The Claritag Advanced is a portable, hand operated device intended for use in the treatment of skin tag removal using a cryogen application system. The Claritag Kit contains the Claritag handheld device and the Claritag Base. The Claritag device houses the Claritag "squeeze and freeze" heads with foam treatment pads and liquid cooling gas. A spare set of treatment heads is included. The Claritag Base will activate the freezing once the heads are placed into the base. Pressing down on the base sends the liquid cooling gas to the Claritag "squeeze and freeze heads." Instructions for Use are included.

AI/ML Overview

The provided text describes the Claritag Advanced device, an over-the-counter (OTC) cryosurgical unit for skin tag removal. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed clinical study for acceptance criteria.

Based on the provided information, I can extract the following details regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily uses a comparison to predicate devices to establish substantial equivalence. It does not explicitly state numerical acceptance criteria for performance metrics (e.g., success rate, safety endpoints) for the Claritag Advanced. Instead, the "performance" is demonstrated by showing similar technological characteristics and safety profiles to legally marketed devices.

Acceptance Criteria Category (Implied from comparison)	Reported Device Performance (Claritag Advanced)
Intended Use	OTC treatment of skin tags in adults age 21 years or older. (Matches predicate for skin tags, and aligns with OTC classification).
Mechanism of Action	Extreme cold freezes skin tag. (Same as predicate).
Cryogen	HP152a. (Different from primary predicate's DMEP, but stated as having "safety characteristics as compared with DMEP," and matches secondary predicate).
Time to freeze skin tag	20 seconds, 2 times. (Different from primary predicate's 40 seconds, but matches secondary predicate).
Visible safety indicator of freezing temperature	Blue tint in foam pads. (Present, unlike primary predicate).
Safety Conditions	Similar warnings regarding flammability, pressurization, heat exposure, and use near open flame, matching or being a superset of predicate warnings. No new issues of safety or effectiveness are deemed to be raised.
Treatment Procedure	Push down on canister until hissing sound starts and stops and foam tips turn blue. Place tips around tag and squeeze for 20 sec. Repeat. (Matches secondary predicate, different from primary).
Number of Treatments	10 (Different from primary predicate's 8, but matches secondary predicate).
Disposal	Entire unit is disposable after emptied of cryogen. (Same as predicate).
Exclusion Criteria (Outer Box Label)	Do not use if diabetic, have poor blood circulation, or diagnosed with blood conditions affected by extreme cold or if younger than 18 years old. (Differs from primary predicate's "younger than 21," aligning with the device's OTC indication for adults 21+ but the exclusion criteria state 18, which is slightly inconsistent. However, the clearance is for age 21 or older).
Biocompatibility	Meets ISO 10993 Requirements. (Stated to meet, same as predicate). This implies specific tests were passed, but the actual acceptance criteria for these tests (e.g., absence of cytotoxicity) are not detailed.
Performance Testing (Mechanical, Effective Duration, Temperature)	Tests performed and "test results show that the subject device is substantially equivalent to the predicate Device." Specific criteria are not provided.
Human Factors	Human factors validation test performed and "test results show that the subject device is substantially equivalent to the predicate Device." Specific criteria are not provided.
Safety/Effectiveness	"raises no new issues of safety or effectiveness." This is the ultimate "acceptance criterion" for 510(k) clearance based on substantial equivalence.

2. Sample Size for Test Set and Data Provenance:

The document mentions "Non-Clinical Test Reports" and lists:

Biocompatibility: Cytotoxicity, Sensitization, Irritation
Performance testing: Mechanical Integrity Testing (ASTM F882-84(2002)), Effective Duration Test, Temperature Testing
Human Factors: Human factors validation test

However, it does not provide any details about the sample size (number of devices tested, number of human subjects, etc.) for these tests or the data provenance (e.g., country of origin, retrospective/prospective). These appear to be lab-based or simulated tests, as no clinical trial data is referenced.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. The document describes non-clinical and human factors testing, and relies on comparison to predicate devices, not on expert-established ground truth for a test set in a diagnostic or clinical performance study.

4. Adjudication Method for Test Set:

Not applicable, as no expert review or adjudication process for a test set (e.g., image interpretation) is described.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in the provided text. This type of study is typically for evaluating AI-assisted diagnostic devices, which is not the nature of the Claritag Advanced.

6. Standalone Performance:

Standalone performance (algorithm only) is not relevant for this device as it is a physical cryosurgical unit, not a software algorithm. Its "performance" is tied to its physical characteristics and how it compares to predicate devices in achieving the intended cryotherapeutic effect. The non-clinical tests (mechanical, temperature, effective duration) contribute to demonstrating its standalone functional performance, but specific metrics beyond "substantially equivalent" are not provided.

7. Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" would be established by the specifications or standards against which the device was tested (e.g., ISO 10993 for biocompatibility, ASTM F882-84(2002) for mechanical integrity). For the overall substantial equivalence, the "ground truth" implicitly relies on the safety and effectiveness profile of the cleared predicate devices.

8. Sample Size for the Training Set:

Not applicable. This device is a physical cryosurgical unit, not a machine learning or AI model that requires a training set.

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

Not applicable, for the same reason as above.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features a stylized human figure. To the right of this is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 02, 2023

DGI Technologies % Marc C. Sanchez, Esq. Regulatory Counsel Contract In-House Counsel and Consultants, LLC (d/b/a FDA Atty) 1717 Pennsylvania Ave NW Suite 1025 Washington, District of Columbia 20006

Re: K222356

Trade/Device Name: Claritag Advanced Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH

Dear Marc Sanchez:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 18, 2023. Specifically, FDA is updating this SE Letter as an administrative correction, to revise the incorrect contact information on the original SE letter.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Mark Trumbore, Ph.D., OHT4: Office of Surgical and Infection Control Devices, 301-796-5436, Mark.Trumbore@fda.hhs.gov.

Sincerely,

Digitally signed by Mark Mark Trumbore -S Trumbore -S 0ate: 2023.06.02

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

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration. The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. Underneath the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

May 18, 2023

DGI Technologies % Russ Olsen VP Global QA/RA Healthy Policy Associates 690 Canton Street Suite 302 Westwood, Massachusetts 02090

Re: K222356

Trade/Device Name: Claritag Advanced Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: April 19, 2023 Received: April 19, 2023

Dear Russ Olsen:

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/cdrh/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.

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

{2}------------------------------------------------

regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about mediation-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/odrh-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-devices/device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

MarkTrumbore -S	Digitally signed byMark Trumbore -SDate: 2023.05.1811:19:29 -04'00'
---------------------	---------------------------------------------------------------------------------

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K222356

Device Name Claritag Advanced

Indications for Use (Describe)

The Claritag Advanced is intended for the OTC treatment of skin tags in adults age 21 years 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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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."

{4}------------------------------------------------

510(k) Summary

The following information is provided as required by 21 CFR 807.92 for the Claritag Advanced 510(k) premarket notification.

Trade Name of Device:	Claritag Advanced
Common Name of Device:	Portable aerosol cryosurgery device
Sponsor:	DGI Group, LLC400 Candelwood CommonsHowell, NJ 07731Telephone: 732-887-5087
Contact person:	Marc C. Sanchez, Esq.Regulatory Counsel1717 Pennsylvania Ave. NW,Suite 1025Washington, D.C. 20006(202) 765-4491msanchez@fdaatty.com

Date: May 17, 2023 Device Class: II Regulation Name and Number: 878.4350 Panel: Office of Health Technology 4, Division of Health Technology 4 A Product Code: GEH Predicate: K211099

Device Description

The Claritag Advanced is a portable, hand operated device intended for use in the treatment of skin tag removal using a cryogen application system. The cryogen application methodology for skin tag removal is a widely accepted practice used by physicians for decades.

The mechanism of action for cryotherapy are the direct effects of freezing on the cells, and the vascular stasis which develops in the tissue after thawing.

Image /page/4/Picture/9 description: The image shows a white Claritag stamp with the word "Claritag" printed vertically in blue on the front. The stamp has a unique design with a textured grip on the sides and a sturdy base. The stamp appears to be new and unused.

The Claritag® Kit contains the Claritag handheld device and the Claritag Base. The

{5}------------------------------------------------

Claritag device houses the Claritag® "squeeze and freeze" heads with foam treatment pads and liquid cooling gas. A spare set of treatment heads is included.

The Claritag Base will activate the freezing once the heads are placed into the base. Pressing down on the base sends the liquid cooling gas to the Claritag "squeeze and freeze heads." Instructions for Use are included.

Intended Use:

The Claritag Advanced is intended for the OTC treatment of skin tags in adults age 21 years or older.

Non-Clinical Test Reports

The following tests were performed on the Claritag Advanced device and the test results show that the subject device is substantially equivalent to the predicate Device.

Biocompatibility:

O Cytotoxicity
Sensitization O
Irritation 0

Performance testing

Mechanical Integrity Testing (as outlined in ASTM F882-84(2002) 0
Effective Duration Test O
Temperature Testing 0

Human Factors: A human factors validation test was performed on the Claritag Advanced device and the test results show that the subject device is substantially equivalent to the predicate Device.

Summary of Substantial Equivalence

The Claritag Advanced and the predicate are for similar uses and rely on the same mode of action. Both devices use cryogenic gases. The cryogenic gas in the Claritag Advanced device was chosen as HP152A due to its safety characteristics as compared with DMEP ("DME") in the Freeze'n Clear device.

{6}------------------------------------------------

Table 1 Technological Characteristics

	Subject Device	Primary Predicate	Secondary Predicate
	Claritag (OTC)	Freeze'n Clear SkinClinic Warts & Tags	Claritag (Rx)
	DGI Technologies	CryoConcepts (sold byDr. Scholl's )	DGI Technologies
Characteristic	K222356	K211099	K190747
Intended Use	Skin Tags	Warts & Skin Tags	Skin Tags
	OTC	OTC	Rx
Cryogen	HP152a	DMEP	HP152a
Contents	Canisters containingcryogenFoam tips in plasticholder to protectsurrounding skin	Canister containingcryogenFoam applicatorTweezers to hold upskin tag	Canisters containingcryogenFoam tips in plasticholder to protectsurrounding skin
Mechanism of Action	Extreme cold freezesskin tag	Extreme cold freezesskin tag or wart	Extreme cold freezesskin tag
Time to freeze skin tag	20 seconds, 2 times	40 seconds	20 seconds, 2 times
Visible safety indicator offreezing temperature	Blue tint in foam pads	None	Blue tint in foam pads
Safety Conditions	Do not puncture ordestroy gas canisterFlammable aerosol.Pressurized canister.May burst if heated. Donot expose totemperatures exceeding400C/1200FDo not smoke or usenear an open flame	Do not puncture orincinerate gas canisterDo not expose to heator store at temperaturesabove 1200FDo not smoke whileusing the product.Keep away from fire orflame.	Do not puncture ordestroy gas canisterFlammable aerosol.Pressurized canister.May burst if heated.Do not expose totemperaturesexceeding 400C/1200FDo not smoke or usenear an open flame
Treatment Procedure	Push down on thecanister until hissingsound starts and stopsand foam tips turn blue.Place the tips aroundthe tag and squeeze for20 sec. Repeat.	Spray the cryogen intothe applicator tosaturate it and thenplace it directly ontothe lesion for 40 sec.	Push down on thecanister until hissingsound starts and stopsand foam tips turnblue. Place the tipsaround the tag andsqueeze for 20 sec.Repeat.
Number of Treatments	10	8	10
Disposal	Entire unit isdisposable afteremptied of cryogen	Entire unit isdisposable afteremptied of cryogen	Entire unit isdisposable afteremptied of cryogen

{7}------------------------------------------------

Outer Box Label - Intended Use	Skin Tag RemovalDevice	Skin Tag Remover inas little as 1 treatment	Skin Tag RemovalDevice
Outer Box Label - ExclusionCriteria	Do not use if you arediabetic, have poor bloodcirculation, or have beendiagnosed with bloodconditions affected byextreme cold or if youngerthan 18 years old	Do not use if you arediabetic, have poor bloodcirculation, or have beendiagnosed with bloodconditions affected byextreme cold or ifyounger than 21 years old	Do not use if you arediabetic, have poorblood circulation, orhave been diagnosedwith blood conditionsaffected by extremecold
Outer Box Label - Warnings	Keep out of reach ofchildren. For ExternalUse Only.Flammable Aerosol.Presurized container.May burst if heated.Keep away from hotsurfaces, sparks openflames and otherignition sources. Donot expose totemperatures exceeding400C/1200F. (Insidelabeling includes all theother predicatewarnings.)	Keep out of reach ofchildren. For ExternalUse Only.Avoid contact witheyes. Avoid inhalingand use only in wellventilated areas. Do noteat. For external useonly. Use only asdirected. Do not spraygas directly onto skin.Misuse of this productmay result in burns andscarring of healthytissue or blindness.	Keep out of reach ofchildren. For ExternalUse Only.Flammable Aerosol.Presurized container.May burst if heated.Keep away from hotsurfaces, sparks openflames and otherignition sources. Donot expose totemperaturesexceeding400C/1200F. (Insidelabeling includes allthe other predicatewarnings.)
Biocompatibility	Meets ISO 10993Requirements	Meets ISO 10993Requirements	Meets ISO 10993Requirements

Conclusion:

Therefore, taking into consideration Table 1 for Substantial Equivalence, an analysis of safety, indications, intended uses, performance, and technological properties, the Claritag Advanced raises no new issues of safety or effectiveness and has been found to be 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.