Compound W Nitro-Freeze

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 2, 2017 Medtech Products Inc. Mr. Vincent Argiro Director, Regulatory Affairs 660 White Plains Rd. Suite 250 Tarrytown, New York 10591 Re: K172373 Trade/Device Name: Compound W Nitro-Freeze Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: October 27, 2017 Received: October 30, 2017 Dear Mr. Argiro: 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): {1}------------------------------------------------ and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@Ida.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). > Sincerely, Jennifer R. Stevenson -S3 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) K172373 Device Name Compound W® Nitro-Freeze Indications for Use (Describe) Compound W® Nitro-Freeze is intended for over-the-counter treatment of common warts in adults and children four years of age or older. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {3}------------------------------------------------ Image /page/3/Picture/2 description: The image shows the logo for Medtech, a Prestige Brands company. The word "MEDTECH" is in large, bold, blue letters. Below the word is a blue line, and below that is the text "a PrestigeBrands company", with the word "PrestigeBrands" in red. # Section 5 – 510(k) Summary ## Compound W® Nitro-Freeze K # ### 1. Submitter | Name & Address: | Medtech Products Inc.<br>660 White Plains Road<br>Tarrytown, NY, 10591 | |-----------------|------------------------------------------------------------------------| | Contact: | Vincent Argiro, RAC | | Title: | Director, Regulatory Affairs | | Phone number: | (914) 524-8721 | | Email: | vargiro@prestigebrands.com | **2. Date Prepared** August 4, 2017 **3. Device Identification** | Trade/Proprietary Name: | Compound W® Nitro-Freeze | |-------------------------|-----------------------------------------| | Common/Usual Name: | Over-the-counter cryogenic wart remover | | Classification Name: | Cryosurgical unit and accessories | | Regulation Number: | 21 C.F.R. § 878.4350 | | Product Code: | GEH [Unit, Cryosurgical, Accessories] | | Device Class: | Class II | | Classification Panel: | General & Plastic Surgery Devices | #### 4. Legally Marketed Predicate Device(s) | Predicate No. 1: | Wartner® Wart Removal System (K032271), Product Code GEH | |------------------|----------------------------------------------------------| | Predicate No. 2: | Wartie® Wart Remover (K140314), Product Code GEH | {4}------------------------------------------------ #### 5. Device Description Compound W® Nitro-Freeze is a pen-like cryogenic device that utilizes pressurized nitrous oxide (N,O, liquefied) to destroy wart tissue through evaporative cooling when the cryogen is delivered via a disposable foam applicator tip. Each Compound W® Nitro-Freeze device is supplied in an outer carton with an Instructions-for-Use leaflet and a bag containing replacement tips. #### 6. Intended Use The Compound W® Nitro-Freeze is an over-the-counter (OTC) device that is intended to be used by lay people to treat common warts and plantar warts. The Compound W® Nitro-Freeze bears the following indications for use statement: Compound W® Nitro-Freeze is intended for over-the-counter treatment of common warts and plantar warts in adults and children four years of age or older. Compound W® Nitro-Freeze has the same intended use as the predicate devices and very minor differences between Compound W® Nitro-Freeze and the predicates with respect to the wording of the indications for use statements do not alter the devices' intended therapeutic effect. #### 7. Substantial Equivalence Discussion The following table compares Compound W® Nitro-Freeze to the predicate devices with respect to intended use and technological characteristics. This comparison of the devices provides detailed information demonstrating the basis for the determination of substantial equivalence. | | Proposed Device | Predicate 1 | Predicate 2 | Differences | |--------------------------------|-----------------------------------------|---------------------------------|---------------------------|-------------| | Trade Name<br>/Device Name | Compound W®<br>Nitro-Freeze | Wartner® Wart<br>Removal System | Wartie® Wart<br>Remover | N/A | | 510(k) Number | TBD | K032271 | K140314 | N/A | | Date Cleared | 90 days from date<br>of receipt by FDA1 | 09/10/2003 | 06/12/2014 | N/A | | Original applicant | Medtech Products<br>Inc. | Wartner USA B.V. | YonMedical B.V. | N/A | | REGULATORY CLASSIFICATION | | | | | | Regulatory Class | Class II | Class II | Class II | None | | Name of Generic<br>Device Type | Cryogenic wart<br>remover | Cryogenic wart<br>remover | Cryogenic wart<br>remover | None | | | | Table 5-1: Comparison of Characteristics | |--|--|------------------------------------------| |--|--|------------------------------------------| ¹ Projected based on Section 510(k) of the FDCA {5}------------------------------------------------ | Regulation | 21 CFR § 878.4350 | 21 CFR § 878.4350 | 21 CFR § 878.4350 | None | | apply tip to wart | sec.; use handle to<br>apply tip to wart | use device to apply<br>tip to wart | | |---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------| | Product Code | GEH | GEH | GEH | None | Duration of<br>treatments | Dependent upon<br>size and location of<br>wart (max 20 sec.<br>for common warts<br>and max 40 sec.<br>for plantar warts | Dependent upon<br>size and location of<br>wart (max 20 sec.<br>for common warts<br>and max 40 sec.<br>for plantar warts | Dependent upon<br>size and location ot<br>wart (max 20 sec.<br>for common warts<br>and max 40 sec.<br>for plantar warts | None | | Applicable<br>Performance<br>Standards or<br>Special Controls | N/A | N/A | N/A | None | Cryogen and<br>Applicator | Nitrous oxide<br>delivered via foam<br>applicator | Dimethyl ether<br>and propane<br>delivered via foam<br>applicator | Dimethyl ether<br>used to cool a<br>metal applicator<br>bead | Yes (see discussion<br>in Sections 8-10 of<br>this summary) | | DEVICE DESCRIPTION - SUBSTANTIAL EQUIVALENCE COMPARATORS | | | | | Temperature at tip<br>(after 40 seconds, in<br>bench testing) | -82.83°C | -33.06°C | -24.01°C | Yes (see discussion<br>in Sections 8-10 of<br>this summary) | | Intended Use | Allow consumers<br>direct access to a<br>safe and effective<br>means to remove<br>common warts and<br>plantar warts. | Allow consumers<br>direct access to a<br>safe and effective<br>means to remove<br>common warts and<br>plantar warts. | Allow consumers<br>direct access to a<br>safe and effective<br>means to remove<br>common warts and<br>plantar warts. | None | Gas flammability | No | Yes | Yes | Improved safety | | OTC or Rx | OTC | OTC | OTC | None | Pressure release<br>feature | Yes | No | No | Yes (see discussion<br>in Section 8 of this<br>summary) | | Indications for Use | For over-the-<br>counter treatment<br>of common warts<br>and plantar warts<br>in adults and<br>children four years<br>of age or older. | For the over-the-<br>counter treatment<br>of common warts<br>and plantar warts. | For the over-the-<br>counter treatment<br>of common warts<br>and plantar warts<br>for patients aged 4<br>years and older. | None | Multiple Use Device | Yes | Yes | Yes | None | | Target Population | Adults and children<br>4 years and older | Adults and<br>children 4 years<br>and older | Adults and<br>children 4 years<br>and older | None | Sterile Device | No | No | No | None | | Technological<br>Characteristics | Pressurized gas to<br>generate extreme<br>cold at an<br>applicator tip | Pressurized gas to<br>generate extreme<br>cold at an<br>applicator tip | Pressurized gas to<br>generate extreme<br>cold at an<br>applicator tip | None | Leaflet included | Yes | Yes | Yes | None | | DEVICE DESCRIPTION - DESIGN FEATURES | | | | | Use environment | Home | Home | Home | None | | Energy | Thermal (removal<br>of heat from<br>treated skin) | Thermal (removal<br>of heat from<br>treated skin) | Thermal (removal<br>of heat from<br>treated skin) | None | Anatomical site of<br>use | Topical - wart | Topical - wart | Topical - wart | None | | Design /<br>Presentation | Pen-like device<br>with disposable<br>foam applicators | Table-top device<br>with disposable<br>foam applicators | Pen-like device<br>with reusable<br>applicator bead | Minor (similar to<br>both predicates) | Electricity or<br>radiation used | No | No | No | None | | Mode of Action | Destruction of<br>infected cells by<br>freezing | Destruction of<br>infected cells by<br>freezing | Destruction of<br>infected cells by<br>freezing | None | | | | | | | Directions for use | Place device on flat<br>surface; push pen<br>into cap for 2 sec.;<br>remove from cap<br>and use device to | Place device on flat<br>surface; assemble<br>tip and handle;<br>push tip/handle<br>into device for 2-3 | Place on flat<br>surface; re-align<br>cap; press cap<br>down for 2 sec.;<br>remove cap and | Minor (similar to<br>both predicates) | | | | | | {6}------------------------------------------------ In accordance with section 513(i)(1)(A) of the FDCA, a device is substantially equivalent (SE) when it has the same intended use and technological characteristics as a legally marketed predicate device. As demonstrated in this traditional 510(k), any differences between the subject device and the cited predicates do not raise different questions of safety or effectiveness and data (including clinical data) establishes that the device is as safe and effective as the predicates. It is on this basis that Compound W® Nitro-Freeze is SE to the cited predicate devices. #### Non-Clinical Performance Data 8. While the design differences between Compound W® Nitro-Freeze and the predicates are minor and non-clinical testing is therefore unnecessary, the cryogenic performance of the device has been properly validated. An in vitro experiment was conducted to determine the temperature generated by Compound W® Nitro-Freeze in comparison to three other over-the-counter cryogenic wart removers currently on the market: the predicates, Wartner and Wartie Wart Remover, and Urgo {7}------------------------------------------------ #### K172373 (marketed in the U.S. as "Wart Freeze" under K130599). Product samples were tested at room temperature after being activated and introduced to an application substrate using a calibrated measuring instrument with a thermocouple sensor. This study clearly demonstrated the freezing performance of Compound W® Nitro-Freeze throughout the maximum treatment time of 40 seconds; the product generated temperatures ranging from -86.08°C (T=0) to -82.83°C (T=40) versus -28.82°C to -33.06°C (Wartner), -20.38°C to -24.01°C (Wartie Wart Remover), and -24.36°C to -1.93°C (Urgo). The performance of the device's pressure release feature was validated in a study involving placement of 20 device samples in a laboratory oven at progressive temperatures of 35°C, 40°C, and 50°C or 38°C and 50°C for 24-hour periods. [10 samples started at 35°C and 10 samples started at 38°C; devices that were not disarmed moved on to the next stage in their respective test groups.] After each exposure period, the devices were cooled at room temperature and then tested to determine which had been successfully disarmed. To determine whether a device was disarmed, the analyst attempted to load (charge) the applicator tip with cryogen; if no cryogen remained in the canister, the device was considered disarmed. As intended, no devices were disarmed at 35°C and all were disarmed at either 38°C, 40°C or 50°C. The non-clinical testing of Compound W® Nitro-Freeze demonstrates the device's freezing performance and the performance of its pressure release feature and therefore supports the substantial equivalence of Compound W® Nitro-Freeze to the cited predicates. #### 9. Clinical Performance Data While there are no differences in intended use and technological characteristics between the Compound W® Nitro-Freeze and the predicates that necessitate conducting a clinical trial, clinical data was provided in the 510(k) submission. A single-center, randomized, multi-arm study in 138 patients (124 per-protocol) was conducted to compare the safety and effectiveness of Compound W® Nitro-Freeze to two over-the-counter cryogenic wart treatments available in the U.S. and abroad (the predicate devices, Wartner and Wartie Wart Remover). That study involved 1-3 treatments with the selected product according to its labeled instructions (second and third treatments only if needed), each followed by evaluator assessments. The results are shown in the table below. | Treatment | Cured after X treatment(s) | | | Not cured after 3 treatments | |--------------|----------------------------|---------------|---------------|------------------------------| | | X=1 | X=2 | X=3 | | | Nitro-Freeze | 34.0% (17/50) | 28.0% (14/50) | 20.0% (10/50) | 18.0% (9/50) | | Wartner | 10.5% (4/38) | 18.4% (7/38) | 18.4% (7/38) | 52.6% (20/38) | | Wartie | 13.9% (5/36) | 8.3% (3/36) | 30.6% (11/36) | 47.2% (17/36) | #### Table 5-2: Primary effectiveness criterion in Study no. 14E2344 {8}------------------------------------------------ ### K172373 This study demonstrated statistically significant superior effectiveness for Compound W® Nitro-Freeze ("Pixie") versus Wartner and Wartie in both overall wart clearance (82.0% vs. 47.4% and 52.8%, respectively after final treatment, p = 0.001) and first-treatment wart clearance (34.0% vs. 10.5% and 13.9%, p = 0.013) with no serious product-related adverse events recorded and an increase in only minor treatment-related symptoms (i.e., wart-site blistering, pain, and burning sensation). With more people experiencing wart removal after one treatment with Compound W® Nitro-Freeze than after two treatments with either of the comparators, any modest increase in nonserious adverse events can be considered offset by the significant increase in product effectiveness. Study no. 14E2344 confirms and demonstrates that Compound W® Nitro-Freeze is substantially equivalent to the legally marketed predicate devices. #### 10. Statement of Substantial Equivalence Compound W® Nitro-Freeze has the same intended use as the predicate devices, Wartner (K032271) and Wartie Wart Remover (K140314), and utilizes the same basic principle of operation (introduction of extreme cold to destroy infected tissue). Like the predicates, Compound W® Nitro-Freeze uses pressurized gas as a cryogen, which it delivers using a disposable foam applicator – the same delivery method employed by the predicate, Wartner. Compound W® Nitro-Freeze and the predicate devices are of roughly the same size and shape and require depression of a device component for 2/3 seconds to release the cryogen and charge the applicator tip, and all three employ the same sizeand location-dependent application times. Although the design of Compound W® Nitro-Freeze relies on a different cryogen than the predicates (nitrous oxide vs. dimethyl ether and propane or dimethyl ether alone), that difference does not raise any new questions of safety and effectiveness that are not associated with the predicate devices and the non-clinical data provided in this submission demonstrate that Compound W® Nitro-Freeze is as safe and effective as the predicates. Compound W® Nitro-Freeze is therefore substantially equivalent to the cited predicate devices.