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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the "Wartie® Advanced Wart Remover". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies against predefined acceptance criteria for novel devices.

Therefore, many of the typical elements of an acceptance criteria and study section for a new medical device are not present in this document. Specifically:

No acceptance criteria table or reported device performance for clinical effectiveness: The document does not define specific clinical effectiveness endpoints (e.g., wart clearance rate, reduction in size) with associated acceptance thresholds.
No clinical study demonstrating device meets acceptance criteria: There is no detailed clinical study described that aims to prove the device's efficacy against such criteria. The document explicitly states "Clinical Testing: N/A" on page 5.
No information on test set sample size, data provenance, experts for ground truth, adjudication methods, or MRMC studies: Since no clinical effectiveness study is presented, these details are not applicable or provided.
No standalone algorithm performance or training set details: This device is a physical cryosurgical unit, not an AI/algorithm-based diagnostic or therapeutic device. Therefore, these concepts are not relevant.
No specific ground truth type for clinical effectiveness: Again, due to the lack of clinical studies measuring effectiveness, specific ground truth methods for clinical outcomes are not described.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical testing. Here's what can be extracted from the document regarding the device's testing and comparison:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, the document does not present a table of clinical acceptance criteria or reported clinical device performance in the typical sense of a novel device proving its efficacy. The acceptance for a 510(k) is based on demonstrating substantial equivalence. The relevant "performance" discussed is in terms of freezing performance in a non-clinical setting, compared to predicates, and biocompatibility.

Acceptance Criteria (Non-Clinical)	Reported Device Performance (Non-Clinical)
Biocompatibility per ISO 10993	Presumed met, as "biological evaluation" is listed as a basis for substantial equivalence. (Specific results not detailed in summary.)
Comparable Freezing Performance (Bench testing)	Demonstrated to show comparable freezing performance between subject device and predicates. (Specific metrics not detailed in summary.)
Mechanical Safety (Pressurized canister)	Secured locking ring to assure mechanical safety.
Thermal Safety (Aerosol activation)	Thermal safety precautions associated with activation.
Product Design Features	Metal applicator for pen-pointed accuracy, conductive gel to optimize freezing, comfort pads for plantar warts.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not applicable. No clinical test set described for demonstrating effectiveness.
Data Provenance: Not applicable for clinical data. Bench testing data provenance is not specified beyond being "bench testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set with human expert ground truth described.

4. Adjudication method for the test set

Not applicable.

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 not an AI-based device, and no MRMC study was performed.

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

Not applicable. This is not an algorithm-based device.

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

For the non-clinical performance (e.g., freezing performance), the "ground truth" would likely be measurements from standardized test setups, comparing characteristics like temperature achieved or cold transfer efficiency. Specific details are not provided in this summary.
For biocompatibility, the ground truth is established by adherence to ISO 10993 standards and the results of tests specified by these standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that utilizes training data sets.

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

Not applicable.

Summary of what the document does provide:

The document focuses on demonstrating substantial equivalence to predicate devices (Wartie® Wart Remover K140314 and Histofreezer® Wart Removal System K023487) by comparing:

Intended Use: All devices are for OTC treatment of common and plantar warts.
Target Population: While the subject device (Wartie® Advanced) is for ages 12+, the predicates are 4+. The document implies this difference does not raise new safety/effectiveness concerns.
Energy Used: All remove thermal energy from the skin.
Design and Cryogen/Applicator Materials: All use DME as cryogen. The primary technological differences identified are the specific applicator design (metal tip vs. sponge) and the inclusion of conductive gel and comfort pads in the subject device.
Non-Clinical Testing: Biocompatibility per ISO 10993 and bench testing to show comparable freezing performance. The conclusion is that these differences "do not create any new risks of safety or effectiveness for the user."

This 510(k) summary is typical for a device seeking clearance based on substantial equivalence, where the emphasis is on demonstrating that the new device is as safe and effective as a legally marketed predicate, rather than establishing de novo clinical efficacy against predetermined criteria for a novel technology.

Summary

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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

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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

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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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Sub. N .: TBD Version: 1.0 11-May-15 Date:

Premarket Notification 510(k) summary (As Required by 21 CFR 807.92)

Submitter807.92(a)(1)	YouMedical Corp BV,Rijnsburgstraat 9-11,1059AT Amsterdam, The Netherlands
Contact Person	Kathleen JohnsonMedical Device Approvals, Inc.PO Box 1124Bryn Mawr, PA 19010kathleen@mdapprovals.com
Date Prepared	06/May/15
Trade Name807.92(a)(2)	Wartie® Advanced Wart Remover
Common Name	OTC Wart Removal System
Classification Name807.92(a)(2)	Cryosurgical unit, accessories
Classification Panel	General & Plastic Surgery
Product Code	GEH
Predicate Device807.92(a)(3)	Wartie® Wart Remover K140314Histofreezer® 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 Description807.92(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 freezinga 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 potentialby directing and isolating the cold temperature onto theapplication area, thereby moisturizing the skin.The freezing of the skin causes damage to the cells housing andprotecting the wart. The wart then both develops a blisterunderneath and then falls off, or the damaged skin cells arediscarded by the body, thereby also effectively removing thewart and the virus.Six disposable comfort pads used to protect the tender plantarwart area after treatment has been completed in case ofparticularly sensitive skin.
Intended Use807.92 (a)(5)	Wartie® Advanced Wart Remover is intended for over-the-countertreatment of common warts and plantar warts to be used in adultsand children 12 years of age and older.
Indications for UseTechnologicalCharacteristics ascompared to thepredicate devices807.92 (a)(6)	The Wartie® Advanced Wart Remover employs a metalapplicator used as cold retraction vehicle. This allow for pen-pointedaccuracy in freezing the skin. Wartie® Advanced WartRemover makes use of a conductive gel to optimize relativefreezing performance, a secured locking ring in order to assuremechanical safety of the pressurized canister, and thermal safetyprecautions are associated with activation of the aerosol. Finally,the product uses thermal energy removed from skin at theanatomical site of a common wart and/or plantar wart.DME applied to skin surface to freeze topical wart
Product Testing807.92 (b)(1)	Biocompatibility per ISO 10993Bench testing to show comparable freezing performance betweensubject device and predicates
Clinical Testing807.92 (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®AdvancedRemover	Wartie®Wart Remover	Histofreezer®WartRemoval System
510(k) number	Not Assigned	K140314	K023487
Intended Use	OTC treatment ofcommon warts andplantar warts.	OTC treatment ofcommon wartsand plantar warts.	OTC treatment ofcommon warts andplantar warts.
Target population	Adults and Children12+.	Adults andChildren 4+.	Adults and Children 4+.
Energy used and/ordelivered	Thermal energyremoved from skinvia a metalinterface.	Thermal energyremoved fromskin via a metalinterface.	Thermal energyremoved from skin via asponge containing liquidgas.
Design	Device requiringapplication of thegel, activation andapplication. Metaltip provides pen-pointed accuracy.	Device requiringactivation andapplication. Metaltip provides pen-pointed accuracy.	Device requiringassembly, activation,and application.
Cryogen andapplicator materials	DME from aerosolcan applied to theskin through ametal core via aNickel tip providingpen-point accuracy	DME from aerosolcan applied to theskin through ametal core via aNickel tip providingpen-point accuracy	DME/Propane fromaerosol can applied tothe skin through asponge core mounted ona plastic applicator.
Summary ofTechnologicalDifferences	The only notable technological differences involve the type ofdevice 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 gelto moisten the skin whereas the predicates do not. Comfort padsare included in Wartie® Advanced Wart Remover to protect tenderplantar warts after treatment. These technological differences donot create any new risks of safety or effectiveness for the user.
Summary ofsimilaritiesConclusion807.92 (b)(3)	All three devices have the same intended use and utilize the sametype of technology.The subject device is substantially equivalent to the predicatedevices based on intended use, principle of operation, biologicalevaluation and non-clinical bench testing. Any identifieddifferences do not constitute new risks of safety or effectiveness tothe user.

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.