Forwarts

• K Number: K201366
• Device Name: Forwarts
• Manufacturer: Pronova Laboratories BV
• Date Cleared: 2021-01-21 ( 244 days)
• Product Code: GEH
• Regulation Number: 878.4350

Intended Use

Forwarts® is indicated for the treatment of warts on hands (common warts) and feet (plantar warts).

Device Description

Forwarts® is a wart removal device that works by the principle of cryotherapy and is intended for the treatment of common and plantar warts. It delivers a precise cryogenic spray directly onto a wart or verruca which causes them to freeze and fall off the skin in approximately 10-14 days. The device consists of a pressurized aerosol can containing 35 ml dimethyl ether (DME). The aerosol can is held in a polypropylene shell (front and back). The front shell contains a distance holder for a safe and regulated application and a visor to point and limit the spray pattern. The translucent back shell contains a ridge for safe handling. The valve system will be extended by an actuator to point and minimize the spray pattern. Forwarts® is supplied with ten (10) protection patches per device to be placed around the wart prior to treatment to help prevent damage of healthy skin. Forwarts® is supplied non-sterile and not intended to be sterilized by the end user. The Forwarts® nozzle should be cleaned after each use with rubbing alcohol (70%).

Predicate Devices

K130599

Reference Devices

K172373, K140314, K032271

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on cryotherapy principles, mechanical components, and standard non-clinical testing. There is no mention of AI or ML in the text.

Therapeutic

Yes.
The device is indicated for the treatment of warts on hands and feet, which is a therapeutic purpose.

Diagnostic

No
The device is described as a "wart removal device" used for the "treatment of warts," indicating a therapeutic rather than a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components including a pressurized aerosol can, polypropylene shell, valve system, actuator, and protection patches. It operates on the principle of cryotherapy, which is a physical process, not a software function.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Forwarts® Function: Forwarts® is a device that applies cryotherapy directly to the skin to treat warts. It does not analyze any biological samples taken from the body.
• Intended Use: The intended use is for the treatment of warts on hands and feet, not for the diagnosis of a condition using in vitro methods.
• Device Description: The description details a physical device that delivers a cryogenic spray externally.

Therefore, Forwarts® falls under the category of a therapeutic device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Forwarts® is indicated for the treatment of warts on hands (common warts) and feet (plantar warts).

Product codes (comma separated list FDA assigned to the subject device)

GEH

Device Description

Forwarts® is a wart removal device that works by the principle of cryotherapy and is intended for the treatment of common and plantar warts. It delivers a precise cryogenic spray directly onto a wart or verruca which causes them to freeze and fall off the skin in approximately 10-14 days. The device consists of a pressurized aerosol can containing 35 ml dimethyl ether (DME). The aerosol can is held in a polypropylene shell (front and back). The front shell contains a distance holder for a safe and regulated application and a visor to point and limit the spray pattern. The translucent back shell contains a ridge for safe handling. The valve system will be extended by an actuator to point and minimize the spray pattern. Forwarts® is supplied with ten (10) protection patches per device to be placed around the wart prior to treatment to help prevent damage of healthy skin. Forwarts® is supplied non-sterile and not intended to be sterilized by the end user. The Forwarts® nozzle should be cleaned after each use with rubbing alcohol (70%).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hands (common warts) and feet (plantar warts)

Indicated Patient Age Range

Not Found

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)

• Biocompatibility Testing per ISO 10993-1: Results support biocompatibility of the device, including ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation), ISO 10993-10 (sensitization), ISO 10993-17 (toxicological risk assessment (TRA)), and ISO 10993-18 (chemical characterization). No carcinogenicity testing was required based on chemical characterization and TRA.
• Shelf Life Testing per ASTM D3090-72: Supports a shelf life of twenty months based on device stability and functionality testing under worst-case simulated conditions.
• Transportation Testing per ASTM D4169: Demonstrates package integrity is maintained after being subjected to impact, drop, vibration, and low-pressure testing under simulated transport conditions.
• Bench Testing: Comparative thermal performance testing was conducted, including thermoelectric testing and a simulated skin model. Measured attributes included freeze temperature extreme, freeze temperature plateau, freeze duration, freeze cycle length, and freeze spot size. The results demonstrated comparable performance to the predicate devices in terms of temperature profile at the target surface and tissue freezing capacity.
• Self-selection / Label Comprehension Study: A self-selection study was performed, demonstrating a success rate of at least 90% when using the device as indicated, based on providing subjects with the Forwarts® labeling.
• Human Factors Study: A Formative Study included Simulated Use Testing focusing on Critical Tasks, Contextual Enquiry, and semi-guided interviews. A Human Factor Validation Test was performed to validate that Forwarts® is safe for its intended use by lay-persons.

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.

K130599

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.

K172373, K140314, K032271

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

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.

Summary

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January 21, 2021

Pronova Laboratories BV % Stuart Goldman Regulatory Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K201366

Trade/Device Name: Forwarts Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: December 21, 2020 Received: December 22, 2020

Dear Stuart Goldman:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201366

Device Name Forwarts®

Indications for Use (Describe)

Forwarts® is indicated for the treatment of warts on hands (common warts) and feet (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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510(k) Summary

Forwarts®

1. Submission Sponsor

Pronova Laboratories BV Kruitpad 16 1398 CP Muiden The Netherlands Office Phone: [phone] Email: [e-mail] Contact: Diede Klever Title: D&D Manager

2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: [phone] Email: [e-mail] Contact: Indraj Bamrah Title: Senior Regulatory Consultant

3. Date Prepared

January 19, 2021

4. Device Identification

Trade/Proprietary Name:	Forwarts®
Common/Usual Name:	Cryosurgical unit and accessories
Classification Name:	Unit, Cryosurgical, Accessories
Regulation Number:	878.4350
Product Code:	GEH
Class:	Class 2
Classification Panel:	General & Plastic Surgery

5. Legally Marketed Predicate Device(s)

Primary Predicate

Device name: Wart Freeze

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510(k) number: K130599 Manufacturer: Koninklijke Utermohlen NV

Wart Freeze is an over the counter cryosurgery product for the treatment of common and plantar warts. The device consists of a pressurized dispenser containing 38 ml dimethyl ether (DME) with a polypropylene applicator that is permanently attached (fixed) to the dispenser.

Secondary Predicates

Device name:	Compound W® Nitro-Freeze
510(k) number:	K172373
Device name:	Wartie® Wart Remover
510(k) number:	K140314
Device name:	Wartner® Wart Removal System
510(k) number:	K032271

6. Indication for Use Statement

Forwarts® is indicated for the treatment of warts on hands (common warts) and feet (plantar warts).

7. Device Description

Forwarts® is a wart removal device that works by the principle of cryotherapy and is intended for the treatment of common and plantar warts. It delivers a precise cryogenic spray directly onto a wart or verruca which causes them to freeze and fall off the skin in approximately 10-14 days. The device consists of a pressurized aerosol can containing 35 ml dimethyl ether (DME). The aerosol can is held in a polypropylene shell (front and back). The front shell contains a distance holder for a safe and regulated application and a visor to point and limit the spray pattern. The translucent back shell contains a ridge for safe handling. The valve system will be extended by an actuator to point and minimize the spray pattern. Forwarts® is supplied with ten (10) protection patches per device to be placed around the wart prior to treatment to help prevent damage of healthy skin. Forwarts® is supplied non-sterile and not intended to be sterilized by the end user. The Forwarts® nozzle should be cleaned after each use with rubbing alcohol (70%).

8. Substantial Equivalence Discussion

The following table compares Forwarts® to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.

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		Table 5A - Comparison of Characteristics
--	--	------------------------------------------

| Attribute | Forwarts® | Wart Freeze /
Koninklijke
Utermohlen NV | Compound W®
Nitro-Freeze /
Medtech
Products Inc. | Wartie® Wart
Remover /
YouMedical B.V. | Wartner® Wart
Removal System
/ Wartner USA
B.V. | Comparison |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K201366 (pending) | K130599 | K172373 | K140314 | K032271 | N/A |
| Product Code | GEH, Unit,
Cryosurgical,
Accessories | GEH, Unit,
Cryosurgical,
Accessories | GEH, Unit,
Cryosurgical,
Accessories | GEH, Unit,
Cryosurgical,
Accessories | GEH, Unit,
Cryosurgical,
Accessories | Same |
| Regulation
Number | 21 CFR 878.4350 | 21 CFR 878.4350 | 21 CFR 878.4350 | 21 CFR 878.4350 | 21 CFR 878.4350 | Same |
| Indications for
Use | Forwarts® is
indicated for the
treatment of warts
on hands (common
warts) and feet
(plantar warts). | Wart Freeze is
indicated for the
removal of common
and plantar warts | 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 | Wartie® Wart
Remover is
indicated for the
over-the-counter
treatment of
common warts
and plantar
warts, for
patients aged 4
years and older. | WARTNER® Wart
Removal System
is indicated for
the over-the-
counter
treatment of
common warts
and plantar
warts. | Same |
| OTC or Rx | OTC | OTC | OTC | OTC | OTC | Same |
| Technological
Characteristics | Pressurized gas
canister that | Pressurized gas
canister that applies | Pen with
pressurized
cartridge that | Pressurized gas
canister that | Pressurized gas
canister that | Similar;
Differences in
cryogen and cold |
| Attribute | Forwarts® | Wart Freeze /
Koninklijke
Utermohlen NV | Compound W®
Nitro-Freeze /
Medtech
Products Inc. | Wartie® Wart
Remover /
YouMedical B.V. | Wartner® Wart
Removal System
/ Wartner USA
B.V. | Comparison |
| | applies extreme
cold to target;
Cryogen (liquefied
dimethyl ether, BP
= -24°C) aerosol
spray is applied
directly to the wart,
causing rapid
freezing. | extreme cold to
target;
Cryogen (liquefied
dimethyl ether, BP =
-24°C) is applied
directly to the wart,
causing rapid
freezing. | applies extreme
cold to target;
Cryogen
(liquefied nitrous
oxide, BP = -89°C)
is loaded onto a
foam applicator,
which is applied
to the wart,
causing rapid
freezing. | applies extreme
cold to target;
Cryogen
(liquefied
dimethyl ether,
BP = -24°C) is
used to
refrigerate a steel
tip, which is
applied to the
wart, causing
rapid freezing. | applies extreme
cold to target;
Cryogen
(liquefied
dimethyl ether /
propane mixture,
BP = -24°C / -
48°C) is loaded
onto a foam
applicator, which
is applied to the
wart, causing
rapid freezing. | application
technique.
The added wind
chill effect of
Forwarts' DME
aerosol spray
results in lower
temperatures
compared to
Wart Freeze. |
| Mechanism of
Action | Cryotherapy
Rapid freezing
followed by slow
thawing, causing
cell injury and
ischemic necrosis. | Cryotherapy;
Rapid freezing
followed by slow
thawing, causing cell
injury and ischemic
necrosis. | Cryotherapy;
Rapid freezing
followed by slow
thawing, causing
cell injury and
ischemic necrosis. | Cryotherapy;
Rapid freezing
followed by slow
thawing, causing
cell injury and
ischemic necrosis. | Cryotherapy;
Rapid freezing
followed by slow
thawing, causing
cell injury and
ischemic necrosis. | Same |
| Materials with
direct patient
contact | DME,
polypropylene
Optional protection
patch: PE foam | DME and
polypropylene | Nitrous oxide and
PU foam | Nickel | DME, propane
and PU foam | Similar to primary
predicate device;
Different from
supplemental
predicate devices. |
| Attribute | Forwarts® | Wart Freeze /
Koninklijke
Utermohlen NV | Compound W®
Nitro-Freeze /
Medtech
Products Inc. | Wartie® Wart
Remover /
YouMedical B.V. | Wartner® Wart
Removal System
/ Wartner USA
B.V. | Comparison |
| Biocompatibility | Established
conform ISO 10993-
1 | Established conform
ISO 10993-1 | Established
conform ISO
10993-1 | Established
conform ISO
10993-1 | Established
conform ISO
10993-1 | Same |
| Maximum
allowed
consecutive
treatments
(2-week
interval) | 4 | 4 | 3 | 3 | 3 | Similar |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Re-Usable | Yes;
Except for optional
protection patch | Yes;
includes applicator | Yes;
except for
disposable
applicator foam
tips | Yes; | Yes;
except for
disposable
applicator foam
tips | Similar;
Skin-contacting
tips of Forwarts
and Wart Freeze
are re-used and
to be cleaned.
Those of
Compound W®
Nitro-Freeze and
Wartner® Wart
Removal System
are disposable. |
| Attribute | Forwarts® | Wart Freeze /
Koninklijke
Utermohlen NV | Compound W®
Nitro-Freeze /
Medtech
Products Inc. | Wartie® Wart
Remover /
YouMedical B.V. | Wartner® Wart
Removal System
/ Wartner USA
B.V. | Comparison |
| Thermal
Performance
Testing | Measured
attributes included:
freeze temperature
extreme, freeze
temperature
plateau, freeze
duration, freeze
cycle length and
freeze spot size | Measured attributes
included: Freeze
temperature
extreme, freeze
temperature
plateau, freeze
duration, freeze
cycle length and
freeze spot size | Measured
attributes
included: freeze
temperature
extreme, freeze
temperature
plateau, freeze
duration, freeze
cycle length and
freeze spot size | Measured
attributes
included: freeze
temperature
extreme, freeze
temperature
plateau, freeze
duration, freeze
cycle length and
freeze spot size | Measured
attributes
included: freeze
temperature
extreme, freeze
temperature
plateau, freeze
duration, freeze
cycle length and
freeze spot size | Similar; Forwarts®
achieves thermal
performance
characteristics
within the ranges
of the predicates
demonstrating
comparable
efficacy.
Temperatures
achieved
demonstrating
that there are no
new questions of
safety. |

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9. Non-Clinical Performance Data

To demonstrate safety and effectiveness of Forwarts® and to show substantial equivalence to the predicate device, Pronova Laboratories BV completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. Forwarts® passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:

• . Biocompatibility Testing per ISO 10993-1 - Supports biocompatibility of the device.
  • O ISO 10993-5 (cytotoxicity)
  • ISO 10993-10 (irritation) o
  • ISO 10993-10 (sensitization) o
  • ISO 10993-17 (toxicological risk assessment (TRA)) O
  • O ISO 10993-18 (chemical characterization)

Based on the chemical characterization testing and TRA that was performed; therefore, no carcinogenicity testing was required.

• Shelf Life Testing per ASTM D3090-72 – Supports shelf life of twenty months.
  Shelf life testing was based on device stability and functionality testing when stored under worst case simulated conditions. The results of the test demonstrate device stability for twenty months.

• Transportation Testing per ASTM D4169 – Demonstrates package integrity maintained.
  Forwarts® in its final shipping configuration was subjected to impact, drop, vibration and low-pressure testing under simulated transport conditions. The results of the testing demonstrated that the packaging configuration is suitable to maintain device integrity.

• Bench Testing - Supports device performance.
  Forwarts® was subjected to comparative thermal performance testing that included thermoelectric testing and a simulated skin model to determine freeze temperature extreme, freeze temperature plateau, freeze duration, freeze cycle length and freeze spot size. The test provided data on both the temperature profile at the target surface and on the tissue freezing capacity of the results of the tests demonstrated comparable performance to the predicate devices.

• Self-selection / Label Comprehension Study – Supports device self-selection and labeling comprehension.
  A self-selection study was performed on Forwarts® to demonstrate a success rate of at least 90% when used as indicated. The study subjects were provided with the Forwarts® labeling (package and instructions for use) for this study.

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• . Human Factors Study – Supports safe usability of the device for lay-person use.
  A Formative Study was conducted on Forwarts® that included Simulated Use Testing focusing on Critical Tasks, combined with Contextual Enquiry and a semi-guided interview with test subjects. A Human Factor Validation Test was then performed to validate that Forwarts® is safe for its intended use.

10. Statement of Substantial Equivalence

Forwarts® has the same intended use as the Wart Freeze predicate device, and the same or similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Performance testing has demonstrated that Forwarts® is as safe and effective as the predicate device. Therefore, Forwarts® is substantially equivalent to the predicate device.