NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY

K130995 · Nuance Medical, LLC · GEH · Jun 14, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K130995
• Device Name: NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY
• Applicant: Nuance Medical, LLC
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Jun 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1,1,1,2-tetrafluoroethane, pentafluoroethane, and 1,1,1-trifluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic keratosis, achrochorodon, molluscum contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, Porokeratosis Plantaris, Angiomas, Keratoacanthoma, chrondrodermatitis, epithelial nevus, Leukoplakia, granuloma pyogenicum, and pyogenic granuloma.

Device Story

Nuance Freeze Spray System is a cryosurgical device used by physicians in dermatology clinics to treat various skin lesions. The device utilizes a standard cryogen composition (R-404a: 1,1,1,2-tetrafluoroethane, pentafluoroethane, and 1,1,1-trifluoroethane) to deliver a spray that freezes target tissue. The physician operates the device to apply the cryogen directly to the lesion, inducing localized tissue destruction through freezing. This methodology follows established dermatological practices for lesion removal. The device provides a non-invasive treatment option for patients with benign or pre-malignant skin conditions, potentially improving clinical outcomes by facilitating the removal of lesions.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Cryosurgical unit using R-404a cryogen (1,1,1,2-tetrafluoroethane 4%, pentafluoroethane 44%, 1,1,1-trifluoroethane 54%). Manual spray delivery mechanism. Class II device (21 CFR 878.4350).

Indications for Use

Indicated for treatment of skin lesions including verruca (warts), plantar warts, seborrheic keratoses, actinic keratosis, achrochorodon, molluscum contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, Porokeratosis Plantaris, Angiomas, Keratoacanthoma, chrondrodermatitis, epithelial nevus, Leukoplakia, granuloma pyogenicum, and pyogenic granuloma.

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

• Cryosurgery, Inc. Verruca-Freeze Cryosurgery Delivery System (K982506)
• Cryosurgery, Inc. Verruca-Freeze Cryosurgery Delivery System (K881349)
• Cryosurgery, Inc. Verruca-Freeze Cryosurgical Delivery System (K944221)

Submission Summary (Full Text)

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### 5. 510(k) Summary

# JUN 1 4 2013

## Nuance Medical, LLC - Nuance Freeze Spray System

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92(c):

#### Owner's Name and Address:

Contact Information:

Date Prepared:

Device Trade Name:

Common Name:

Classification Name:

Predicate Devices:

Nuance Medical, LLC 300 Carlsbad Village Drive, Suite 108 Carlsbad, CA 92008 [phone]

Marc S. Lieberman Nuance Medical. LLC 300 Carlsbad Village Drive, Suite 108 Carlsbad, CA 92008 [phone]

June 14, 2013

Nuance Freeze Spray System

Cryogen Spray: 1.1.1.2-tetrafluoroethane, Pentafluoroethane, and 1,1,1-trifluoroethane or R-404a

Class II - "Unit, Cryosurgical Accessories" (Regulation 21CFR 878.4350; Product Code: GEH)

Primary: Cryosurgery, Inc. Verruca-Freeze Cryosurgery Delivery System K982506

Secondary: Cryosurgery, Inc. Verruca-Freeze Cryosurgery Delivery System K881349

Secondary: Cryosurgery, Inc. Verruca-Freeze Cryosurgical Delivery System K944221

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### Description of the Device:

ﺔ ﺗ

The Nuance Freeze Spray System is used in the practice of dermatology in the treatment of skin lesions using a cryogen spray system. This methodology is an accepted practice used by physicians for decades using accepted procedures and techniques. It utilizes a standard cryogen composition profile to freeze common skin lesions.

### Indications for Use:

The Nuance Freeze Spray System indications for use as follows:

1.1.1.2-tetrafluoroethane, pentafluoroethane, and 1,1,1-trifluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic keratosis, achrochorodon, molluscum contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, Porokeratosis Plantaris, Angiomas, Keratoacanthoma, chrondrodermatitis, epithelial nevus, Leukoplakia, granuloma pyogenicum, and pyogenic granuloma.

#### Technical Characteristics:

The cryogen used in the Nuance Freeze Spray System is 1,1,1,2-tetrafluoroethane, Pentafluoroethane, and 1,1,1-trifluoroethane also commonly known as R-404a and is produced as a standard formulation by numerous chemical companies. Nuance Medical is using the exact same chemical composition and formulation as the predicate device. All other characteristics of the Nuance System are designed to be identical or nearly identical as the predicate device. The methods for delivering the cryogen are similar to the predicate.

#### Substantial Equivalence:

Nuance Freeze Spray System and its predicate devices that are used for the treatments of skin lesions using cryogen with the same chemical composition by type and percent of components: 1.1.2-tetrafluoroethane (4%), Pentafluoroethane (44%), and 1.1.1-trifluoroethane (54%). Differences in the technological characteristics are negligible and would be limited to discussion and promotion of product, marketing materials, cosmetic labeling, etc. Nuance Freeze Spray System and its predicate devices do not raise any new issues of safety or efficacv. Thus. Nuance Freeze Spray System is substantially equivalent to the predicate devices for treatment of certain skin lesions outlined in the indications for use.

#### Conclusion:

Based on the indications for use, technological characteristics, and comparison to predicate devices, the proposed device has been shown to be safe and effective for its intended use.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle symbol on the right and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The eagle is depicted with three curved lines forming its body and wings.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-002

June 14, 2013

Nuance Medical. LLC % Marc S. Lieberman President and CEO 300 Carlsbad Village Drive, Suite 108 Carlsbad, California 92008

Re: K130995

Trade/Device Name: Nuance Freeze Spray System Regulation Number: 21 CFR 878.4350 Regulation Name: Crvosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: April 06, 2013 Received: April 16, 2013

Dear Mr. Lieberman:

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. Iisting 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

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Page 2 - Marc S. Lieberman

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDeyices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Neil R.P. Orgden

ForMark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 4. Statement of Indications for Use

510(k) Number (if known): K130995

Device Name: Nuance Freeze Spray System

Indications for Use: 1,1,1,2-tetrafluoroethane, pentafluoroethane, and 1,1,1trifluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic keratosis, achrochorodon, molluscum contagiosum, age spots. dermatofibroma, small keltoids, granuloma annulare, Porokeratosis Plantaris, Angiomas. Keratoacanthoma, chrondrodermatitis, epithelial nevus, Leukoplakia, granuloma pyogenicum, and pyogenic granuloma.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ___________________________________________________________________________________________________________________________________________________________________

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joshua C. Nipper -S

(Division Sign-Off) Division of Surgical Devices (DSD) 510(k) Number K130995