(129 days)
No
The device description details a cryosurgical system and salicylic acid gel, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended for the removal of common and plantar warts, which is a therapeutic purpose.
No
The device is described as a cryosurgical system for the removal of common and plantar warts, and it includes a wart remover gel. Its intended use is for "over-the-counter removal" of warts, not for diagnosing them.
No
The device description explicitly lists multiple hardware components, including a pressurized aerosol spray canister, a reusable actuator/cap, disposable foam applicators, and comfort pads.
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 removal of warts, which is a therapeutic action performed directly on the patient's body.
- Device Description: The components are a cryosurgical system and a topical salicylic acid gel. These are used for physical or chemical treatment of the wart, not for analyzing a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. IVDs are used to diagnose diseases or conditions based on the analysis of such samples.
Therefore, the Compound W® Wart Removal System Dual Power is a therapeutic device used for the treatment of warts, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For the over-the-counter removal of common and plantar warts.
Product codes (comma separated list FDA assigned to the subject device)
GEH
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
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 or older
Intended User / Care Setting
Over-The-Counter Use
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)
Not Found
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.
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
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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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3
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: (914) 524-6836
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: (512) 327-9997
Contact: Kathryn A Coressel, Senior Consultant, RA
Email: project.management@emergogroup.com
3. Date Prepared
September 14, 2016
4
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.
5
| Manufacturer | Schering-Plough
HealthCare Products, Inc. | MedTech Products, Inc. | Significant
Differences | | |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--|--|
| Trade Name | Dr Scholl's Dual Action
Freeze Away Wart
Remover | Compound W® Wart
Removal System Dual
Power | | | |
| 510(k) Number | K052259 | TBD | Not Applicable | | |
| Product Code | GEH | SAME | NONE | | |
| Regulation Number | 878.4350 | SAME | NONE | | |
| Regulation Name | Cryosurgical unit and
accessories | SAME | NONE | | |
| Indications for Use | Dr. Scholl's® Dual Action
Freeze Away TM Wart
Remover is indicated for
the over-the-counter
removal of common and
plantar warts. | Compound W® Wart
Removal System Dual
Power is indicated for the
over-the-counter removal
of common and plantar
warts. | SAME | | |
| Presentation of kit | Kit contains both the
cryogen spray and salicylic
acid components in the
same kit. | SAME | NONE | | |
| Sterile | No components are
provided as sterile. | SAME | NONE | | |
| Single-Use | Only the disposable
applicators are single-use. | SAME | NONE | | |
| Target Population | Adults and children 4 or
older | SAME | NONE | | |
| Biocompatibility | Complies with ISO 10993 | SAME | NONE | | |
| Cryogen spray | | | | | |
| Application | Portable cryosurgical
system comprised of an
aerosol pressurized
canister containing cryogen
and an applicator that
applies the cryogen to the
wart. | SAME | NONE | | |
Table 5A – Comparison of Characteristics
6
| Manufacturer | Schering-Plough
HealthCare Products, Inc. | MedTech Products, Inc. | Significant
Differences |
|------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Trade Name | Dr Scholl's Dual Action
Freeze Away Wart
Remover | Compound W® Wart
Removal System Dual
Power | |
| Formulation | A mixture of dimethyl ether
and propane | SAME | NONE |
| Freeze time | Dependent upon type and
size of wart | Identical treatment times
as predicate | NONE |
| Salicylic Acid | | | |
| Application | Post cryo-treatment with a
reusable applicator to
apply the acid to the wart. | Application is via a
squeezable tube | Difference does
not raise new
concerns for
safety or
effectiveness. |
| Formulation | A 17% /salicylic acid
solution | A 17% /salicylic acid gel | Difference does
not raise new
concerns for
safety or
effectiveness. |
| Frequency of Use | One drop of the liquid can
be applied to the wart 24
hours post cryo-treatment. | Apply 1 drop at a time to
cover the wart. Repeat
once or twice a day as
needed. | Difference does
not raise new
concerns for
safety or
effectiveness. |