(113 days)
Not Found
No
The summary describes a device that uses cryogenic gas for tissue destruction and bench testing focused on temperature and cell destruction, with no mention of AI or ML.
Yes.
The device is used for the "surgical destruction of target tissue" to treat various lesions and conditions, which is inherently a therapeutic function.
No
The device is described as an instrument for surgical destruction of target tissue using cryogenic gases, which is a treatment modality, not a diagnostic one.
No
The device description explicitly states that the device "gently dispenses cryogen gas into an applicator or a uniquely designed cone," indicating a physical hardware component for delivering the cryotherapy.
Based on the provided information, the CryoTouch™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures." This describes a therapeutic procedure performed directly on a patient's body.
- Device Description: The device description details how the device applies cold to a lesion for "cryosurgical treatment." This is a surgical intervention.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide diagnostic information. The bench testing described focuses on the device's ability to destroy red blood cells in agar, which is a performance test of the device's cryosurgical capability, not a diagnostic test.
IVD devices are used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The CryoTouch™ is a therapeutic device used for direct treatment of lesions on the body.
N/A
Intended Use / 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
- 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
Product codes
GEH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
target tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Licensed Medical Professionals
Licensed Practitioners
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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
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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