Wart Freeze (private label trade mark: Wart Freezer, Cryogenic Wart Remover) is indicated for the removal of common and plantar warts.
The product is indicated for the removal of common and plantar warts.

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 .
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.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "Wart Freeze," which is an over-the-counter cryosurgery product for wart removal. The document focuses on establishing substantial equivalence to a predicate device (K101049) and demonstrating the safety and effectiveness of the modified device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the typical sense of numerical thresholds for clinical performance. Instead, it demonstrates performance through comparative laboratory testing and characterization against a predicate device and established safety standards. The primary acceptance criterion here is substantial equivalence to the predicate device, especially in terms of functionality, safety, and indications for use.

Acceptance Criterion (Implicit)	Reported Device Performance
Cryogen Delivery & Application Effectiveness
- Ability to deliver cryogen to wart	- Device applies cryogen directly to the wart via a permanently attached applicator.
- Comparable effectiveness to predicate devices	- Comparative laboratory testing using a phantom skin model indicated that the various competitor products (including the predicate) are similar in effectiveness.
- Consistent cold generation	- Applicator surface at the tip reaches -50 °C. The effectiveness of predicates is stated to be identical.
- Appropriate freeze time (dose-technique related)	- 3-short presses resulted in a freeze time of 1.31 seconds. - 3-long presses resulted in a freeze time of 1.99 seconds.
- Maximum acceptable concentration of DME administered	- Maximum acceptable concentration of DME administered was 0.37 mg/ml during both dose techniques, ensured by a safety (dose) valve.
Biocompatibility
- Applicator material safety	- Biocompatibility testing (ISO 10993:5 Tests for in vitro cytotoxicity) performed on the polypropylene applicator in contact with cryogen. - The applicator material was found to be non-lysic.
Chemical Residuals/Leachables
- Absence of harmful chemical residuals/leachables	- Laboratory testing concluded no chemical residuals in dimethylether/polypropylene extracts, indicating no leachable components between the applicator and cryogen.
Cryogen Safety (Dimethylether - DME)
- Non-toxic by inhalation	- DME inhalation studies (by suppliers), including US National Toxicological Programme (NTP) acute toxicity studies (LC50) on mouse and rabbit. - Concluded DME did not produce acute toxicity in animal models or bacteria (Ames Salmonella Typhimiurium). - Developmental toxicity studies in animal models showed no significant toxic effect on mice or rabbit pups. - DME received a ranking of "not acutely toxic" by the NTT. - Current exposure limits (1000 ppm or 0.1% DME for 8-hour daily life-time exposures) are significantly higher than typical consumer product exposures (~100 ppm for short periods <15 min/day), which are far below levels to induce CNS effects.
Ease of Use/Safety Features
- Incorporates safety mechanisms	- Design incorporates a safety valve. - Dispenser requires being held upside down and actuated 3 times before cryogen is administered. - Predicate device has identical safety valve mechanism.
Intended Use
- Indicated for common and plantar warts (OTC for adults and children 4+)	- Device is indicated for the removal of common and plantar warts, OTC, for adults and children 4 years of age and older. - Predicate device has identical intended use.

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

The testing conducted for this device appears to be all laboratory-based or pre-clinical studies, not a human clinical trial test set in the traditional sense.

Comparative laboratory testing: Involved "predicate devices using a phantom skin model." The sample size (number of phantom skin models or tests) is not specified.
Applicator temperature laboratory test: Used "infrared camera technology." Sample size (number of tests/measurements) is not specified.
Dose technique testing: Used "infrared (IR) camera technology." Sample size (number of tests/measurements for each dose technique) is not specified.
Biocompatibility testing: Performed "in line with ISO 10993:5 Tests for in vitro cytotoxicity." While "testing was performed," the specific sample size (e.g., number of cell cultures, replicates) is not detailed.
Chemical residual testing: "Laboratory testing was conducted." Sample size (number of extractions, analyses) is not specified.
Inhalation studies on dimethylether: "Conducted by the suppliers." The US National Toxicological Programme (NTP) conducted "acute toxicity studies (LC50)" and "developmental toxicity studies" on mouse and rabbit models. The exact number of animals is not specified in this summary.

Data Provenance: All data appears to be from laboratory studies and existing toxicological literature/supplier data, not human patient data. There is no mention of country of origin for the studies, but the NTP study suggests US involvement for those specific studies.

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

Since this is not a human clinical study with a "test set" of patient cases requiring expert interpretation for ground truth, this information is not applicable. The "ground truth" for the laboratory tests was derived from physical measurements (temperature, concentration, freeze time) or established scientific methods (cytotoxicity assays, toxicology studies).

4. Adjudication Method for the Test Set

As there is no human-interpreted test set for this device, an adjudication method is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance?

This is not an AI/CAD device. No MRMC study was performed, and this question is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not an algorithm-based device. No standalone performance study of an algorithm was done, and this question is not applicable.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the verifiable outcomes or measurements from the laboratory and pre-clinical studies:

Quantitative Measurements: Applicator temperature (-50 °C), freeze times (1.31s, 1.99s), DME concentration (0.37 mg/ml), stated exposure limits (1000 ppm).
Standardized Assay Results: Biocompatibility (non-lysic via ISO 10993:5), chemical residuals (none detected).
Toxicological Study Endpoints: Acute toxicity (no acute toxicity in animal models/bacteria, "not acutely toxic" ranking), developmental toxicity (no significant toxic effect in animal models).
Comparative Assessment: Functional similarity to predicate devices based on phantom skin model behavior.

8. The Sample Size for the Training Set

This device did not involve machine learning or AI; therefore, there is no "training set." All reported studies are for performance evaluation or characterization.

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

As there is no training set, this question is not applicable.

Summary

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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	Predicatecomparison	510(k)Number
Wart Freeze	KoninklijkeUtermöhlen	Intended use,technology,materials	K101049	Primary predicatefor changes

Description of the device:

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

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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:

1. 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.
1. 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

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periods of time (<15 minutes/day). This is far below the levels to induce central nervous system effects. (CONFIDENTIAL)

ﻧﮯ Comparison to predicate devices

Application

The product administers cryogen directly onto the wart by way of an applicator permanently fixed to the dispenser.

Applicator effectiveness duration

The applicator maintains a temperature of -50 ° C. The effectiveness of predicates is identical.

Cryogen

The product uses 100% dimethylether, same as predicate device.

Safe!Ease of use

The design of the product incorporates the use of a safety valve. The dispenser is held upside down and actuated by pressing the bottom of the dispenser 3 times before the safety valve allows cryogen to be administered into the applicator and onto the wart. The predicate device has identical safety valve mechanism.

Indications for use

The product is indicated for over-the-counter treatment of common and plantar warts. The predicate device is indicated for identical intended use.

Conclusions

Based on the information presented above, it is concluded that the from the data supports the safety and effectiveness of the Wart Freezer. It is indicated that based on the safety data related to the ingredient, dimethylether, and similar labelling to the predicate device, this product should be qualified for the special 510k submission.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Letter dated: June 5, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Koninklijke Utermohlen NV % KRM Associates Kenneth R. Michael, Pharm.D., RAC, ASC 11956 Bernardo Plaza Drive, #417 San Diego, California 92128-1317

Re: K130599

ﺭ

Trade/Device Name: Wart Freeze Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: April 29, 2013 Received: May 06, 2013

Dear Dr. Michael:

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. 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 801); medical device reporting (reporting of medical

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Page 2 - Kenneth R. Michael, Pharm.D., RAC, ASC

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N.J.Mielkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K130599

Device Name, Wart Freeze

Indications For Use: The product is indicated for the removal of common and plantar warts.

Prescription Use (Part-21-CFR-801-Subpart-D)- AND/OR

Over-The-Counter Use × -(21-CFR-801-Subpart-C)-

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogdens 2013.06.06 11:2:10:11:9 -04'00'

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number__K130599

Page 1 of 1

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.