(52 days)
Not Found
No
The device description focuses on a cryotherapy mechanism using difluoroethane gas and does not mention any AI or ML components. The "Mentions AI, DNN, or ML" section is also marked as "Not Found".
Yes
The device is intended for the treatment of common and plantar warts, which is a therapeutic purpose.
No
Explanation: The device is intended for the treatment (removal) of warts by freezing them, not for diagnosing any condition. Its function is therapeutic, not diagnostic.
No
The device description clearly outlines physical components including a container of cryogen gas, a plastic holder, and a foam-wrapped tip, indicating it is a hardware-based device for cryotherapy.
Based on the provided information, the Skin Clinic Freeze Point product is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Skin Clinic Freeze Point product is a therapeutic device. Its intended use is to treat common and plantar warts by freezing them directly on the body. It does not analyze any bodily specimens.
The description clearly outlines a physical treatment method applied externally to the wart, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Skin Clinic Freeze Point product is intended for the treatment of common and plantar warts by OTC consumers. May be used with children 4 years of age or older under adult supervision.
Product codes
GEH
Device Description
The Skin Clinic Freeze Point device utilizes extreme cold to facilitate the removal of warts and by freezing. Each kit contains a container of cryogen gas in a plastic holder and instructions for use. The device is for OTC use and utilizes difluoroethane cryogen delivered from the canister into a foam wrapped tip which acts as a reservoir for the cryogen gas. The gas rapidly evaporates and cools the applicator to as low as -50°C. The applicator is then placed against the wart for up to 40 seconds which freezes the targeted tissue. The frozen 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
4 years of age or older
Intended User / Care Setting
OTC consumers
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
Bench testing: compared the temperatures attained by the Wartie and Freeze n Clear Skin Clinic predicate devices to the Skin Clinic Freeze Point product to demonstrate that they were comparable. Additional bench testing: using an in vitro method compared all the same products and showed they were comparable in their ability to freeze and destroy target cells.
Human factors usability study: evaluated consumers ability to comprehend and understand the labelling and use of the product for over-the-counter indication.
Key Metrics
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.
October 25, 2024
CryoConcepts LP Sam Niedbala, Ph.D. CEO 1100 Conroy Place Easton, Pennsylvania 18040
Re: K242625
Trade/Device Name: Skin Clinic Freeze Point Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: August 30, 2024 Received: September 3, 2024
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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
Sincerely,
Digitally signed by Long H. Chen Long H. Chen-S Date: 2024.10.25 09:30:41 -04'00'
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
3
Indications for Use
510(k) Number (if known) K242625
Device Name Skin Clinic Freeze Point
Indications for Use (Describe)
The Skin Clinic Freeze Point product is intended for the treatment of common and plantar warts by OTC consumers. May be used with children 4 years of age or older under adult supervision.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K242625
Premarket Notification
510(K) SUMMARY
(As Required by 21 CFR 807.92)
I. SUBMITTER
CryoConcepts LP, 1100 Conroy Place Easton, PA 18040 Phone: 855-355-2796 Contact: Sam Niedbala, Ph.D. October 24, 2024
II. DEVICE
Name of Device: Skin Clinic Freeze Point
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
Skin Clinic Freeze n' Clear for Skin Tags & Warts K211099
Wartie Wart Remover K140314
IV. DEVICE DESCRIPTION
The Skin Clinic Freeze Point device utilizes extreme cold to facilitate the removal of warts and by freezing. Each kit contains a container of cryogen gas in a plastic holder and instructions for use. The device is for OTC use and utilizes difluoroethane cryogen delivered from the canister into a foam wrapped tip which acts as a reservoir for the cryogen gas. The gas rapidly
Page 1 of 4
5
evaporates and cools the applicator to as low as -50°C. The applicator is then placed against the wart for up to 40 seconds which freezes the targeted tissue. The frozen 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 Skin Clinic Freeze Point for Warts product is intended for the OTC treatment of common warts and plantar warts. May be used with children 4 years of age or older under adult supervision.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
A summary of the technological characteristics for the Skin Clinic Freeze Point for Warts vs Freeze 'n Clear Skin Clinic for Warts/Skin Tags and the Wartie are provided in the following table. Each of these products utilize the same technological characteristics as shown in the table below.
| Technological
Characteristics | Freeze 'n Clear Skin
Clinic for
Warts (K211099) | Wartie
(K2130314) | Skin Clinic Freeze
Point for Warts
(Subject Device) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| -Intended 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. | Wartie Wart Remover is
intended for the over the
counter treatment of
common and plantar
warts to be used in
adults and children 4
years of age and older | The Skin Clinic Freeze
Point for Warts product
is intended for the OTC
treatment of common
warts and plantar warts.
May be used with
children 4 years of age
or older under adult
supervision. |
| -Cryogen | Mixture of DMEP | Mixture of DMEP | Difluoroethane |
| Technological
Characteristics | Freeze 'n Clear Skin
Clinic for
Warts (K211099) | Wartie
(K2130314) | Skin Clinic Freeze
Point for Warts
(Subject Device) |
| -Materials | -canister containing
cryogen
-Foam Applicators | -canister containing
cryogen
-Metal Tip Applicator | -canister containing
cryogen
-Foam and Metal Tip
Applicator |
| -Mode of Use | Cryogen dispensed into
foam applicator which is
then applied to wart | Cryogen dispensed onto
metal tip which is then
applied to wart | Cryogen dispensed onto
foam surrounding the
metal tip which is then
applied to wart |
| -Mechanism of
action | 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
-Do not expose to heat
or store at temperatures
above 120°F.
-Store at room
temperature 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 | -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 |
| -Treatment
Procedure | Spray the cryogen into
the applicator and then
place it directly onto the
wart for a specified
number of seconds | Spray the cryogen into
the applicator and then
place it directly onto the
wart for a specified
number of seconds | Spray the cryogen into
the applicator and then
place it directly onto the
wart for a specified
number of seconds |
| Technological
Characteristics | Freeze 'n Clear Skin
Clinic for
Warts (K211099) | Wartie
(K2130314) | Skin Clinic Freeze
Point for Warts
(Subject Device) |
| -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. |
| -Defined
Operators | OTC for consumer use | OTC for consumer use | OTC for consumer use |
| -Service / Repair | None | None | None |
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7
VII. PERFORMANCE DATA
As part of the submission, 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 Wartie and Freeze n Clear Skin Clinic predicate devices to the Skin Clinic Freeze Point product to demonstrate that they were comparable. Additional bench testing using an in vitro method compared all the same products and showed they were comparable in their ability to freeze and destroy target cells.
A human factors usability study was performed in support of the over-the-counter indication for Skin Clinic Freeze Point product to treat common and plantar warts. The human factors usability testing evaluated consumers ability to comprehend and understand the labelling and use of the product.
VIII. CONCLUSIONS
The Skin Clinic Freeze Point product is substantially equivalent to the Freeze n Clear Skin Clinic Wart/Skin Tag product (K211099) and the Wartie wart treatment product (K140314) predicate devices. All are intended for OTC treatment of common and plantar warts. The combination of studies and performance data presented demonstrates the subject device is as safe and effective as the predicate device(s) for the intended use.