(223 days)
Not Found
No
The description focuses on a cryotherapy device using a cryogen application system, a widely accepted practice. There is no mention of AI, ML, image processing, or any data-driven algorithms in the device description, intended use, or performance studies.
Yes.
The device is indicated for the treatment of skin tags, which is a therapeutic purpose.
No
The device is described as a treatment device for skin tag removal using cryogen application, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "portable, hand operated device" containing a "canister containing aerosolized cryogen" and other physical components, indicating it is a hardware device.
Based on the provided information, the Claritag device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "treatment of achrochordons (skin tags)". This is a therapeutic use, not a diagnostic one.
- Device Description: The device is described as a "portable, hand operated device intended for use in the treatment of skin tag removal using a cryogen application system." This further reinforces its therapeutic purpose.
- Mechanism of Action: The mechanism of action is the direct effects of freezing on cells and vascular stasis, which are related to tissue treatment, not diagnosis.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Claritag device directly treats a physical condition (skin tags) on the body.
N/A
Intended Use / Indications for Use
Claritag is indicated for use in the treatment of achrochordons (skin tags).
Product codes (comma separated list FDA assigned to the subject device)
GEH
Device Description
The Claritag device is indicated for the treatment of skin tags. Claritag® 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 Claritag device is provided in a kit containing the main device (canister containing aerosolized cryogen, fitted with two treatment head activation base, 20 disposal single use foam pads, tweezers (which are provided as an optional accessory) and Instructions for Use.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The following non-clinical performance data are provided in support of the substantial equivalence determination:
Biocompatibility:
- Cytotoxicity
- Sensitization
- Irritation
Performance testing
- Claritag Predicate Comparison: The temperature of the foam pads of the Claritag device and the predicate device were measured ten times using a simulated skin model. Both Claritag device and predicate device measurements met the minimum temperature requirement of -20 °C.
- Claritag Ballistic Gel Test: Depth of temperature penetration of the Claritag device was measured at 1, 2 and 3 mm from the outer face of the ballistic gelatin. This test confirmed that the Claritag device's cryogenic gas freezing effect decreases with depth and demonstrates the safety and effectiveness of the Claritag in the treatment of acrochordons (skin tags).
- Shelf Life: The Claritag device has real time data that represents a one-year shelf life consistent with the predicate device.
- Package Performance Testing for Claritag device passed package performance testing pursuant to ISTA 6 -Fed Ex-A.
- Claritag & Predicate Pad Temperature Comparison Test: Temperature testing of the Claritag device and the predicate device both achieved an average minimum temperature of -20 °C.
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.
Not Found
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
October 31, 2019
DGI Technologies % Russ Olsen VP Global OA/RA Health Policy Associates 690 Canton Street. Suite 302 Westwood, Massachusetts 02090
Re: K190747
Trade/Device Name: Claritag Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: March 20, 2019 Received: March 22, 2019
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.
1
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 Advice (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
2
Indications for Use
510(k) Number (if known) K190747
Device Name Claritag
Indications for Use (Describe)
Claritag is indicated for use in the treatment of achrochordons (skin tags).
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Registration Under Section 301, Sales, Distribution | ☐ Over-The-Counter Health/OTC Medical Device |
|---|---|
| ------------------------------------------------------------------------------------------------ | ---------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Prepared in accordance with 21 CFR 807.92
GENERAL INFORMATION
510(k) owner name address and telephone:
DGI Technologies 301 Madison Avenue Lakewood, NJ 08701 USA Telephone: 732-887-5087
Name of contact person info:
Russ Olsen Health Policy Associates, Inc. 690 Canton Street, Suite 302 Westwood, MA 02090 Telephone: 781.329.2993 Fax: 781 329.2968 rolsen@healthpolicyassociates.com
Date Prepared:
October 30, 2019
DEVICE INFORMATION:
Trade Name: Common Name: Classification Name: Regulation Number: Regulatory Class: Product Code:
Claritag® Portable aerosol cryosurgery device Cryosurgical Unit and Accessories 21 CFR 878.4350 Class II GEH
PREDICATE DEVICE INFORMATON:
Trade Name: Common Name: 510(k) Number: Decision Date:
Cool Renewal Cryosurgical Unit and Accessories K161296 February 9, 2011
DEVICE DESCRIPTION:
The Claritag device is indicated for the treatment of skin tags. Claritag® 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 Claritag device is provided in a kit containing the main device (canister containing aerosolized cryogen, fitted with two treatment head activation base, 20 disposal single use foam pads, tweezers (which are provided as an optional accessory) and Instructions for Use.
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.
4
INTENDED USE OF CLARITAG
The Claritaq device is indicated for use in the treatment of acrochordons (skin tags).
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The intended use and principles of operation of the Claritag device are substantially equivalent to the predicate device. Both devices incorporate the same basic cryosurgical design for skin tag removal, i.e., two foam pads treated with cryogen that enclose the skin tag and, after brief exposure, freezes the skin tag, The skin tag then thaws, and ultimately the skin tag tissue is destroyed. Both the Claritag device and the predicate achieve the minimum freeze temperature of -20°C, the widely accepted temperature required to destroy skin tags.
The differences between the Claritag device and the predicate are related to the cryogenic gas, and minor design elements. The Claritag device uses an alternative gas, which is more environmentally friendly versus the predicate device's cryogen gas. The Claritag device incorporates a dual head design with foam pads which wrap around, squeeze and freeze the skin tag. The predicate device uses "foam tipped skin tag tweezers" to wrap around, squeeze and freeze the skin tag. Any other differences are considered to be minor in nature and do not raise any new questions about safety and effectiveness.
PERFORMANCE DATA
The following non-clinical performance data are provided in support of the substantial equivalence determination:
Biocompatibility:
- Cytotoxicity o
- o Sensitization
- O Irritation
Performance testing
- Claritag Predicate Comparison: The temperature of the foam pads of the Claritag device and o the predicate device were measured ten times using a simulated skin model. Both Claritag device and predicate device measurements met the minimum temperature requirement of -20 °C.
- Claritag Ballistic Gel Test: Depth of temperature penetration of the Claritan device was o measured at 1, 2 and 3 mm from the outer face of the ballistic gelatin. This test confirmed that the Claritag device's cryogenic gas freezing effect decreases with depth and demonstrates the safety and effectiveness of the Claritag in the treatment of acrochordons (skin tags).
- Shelf Life: The Claritag device has real time data that represents a one-year shelf life o consistent with the predicate device.
- O Package Performance Testing for Claritag device passed package performance testing pursuant to ISTA 6 -Fed Ex-A.
- Claritag & Predicate Pad Temperature Comparison Test: Temperature testing of the Claritag O device and the predicate device both achieved an average minimum temperature of -20 °C.
Conclusion:
The non-clinical performance data demonstrate that the Claritag device performs comparably to the predicate device that is currently marketed for the same intended use. Based upon the information submitted in this Traditional 510(k) premarket notification, the Claritag device is substantially equivalent to the Cool Renewal (K161296).