Who is the manufacturer of Wartie Advanced Wart Remover or other proprietary name?

Youmedical Corp BV filed the 510(k) submission for Wartie Advanced Wart Remover or other proprietary name (K151309).

What is the FDA product code for Wartie Advanced Wart Remover or other proprietary name?

GEH. It is classified under 21 CFR 878.4350 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Wartie Advanced Wart Remover or other proprietary name?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Wartie Advanced Wart Remover or other proprietary name?

Wartie® Wart Remover (K140314); Histofreezer® Wart Removal System (K023487).

Who can help prepare an FDA 510(k) submission like Wartie Advanced Wart Remover or other proprietary name?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Wartie Advanced Wart Remover or other proprietary name

K151309 · Youmedical Corp BV · GEH · Aug 14, 2015 · General, Plastic Surgery

Device Facts

Record ID	K151309
Device Name	Wartie Advanced Wart Remover or other proprietary name
Applicant	Youmedical Corp BV
Product Code	GEH · General, Plastic Surgery
Decision Date	Aug 14, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4350
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Wartie® Advanced Wart Remover is intended for over-the-counter treatment of common warts and plantar warts to be used in adults and children 12 years of age and older.

Device Story

Device is an OTC cryosurgical system for home use. Input: pressurized canister containing dimethyl ether (DME) cryogen. Operation: user applies conductive gel to wart; activates canister to cool metal applicator tip; applies cold tip to wart to freeze skin tissue. Output: localized freezing of wart tissue, causing blister formation and subsequent removal of wart and virus. Includes disposable comfort pads for plantar wart protection. Healthcare provider role: none; patient self-use. Benefit: effective removal of common and plantar warts via controlled cryotherapy.

Clinical Evidence

No clinical data. Substantial equivalence supported by biocompatibility testing per ISO 10993 and bench testing comparing freezing performance to predicate devices.

Technological Characteristics

Cryosurgical unit using dimethyl ether (DME) as cryogen. Features a metal applicator tip for thermal energy removal, conductive gel for thermal coupling/moistening, and a mechanical locking ring for canister safety. Dimensions/form factor: handheld aerosol canister with applicator. Sterilization: not specified. Software: none.

Indications for Use

Indicated for the over-the-counter treatment of common warts and plantar warts in patients ages 12 years 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

Wartie® Wart Remover (K140314)
Histofreezer® Wart Removal System (K023487)

Related Devices

K101049 — WART FREEZE · Koninklijke Utermohlen NV · Jun 23, 2011
K060859 — COMPOUND W FREEZE OFF WART REMOVAL SYSTEM · OraSure Technologies, Inc. · Jul 18, 2006
K242932 — Skin Clinic Nitro Clear Wart Remover · Cryoconcepts LP · Apr 15, 2025
K242625 — Freeze Point & Private Label Versions · Cryoconcepts LP · Oct 25, 2024
K032271 — WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022) · Wartner USA B.V. · Sep 10, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other, resembling a stylized bird. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 14, 2015 YouMedical Corp BV % Ms. Kathleen Johnson Medical Device Approvals Incorporated P.O. Box 1124 Bryn Mawr, Pennsylvania 19010 Re: K151309 Trade/Device Name: Wartie® Advanced Wart Remover Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: May 11, 2015 Received: May 18, 2015 Dear Ms. Johnson: 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 {1}------------------------------------------------ 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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, # David Krause -S - Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page. #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) #### Device Name Wartie® Advaced Wart Remover Indications for Use (Describe) Wartie® Advanced Wart Remover is indicated for the over-the-counter treatment of common warts for patients ages 12 years and older. Type of Use (Select one or both, as applicable) [ Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. Image /page/2/Figure/13 description: The image shows a form section labeled "FOR FDA USE ONLY". Below this, the text "Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)" is present, indicating a space for a signature. The signature area is demarcated by a rectangular box with two diagonal lines forming an 'X' across it, suggesting that the area is reserved for official use and signature. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for YouMedical. The logo consists of a stylized graphic to the left of the text "YouMedical". The graphic is made up of intersecting blue and green shapes. Sub. N .: TBD Version: 1.0 11-May-15 Date: ## Premarket Notification 510(k) summary (As Required by 21 CFR 807.92) | Submitter 807.92(a)(1) | YouMedical Corp BV, Rijnsburgstraat 9-11, 1059AT Amsterdam, The Netherlands | |---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Kathleen Johnson Medical Device Approvals, Inc. PO Box 1124 Bryn Mawr, PA 19010 kathleen@mdapprovals.com | | Date Prepared | 06/May/15 | | Trade Name 807.92(a)(2) | Wartie® Advanced Wart Remover | | Common Name | OTC Wart Removal System | | Classification Name 807.92(a)(2) | Cryosurgical unit, accessories | | Classification Panel | General & Plastic Surgery | | Product Code | GEH | | Predicate Device 807.92(a)(3) | Wartie® Wart Remover K140314 Histofreezer® Wart Removal System K023487 | | Predicate Comparison | Wartie® Wart Remover K140314: Intended use, technology, materials, label. Histofreezer® Wart Removal System K023487: Intended use, technology, materials. | | Device Description 807.92(a)(4) | The Wartie® Advanced Wart Remover is an over the counter cryosurgery product (for the treatment of warts), to be used at home. The device consists of: - A pressurized canister filled with 50mL of the compressed liquid gas dimethyl ether with a custom application unit used to administer the cold delivered by the cryogen to the wart. - One 3 mL tube of conductive gel (also called gel). - Six disposable comfort pads. - Instructions for use in which you can read about the product how it works, how to use the product | | | to treat warts, warnings and limitations. | | Operating Principle | Wartie® Advanced Wart Remover technology involves freezing a wart (common and/or plantar) using a very cold liquid gas (cryogen) that is released into a patented-pending applicator. The applicator becomes very cold and is able to freeze the skin. A tube of conductive gel that maximizes the freezing potential by directing and isolating the cold temperature onto the application area, thereby moisturizing the skin. The freezing of the skin causes damage to the cells housing and protecting the wart. The wart then both develops a blister underneath and then falls off, or the damaged skin cells are discarded by the body, thereby also effectively removing the wart and the virus. Six disposable comfort pads used to protect the tender plantar wart area after treatment has been completed in case of particularly sensitive skin. | | Intended Use 807.92 (a)(5) | Wartie® Advanced Wart Remover is intended for over-the-counter treatment of common warts and plantar warts to be used in adults and children 12 years of age and older. | | Indications for Use Technological Characteristics as compared to the predicate devices 807.92 (a)(6) | The Wartie® Advanced Wart Remover employs a metal applicator used as cold retraction vehicle. This allow for pen-pointed accuracy in freezing the skin. Wartie® Advanced Wart Remover makes use of a conductive gel to optimize relative freezing performance, a secured locking ring in order to assure mechanical safety of the pressurized canister, and thermal safety precautions are associated with activation of the aerosol. Finally, the product uses thermal energy removed from skin at the anatomical site of a common wart and/or plantar wart. DME applied to skin surface to freeze topical wart | | Product Testing 807.92 (b)(1) | Biocompatibility per ISO 10993 Bench testing to show comparable freezing performance between subject device and predicates | | Clinical Testing 807.92 (b)(2) | N/A | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for YouMedical. The logo consists of a blue and green abstract symbol on the left, followed by the word "YouMedical" in a sans-serif font. The word "You" is in green, while "Medical" is in blue. Date: 11-May-15 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for YouMedical. The logo consists of a blue and green abstract symbol on the left, followed by the text "YouMedical" in a combination of green and blue colors. The word "You" is in green, while "Medical" is in blue. r #### Premarket Notification 510(k) Summary Wartie® Advanced Wart Remover TBD Sub. N .: Version: Date: 11-May-15 | Substantial Equivalence Information | | | | |-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------| | | Wartie® Advanced Remover | Wartie® Wart Remover | Histofreezer® Wart Removal System | | 510(k) number | Not Assigned | K140314 | K023487 | | Intended Use | OTC treatment of common warts and plantar warts. | OTC treatment of common warts and plantar warts. | OTC treatment of common warts and plantar warts. | | Target population | Adults and Children 12+. | Adults and Children 4+. | Adults and Children 4+. | | Energy used and/or delivered | Thermal energy removed from skin via a metal interface. | Thermal energy removed from skin via a metal interface. | Thermal energy removed from skin via a sponge containing liquid gas. | | Design | Device requiring application of the gel, activation and application. Metal tip provides pen- pointed accuracy. | Device requiring activation and application. Metal tip provides pen- pointed accuracy. | Device requiring assembly, activation, and application. | | Cryogen and applicator materials | DME from aerosol can applied to the skin through a metal core via a Nickel tip providing pen-point accuracy | DME from aerosol can applied to the skin through a metal core via a Nickel tip providing pen-point accuracy | DME/Propane from aerosol can applied to the skin through a sponge core mounted on a plastic applicator. | | Summary of Technological Differences | The only notable technological differences involve the type of device applicator used to deliver the cryogen. The Histofreezer® Wart Removal System device uses a sponge and the Wartie® systems use a metal tip. The subject device uses a conductive gel to moisten the skin whereas the predicates do not. Comfort pads are included in Wartie® Advanced Wart Remover to protect tender plantar warts after treatment. These technological differences do not create any new risks of safety or effectiveness for the user. | | | | Summary of similarities Conclusion 807.92 (b)(3) | All three devices have the same intended use and utilize the same type of technology. The subject device is substantially equivalent to the predicate devices based on intended use, principle of operation, biological evaluation and non-clinical bench testing. Any identified differences do not constitute new risks of safety or effectiveness to the user. | | |