Wart Freeze is indicated for the removal of common and plantar. The wart remover product is intended to be used in adults and children 4 years of age and over.

Device Description

Wart Freeze is an over the counter cryosurgical product to remove common and plantar warts. The device consists of the following: Pressurized canister with the cryogen liquid dimethyl ether (DME), a dose valve which expels a specific quantity of the cryogen onto the wart, a polypropylene reusable applicator, 70% alcohol disposable cleansing swabs, Protective plasters (bandages).

AI/ML Overview

The provided text describes a 510(k) Pre-market Notification for the "Wart Freeze" device. This is a submission to demonstrate substantial equivalence to previously cleared devices, not typically a full clinical study with acceptance criteria and performance metrics in the way a novel AI/software medical device would be.

Therefore, many of the requested elements for a detailed AI/software device study (such as MRMC studies, sample sizes for training/test sets, expert qualifications for ground truth establishment, etc.) are not applicable or not provided in this type of regulatory document.

However, I can extract information related to the device's pre-clinical testing, which serves as a form of "acceptance criteria" and "study" for this specific type of device.

Here's the breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

Since this is a traditional 510(k) for a cryosurgical device, the "acceptance criteria" are not reported as specific numerical performance metrics (like sensitivity, specificity) but rather as successful completion of various functionality and safety tests demonstrating equivalence to predicate devices. The performance is "reported" as supporting the safety and effectiveness.

Acceptance Criteria (What was tested)	Reported Device Performance (Outcome)
Comparative testing with predicate devices using a phantom skin model	Supports safety and effectiveness; suggests similar performance to predicates.
Applicator temperature test	Successfully determined the degree of cold generated by the cryogen on the applicator.
Dose technique test (dispensing freeze time)	Determined dispensing freeze time for two potential techniques; subsequent testing showed no difference in effectiveness between techniques.
Maximum allowable concentration of DME	Successfully determined.
Biocompatibility testing (cryogen & applicator material)	Determined safety of cryogen and applicator material.
Safety test (chemical residuals, leachable/degradable components)	Successfully identified any potential chemical residuals.
Label comprehension study	Ensured instructions for use and package label were clear and understandable for safe and effective use.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated for each test. For the "phantom skin test model," no sample size (number of tests or phantoms) is provided. No human subjects test set is mentioned.
Data Provenance: Not explicitly stated. The manufacturer is Koninklijke Utermöhlen NV, located in the Netherlands. The 510(k) submission was made to the FDA in the USA. Given the nature of pre-clinical bench testing, the data would likely originate from laboratory settings where the tests were performed.
Retrospective/Prospective: These pre-clinical tests are prospective in nature, as they are specifically conducted to evaluate the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a physical device undergoing pre-clinical bench and lab tests. There is no mention of human experts establishing "ground truth" for a test set in the context of diagnostic accuracy, image interpretation, or clinical outcomes. The "ground truth" for these tests would be objective measurements (e.g., temperature readings, concentrations, visual inspection for clarity of labels).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where multiple experts evaluate ambiguous cases or determine ground truth in a consensus-driven manner for diagnostic accuracy studies. This document describes bench and lab testing of a physical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a cryosurgical device for wart removal, not an AI/software device. No MRMC study or AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical cryosurgical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the pre-clinical tests varied by test type:
- Comparative testing: Performance against predicate devices on a phantom skin model.
- Temperature test: Direct measurement of temperature.
- Dose technique test: Measurement of freeze time and assessment of "effectiveness" (likely through simulated application or efficacy on phantom models).
- DME concentration: Chemical analysis.
- Biocompatibility/Safety: Standardized ISO or similar biocompatibility tests for materials and chemical component analysis for safety.
- Label comprehension: Survey results on public understanding of the instructions.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

Summary

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K101049

JUN 2 3 2011

Koninklijke Utermöhlen NV Traditional 510(k)

Wart Freeze

Section B - 510(k) Summary

Manufacture Name:	Koninklijke Utermöhlen NV
Contact Name:	Foki van 't Zand
Postal Address:	De Overweg 1, 8471 ZA Wolvega
Phone Number:	+31 (0) 561-693310
Title:	Quality Control Manager
Date:	April 14, 2010

Device Proprietary Name:	Wart Freeze
Device Common or Usual Name:	OTC wart removal system
Classification Name:	Cryosurgical unit, accessories
Classification Code:	GEH
Regulation Number:	21 CFR 878.4350

Predicate Devices:

Substantial equivalence is claimed to the following devices.

Name of Device	Manufacturer	Predicate Comparison	510(k) Number
Wartner WartRemoval System	Wartner MedicalProducts	Intended Use,technology, materials	K011708
Wartner WartRemoval System	Wartner USA b.v	Intended Use,technology, materials	K032271
Dr. Scholl's FreezeAway Wart Remover	Schering-PloughHealthCare Products, Inc	Intended Use,technology, materials	K031697
Histofreezer WartRemoval System	OraSure Technologies, Inc	Intended Use,technology, materials	K023487
Acon 30 SecondReliable DigitalThermometer	ACON Laboratories, Inc	Labeling related tocleaning	K060173

Description of the Device

Wart Freeze is an over the counter cryosurgical product to remove common and plantar warts.

The device consists of the following:

. Pressurized canister with the cryogen liquid dimethyl ether (DME)
. a dose valve which expels a specific quantity of the cryogen onto the wart
a polypropylene reusable applicator .
70% alcohol disposable cleansing swabs
Protective plasters (bandages) .

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Intended Use/Indications for Use

Wart Freeze is indicated for the removal of common and plantar. The wart remover product is intended to be used in adults and children 4 years of age and over.

Technological Characteristics

The subject and predicate devices are portable cryosurgical systems comprised of a canister containing cryogen and an applicator to apply the cryogen to the wart.

Pre-Clinical Testing

The following functionality tests on the finished product and/or components were performed:

I. Comparative testing between Wart Freeze and the predicate devices using a phantom skin test model.
1. Applicator temperature test to determine the degree of cold generated by the cryogen on the applicator.
1. Dose technique test to determine the dispensing freeze time between the two potential dose techniques. Subsequent testing was conducted to determine whether or not there was any difference in the effectiveness between the dose techniques.
1. The maximum allowable concentration of DME was determined

Biocompatibility testing was performed to determine the safety of the cryogen as well as the material used to manufacture the applicator. In addition, a safety test was conducted on the finished product to identify any potential chemical residuals including leachable or degradable components.

A label comprehension study was performed to ensure that the instructions for use as well as the package label were clear and understandable by the general public for the safe and effective use of the device.

It was concluded that the bench, biocompatibility and label comprehension studies support the safety and effectiveness of Wart Freeze.

Substantial Equivalence Discussion

The subject and predicate devices are similar in terms of application, safety and ease of use and indications for use.

Conclusion

Based on the information provided in this 510(k) premarket notification, Wart Freeze is substantially equivalent in terms of safety and effectiveness to the predicate devices identified above.

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Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

JUN 2 3 2011

Koninklijke Utermohlen NV % Canreg, Inc. Shirley Furesz, Ph.D., RAC Manager, Regulatory Affairs - Devices 4 Innovation Drive Dundas, Ontario, Canada L9H 7P3

Re: K101049

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: June 13, 2011 Received: June 14, 2011

Dear Dr. Furesz:

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.

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Page 2 - Shirley Furesz, Ph.D., RAC

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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Fia Melkerson
N. Melkerson 0500 O.K

Mark N. Melker Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section A - Indications for Use

510(k) Number: K101049

Device Name: Wart Freeze

Indication for Use:

Wart Freeze is indicated for the removal of common and plantar warts.

Prescription Use Over the Counter Use X And/Or (21 CFR Part 801 Subpart D) (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off
Division of General, Restorative and Neurological Devices
510(k)_**_(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number K101049

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.