(430 days)
Not Found
No
The device description and performance studies focus on cryotherapy and usability, with no mention of AI or ML.
Yes
The device is intended for the OTC treatment of common warts, plantar warts, and skin tags by freezing them, which is a therapeutic action.
No
The device is intended for the treatment (removal) of warts and skin tags by freezing, not for their diagnosis.
No
The device description clearly outlines physical components including a container of cryogen gas, foam applicators, and tweezers, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of common warts, plantar warts, and skin tags by freezing. This is a therapeutic action performed directly on the patient's body.
- Device Description: The device applies a cryogen to the skin to freeze tissue. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. The device's function is to remove the wart or skin tag, not to diagnose its presence or characteristics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Freeze 'n Clear Skin Clinic for Warts and Skin Tags product is intended for the OTC treatment of common warts, plantar warts, and skin tags.
Product codes (comma separated list FDA assigned to the subject device)
GEH
Device Description
The Freeze 'n Clear Skin Clinic for Warts and Skin Tags product utilizes extreme cold to facilitate the removal of warts and skin tags by freezing. Each kit contains a container of cryogen gas, foam applicators, tweezers and instructions for use. The device is for OTC use and utilizes a combination of dimethyl ether, propane and isobutane delivered from the canister into a foam applicator which acts as a reservoir for the cryogen gas. The gas rapidly evaporates and cools the applicator to approximately -55°C. The applicator is then placed against the wart or skin tag for 40 seconds which freezes the targeted tissue. The frozen skin tag or wart falls away over time and new epidermis grows in its place. One to four treatments with intervals of two weeks may be required.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
OTC for consumer use
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)
This submission added the indication to the Freeze 'n Clear Skin Clinic product to treat skin tags. As part of the data provided, the product was tested for biocompatibility including cytotoxicity, sensitivity, irritation according to FDA's biocompatibility 2020 guidance and meets the requirements of ISO 10993. Bench testing compared the temperatures attained by the Histofreezer Professional predicate device and Freeze 'n Clear Skin Clinic product to demonstrate that they were equivalent. Additional bench testing using an in vitro model also demonstrated the Histofreezer Professional and Freeze 'n Clear Skin Clinic products were equivalent in their ability to freeze and destroy target cells. A clinical study and human factors usability study was performed in support of the over-the-counter indication for skin tags. The clinical study was performed at 3 US, dermatology offices with over 300 subjects. It consisted of two parts, a label comprehension part for self-diagnosis and self-selection and an actual use part. Human factors usability testing also evaluated label comprehension and simulated use. The studies demonstrated the majority of subjects were able to self-diagnosis, self-select for the product, understand the directions, and appropriately use the product. Additionally, historical data was presented showing the low number of complaints and adverse events seen outside the US with the Freeze 'n Clear product used either for warts or skin tags.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 17, 2022
CryoConcepts LP Sam Niedbala PhD CEO 205 Webster St Bethlehem, Pennsylvania 18015
Re: K211099
Trade/Device Name: Freeze'n Clear Skin Clinic Warts & Tags Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: April 7, 2021 Received: May 16, 2021
Dear Sam Niedbala PhD:
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
1
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211099
Device Name
Freeze 'n Clear Skin Clinic for Warts and Skin Tags
Indications for Use (Describe)
The Freeze 'n Clear Skin Clinic for Warts and Skin Tags product is intended for the OTC treatment of common warts, plantar warts, and skin tags.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K211099 510(K) SUMMARY
I. SUBMITTER
CryoConcepts LP, 205 Webster St. Bethlehem PA 18015 Phone: 855-355-2796 Contact: Sam Niedbala, Ph.D. June 16, 2022
II. DEVICE
Name of Device: Freeze 'n Clear Skin Clinic for Warts and Skin Tags
Usual Name - Cryosurgical unit and accessories
Classification Name - General & Plastic Surgery
Regulatory Class: II
Code of Federal Regulation: 878.4350
Product Code: GEH
III. PREDICATE DEVICES
OTC Wart Removal System K023487
Histofreezer Professional K933327
Claritag K190747
IV. DEVICE DESCRIPTION
The Freeze 'n Clear Skin Clinic for Warts and Skin Tags product utilizes extreme cold to facilitate the removal of warts and skin tags by freezing. Each kit contains a container of cryogen gas, foam applicators, tweezers and instructions for use. The device is for OTC use and utilizes a combination of dimethyl ether, propane and isobutane delivered from the canister into a
Page 1 of 5
4
foam applicator which acts as a reservoir for the cryogen gas. The gas rapidly evaporates and cools the applicator to approximately -55°C. The applicator is then placed against the wart or skin tag for 40 seconds which freezes the targeted tissue. The frozen skin tag or wart falls away over time and new epidermis grows in its place. One to four treatments with intervals of two weeks may be required.
V. INDICATIONS FOR USE
The Freeze 'n Clear Skin Clinic for Warts and Skin Tags product is intended for the OTC treatment of common warts, plantar warts, and skin tags.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
A summary of the technological characteristics for the Freeze 'n Clear Skin Clinic for Warts vs Freeze 'n Clear Skin Clinic for Warts and Skin Tags as well as the Histofreezer professional and Claritag predicates are provided in the following table. Each of these products utilize the same technological characteristics and cryogens as shown in the table below.
| Technological
Characteristics | Freeze 'n Clear
Skin Clinic for
Warts (K023487) | Histofreezer
Professional
(K933327) | Claritag
(K190747) | Freeze 'n Clear
Skin Clinic for
Warts and Skin
Tags (Subject
Device) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| -Intended Use | The Freeze 'n Clear
Skin Clinic
Advanced Wart
product is intended
for consumer use
for the removal of
common warts and
plantar warts | For the
cryosurgical
treatment of lesions
including warts and
skin tags. Rx Only. | Claritag is
indicated for use in
the treatment of
acrochordons (skin
tags) | The Freeze 'n Clear
Skin Clinic for
Warts and Skin
Tags product is
intended for
consumer use for
the treatment of
common warts,
plantar warts and
skin tags |
| -Cryogen | Mixture of DMEP | Mixture of DMEP | Mixture of DMEP | Mixture of DMEP |
| Technological
Characteristics | Freeze 'n Clear
Skin Clinic for
Warts (K023487) | Histofreezer
Professional
(K933327) | Claritag
(K190747) | Freeze 'n Clear
Skin Clinic for
Warts and Skin
Tags (Subject
Device) |
| -Materials | -canister containing
cryogen
-Foam tipped
applicators | -canister containing
cryogen
-Foam tipped
applicators | -canister containing
cryogen and
disposable foam
pads, Tweezers | -canister containing
cryogen
-Foam tipped
applicators and
-Tweezers |
| -Mode of Use | Cryogen dispensed
into foam
applicator which is
then applied to the
lesion | Cryogen dispensed
into foam
applicator which is
then applied to the
lesion | Cryogen dispensed
into foam pads
which are then
applied to the
lesion | Cryogen dispensed
into foam
applicator which is
then applied to the
lesion |
| -Mechanism of
action | Extreme cold
destroys the target
tissue | Extreme cold
destroys the target
tissue | Extreme cold
destroys the target
tissue | Extreme cold
destroys the target
tissue |
| -Storage &
Safety
Conditions | -Keep away from
fire or flame
-Do not smoke
while using the
product
-Do not puncture or
incinerate canister | -Keep away from
fire or flame
-Do not smoke
while using the
product
-Do not puncture or
incinerate canister | -Highly
Flammable
-Store at room
temperature
between 68°-77°F
and away from
heat. | -Keep away from
fire or flame
-Do not smoke
while using the
product
-Do not puncture or
incinerate canister |
| | -Do not expose to
heat or store at
temperatures above
120°F.
-Store at room
temperature away
from heat | -Do not expose to
heat or store at
temperatures above
120°F.
-Store at room
temperature away
from heat | -Protect from
sunlight and do not
expose to
temperature above
120°F
-Contents under
pressure.
-Do not puncture or
incinerate | -Do not expose to
heat or store at
temperatures above
120°F.
-Store at room
temperature away
from heat |
| Technological
Characteristics | Freeze 'n Clear
Skin Clinic for
Warts (K023487) | Histofreezer
Professional
(K933327) | Claritag
(K190747) | Freeze 'n Clear
Skin Clinic for
Warts and Skin
Tags (Subject
Device) |
| | | | container, even if
empty | |
| -Treatment
Procedure | Spray the cryogen
into the applicator
to saturate it and
then place it
directly onto the
lesion for a
specified number of
seconds | Spray the cryogen
into the applicator
to saturate it and
then place it
directly onto the
lesion for a
specified number
of seconds | Spray the cryogen
into the foam pads
to saturate them
and then place
them directly onto
the lesion for a
specified number
of seconds | Spray the cryogen
into the applicator
to saturate it and
then place it
directly onto the
lesion for a
specified number
of seconds |
| -Disposal | Entire unit is
disposable after
emptied of
cryogen. | Entire unit is
disposable after
emptied of
cryogen. | Entire unit is
disposable after
emptied of
cryogen. | Entire unit is
disposable after
emptied of
cryogen. |
| -Defined
Operators | OTC for consumer
use | Rx Use Only | Rx Use Only | OTC for consumer
use |
| -Service /
Repair | None | None | None | None |
5
6
VII. PERFORMANCE DATA
This submission added the indication to the Freeze 'n Clear Skin Clinic product to treat skin tags. As part of the data provided, the product was tested for biocompatibility including cytotoxicity, sensitivity, irritation according to FDA's biocompatibility 2020 guidance and meets the requirements of ISO 10993.
Bench testing compared the temperatures attained by the Histofreezer Professional predicate device and Freeze 'n Clear Skin Clinic product to demonstrate that they were equivalent. Additional bench testing using an in vitro model also demonstrated the Histofreezer Professional and Freeze 'n Clear Skin Clinic products were equivalent in their ability to freeze and destroy target cells.
A clinical study and human factors usability study was performed in support of the over-thecounter indication for skin tags. The clinical study was performed at 3 US, dermatology offices with over 300 subjects. It consisted of two parts, a label comprehension part for self-diagnosis and self-selection and an actual use part. Human factors usability testing also evaluated label
7
comprehension and simulated use. The studies demonstrated the majority of subjects were able to self-diagnosis, self-select for the product, understand the directions, and appropriately use the product. Additionally, historical data was presented showing the low number of complaints and adverse events seen outside the US with the Freeze 'n Clear product used either for warts or skin tags
VIII. CONCLUSIONS
The Freeze 'n Clear Skin Clinic K023487 predicate device is indicated for OTC treatment of common and plantar warts. This submission adds the indication for the treatment of skin tags to the Freeze 'n Clear Skin Clinic K211099 device. The combination of studies and performance data presented demonstrates the subject device is as safe and effective as the predicate device(s) as indicated for use.