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%).

AI/ML Overview

The provided document describes the "Forwarts®" device, a cryosurgical unit for wart removal. Here's a breakdown of the acceptance criteria and the study information based on the text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than listing specific, quantified acceptance criteria with corresponding performance data in a direct tabular format. However, based on the non-clinical performance data section, we can infer the acceptance criteria and the device's reported performance against them.

Acceptance Criterion (Inferred)	Reported Device Performance
Biocompatibility: Device materials in contact with the patient should be biocompatible.	Supports biocompatibility of the device, conforming to ISO 10993-1 (cytotoxicity, irritation, sensitization, toxicological risk assessment, chemical characterization). No carcinogenicity testing required based on TRA.
Shelf Life: Device should maintain stability and functionality for a specified duration.	Supports shelf life of twenty months. Demonstrated stability for twenty months under worst-case simulated conditions per ASTM D3090-72.
Transportation Integrity: Packaging should protect the device during transport.	Demonstrates package integrity maintained. Subjected to impact, drop, vibration, and low-pressure testing under simulated transport conditions per ASTM D4169, showing suitability of packaging.
Thermal Performance: Achieve comparable freezing characteristics to predicate devices.	Supports device performance. Comparative thermal performance testing (thermoelectric and simulated skin model) showed comparable performance to the predicate devices regarding freeze temperature extreme, plateau, duration, cycle length, and spot size. Achieved thermal performance characteristics within the ranges of the predicates, demonstrating comparable efficacy and no new questions of safety.
Self-selection/Label Comprehension: Lay-users can correctly self-select and understand labeling.	Supports device self-selection and labeling comprehension with a success rate of at least 90% when used as indicated.
Human Factors (Usability): Safe usability for lay-person use.	Supports safe usability of the device for lay-person use. Formative Study (Simulated Use Testing, Contextual Enquiry, semi-guided interview) and Human Factor Validation Test validated safe intended use.
Substantial Equivalence: Maintain similar safety and effectiveness profile as predicate devices.	Substantially equivalent to the predicate device. Same intended use, same or similar technological characteristics. Performance testing demonstrated similar safety and effectiveness, raising no new or different questions of safety and effectiveness.

2. Sample Size for the Test Set and Data Provenance:

The document does not explicitly state a sample size for the "test set" in the context of clinical trials or specific data points. The studies mentioned are:

Biocompatibility: General testing per ISO 10993 standards. No specific sample size for a "test set" mentioned; likely refers to laboratory testing of materials.
Shelf Life: Testing of device stability and functionality under simulated conditions. No specific sample size for a "test set" mentioned.
Transportation Testing: Testing of the device in its final shipping configuration. No specific sample size for a "test set" mentioned.
Bench Testing (Thermal Performance): Thermoelectric testing and simulated skin model. No specific sample size for a "test set" mentioned; likely refers to laboratory measurements.
Self-selection / Label Comprehension Study: "Study subjects were provided with the Forwarts® labeling." No specific sample size provided, nor directly stated provenance (e.g., country of origin, retrospective/prospective).
Human Factors Study: "Formative Study... included Simulated Use Testing... and a semi-guided interview with test subjects. A Human Factor Validation Test was then performed." No specific sample size provided, nor directly stated provenance.

It is important to note that this submission is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to legally marketed predicate devices rather than requiring extensive clinical trials with large test sets typically seen for PMA submissions. The studies mentioned are primarily non-clinical or usability studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not describe the use of experts to establish ground truth for any test sets. The studies mentioned (biocompatibility, shelf life, transportation, thermal performance, self-selection, human factors) do not typically involve expert consensus for ground truth in the way a diagnostic AI device would, where expert radiologists/pathologists review cases.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned as there is no specific "test set" and ground truth establishment by experts as would be seen in a clinical trial for a diagnostic device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. The device is a cryosurgical unit, not a diagnostic AI device that would typically involve human readers.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

This question is not applicable to the Forwarts® device, as it is a cryosurgical unit and not an algorithm or AI system.

7. Type of Ground Truth Used:

The "ground truth" for the various non-clinical and usability studies is inherent in the methodology:

Biocompatibility: Established by adhering to ISO 10993 standards.
Shelf Life: Determined by stability and functionality over time under simulated conditions.
Transportation Testing: Demonstrated by maintaining package integrity and device functionality after simulated transport.
Thermal Performance: Measured physical characteristics (temperature, duration, size of freeze spot) with comparative data against predicate devices.
Self-selection / Label Comprehension: Success rate based on participant actions and comprehension during the study.
Human Factors Study: Validation of safe usability based on observations during simulated use and interviews.

8. Sample Size for the Training Set:

This question is not applicable as the Forwarts® device is a physical cryosurgical unit and not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable as the Forwarts® device is a physical cryosurgical unit and not an AI/ML algorithm that requires a training set.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: +31 294 46 66 11 Email: diede.klever@pronovalab.com 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: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com 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

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
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Attribute	Forwarts®	Wart Freeze /KoninklijkeUtermohlen NV	Compound W®Nitro-Freeze /MedtechProducts Inc.	Wartie® WartRemover /YouMedical B.V.	Wartner® WartRemoval System/ Wartner USAB.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
RegulationNumber	21 CFR 878.4350	21 CFR 878.4350	21 CFR 878.4350	21 CFR 878.4350	21 CFR 878.4350	Same
Indications forUse	Forwarts® isindicated for thetreatment of wartson hands (commonwarts) and feet(plantar warts).	Wart Freeze isindicated for theremoval of commonand plantar warts	Compound W®Nitro-Freeze isintended forover-the-countertreatment ofcommon wartsand plantar wartsin adults andchildren fouryears of age orolder	Wartie® WartRemover isindicated for theover-the-countertreatment ofcommon wartsand plantarwarts, forpatients aged 4years and older.	WARTNER® WartRemoval Systemis indicated forthe over-the-countertreatment ofcommon wartsand plantarwarts.	Same
OTC or Rx	OTC	OTC	OTC	OTC	OTC	Same
TechnologicalCharacteristics	Pressurized gascanister that	Pressurized gascanister that applies	Pen withpressurizedcartridge that	Pressurized gascanister that	Pressurized gascanister that	Similar;Differences incryogen and cold
Attribute	Forwarts®	Wart Freeze /KoninklijkeUtermohlen NV	Compound W®Nitro-Freeze /MedtechProducts Inc.	Wartie® WartRemover /YouMedical B.V.	Wartner® WartRemoval System/ Wartner USAB.V.	Comparison
	applies extremecold to target;Cryogen (liquefieddimethyl ether, BP= -24°C) aerosolspray is applieddirectly to the wart,causing rapidfreezing.	extreme cold totarget;Cryogen (liquefieddimethyl ether, BP =-24°C) is applieddirectly to the wart,causing rapidfreezing.	applies extremecold to target;Cryogen(liquefied nitrousoxide, BP = -89°C)is loaded onto afoam applicator,which is appliedto the wart,causing rapidfreezing.	applies extremecold to target;Cryogen(liquefieddimethyl ether,BP = -24°C) isused torefrigerate a steeltip, which isapplied to thewart, causingrapid freezing.	applies extremecold to target;Cryogen(liquefieddimethyl ether /propane mixture,BP = -24°C / -48°C) is loadedonto a foamapplicator, whichis applied to thewart, causingrapid freezing.	applicationtechnique.The added windchill effect ofForwarts' DMEaerosol sprayresults in lowertemperaturescompared toWart Freeze.
Mechanism ofAction	CryotherapyRapid freezingfollowed by slowthawing, causingcell injury andischemic necrosis.	Cryotherapy;Rapid freezingfollowed by slowthawing, causing cellinjury and ischemicnecrosis.	Cryotherapy;Rapid freezingfollowed by slowthawing, causingcell injury andischemic necrosis.	Cryotherapy;Rapid freezingfollowed by slowthawing, causingcell injury andischemic necrosis.	Cryotherapy;Rapid freezingfollowed by slowthawing, causingcell injury andischemic necrosis.	Same
Materials withdirect patientcontact	DME,polypropyleneOptional protectionpatch: PE foam	DME andpolypropylene	Nitrous oxide andPU foam	Nickel	DME, propaneand PU foam	Similar to primarypredicate device;Different fromsupplementalpredicate devices.
Attribute	Forwarts®	Wart Freeze /KoninklijkeUtermohlen NV	Compound W®Nitro-Freeze /MedtechProducts Inc.	Wartie® WartRemover /YouMedical B.V.	Wartner® WartRemoval System/ Wartner USAB.V.	Comparison
Biocompatibility	Establishedconform ISO 10993-1	Established conformISO 10993-1	Establishedconform ISO10993-1	Establishedconform ISO10993-1	Establishedconform ISO10993-1	Same
Maximumallowedconsecutivetreatments(2-weekinterval)	4	4	3	3	3	Similar
Sterility	Non-sterile	Non-sterile	Non-sterile	Non-sterile	Non-sterile	Same
Re-Usable	Yes;Except for optionalprotection patch	Yes;includes applicator	Yes;except fordisposableapplicator foamtips	Yes;	Yes;except fordisposableapplicator foamtips	Similar;Skin-contactingtips of Forwartsand Wart Freezeare re-used andto be cleaned.Those ofCompound W®Nitro-Freeze andWartner® WartRemoval Systemare disposable.
Attribute	Forwarts®	Wart Freeze /KoninklijkeUtermohlen NV	Compound W®Nitro-Freeze /MedtechProducts Inc.	Wartie® WartRemover /YouMedical B.V.	Wartner® WartRemoval System/ Wartner USAB.V.	Comparison
ThermalPerformanceTesting	Measuredattributes included:freeze temperatureextreme, freezetemperatureplateau, freezeduration, freezecycle length andfreeze spot size	Measured attributesincluded: Freezetemperatureextreme, freezetemperatureplateau, freezeduration, freezecycle length andfreeze spot size	Measuredattributesincluded: freezetemperatureextreme, freezetemperatureplateau, freezeduration, freezecycle length andfreeze spot size	Measuredattributesincluded: freezetemperatureextreme, freezetemperatureplateau, freezeduration, freezecycle length andfreeze spot size	Measuredattributesincluded: freezetemperatureextreme, freezetemperatureplateau, freezeduration, freezecycle length andfreeze spot size	Similar; Forwarts®achieves thermalperformancecharacteristicswithin the rangesof the predicatesdemonstratingcomparableefficacy.Temperaturesachieveddemonstratingthat there are nonew questions ofsafety.

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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.

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.