CryoTouch

{0}------------------------------------------------ #### 510(K) Summary # CryoTouch™ ## PREMARKET NOTIFICATION 510(K) SUMMARY ## I. SUBMITTER CryoConcepts LP, 205 Webster St. Bethlehem PA 18015 Phone: 855-355-2796 Contact: Dr. Sam Niedbala Prepared 4 December 2018 II. DEVICE Name of Device: CryoTouch™ Usual Name – Cryosurgical unit and accessories Classification Name - General & Plastic Surgery Regulatory Class: GEH Product Code: GEH III. PREDICATE DEVICE Verruca Freeze K982506 #### IV. DEVICE DESCRIPTION The CryoTouch™ device gently dispenses cryogen gas into an applicator or a uniquely designed cone. The applicator or cone is then used to apply the extreme cold to the lesion being treated to effect cryosurgical treatment. #### V. INDICATIONS FOR USE The CryoTouch™ is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the types of lesions that may be treated: - Verruca (warts) ● - Plantar warts - Seborrheic Keratoses - Actinic Keratoses - Achrochordon ● {1}------------------------------------------------ - Molluscum Contagiosum ● - Age Spots - Dermafibroma - Small Keloids ● - Granuloma Annulare ● - Porokeratosis Plantaris ● - Angiomas - Lentigo Maligna - Keratoacanthoma - Basal Cell Carcinomas ● - Bowen's Disease - Lentigo Discrete - Chondrodermatitis - Epithelial Nevus - Leukoplakia ● - Granuloma Pyogenicum ● - Kaposi's Sarcoma ● - o Pyogenic Granuloma ### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE A summary of the technological characteristics for the CryoTouch™ versus the Verruca Freeze predicate is provided in the following table. | Technological<br>Characteristics | Verruca Freeze<br>K982506 | CryoTouch | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | -Intended Use | Intended Use:<br>Tetrafluoroethane,<br>Pentafluoroethane,<br>and Trifluoroethane is<br>to be used for the<br>treatment of:<br>-verruca (warts),<br>including plantar<br>warts,<br>-seborrheic keratoses,<br>-actinic keratoses,<br>-achrochordon (skin<br>tags),<br>-molluscum<br>contagiosum,<br>-age spots,<br>-dermafibroma,<br>-small keloids. | Intended Use:<br>Pentafluoroethane<br>and Difluoromethane<br>is to be used for the<br>treatment of:<br>-verruca (warts),<br>including plantar<br>warts,<br>-seborrheic keratoses,<br>-actinic keratoses,<br>-achrochordon (skin<br>tags),<br>-molluscum<br>contagiosum,<br>-age spots,<br>-dermafibroma,<br>-small keloids,<br>-granuloma annulare. | | Technological<br>Characteristics | Verruca Freeze<br>K982506 | CryoTouch | | | -granuloma<br>-annulare,<br>-porokeratosis<br>plantaris,<br>-angiomas,<br>-lentigo maligna,<br>-keratoacanthoma,<br>-basal cell carcinoma,<br>-bowen's disease,<br>-lentigo discrete,<br>-chondrodermatitis,<br>-epithelial nevus,<br>-leukoplakia,<br>-granuloma pyogenicum,<br>-kaposi's sarcoma,<br>-pyogenic granuloma(1) | -porokeratosis<br>plantaris,<br>-angiomas,<br>-lentigo maligna,<br>-keratoacanthoma,<br>-basal cell<br>carcinoma,<br>-bowen's disease,<br>-lentigo discrete,<br>-chondrodermatitis,<br>-epithelial nevus,<br>-leukoplakia,<br>-granuloma<br>pyogenicum,<br>-kaposi's sarcoma,<br>-pyogenic granuloma | | -Cryogen<br>Characteristics | Mixture of<br>Tetrafluoroethane,<br>Pentafluoroethane,<br>and Trifluoroethane | Mixture of<br>Pentafluoroethane<br>and Difluoromethane | | Cryogen Gas<br>Boiling Point | -48(°C) | -52(°C) | | -Materials | -Aerosol canister<br>containing cryogen<br>-Foam tipped<br>applicators<br>-Plastic cones of<br>various sizes | -Aerosol canister<br>containing cryogen<br>-Cellulose applicators<br>-Cones with various<br>size adaptors | | -Mode of Use | Uses both cones and<br>applicators to apply<br>cryogen to the skin | Uses both cones and<br>applicator to apply<br>cryogen to the skin | | -Mechanism of<br>action | A mixture of<br>Tetrafluoroethane,<br>Pentafluoroethane,<br>and Trifluoroethane is<br>delivered to the skin<br>either by spraying<br>through the cone or<br>spraying into a bud<br>which contacts the<br>skin. The boiling point | A mixture of<br>Pentafluoroethane<br>and Difluoromethane<br>is delivered to the<br>skin either by<br>spraying through the<br>cone or spraying into<br>an applicator which<br>contacts the skin. The | | Technological<br>Characteristics | Verruca Freeze<br>K982506 | CryoTouch | | | of the gas mixture is -<br>$-48°C$ (2) | boiling point of the<br>gas mixture is<br>$-52°C$ (3) | | -Storage Conditions | Store in a room where<br>the temperature does<br>not exceed 120°F and<br>the canister is kept out<br>of direct sunlight (2) | Canisters should be<br>stored at room<br>temperature and<br>should not be<br>subjected to<br>temperatures over<br>125°F (3) | | -Safety | -Non-Flammable<br>under use conditions<br>-MSDS Provided | -Non-Flammable<br>under use conditions<br>-MSDS Provided | | -Treatment<br>Procedure | Spray the cryogen<br>either onto the bud to<br>saturate it and then<br>place the bud directly<br>onto the lesion or<br>spray the cryogen<br>through the cone onto<br>the lesion | Spray the cryogen<br>either into the<br>applicator to saturate<br>it and then place the<br>applicator directly<br>onto the lesion or<br>spray the cryogen<br>through the attached<br>cone onto the lesion | | -Operation | Gas dispense initiated<br>by applying pressure<br>to the trigger and<br>stopped by releasing<br>the trigger. | Gas dispense initiated<br>by applying pressure<br>to the trigger and<br>stopped by releasing<br>the trigger. | | -Disposal | Entire unit is<br>disposable after<br>emptied of cryogen.<br>The cones are<br>reusable, and the buds<br>are disposable | Entire unit is<br>disposable after<br>emptied of cryogen.<br>The cone is reusable.<br>The cone adapters<br>and applicators are<br>disposable | | -Defined Operators | Licensed Medical<br>Professionals | Licensed<br>Practitioners | | -Service/Repair | None | None | {2}------------------------------------------------ {3}------------------------------------------------ VII. PERFORMANCE DATA {4}------------------------------------------------ Cryosurgery works to destroy target lesions through applied extreme cold. When sufficient heat has been removed from the treated spot, the tissue is destroyed through cell lysis and vascular stasis. The CryoTouch™ device utilizes a mixture of Pentafluoroethane and Difluoromethane while the predicate Verruca Freeze utilizes a mixture of Tetrafluoroethane, Pentafluoroethane, and Trifluoroethane. All of these gases are within the same family of refrigerants and reach similar temperatures. Bench testing in this submission focused on demonstrating the equivalency of temperatures over their treatment times while using cone or applicators from the CryoTouch™ and Verruca Freeze. A second bench test also used the CryoTouch™ and Verruca Freeze, comparing each device and its ability to destroy red blood cells immobilized in agar. #### VIII. CONCLUSIONS Various types and mixtures of refrigerants are well-established and used in cryosurgical products to achieve sufficiently low temperatures to effect tissue destruction through extreme cold temperatures. The comparison bench testing of the CryoTouch TM to Verruca Freeze shows that the temperatures attained are sufficient for cryosurgery. The data, therefore, supports the substantial equivalence between CryoTouch™ and the predicate. {5}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K183601 #### Device Name CryoTouch (TM) Indications for Use (Describe) The CryoTouch is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the types of lesions that may be treated: - · Verruca (warts) - · Plantar warts - · Seborrheic Keratoses - Actinic Keratoses - · Achrochordon - Molluscum Contagiosum - · Age Spots - Dermafibroma - Small Keloids - Granuloma Annulare - Porokeratosis Plantaris - · Angiomas - · Lentigo Maligna - Keratoacanthoma - Basal Cell Carcinomas - · Bowen's Disease - · Lentigo Discrete - Chondrodermatitis - · Epithelial Nevus - · Leukoplakia - Granuloma Pyogenicum - · Kaposi's Sarcoma - · Pyogenic Granuloma Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {6}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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April 18, 2019 CryoConcepts LP Sam Niedbala CEO 205 Webster Street Bethlehem, Pennsylvania 18015 Re: K183601 Trade/Device Name: CryoTouch Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: April 16, 2019 Received: April 17, 2019 #### Dear Sam Niedbala: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {8}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, 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