare CS Surgical System described in this<br>submission is, in our opinion, substantially equivalent to the predicate devices. |

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol. The symbol and text are all in black, set against a white background.

FEB 2 1 2008

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Endocare, Inc. c/o Ms. Laura Danielson 510(k) Program Manager TUV Product Service 1775 Old Highway 8 NW New Brighton, MN 55112-1891

Re: K032333

Trade Name: Cryocare CS Surgical System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II (two) Product Code: OCL, GEH, IYN, IYO, ITX Dated: July 28, 2003 Received: July 29, 2003

Dear Ms. Danielson:

This letter corrects our substantially equivalent letter for this application.

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 - Ms. Laura Danielson

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 [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 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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#### Endocare, Inc. Traditional 510(k): Cryocare CS Surgical System

# Indications for Use Statement

510(k) Number:

K 032333

Cryocare CS Surgical System Device Name:

#### Indications for Use:

The Cryocare CS Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.

In addition, the system is intended for use in the following indications:

#### General Surgery

- Destruction of warts or lesions .
- Palliation of tumors of the oral cavity, rectum and skin .
- Ablation of leukoplakia of the mouth, 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, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, recurrent cancerous lesions

# PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _________ (Per 21 CFR 801.109)

lettu with

Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number 032337

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# Endocare, Inc. Traditional 510(k): Cryocare CS Surgical System

# Indications for Use Statement (Continued)

#### Urology

- Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia .
#### Gynecology

- Ablation of malignant neoplasia or benign dysplasia of the female genitalia .
#### Oncology

- Ablation of cancerous or malignant tissue ●
- Ablation of benign tumors ●
- Palliative intervention ●

#### Neurology

- Freezing of nerve tissue in pain management/cryoanalgesia ●
#### Dermatology

- Ablation or freezing of skin cancers and other cutaneous disorders .
#### Proctology

- Ablation of benign or malignant growths of the anus or rectum .
- Ablation of hemorrhoids ●

#### Thoracic Surgery

- Ablation of arrhythmic cardiac tissue .
- Ablation of cancerous lesions ●

# PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

PRESCRIPTION USE_______ (PER 21 CFR 801.109)