Compound W Wart Removal System Dual Power

• K Number: K161294
• Device Name: Compound W Wart Removal System Dual Power
• Manufacturer: MEDTECH PRODUCTS INC.
• Date Cleared: 2016-09-15 ( 129 days)
• Product Code: GEH
• Regulation Number: 878.4350
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K032271 , K052259
• Predicate For: N/A

Intended Use

For the over-the-counter removal of common and plantar warts.

Device Description

The Compound W® Wart Removal System Dual Power is a cryosurgical system for the over-the-counter removal of common and plantar warts. Compound W® Wart Removal System Dual Power consists of the following:

• O Pressurized aerosol spray canister with a mixture of dimethyl ether and propane (K032271)
• o Reusable actuator/cap that releases the cryogen onto the disposable applicators
• Disposable foam applicators O
• Salicylic acid gel wart remover provided in a squeeze tube (in compliance with OTC O monograph 21 CFR 358 subpart B)
• O Comfort pads
• Instruction Leaflet o

AI/ML Overview

This document is a 510(k) premarket notification for the "Compound W® Wart Removal System Dual Power." It primarily establishes substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of clinical performance.

While the document details comparisons between the new device and a predicate device (Dr Scholl's® Dual Action Freeze Away™ Wart Remover) to demonstrate substantial equivalence, it does not contain information about:

1. A table of acceptance criteria and reported device performance: The document compares technical characteristics and indications for use, but there are no specific numerical acceptance criteria (e.g., success rates, cure rates) or corresponding performance data from a clinical study for the new device.
2. Sample size used for the test set and data provenance: No clinical test set data is provided.
3. Number of experts used to establish ground truth and their qualifications: Not applicable, as no clinical test set data is discussed.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned. The device is a direct-to-consumer product, not typically requiring comparative effectiveness studies against human readers for diagnostic tasks.
6. Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable, as this is a physical device, not an AI algorithm trained on data.
9. How ground truth for the training set was established: Not applicable.

However, based on the provided text, we can infer the "acceptance criteria" through the lens of "substantial equivalence" to the predicate device. The primary acceptance criterion for the FDA 510(k) pathway is that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or if it has different technological characteristics, it does not raise new questions of safety or effectiveness and is as safe and effective as the predicate device.

Here's an attempt to structure the answer based on the provided document, interpreting the "acceptance criteria" as meeting substantial equivalence to the predicate:

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The provided document is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device rather than presenting a de novo clinical study with specific performance acceptance criteria. Therefore, the "acceptance criteria" are implied by the FDA's regulatory standard for 510(k) clearance, which means the device must be as safe and effective as a predicate device and not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (Comparison to Predicate)
Intended Use (Over-the-counter removal of common and plantar warts)	SAME as predicate device (Dr Scholl's® Dual Action Freeze Away™ Wart Remover). The device, Compound W® Wart Removal System Dual Power, is intended for the over-the-counter removal of common and plantar warts.
Principles of Operation (Cryosurgical system with adjunctive salicylic acid)	SAME as predicate device. Both devices consist of a pressurized aerosol spray canister with a mixture of dimethyl ether and propane (cryogen), applicators for cryogen, and a salicylic acid war remover.
Technological Characteristics	Cryogen spray application: SAME as predicate (portable cryosurgical system comprised of an aerosol pressurized canister containing cryogen and an applicator that applies the cryogen to the wart). Cryogen formulation: SAME as predicate (a mixture of dimethyl ether and propane). Freeze time: Identical treatment times as predicate (dependent upon type and size of wart). Salicylic Acid Application: DIFFERENCE from predicate. The predicate uses a reusable applicator to apply acid post-cryo. The new device uses a squeezable tube for application. The manufacturer states this difference does not raise new concerns for safety or effectiveness. Salicylic Acid Formulation: DIFFERENCE from predicate. The predicate uses a 17% salicylic acid solution. The new device uses a 17% salicylic acid gel. The manufacturer states this difference does not raise new concerns for safety or effectiveness. Frequency of Use (Salicylic Acid): DIFFERENCE from predicate. Predicate: One drop of liquid 24 hours post cryo-treatment. New device: Apply 1 drop at a time, repeat once or twice a day as needed. The manufacturer states this difference does not raise new concerns for safety or effectiveness.
Materials	Biocompatibility: Complies with ISO 10993 (SAME as predicate). Sterility: No components are provided as sterile (SAME as predicate). Single-Use: Only disposable applicators are single-use (SAME as predicate).
Target Population	SAME as predicate (Adults and children 4 or older).

2. Sample size used for the test set and the data provenance:
The document does not describe a clinical performance study with a test set. The basis for clearance is substantial equivalence to a predicate device based on comparison of characteristics and technological features.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set data is presented.

4. Adjudication method for the test set:
Not applicable, as no clinical test set data is presented.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done or reported in this document. This type of study is typically conducted for diagnostic devices where human interpretation of images or signals is involved. The device is a therapeutic cryosurgical unit.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an AI algorithm.

7. The type of ground truth used:
Not applicable, as no clinical data with ground truth is discussed for the device's performance. The "ground truth" in the context of a 510(k) is effectively the established safety and effectiveness of the identified predicate device that the new device is compared against.

8. The sample size for the training set:
Not applicable, as this is a physical medical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established:
Not applicable, as this is a physical medical device, not an AI algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 15, 2016

MedTech Products, Inc. % Ms. Kathryn Coressel Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400. Austin, Texas 78701

Re: K161294

Trade/Device Name: Compound W Wart Removal System Dual Power Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: July 29, 2016 Received: August 2, 2016

Dear Ms. Coressel:

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 devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth

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in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Christopher J. Ronk -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161294

Device Name

Compound W® Wart Removal System Dual Power

Indications for Use (Describe) For the over-the-counter removal of common and plantar warts.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5 – 510(k) Summary

Compound W® Wart Removal System Dual Power

K # _161294

1. Submission Sponsor

MedTech Products Inc. 660 White Plains Road

Tarrytown, NY, 10591

USA

Phone number: [phone]

Contact: Czarina Ochoa

Title: Regulatory Affairs Manager

2. Submission Correspondent

Emergo Global Consulting, LLC

816 Congress Avenue, Suite 1400

Austin, TX 78701

Cell Phone: PHONE

Office Phone: [phone]

Contact: Kathryn A Coressel, Senior Consultant, RA

Email: [e-mail]

3. Date Prepared

September 14, 2016

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4. Device Identification

Trade/Proprietary Name:	Compound W® Wart Removal System Dual Power
Common/Usual Name:	OTC Wart Removal System
Classification Name:	Cryosurgical unit and accessories
Regulation Number:	878.4350
Product Code:	GEH
Device Class:	Class II
Classification Panel:	General & Plastic Surgery

5. Legally Marketed Predicate Device(s)

Dr Scholl's® Dual Action Freeze Away™ Wart Remover (K052259)

6. Device Description

The Compound W® Wart Removal System Dual Power is a cryosurgical system for the over-the-counter removal of common and plantar warts.

Compound W® Wart Removal System Dual Power consists of the following:

• O Pressurized aerosol spray canister with a mixture of dimethyl ether and propane (K032271)
• o Reusable actuator/cap that releases the cryogen onto the disposable applicators
• Disposable foam applicators O
• Salicylic acid gel wart remover provided in a squeeze tube (in compliance with OTC O monograph 21 CFR 358 subpart B)
• O Comfort pads
• Instruction Leaflet o

7. Indication for Use Statement

Compound W® Wart Removal System Dual Power is intended for the over-the-counter removal of common and plantar warts.

8. Substantial Equivalence Discussion

The following table compares the Compound W® Wart Removal System Dual Power to the predicate device with respect to indications for use, principles of operation, technological characteristics, and materials . The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

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Manufacturer	Schering-PloughHealthCare Products, Inc.	MedTech Products, Inc.	SignificantDifferences
Trade Name	Dr Scholl's Dual ActionFreeze Away WartRemover	Compound W® WartRemoval System DualPower
510(k) Number	K052259	TBD	Not Applicable
Product Code	GEH	SAME	NONE
Regulation Number	878.4350	SAME	NONE
Regulation Name	Cryosurgical unit andaccessories	SAME	NONE
Indications for Use	Dr. Scholl's® Dual ActionFreeze Away TM WartRemover is indicated forthe over-the-counterremoval of common andplantar warts.	Compound W® WartRemoval System DualPower is indicated for theover-the-counter removalof common and plantarwarts.	SAME
Presentation of kit	Kit contains both thecryogen spray and salicylicacid components in thesame kit.	SAME	NONE
Sterile	No components areprovided as sterile.	SAME	NONE
Single-Use	Only the disposableapplicators are single-use.	SAME	NONE
Target Population	Adults and children 4 orolder	SAME	NONE
Biocompatibility	Complies with ISO 10993	SAME	NONE
Cryogen spray
Application	Portable cryosurgicalsystem comprised of anaerosol pressurizedcanister containing cryogenand an applicator thatapplies the cryogen to thewart.	SAME	NONE

Table 5A – Comparison of Characteristics

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Manufacturer	Schering-PloughHealthCare Products, Inc.	MedTech Products, Inc.	SignificantDifferences
Trade Name	Dr Scholl's Dual ActionFreeze Away WartRemover	Compound W® WartRemoval System DualPower
Formulation	A mixture of dimethyl etherand propane	SAME	NONE
Freeze time	Dependent upon type andsize of wart	Identical treatment timesas predicate	NONE
Salicylic Acid
Application	Post cryo-treatment with areusable applicator toapply the acid to the wart.	Application is via asqueezable tube	Difference doesnot raise newconcerns forsafety oreffectiveness.
Formulation	A 17% /salicylic acidsolution	A 17% /salicylic acid gel	Difference doesnot raise newconcerns forsafety oreffectiveness.
Frequency of Use	One drop of the liquid canbe applied to the wart 24hours post cryo-treatment.	Apply 1 drop at a time tocover the wart. Repeatonce or twice a day asneeded.	Difference doesnot raise newconcerns forsafety oreffectiveness.

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.