CRYOCARE CS SURGICAL SYSTEM

K141110 · Healthtronics · GEH · Jun 25, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K141110
• Device Name: CRYOCARE CS SURGICAL SYSTEM
• Applicant: Healthtronics
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Jun 25, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

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, oncology, oncology, 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 hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, 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

Mobile console system for cryoablative tissue destruction; utilizes cryoprobes to deliver extreme cold to target tissue; TempProbe devices monitor surrounding tissue temperatures. Operated by clinicians in surgical settings (open, minimally invasive, or endoscopic). System freezes/ablates tissue to treat various benign and malignant conditions, including prostate cancer, tumors, and skin lesions. Output allows real-time monitoring of ablation progress via temperature feedback, enabling precise control of the ice-ball formation to ensure effective tissue destruction while sparing surrounding healthy structures.

Clinical Evidence

Bench testing only. Verification and validation activities included isotherm testing, functional testing (ice-ball necking, shaft leak, noise), shelf-life testing, electrical safety testing, electromagnetic compatibility testing, and software verification and validation.

Technological Characteristics

Mobile console system with cryoprobes and TempProbe temperature monitoring devices. Features vacuum-insulated cryoprobes with modified sleeve material and optional right-angle handles (1.7mm and 2.4mm diameters). System utilizes extreme cold for tissue ablation. Includes minor hardware and software updates. Conforms to international standards for electrical safety and electromagnetic compatibility.

Indications for Use

Indicated for patients requiring tissue ablation or freezing in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary, and thoracic surgery. Includes treatment of prostate/kidney tissue, liver metastases, tumors, skin lesions, warts, and nerve tissue for pain management.

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

• Cryocare CS-3 Surgical System (K101333)
• Endocare 2.4mm V-Probe Cryoprobe (K101333)
• Endocare 2.4 mm Cryoprobe (K011074)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 25, 2015

HealthTronics Incorporated Ms. Maritza Ward Manager, Regulatory Affairs 9825 Spectrum Drive, Building 2 Austin, Texas 78717

Re: K141110

Trade/Device Name: Cryocare CS® Surgical System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: May 20, 2015 Received: May 21, 2015

Dear Ms. Ward:

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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Ms. Maritza Ward

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

# Indications for Use

510(k) Number (if known)

#### K141110

Device Name Cryocare CS Surgical System

# Indications for Use (Describe)

The Cryocare CS™ Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, oncology, oncology, 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 hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, 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

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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HealthTronics™

#### Cryocare CS® Surgical System 510(k) Summary K141110

| DATE: | May 20, 2015 |
|------------------------|-------------------------------------------------------------------------------------------------------------|
| COMPANY: | Endocare, a wholly owned subsidiary of HealthTronics, Inc. 9825 Spectrum Drive, Building 2 Austin, TX 78717 |
| CONTACT: | Maritza Ward Manager, Regulatory Affairs Telephone: [phone] Fax: [phone] |
| PROPRIETARY TRADE NAME | CryoCare CS® Surgical System |
| CLASSIFICATION NAME: | Cryosurgical Unit and Accessories |
| CLASS: | II |
| PRODUCT CODE: | GEH |
| REGULATION NUMBER: | 21 CFR 878.4350 |

| Cryocare CS®-3 Surgical System | K101333 | Cleared 06/14/2010 |
|------------------------------------|---------|--------------------|
| Endocare® 2.4mm V-Probe™ Cryoprobe | K101333 | Cleared 06/14/2010 |
| Endocare® 2.4 mm Cryoprobe | K011074 | Cleared 02/28/2006 |

## PRODUCT DESCRIPTION:

The Endocare™ Cryocare CS® Surgical System is a mobile console system intended for cryoablative tissue destruction. The system consists of a compact, easy to operate console and associated accessories that include cryoprobes to deliver cold temperatures to the targeted tissue, and TempProbe® devices to monitor temperatures in the surrounding tissue.

#### 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

HealthTronics, Inc. 1 9825 Spectrum Drive, Building 3 | Austin, TX 787 17 | 512.328.2892

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Image /page/5/Picture/0 description: The image shows the logo for HealthTronics. The logo consists of a stylized "HT" inside of a circle on the left, followed by the word "HealthTronics" in a sans-serif font. The letters are outlined in black, and the word "HealthTronics" is slightly slanted to the right. There is a trademark symbol to the right of the word.

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

# TECHNOLOGICAL CHARACTERISTICS:

The proposed Cryocare CS Surgical System console and cryoprobe designs are identical to their predicates with the exception of

- . minor hardware and software updates, relative to the console
- . a modification to the material used to fabricate the vacuum sleeve for vacuum insulated cryoprobes

HealthTronics, Inc. 19825 Spectrum Drive, Building 3 | Austin, TX 78717 | 512.328.2892

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Image /page/6/Picture/0 description: The image shows the word "HealthTronics" in a stylized font. To the left of the word is a logo consisting of the letters "HT" inside of a circle. The letters in the word "HealthTronics" are outlined in black. The logo and the word are slightly tilted to the right.

- . a new right-angle handle design option for the cryoprobes offered in 1.7 mm and 2.4 mm diameters.
The subject designs have the same fundamental technological features and intended use and are compatible with the same Cryocare CS Surgical System consoles and accessories as their predicate designs.

# NON-CLINICAL TESTING

Appropriate product testing was performed on all subject devices to evaluate conformance to product specifications and equivalence to the predicate designs. Verification and validation for the proposed modifications were conducted in accordance with internal protocols conforming to international standards and FDA guidance documents.

## Verification /Validation Activities

- Performance Testing ●
- o Isotherm Testing
- o Functional Testing (ice-ball necking, shaft leak, noise)
- Shelf-Life Testing
- Electrical Safety Testing .
- Electromagnetic Compatibility Testing
- Software Verification and Validation .

## CONCLUSION:

Based on a comparison of indications for use and technological characteristics, the proposed devices have demonstrated substantial equivalence to their predicates and are shown to be safe and effective for their intended use.