(87 days)
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 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.
The document describes the device Compound W® Nitro-Freeze, an over-the-counter cryogenic wart remover. The following summarizes the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a formalized table of acceptance criteria. Instead, substantial equivalence to legally marketed predicate devices (Wartner® Wart Removal System (K032271) and Wartie® Wart Remover (K140314)) is claimed based on comparable intended use, technological characteristics, and safety/effectiveness data. The performance is reported in terms of freezing temperature and clinical effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance (Compound W® Nitro-Freeze) | Reference Performance (Predicates) |
|---|---|---|
| Freezing Performance (Bench Test; after 40 sec.) | -82.83°C | Wartner: -33.06°C; Wartie: -24.01°C; Urgo: -1.93°C |
| Pressure Release Feature | No devices disarmed at 35°C; All disarmed at either 38°C, 40°C or 50°C. | Not explicitly compared to predicates, but confirmed to function as intended. |
| Overall Wart Clearance (Clinical Study) | 82.0% (after final treatment) | Wartner: 47.4%; Wartie: 52.8% |
| First-Treatment Wart Clearance (Clinical Study) | 34.0% | Wartner: 10.5%; Wartie: 13.9% |
| Serious Product-Related Adverse Events | None recorded | Not explicitly detailed for predicates, but implied to be comparable |
| Non-Serious Adverse Events (e.g., blistering, pain, burning) | Increase compared to predicates, but considered offset by increased effectiveness | Predicates' specific rates not detailed, but implied to be lower |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study): 138 patients randomized, with 124 per-protocol.
- Nitro-Freeze arm: 50 patients
- Wartner arm: 38 patients
- Wartie arm: 36 patients
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It mentions "a single-center... study," but the location of this center is not specified. The study is described as a "multi-arm study," indicating a prospective design (patients were enrolled and treated).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The document mentions "evaluator assessments" following treatments in the clinical study, but does not specify the number or qualifications of these evaluators or how "ground truth" (i.e., wart clearance) was established, aside from the term "cured."
4. Adjudication Method
This information is not provided in the document.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not conducted for this device. The clinical study was a direct comparison of the device's effectiveness against predicate devices in treating warts in human subjects, not a study evaluating human reader performance with or without AI assistance.
6. Standalone Performance Study
A standalone, algorithm-only performance study was not conducted as this is a physical medical device (cryogenic wart remover), not an AI/software as a medical device.
7. Type of Ground Truth Used
For the clinical performance data, the ground truth was based on clinical assessment of wart clearance, described as "cured" after a certain number of treatments.
8. Sample Size for the Training Set
This information is not applicable/not provided. The device is an over-the-counter physical cryogenic wart remover, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training set Was Established
This information is not applicable as there is no training set for this type of device.
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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):
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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
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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)
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Section 5 – 510(k) Summary
Compound W® Nitro-Freeze
K #
1. Submitter
| Name & Address: | Medtech Products Inc.660 White Plains RoadTarrytown, 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 |
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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/Device Name | Compound W®Nitro-Freeze | Wartner® WartRemoval System | Wartie® WartRemover | N/A |
| 510(k) Number | TBD | K032271 | K140314 | N/A |
| Date Cleared | 90 days from dateof receipt by FDA1 | 09/10/2003 | 06/12/2014 | N/A |
| Original applicant | Medtech ProductsInc. | Wartner USA B.V. | YonMedical B.V. | N/A |
| REGULATORY CLASSIFICATION | ||||
| Regulatory Class | Class II | Class II | Class II | None |
| Name of GenericDevice Type | Cryogenic wartremover | Cryogenic wartremover | Cryogenic wartremover | None |
| Table 5-1: Comparison of Characteristics | ||
|---|---|---|
| -- | -- | ------------------------------------------ |
1 Projected based on Section 510(k) of the FDCA
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| Regulation | 21 CFR § 878.4350 | 21 CFR § 878.4350 | 21 CFR § 878.4350 | None | apply tip to wart | sec.; use handle toapply tip to wart | use device to applytip to wart | ||
|---|---|---|---|---|---|---|---|---|---|
| Product Code | GEH | GEH | GEH | None | Duration oftreatments | Dependent uponsize and location ofwart (max 20 sec.for common wartsand max 40 sec.for plantar warts | Dependent uponsize and location ofwart (max 20 sec.for common wartsand max 40 sec.for plantar warts | Dependent uponsize and location otwart (max 20 sec.for common wartsand max 40 sec.for plantar warts | None |
| ApplicablePerformanceStandards orSpecial Controls | N/A | N/A | N/A | None | Cryogen andApplicator | Nitrous oxidedelivered via foamapplicator | Dimethyl etherand propanedelivered via foamapplicator | Dimethyl etherused to cool ametal applicatorbead | Yes (see discussionin Sections 8-10 ofthis summary) |
| DEVICE DESCRIPTION - SUBSTANTIAL EQUIVALENCE COMPARATORS | Temperature at tip(after 40 seconds, inbench testing) | -82.83°C | -33.06°C | -24.01°C | Yes (see discussionin Sections 8-10 ofthis summary) | ||||
| Intended Use | Allow consumersdirect access to asafe and effectivemeans to removecommon warts andplantar warts. | Allow consumersdirect access to asafe and effectivemeans to removecommon warts andplantar warts. | Allow consumersdirect access to asafe and effectivemeans to removecommon warts andplantar warts. | None | Gas flammability | No | Yes | Yes | Improved safety |
| OTC or Rx | OTC | OTC | OTC | None | Pressure releasefeature | Yes | No | No | Yes (see discussionin Section 8 of thissummary) |
| Indications for Use | For over-the-counter treatmentof common wartsand plantar wartsin adults andchildren four yearsof age or older. | For the over-the-counter treatmentof common wartsand plantar warts. | For the over-the-counter treatmentof common wartsand plantar wartsfor patients aged 4years and older. | None | Multiple Use Device | Yes | Yes | Yes | None |
| Target Population | Adults and children4 years and older | Adults andchildren 4 yearsand older | Adults andchildren 4 yearsand older | None | Sterile Device | No | No | No | None |
| TechnologicalCharacteristics | Pressurized gas togenerate extremecold at anapplicator tip | Pressurized gas togenerate extremecold at anapplicator tip | Pressurized gas togenerate extremecold at anapplicator tip | None | Leaflet included | Yes | Yes | Yes | None |
| DEVICE DESCRIPTION - DESIGN FEATURES | Use environment | Home | Home | Home | None | ||||
| Energy | Thermal (removalof heat fromtreated skin) | Thermal (removalof heat fromtreated skin) | Thermal (removalof heat fromtreated skin) | None | Anatomical site ofuse | Topical - wart | Topical - wart | Topical - wart | None |
| Design /Presentation | Pen-like devicewith disposablefoam applicators | Table-top devicewith disposablefoam applicators | Pen-like devicewith reusableapplicator bead | Minor (similar toboth predicates) | Electricity orradiation used | No | No | No | None |
| Mode of Action | Destruction ofinfected cells byfreezing | Destruction ofinfected cells byfreezing | Destruction ofinfected cells byfreezing | None | |||||
| Directions for use | Place device on flatsurface; push peninto cap for 2 sec.;remove from capand use device to | Place device on flatsurface; assembletip and handle;push tip/handleinto device for 2-3 | Place on flatsurface; re-aligncap; press capdown for 2 sec.;remove cap and | Minor (similar toboth predicates) |
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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
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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
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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.
§ 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.