Who is the manufacturer of CryoTouch?

Cryoconcepts LP filed the 510(k) submission for CryoTouch (K183601).

What is the FDA product code for CryoTouch?

GEH. It is classified under 21 CFR 878.4350 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for CryoTouch?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CryoTouch?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CryoTouch

K183601 · Cryoconcepts LP · GEH · Apr 18, 2019 · General, Plastic Surgery

Device Facts

Record ID	K183601
Device Name	CryoTouch
Applicant	Cryoconcepts LP
Product Code	GEH · General, Plastic Surgery
Decision Date	Apr 18, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4350
Device Class	Class 2
Attributes	Therapeutic

Intended 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 - 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

Device Story

CryoTouch is a cryosurgical unit for tissue destruction. It uses an aerosol canister containing a mixture of Pentafluoroethane and Difluoromethane. The device dispenses cryogen gas through an applicator or a cone directly onto the target lesion. The extreme cold induces tissue destruction via cell lysis and vascular stasis. It is operated by licensed practitioners in a clinical setting. The practitioner initiates gas flow by pressing a trigger and stops it by releasing the trigger. The device is disposable after the cryogen is depleted, while the cone is reusable. The device benefits patients by providing a method for the surgical removal of various benign and malignant skin lesions.

Clinical Evidence

Bench testing only. Comparison of temperature profiles over treatment time using cones and applicators for both CryoTouch and the predicate. Additional bench study compared the ability of both devices to destroy red blood cells immobilized in agar.

Technological Characteristics

Cryosurgical unit consisting of an aerosol canister, cellulose applicators, and cones with size adaptors. Uses a mixture of Pentafluoroethane and Difluoromethane (boiling point -52°C). Manual operation via trigger. Non-flammable under use conditions. Disposable unit; reusable cone.

Indications for Use

Indicated for surgical destruction of target tissue via extreme cold. Applicable to patients with 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, and pyogenic granuloma. Prescription use only.

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

Verruca Freeze (K982506)

Related Devices

K201740 — Hydrozid · Medilink A/S · Jul 7, 2021
K221897 — Hydrozid Precise · Bibawo Medical A/S · May 30, 2023
K982506 — VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM · Cryosurgery, Inc. · Jan 27, 1999
K172769 — CryOmega Flexx · Cryoconcepts LP · Nov 30, 2017
K152203 — UTERMOHLEN CRYO PROFESSIONAL · Koninklijke (Royal) Utermohlen · Nov 6, 2015

Submission Summary (Full Text)

{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 Characteristics | Verruca Freeze K982506 | CryoTouch | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | -Intended Use | Intended Use: Tetrafluoroethane, Pentafluoroethane, and Trifluoroethane is to be used for the treatment of: -verruca (warts), including plantar warts, -seborrheic keratoses, -actinic keratoses, -achrochordon (skin tags), -molluscum contagiosum, -age spots, -dermafibroma, -small keloids. | Intended Use: Pentafluoroethane and Difluoromethane is to be used for the treatment of: -verruca (warts), including plantar warts, -seborrheic keratoses, -actinic keratoses, -achrochordon (skin tags), -molluscum contagiosum, -age spots, -dermafibroma, -small keloids, -granuloma annulare. | | Technological Characteristics | Verruca Freeze K982506 | CryoTouch | | | -granuloma -annulare, -porokeratosis plantaris, -angiomas, -lentigo maligna, -keratoacanthoma, -basal cell carcinoma, -bowen's disease, -lentigo discrete, -chondrodermatitis, -epithelial nevus, -leukoplakia, -granuloma pyogenicum, -kaposi's sarcoma, -pyogenic granuloma(1) | -porokeratosis plantaris, -angiomas, -lentigo maligna, -keratoacanthoma, -basal cell carcinoma, -bowen's disease, -lentigo discrete, -chondrodermatitis, -epithelial nevus, -leukoplakia, -granuloma pyogenicum, -kaposi's sarcoma, -pyogenic granuloma | | -Cryogen Characteristics | Mixture of Tetrafluoroethane, Pentafluoroethane, and Trifluoroethane | Mixture of Pentafluoroethane and Difluoromethane | | Cryogen Gas Boiling Point | -48(°C) | -52(°C) | | -Materials | -Aerosol canister containing cryogen -Foam tipped applicators -Plastic cones of various sizes | -Aerosol canister containing cryogen -Cellulose applicators -Cones with various size adaptors | | -Mode of Use | Uses both cones and applicators to apply cryogen to the skin | Uses both cones and applicator to apply cryogen to the skin | | -Mechanism of action | A mixture of Tetrafluoroethane, Pentafluoroethane, and Trifluoroethane is delivered to the skin either by spraying through the cone or spraying into a bud which contacts the skin. The boiling point | A mixture of Pentafluoroethane and Difluoromethane is delivered to the skin either by spraying through the cone or spraying into an applicator which contacts the skin. The | | Technological Characteristics | Verruca Freeze K982506 | CryoTouch | | | of the gas mixture is - $-48°C$ (2) | boiling point of the gas mixture is $-52°C$ (3) | | -Storage Conditions | Store in a room where the temperature does not exceed 120°F and the canister is kept out of direct sunlight (2) | Canisters should be stored at room temperature and should not be subjected to temperatures over 125°F (3) | | -Safety | -Non-Flammable under use conditions -MSDS Provided | -Non-Flammable under use conditions -MSDS Provided | | -Treatment Procedure | Spray the cryogen either onto the bud to saturate it and then place the bud directly onto the lesion or spray the cryogen through the cone onto the lesion | Spray the cryogen either into the applicator to saturate it and then place the applicator directly onto the lesion or spray the cryogen through the attached cone onto the lesion | | -Operation | Gas dispense initiated by applying pressure to the trigger and stopped by releasing the trigger. | Gas dispense initiated by applying pressure to the trigger and stopped by releasing the trigger. | | -Disposal | Entire unit is disposable after emptied of cryogen. The cones are reusable, and the buds are disposable | Entire unit is disposable after emptied of cryogen. The cone is reusable. The cone adapters and applicators are disposable | | -Defined Operators | Licensed Medical Professionals | Licensed 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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, reflecting the organization's role in regulating food and drugs. 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