(65 days)
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.
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.
This 510(k) summary for the Nuance Freeze Spray System does not contain a study that proves the device meets specific acceptance criteria in the way a traditional clinical study with defined endpoints and statistical analysis would. Instead, the submission relies on the concept of substantial equivalence to previously cleared predicate devices.
Therefore, many of the requested elements regarding acceptance criteria and study design are not applicable or cannot be extracted from the provided text.
Here is an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The submission does not define specific acceptance criteria (e.g., a specific percentage reduction in lesion size, a cure rate, or a predefined safety profile) nor does it report performance metrics from a dedicated study against such criteria for the Nuance Freeze Spray System itself. The device's "performance" is implicitly assumed to be equivalent to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. There was no specific test set or clinical study conducted for the Nuance Freeze Spray System described in this document. The device relies on comparing its characteristics to predicate devices that have already demonstrated safety and effectiveness through their past clearances.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable, as no dedicated test set or ground truth establishment process is described for this specific submission. The established practices and efficacy of cryogen spray for dermatological conditions, as supported by the predicate devices, serve as the foundational "ground truth."
4. Adjudication Method for the Test Set
Not applicable, as no test set or adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (cryogen spray system), not an AI/imaging device. Therefore, MRMC studies and AI effectiveness are irrelevant to this submission.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" implicitly relied upon is the established clinical efficacy and safety of cryogen spray systems, particularly those using the specified chemical composition, for the treatment of various skin lesions, as evidenced by the predicate devices. This can be considered accepted clinical practice and outcomes data from previously cleared devices and general medical knowledge.
8. The Sample Size for the Training Set
Not applicable. The Nuance Freeze Spray System is a physical device, and its clearance is based on substantial equivalence rather than a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
Summary of the Basis for Clearance:
The Nuance Freeze Spray System gained 510(k) clearance based on Substantial Equivalence to legally marketed predicate devices:
- Primary Predicate: Cryosurgery, Inc. Verruca-Freeze Cryosurgery Delivery System (K982506)
- Secondary Predicates: Cryosurgery, Inc. Verruca-Freeze Cryosurgery Delivery System (K881349) and (K944221)
The "study" that proves the device meets the acceptance criteria is effectively this comparison demonstrating substantial equivalence. The core arguments for substantial equivalence are:
- Identical Indications for Use: The Nuance Freeze Spray System is intended for the treatment of the same specific skin lesions as the predicate devices.
- Identical Technical Characteristics (Cryogen Composition): The cryogen used (1,1,1,2-tetrafluoroethane, pentafluoroethane, and 1,1,1-trifluoroethane, also known as R-404a) is stated to be the "exact same chemical composition and formulation as the predicate device."
- Similar Delivery Method: The methods for delivering the cryogen are described as "similar to the predicate."
- No New Issues of Safety or Efficacy: The statement explicitly says, "Nuance Freeze Spray System and its predicate devices do not raise any new issues of safety or efficacy."
Therefore, the "acceptance criteria" for the Nuance Freeze Spray System's clearance were met by demonstrating that it is fundamentally the same in terms of composition, intended use, and operational principles as already cleared devices, thereby inferring equivalent safety and effectiveness without requiring a new clinical performance study.
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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 (760) 525-4032
Marc S. Lieberman Nuance Medical. LLC 300 Carlsbad Village Drive, Suite 108 Carlsbad, CA 92008 (760) 525-4032
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 (800) 638-2041 or (301) 796-7100 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
§ 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.