(435 days)
No
The device description and performance studies focus on the physical components and cryosurgical mechanism, with no mention of AI or ML.
Yes.
The device is used to remove common and plantar warts, which is a therapeutic action aimed at treating a medical condition.
No
The device is indicated for the removal of common and plantar warts, which is a treatment function, not a diagnostic one. It uses cryosurgery to treat warts, not to identify or diagnose them.
No
The device description explicitly lists hardware components such as a pressurized canister, dose valve, applicator, cleansing swabs, and protective plasters.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the removal of common and plantar warts. This is a therapeutic or treatment purpose, not a diagnostic one.
- Device Description: The device uses cryosurgery (freezing) to physically remove the wart. It does not analyze biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to identify, characterize, or monitor a disease or condition through the examination of in vitro specimens.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. Wart Freeze does not fit this description.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
GEH
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) .
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
adults and children 4 years of age and over.
Intended User / Care Setting
Not Found
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)
Pre-Clinical Testing:
- Comparative testing between Wart Freeze and the predicate devices using a phantom skin test model.
- Applicator temperature test to determine the degree of cold generated by the cryogen on the applicator.
- 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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K011708, K032271, K031697, K023487
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 Wart | |||
| Removal System | Wartner Medical | ||
| Products | Intended Use, | ||
| technology, materials | K011708 | ||
| Wartner Wart | |||
| Removal System | Wartner USA b.v | Intended Use, | |
| technology, materials | K032271 | ||
| Dr. Scholl's Freeze | |||
| Away Wart Remover | Schering-Plough | ||
| HealthCare Products, Inc | Intended Use, | ||
| technology, materials | K031697 | ||
| Histofreezer Wart | |||
| Removal System | OraSure Technologies, Inc | Intended Use, | |
| technology, materials | K023487 | ||
| Acon 30 Second | |||
| Reliable Digital | |||
| Thermometer | ACON Laboratories, Inc | Labeling related to | |
| 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) .
1
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.
-
- Applicator temperature test to determine the degree of cold generated by the cryogen on the applicator.
-
- 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.
-
- 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three wavy lines extending from the head, possibly representing hair or movement.
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.
3
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
4
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