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.

AI/ML Overview

The CryoTouch™ device is a cryosurgical unit intended for the destruction of various lesions by applying cryogenic gases at low temperatures. The submission aims to demonstrate substantial equivalence to the predicate device, Verruca Freeze K982506.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative "acceptance criteria" in the traditional sense (e.g., a specific temperature range to be achieved with a defined tolerance). Instead, the performance objective is to demonstrate equivalency of temperature and cryosurgical effect compared to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Equivalency of Temperature Attained	"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." "The comparison bench testing of the CryoTouch TM to Verruca Freeze shows that the temperatures attained are sufficient for cryosurgery." The CryoTouch™ cryogen gas boiling point is -52°C, compared to -48°C for the predicate, indicating a similar or slightly colder temperature.
Sufficient Cryosurgical Effect (Tissue Destruction)	"When sufficient heat has been removed from the treated spot, the tissue is destroyed through cell lysis and vascular stasis." "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." "The data, therefore, supports the substantial equivalence between CryoTouch™ and the predicate."
Similar Mode of Operation and Safety Characteristics	The comparison table shows remarkably similar characteristics for intended use, materials, mode of use, mechanism of action, storage conditions, safety, treatment procedure, operation, disposal, and defined operators. The only significant difference is the specific cryogen mixture and its boiling point, which are handled in the temperature equivalency testing.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The study involved "bench testing" and "a second bench test." The quantity of devices, cones/applicators, or agar samples used is not detailed.
Data Provenance: The data is generated from bench testing, meaning it was conducted in a laboratory setting. There is no information about country of origin of the data as it's a technical bench study. It is inherently prospective as the tests were designed and executed to compare the devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is generally not applicable to the bench testing described. The "ground truth" here is objective physical measurements (temperature, red blood cell destruction) rather than expert interpretation of medical images or clinical outcomes. There is no mention of experts being used in this capacity for the bench tests.

4. Adjudication Method for the Test Set

Not applicable. The bench tests involved objective measurements, not subjective evaluations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images. This submission describes a cryosurgical device, and its performance evaluation focused on its physical characteristics and direct effect on biological material in a lab setting. It does not involve human readers interpreting cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not an AI/algorithm-driven device. Its performance is assessed physically.

7. Type of Ground Truth Used

The ground truth used in the bench testing was:

Physical Measurements: Primarily temperature profiles attained by the device.
Direct Biological Effect: The device's ability to destroy red blood cells immobilized in agar, serving as a simplified model for tissue destruction.

8. Sample Size for the Training Set

Not applicable. This is a medical device, not an AI/ML model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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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

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 ●

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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.

TechnologicalCharacteristics	Verruca FreezeK982506	CryoTouch
-Intended Use	Intended Use:Tetrafluoroethane,Pentafluoroethane,and Trifluoroethane isto be used for thetreatment of:-verruca (warts),including plantarwarts,-seborrheic keratoses,-actinic keratoses,-achrochordon (skintags),-molluscumcontagiosum,-age spots,-dermafibroma,-small keloids.	Intended Use:Pentafluoroethaneand Difluoromethaneis to be used for thetreatment of:-verruca (warts),including plantarwarts,-seborrheic keratoses,-actinic keratoses,-achrochordon (skintags),-molluscumcontagiosum,-age spots,-dermafibroma,-small keloids,-granuloma annulare.
TechnologicalCharacteristics	Verruca FreezeK982506	CryoTouch
	-granuloma-annulare,-porokeratosisplantaris,-angiomas,-lentigo maligna,-keratoacanthoma,-basal cell carcinoma,-bowen's disease,-lentigo discrete,-chondrodermatitis,-epithelial nevus,-leukoplakia,-granuloma pyogenicum,-kaposi's sarcoma,-pyogenic granuloma(1)	-porokeratosisplantaris,-angiomas,-lentigo maligna,-keratoacanthoma,-basal cellcarcinoma,-bowen's disease,-lentigo discrete,-chondrodermatitis,-epithelial nevus,-leukoplakia,-granulomapyogenicum,-kaposi's sarcoma,-pyogenic granuloma
-CryogenCharacteristics	Mixture ofTetrafluoroethane,Pentafluoroethane,and Trifluoroethane	Mixture ofPentafluoroethaneand Difluoromethane
Cryogen GasBoiling Point	-48(°C)	-52(°C)
-Materials	-Aerosol canistercontaining cryogen-Foam tippedapplicators-Plastic cones ofvarious sizes	-Aerosol canistercontaining cryogen-Cellulose applicators-Cones with varioussize adaptors
-Mode of Use	Uses both cones andapplicators to applycryogen to the skin	Uses both cones andapplicator to applycryogen to the skin
-Mechanism ofaction	A mixture ofTetrafluoroethane,Pentafluoroethane,and Trifluoroethane isdelivered to the skineither by sprayingthrough the cone orspraying into a budwhich contacts theskin. The boiling point	A mixture ofPentafluoroethaneand Difluoromethaneis delivered to theskin either byspraying through thecone or spraying intoan applicator whichcontacts the skin. The
TechnologicalCharacteristics	Verruca FreezeK982506	CryoTouch
	of the gas mixture is -$-48°C$ (2)	boiling point of thegas mixture is$-52°C$ (3)
-Storage Conditions	Store in a room wherethe temperature doesnot exceed 120°F andthe canister is kept outof direct sunlight (2)	Canisters should bestored at roomtemperature andshould not besubjected totemperatures over125°F (3)
-Safety	-Non-Flammableunder use conditions-MSDS Provided	-Non-Flammableunder use conditions-MSDS Provided
-TreatmentProcedure	Spray the cryogeneither onto the bud tosaturate it and thenplace the bud directlyonto the lesion orspray the cryogenthrough the cone ontothe lesion	Spray the cryogeneither into theapplicator to saturateit and then place theapplicator directlyonto the lesion orspray the cryogenthrough the attachedcone onto the lesion
-Operation	Gas dispense initiatedby applying pressureto the trigger andstopped by releasingthe trigger.	Gas dispense initiatedby applying pressureto the trigger andstopped by releasingthe trigger.
-Disposal	Entire unit isdisposable afteremptied of cryogen.The cones arereusable, and the budsare disposable	Entire unit isdisposable afteremptied of cryogen.The cone is reusable.The cone adaptersand applicators aredisposable
-Defined Operators	Licensed MedicalProfessionals	LicensedPractitioners
-Service/Repair	None	None

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VII. PERFORMANCE DATA

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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.

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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.

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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

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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

Regulation Number and Section

§ 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.