WART FREEZE

K101049 · Koninklijke Utermohlen NV · GEH · Jun 23, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K101049
• Device Name: WART FREEZE
• Applicant: Koninklijke Utermohlen NV
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Jun 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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

Device Story

Wart Freeze is an OTC cryosurgical system for removing common and plantar warts. The device consists of a pressurized canister containing dimethyl ether (DME) cryogen, a dose valve, a reusable polypropylene applicator, alcohol cleansing swabs, and protective bandages. The user operates the device by dispensing a specific quantity of cryogen onto the applicator, which is then applied to the wart to induce freezing. The device is intended for home use by consumers. It provides a non-invasive method for wart removal, offering a benefit similar to existing cryosurgical products.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including comparative phantom skin model testing, applicator temperature testing, dose technique effectiveness testing, and determination of maximum allowable DME concentration. Biocompatibility and chemical residual/leachable testing were performed. A label comprehension study confirmed the instructions for use are clear for the general public.

Technological Characteristics

Portable cryosurgical system. Components: pressurized canister (dimethyl ether), polypropylene reusable applicator, alcohol swabs, bandages. Principle: cryotherapy via localized freezing. Standalone device; no software or electronics.

Indications for Use

Indicated for removal of common and plantar warts in adults and children 4 years of age and older.

Regulatory Classification

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.

Predicate Devices

• Wartner Wart Removal System (K011708)
• Wartner Wart Removal System (K032271)
• Dr. Scholl's Freeze Away Wart Remover (K031697)
• Histofreezer Wart Removal System (K023487)

Reference Devices

• Acon 30 Second Reliable Digital Thermometer (K060173)

Submission Summary (Full Text)

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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: | [phone] |
| 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 Wart<br>Removal System | Wartner Medical<br>Products | Intended Use,<br>technology, materials | K011708 |
| Wartner Wart<br>Removal System | Wartner USA b.v | Intended Use,<br>technology, materials | K032271 |
| Dr. Scholl's Freeze<br>Away Wart Remover | Schering-Plough<br>HealthCare Products, Inc | Intended Use,<br>technology, materials | K031697 |
| Histofreezer Wart<br>Removal System | OraSure Technologies, Inc | Intended Use,<br>technology, materials | K023487 |
| Acon 30 Second<br>Reliable Digital<br>Thermometer | ACON Laboratories, Inc | Labeling related to<br>cleaning | 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.
- 2. Applicator temperature test to determine the degree of cold generated by the cryogen on the applicator.
- 3. 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.
- 4. 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 [phone] or [phone] 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