(287 days)
No
The device description and performance studies focus on mechanical and cryogen application, with no mention of AI or ML technologies.
Yes
The device is intended for the OTC treatment of skin tags, which is a medical condition, making it a therapeutic device.
No
The device is intended for the treatment (removal) of skin tags, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical, hand-operated device with a cryogen application system, including a handheld device, base, treatment heads, and cooling gas. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the Claritag Advanced is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Claritag Advanced Function: The Claritag Advanced is a device that directly treats skin tags on the body using cryotherapy (freezing). It does not analyze any specimens taken from the body.
- Intended Use: The intended use clearly states "treatment of skin tags," not diagnosis or analysis of a sample.
- Device Description: The description focuses on the physical device and its mechanism for applying cryogen to the skin tag.
- Lack of IVD-related information: The document does not mention any analysis of biological samples, laboratory procedures, or diagnostic results.
Therefore, the Claritag Advanced falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Claritag Advanced is intended for the OTC treatment of skin tags in adults age 21 years or older.
Product codes (comma separated list FDA assigned to the subject device)
GEH
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin tags
Indicated Patient Age Range
adults age 21 years or older.
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)
Non-Clinical Test Reports:
- Biocompatibility: Cytotoxicity, Sensitization, Irritation.
- Performance testing: Mechanical Integrity Testing (as outlined in ASTM F882-84(2002)), Effective Duration Test, Temperature Testing.
- 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.
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.
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.
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
§ 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.
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,
| Mark
Trumbore -S | Digitally signed by
Mark Trumbore -S
Date: 2023.05.18
11:19:29 -04'00' |
| --------------------- | --------------------------------------------------------------------------------- |
|---|
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
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)
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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, LLC |
| 400 Candelwood Commons | |
| Howell, NJ 07731 | |
| Telephone: 732-887-5087 | |
| Contact person: | Marc C. Sanchez, Esq. |
| Regulatory Counsel | |
| 1717 Pennsylvania Ave. NW, | |
| Suite 1025 | |
| Washington, D.C. 20006 | |
| (202) 765-4491 | |
| msanchez@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 Skin | ||
| Clinic Warts & Tags | Claritag (Rx) | ||
| DGI Technologies | CryoConcepts (sold by | ||
| Dr. 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 containing | ||
| cryogen | |||
| Foam tips in plastic | |||
| holder to protect | |||
| surrounding skin | Canister containing | ||
| cryogen | |||
| Foam applicator | |||
| Tweezers to hold up | |||
| skin tag | Canisters containing | ||
| cryogen | |||
| Foam tips in plastic | |||
| holder to protect | |||
| surrounding skin | |||
| Mechanism of Action | Extreme cold freezes | ||
| skin tag | Extreme cold freezes | ||
| skin tag or wart | Extreme cold freezes | ||
| skin tag | |||
| Time to freeze skin tag | 20 seconds, 2 times | 40 seconds | 20 seconds, 2 times |
| Visible safety indicator of | |||
| freezing temperature | Blue tint in foam pads | None | Blue tint in foam pads |
| Safety Conditions | Do not puncture or | ||
| destroy gas canister | |||
| Flammable aerosol. | |||
| Pressurized canister. | |||
| May burst if heated. Do | |||
| not expose to | |||
| temperatures exceeding | |||
| 400C/1200F | |||
| Do not smoke or use | |||
| near an open flame | Do not puncture or | ||
| incinerate gas canister | |||
| Do not expose to heat | |||
| or store at temperatures | |||
| above 1200F | |||
| Do not smoke while | |||
| using the product. | |||
| Keep away from fire or | |||
| flame. | Do not puncture or | ||
| destroy gas canister | |||
| Flammable aerosol. | |||
| Pressurized canister. | |||
| May burst if heated. | |||
| Do not expose to | |||
| temperatures | |||
| exceeding 400C/1200F | |||
| Do not smoke or use | |||
| near an open flame | |||
| Treatment Procedure | Push down on the | ||
| canister until hissing | |||
| sound starts and stops | |||
| and foam tips turn blue. | |||
| Place the tips around | |||
| the tag and squeeze for | |||
| 20 sec. Repeat. | Spray the cryogen into | ||
| the applicator to | |||
| saturate it and then | |||
| place it directly onto | |||
| the lesion for 40 sec. | Push down on the | ||
| canister until hissing | |||
| sound starts and stops | |||
| and foam tips turn | |||
| blue. Place the tips | |||
| around the tag and | |||
| squeeze for 20 sec. | |||
| Repeat. | |||
| Number of Treatments | 10 | 8 | 10 |
| Disposal | Entire unit is | ||
| disposable after | |||
| emptied of cryogen | Entire unit is | ||
| disposable after | |||
| emptied of cryogen | Entire unit is | ||
| disposable after | |||
| emptied of cryogen |
7
| Outer Box Label - Intended Use | Skin Tag Removal
Device | Skin Tag Remover in
as little as 1 treatment | Skin Tag Removal
Device |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Outer Box Label - Exclusion
Criteria | Do not use if you are
diabetic, have poor blood
circulation, or have been
diagnosed with blood
conditions affected by
extreme cold or if younger
than 18 years old | Do not use if you are
diabetic, have poor blood
circulation, or have been
diagnosed with blood
conditions affected by
extreme cold or if
younger than 21 years old | Do not use if you are
diabetic, have poor
blood circulation, or
have been diagnosed
with blood conditions
affected by extreme
cold |
| Outer Box Label - Warnings | Keep out of reach of
children. For External
Use Only.
Flammable Aerosol.
Presurized container.
May burst if heated.
Keep away from hot
surfaces, sparks open
flames and other
ignition sources. Do
not expose to
temperatures exceeding
400C/1200F. (Inside
labeling includes all the
other predicate
warnings.) | Keep out of reach of
children. For External
Use Only.
Avoid contact with
eyes. Avoid inhaling
and use only in well
ventilated areas. Do not
eat. For external use
only. Use only as
directed. Do not spray
gas directly onto skin.
Misuse of this product
may result in burns and
scarring of healthy
tissue or blindness. | Keep out of reach of
children. For External
Use Only.
Flammable Aerosol.
Presurized container.
May burst if heated.
Keep away from hot
surfaces, sparks open
flames and other
ignition sources. Do
not expose to
temperatures
exceeding
400C/1200F. (Inside
labeling includes all
the other predicate
warnings.) |
| Biocompatibility | Meets ISO 10993
Requirements | Meets ISO 10993
Requirements | Meets ISO 10993
Requirements |
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.