(125 days)
The CryoFreeze Wart and Skin Tag Remover is intended for use in the over-the-counter treatment of common warts and plantar warts in adults and children age 4 years or older and over-the-counter treatment of skin tags in adults age 22 years or older.
The CryoFreeze Wart and Skin Taq Remover is an over-the-counter (OTC) cryotherapy device designed for the treatment of common, plantar warts, and skin tags. The device includes:
- A pressurized aerosol canister filled with a liquid mixture of the compressed gases dimethyl ether, propane, and isobutane
- Applicator swabs
- Detailed instructions, including illustrated descriptions
To use the device, the user must insert an applicator swab into the actuator, saturate the swab with cryogen, and apply the foam tip of the swab directly onto the lesion, holding it in place for 40 seconds. After removal, the frozen tissue will appear white and begin to thaw, typically taking 20-40 seconds.
The device is non-sterile and intended for home use by laypersons. No special training or sterilization is required for operation.
The provided document is a 510(k) summary for the CryoFreeze Wart and Skin Tag Remover, which is a cryosurgical unit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with acceptance criteria in the same way a PMA (Pre-Market Approval) or de novo submission might.
Therefore, the document does not contain the detailed information required to fully answer all aspects of your request, specifically regarding clinical studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/algorithm performance. The device described is a physical medical device, not an AI/software as a medical device (SaMD).
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical trial for performance outcomes (e.g., cure rates, recurrence). Instead, substantial equivalence is demonstrated through technological comparison and non-clinical performance testing against a reference device.
| Characteristic / Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Technological Characteristics | Same as predicate/reference device | Matches predicate (K211099) and reference (K243454) for:- Use (OTC)- Mechanism of action (extreme cold destroys tissue)- Cryogen material (dimethyl ether, propane, isobutane)- Freeze temperature (-55°C)- Design (canister, applicators, tweezers)- Treatment procedure- Storage & safety conditions- Disposal- Defined operators (consumer use) |
| Output Temperature of Cryogen | Equivalent to reference device (Verruca-Freeze H) | Confirmed equivalent to reference device |
| Freeze Charge Hold Time | Equivalent to reference device (Verruca-Freeze H) | Confirmed equivalent to reference device |
| Visual Confirmation of Ice Ball | Equivalent to reference device (Verruca-Freeze H) | Confirmed equivalent to reference device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not applicable in the context of this 510(k) for a physical cryosurgical device. The document mentions "comparative performance testing against the reference device," but it does not specify sample sizes for these non-clinical tests (e.g., how many times temperature was measured, or how many freeze cycles were observed).
- Data Provenance: Not specified, but generally, non-clinical tests for 510(k) devices are conducted by the manufacturer or a contract research organization.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not provided because the device is a physical cryosurgical unit, and the testing described is non-clinical performance testing rather than clinical evaluation against an expert-determined ground truth for diagnostic accuracy, for example.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided as the testing described is non-clinical performance testing, not a clinical trial requiring adjudication of patient outcomes or diagnostic readings by experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This device is a direct-to-consumer physical cryosurgical tool, not an AI or imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance tests, the "ground truth" would be the measured physical properties (e.g., temperature) as determined by calibrated instruments, and visual observations (e.g., ice ball formation). This is not a "ground truth" in the clinical or diagnostic sense.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML product and does not have a "training set."
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI/ML product and does not have a "training set."
In summary, the provided 510(k) letter and summary establish substantial equivalence for the CryoFreeze Wart and Skin Tag Remover based on its technological characteristics and non-clinical performance being comparable to previously cleared predicate and reference devices. It does not involve AI or clinical studies with expert-adjudicated ground truth as would be relevant for software/AI-based medical devices.
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March 13, 2025
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CryoSurgery, Inc. Ronald Mcdow CEO and Medical Director 5829 Old Harding Pike Nashville, Tennessee 37205
Re: K243487
Trade/Device Name: CryoFreeze Wart and Skin Tag Remover Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: February 12, 2025 Received: February 12, 2025
Dear Ronald Mcdow:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
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Sincerely,
Image /page/2/Picture/3 description: The image shows a digital signature of James H. Jang. The signature includes the name "James H. Jang -S" on the left side of the image. On the right side, it states that the signature is digitally signed by James H. Jang -S, with a date of 2025.03.13 and a timestamp of 11:38:50 -04'00'.
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K243487
Device Name
CryoFreeze Wart and Skin Tag Remover
Indications for Use (Describe)
The CryoFreeze Wart and Skin Tag Remover is intended for use in the over-the-counter treatment of common warts and plantar warts in adults and children age 4 years or older and over-the-counter treatment of skin tags in adults age 22 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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510(k) Summary
-
- Submission Sponsor CryoSurgery, Inc. 5829 Old Harding Pike Nashville, TN 37205 (615) 354-0414 info@cryosurgeryinc.com 2. Contact Person Ronald McDow 5829 Old Harding Pike Nashville, TN 37205 (615) 354-0414 3. Date Prepared Updated 03/07/2025 4. Device Identification
| Trade / Proprietary Name | CryoFreeze Wart and Skin Tag Remover |
|---|---|
| Common / Used Name | OTC Cryosurgical Device |
| Regulation | 878.4350 - Cryosurgical unit and accessories |
| Product Code | GEH |
| Class | 2 |
-
- Predicate Device
| Device Name | Freeze 'n Clear Skin Clinic for Warts and Skin Tags |
|---|---|
| 510(k) Number | K211099 |
| Regulation Number | 878.4350 - Cryosurgical unit and accessories |
| Product Code | GEH |
| Class | 2 |
| Reference Device | |
| Device Name | Verruca-Freeze H |
| 510(k) Number | K243454 |
| Regulation Number | 878.4350 - Cryosurgical unit and accessories |
| Product Code | GEH |
| Class | 2 |
7. Description of the Subject Device
The CryoFreeze Wart and Skin Taq Remover is an over-the-counter (OTC) cryotherapy device designed for the treatment of common, plantar warts, and skin tags. The device includes:
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Image /page/5/Picture/1 description: The image shows the logo for Cryosurgery, Inc. The logo is blue and features a stylized letter "C" on the left side. To the right of the "C" is the text "RYOSURGERY, INC." The text is also in blue and is in a sans-serif font.
- A pressurized aerosol canister filled with a liquid mixture of the compressed gases dimethyl ether, ● propane, and isobutane
- Applicator swabs
- Detailed instructions, including illustrated descriptions
To use the device, the user must insert an applicator swab into the actuator, saturate the swab with cryogen, and apply the foam tip of the swab directly onto the lesion, holding it in place for 40 seconds. After removal, the frozen tissue will appear white and begin to thaw, typically taking 20-40 seconds.
The device is non-sterile and intended for home use by laypersons. No special training or sterilization is required for operation.
8. Indications for Use
The CryoFreeze Wart and Skin Tag Remover is intended for the counter treatment of common warts and plantar warts in adults and children age 4 years or older and over-the-counter treatment of skin tags in adults age 22 or older.
9. Technological Comparison
The subject device has the same technological characteristics as the predicate device. It shares the same intended use, mechanism of action, and design as the predicate device.
Additionally, the subject device has the same technological characteristics, mechanism of action, design as the reference device Verruca-Freeze H.
| TechnologicalCharacteristics | Subject Device:CryoFreeze Wart and Skin TagRemover | Predicate Device:Freeze 'n ClearSkin Clinic for Warts and SkinTags |
|---|---|---|
| Trade Name / Device Name | CryoFreeze™ Wart and Skin TagRemover | Skin Clinic Freeze 'n Clear forWarts and Skin Tags |
| 510(k) Number | K243487 | K211099 |
| Indications for Use | The CryoFreeze Wart and SkinTag Remover is intended for usein the over-the-counter treatmentof common warts and plantarwarts in adults and children age4 years or older and over-the-counter treatment of skin tags inadults age 22 years or older. | The Freeze n' Clear Skin Clinicfor Warts and Skin Tags productis intended for OTC treatment ofcommon warts, plantar warts,and skin tags. |
| Cryogen Material | Mixture of dimethyl ether,propane, and isobutane | Mixture of dimethyl ether,propane, and isobutane |
| Freeze Temperature | -55°C | -55°C |
| Design | -Cryogen canister with attachedsafety shield-Foam-tipped applicators-Disposable tweezers | -Cryogen canister with attachedsafety shield-Foam-tipped applicators-Disposable tweezers |
| Mechanism of Action | Extreme cold destroys the targettissue | Extreme cold destroys the targettissue |
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510(k) Summary
Image /page/6/Picture/1 description: The image shows the logo for "Cryosurgery, Inc.". The logo is in blue and features a stylized "C" that is open on the right side. The text "RYOSURGERY, Inc." is to the right of the "C", with "RYOSURGERY" on the same line as the top of the "C" and "Inc." on the same line as the bottom of the "C".
CryoFreeze Wart and Skin Tag Remover K243487
| Treatment Procedure | Cryogen is dispensed into foamapplicator which is then appliedto the lesion for a specifiednumber of seconds. | |
|---|---|---|
| -Keep away from fire or flame-Do not smoke while using theproduct | -Keep away from fire or flame-Do not smoke while using theproduct | |
| Storage and Safety Conditions | -Do not puncture or incineratecanister | -Do not puncture or incineratecanister |
| -Do not expose to heat or storeat temperatures above 120°F. | -Do not expose to heat or storeat temperatures above 120°F. | |
| -Store at room temperature awayfrom heat | -Store at room temperature awayfrom heat | |
| Disposal | Entire unit is disposable afteremptied of cryogen. | Entire unit is disposable afteremptied of cryogen. |
| Defined Operators | OTC for consumer use | OTC for consumer use |
10. Non-Clinical Performance Data
CryoFreeze Wart and Skin Tag Remover underwent comparative performance testing against the reference device, Verruca-Freeze H. The tests included output temperature of cryogen, freeze charge hold time, and visual confirmation of the ice ball. The comparison of test data confirmed that the subject device performs equivalently to the reference device.
- Statement of Substantial Equivalence
Based on the information presented, it is concluded that the CryoFreeze Wart and Skin Tag Remover device is substantially equivalent to the predicate device Freeze 'n Clear Skin Clinic for Warts and Skin Tags.
§ 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.