(90 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the cryosurgery system, with no mention of AI or ML algorithms for diagnosis, treatment planning, or any other function.
Yes
Explanation: The device is indicated for the removal of common and plantar warts, which is a treatment for a medical condition.
No
The device is marketed for the removal of common and plantar warts, which is a treatment, not a diagnostic, function.
No
The device description clearly outlines physical components including a pressurized dispenser (canister) containing dimethylether and a polypropylene applicator. It also mentions disposable cleansing swabs. These are all hardware components, not software.
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 removal of common and plantar warts. This is a therapeutic or treatment purpose, not a diagnostic one. IVDs are used to diagnose, monitor, or screen for diseases or conditions in vitro (outside the body).
- Device Description: The device is a cryosurgery product that applies a cryogen directly to the wart. This is a physical treatment method.
- Performance Studies: The performance studies focus on the functionality of the device in freezing the wart (applicator temperature, freeze time) and the safety of the components (biocompatibility, chemical residuals, inhalation studies). These are relevant to a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue) or providing information about a patient's health status based on such analysis.
In summary, the device's function is to physically treat warts, not to diagnose or provide information about a medical condition through in vitro analysis.
N/A
Intended Use / Indications for Use
Wart Freeze (private label trade mark: Wart Freezer, Cryogenic Wart Remover) is indicated for the removal of common and plantar warts.
The wart remover product is intended to be used in adults and children 4 years of age and older.
Product codes (comma separated list FDA assigned to the subject device)
GEI-I, GEH
Device Description
Wart Freeze is a private label (private label trade mark: Wart Freezer, Cryogenic Wart Remover) over the counter cryosurgery product for the treatment of common and plantar warts. The device consists of the following:
- A pressurised dispenser (canister) containing as ingredient 38ml dimethylether (DME) with a . polypropylene applicator that is permanently attached (fixed) to the dispenser. The gas does not harm the ozone layer. The applicator is used to administer the cryogen directly to the wart. The applicator is cleaned after each use.
- Disposable 70% alcohol cleansing swabs for cleaning the applicator after each use .
- Instruction for use .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
common and plantar warts
Indicated Patient Age Range
adults and children 4 years of age and older.
Intended User / Care Setting
over the counter
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)
Laboratory (functionality) testing (CONFIDENTIAL)
-
- Comparative laboratory testing using predicate devices using a phantom skin model. The predicates were used in accordance with their instructions. The functionality testing indicated that the various competitor products are similar in effectiveness.
- Applicator temperature laboratory test using an infrared camera technology was conducted to 2. determine the degree of cold generated by the cryogen on the applicator. The applicator surface at the tip of the applicator (part placed over the wart after dispensing the cryogen) is -50 ° C.
-
- Dose technique testing using infrared (IR) camera technology to determine the dispensing freeze time between the two potential dose techniques, i.e., 3 short presses of the dispenser versus 3 long presses of the dispenser. The test also evaluated effectiveness of freeze time between the dose techniques. The effectiveness of 3-short presses resulted in a freeze time of 1.31 seconds versus 1.99 seconds for 3-long presses. The maximum acceptable concentration of DME administered was 0,37 mg/ml during both dose techniques as result of safety (dose) valve used.
Biocompatibility testing c.
Biocompatibility testing was performed on the applicator in line with ISO 10993:5 Tests for in vitro cyloloxicity. The test was conducted to determine the safety of the cryogen and applicator material, polypropylene. The applicator material when in contact with the cryogen was found to be non-lysic. (CONFIDENTIAL)
d. Chemical residual testing
Laboratory testing was conducted to assess and identify any potential chemical residuals including leachable or degradable components. The test concluded that there were no chemical residuals in the dimethylether/polypropyelene extracts whereby there is no leachable between the applicator and cryogen, dimethylether. (CONFIDENTIAL)
e. Inhalation studies on the dimethylether
Dimethylether inhalation studies were conducted by the suppliers. The US National Toxicological Programme (NTP) conducted acute toxicity studies (LC:o)) on mouse and rabbit. The study concluded that DME did not produce acute toxicity in animal models or bacteria (genus: Ames Salmonella Typhimiurium). Developmental toxicity studies in animal models also showed that DME did not have any significant toxic effect on the mice or rabbit pups. There is however a limitation in the availability of human data when it comes to DME developmental and reproductive toxicity in human beings. DME received a ranking of not acutely toxic by the NTT. Current exposure limits for DME has been set at 1000 ppm or 0.1% DME for an 8-hour daily life-time exposures of the exposures for consumer products where DME is used have been shown to be in the range of 100 ppm for short periods of time (
§ 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
K130599
510K SUMMARY
| Submitter's name: | Koninklijke Utermöhlen N.V.
De Overweg 1, 8471 ZA Wolvega, the Netherlands | | |
|------------------------------|-------------------------------------------------------------------------------|--|--|
| Address: | | | |
| Telephone number: | 431 26 1 693 366 | | |
| Title: | CEO | | |
| Contact Person: | D van der Vat | | |
| Date of 510k special: | 1 March 2013 | | |
| Device Proprietary Name: | Wart Freeze | | |
| Device common or usual name: | OTC wart removal system | | |
| Classification name. | Cryosurgical unit, accessories | | |
| Classification code: | GEI-I | | |
| Regulation Number: | 21 CFR 878.4350 | | |
Substantial equivalence / predicate devices (Confidential)
The following device listed in the table is predicate device based on technology, method of application and materials for this 510k Special.
| Name of device | Manufacturer | Predicate
comparison | 510(k)
Number | |
|----------------|---------------------------|-------------------------------------------|------------------|----------------------------------|
| Wart Freeze | Koninklijke
Utermöhlen | Intended use,
technology,
materials | K101049 | Primary predicate
for changes |
Description of the device:
Wart Freeze is a private label (private label trade mark: Wart Freezer, Cryogenic Wart Remover) over the counter cryosurgery product for the treatment of common and plantar warts. The device consists of the following:
- A pressurised dispenser (canister) containing as ingredient 38ml dimethylether (DME) with a . polypropylene applicator that is permanently attached (fixed) to the dispenser. The gas does not harm the ozone layer. The applicator is used to administer the cryogen directly to the wart. The applicator is cleaned after each use.
- Disposable 70% alcohol cleansing swabs for cleaning the applicator after each use .
- Instruction for use .
Indications for use statement
Wart Freeze (private label trade mark: Wart Freezer, Cryogenic Wart Remover) is indicated for the removal of common and plantar warts.
Intended use
The wart remover product is intended to be used in adults and children 4 years of age and older.
5 2013 JUN
1
Statement of technological characteristics of the device
- The Wart Freeze (private label trade mark: Wart Freezer, Cryogenic Wart Remover) is a 21. cryosurgical system comprised of a dispenser containing as ingredient, dimethylether (DME), and a permanently attached (fixed) applicator to apply the cryogen directly to the wart.
ﺷ Laboratory (functionality) testing (CONFIDENTIAL)
The following testing was conducted:
-
- Comparative laboratory testing using predicate devices using a phantom skin model. The predicates were used in accordance with their instructions. The functionality testing indicated that the various competitor products are similar in effectiveness.
- Applicator temperature laboratory test using an infrared camera technology was conducted to 2. determine the degree of cold generated by the cryogen on the applicator. The applicator surface at the tip of the applicator (part placed over the wart after dispensing the cryogen) is -50 ° C.
-
- Dose technique testing using infrared (IR) camera technology to determine the dispensing freeze time between the two potential dose techniques, i.e., 3 short presses of the dispenser versus 3 long presses of the dispenser. The test also evaluated effectiveness of freeze time between the dose techniques. The effectiveness of 3-short presses resulted in a freeze time of 1.31 seconds versus 1.99 seconds for 3-long presses. The maximum acceptable concentration of DME administered was 0,37 mg/ml during both dose techniques as result of safety (dose) valve used.
Biocompatibility testing c.
Biocompatibility testing was performed on the applicator in line with ISO 10993:5 Tests for in vitro cyloloxicity. The test was conducted to determine the safety of the cryogen and applicator material, polypropylene. The applicator material when in contact with the cryogen was found to be non-lysic. (CONFIDENTIAL)
d. Chemical residual testing
Laboratory testing was conducted to assess and identify any potential chemical residuals including leachable or degradable components. The test concluded that there were no chemical residuals in the dimethylether/polypropyelene extracts whereby there is no leachable between the applicator and cryogen, dimethylether. (CONFIDENTIAL)
e. Inhalation studies on the dimethylether
Dimethylether inhalation studies were conducted by the suppliers. The US National Toxicological Programme (NTP) conducted acute toxicity studies (LC:o)) on mouse and rabbit. The study concluded that DME did not produce acute toxicity in animal models or bacteria (genus: Ames Salmonella Typhimiurium). Developmental toxicity studies in animal models also showed that DME did not have any significant toxic effect on the mice or rabbit pups. There is however a limitation in the availability of human data when it comes to DME developmental and reproductive toxicity in human beings. DME received a ranking of not acutely toxic by the NTT. Current exposure limits for DME has been set at 1000 ppm or 0.1% DME for an 8-hour daily life-time exposures of the exposures for consumer products where DME is used have been shown to be in the range of 100 ppm for short
2
periods of time (