(88 days)
Not Found
No
The device description and performance studies focus on cryosurgery and physical components, with no mention of AI or ML.
Yes
The device is used for the treatment of common warts and plantar warts, which qualifies it as a therapeutic device.
No
The device is described as a "Wart Remover" and is indicated for the "treatment of common warts." It performs cryosurgery to remove warts, which is a therapeutic action, not a diagnostic one.
No
The device description explicitly lists physical components such as a pressurized canister, conductive gel, and comfort pads, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "over-the-counter treatment of common warts". This is a therapeutic treatment applied directly to the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a cryosurgery product that applies cold to the wart. This is a physical treatment method.
- No mention of in vitro testing: There is no indication that this device is used to examine samples (like blood, urine, tissue, etc.) outside of the body to diagnose a condition.
IVD devices are used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device directly treats a condition on the body.
N/A
Intended Use / Indications for Use
Wartie® Advanced Wart Remover is indicated for the over-the-counter treatment of common warts for patients ages 12 years and older.
Product codes (comma separated list FDA assigned to the subject device)
GEH
Device Description
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.
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
12 years and older
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)
Product Testing:
Biocompatibility per ISO 10993
Bench testing to show comparable freezing performance between subject device and predicates
Clinical Testing:
N/A
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.
Wartie® Wart Remover K140314, Histofreezer® Wart Removal System 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.
Not Found
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
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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.
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3
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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:
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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 |
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Date:
11-May-15
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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. |