(26 days)
Not Found
No
The device description details a simple cryosurgical system using a pressurized canister and foam swabs. There is no mention of any computational or analytical components that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Description of the training set, sample size, data source, and annotation protocol" sections are explicitly marked as "Not Found".
Yes
The device is indicated for use in the treatment of various skin lesions, which directly implies a therapeutic purpose.
No
The device description clearly states it is used for "treatment of benign skin lesions" and describes a procedure involving cryosurgery to "freeze lesions and destroy the underlying tissue." There is no mention of it being used to analyze or identify medical conditions.
No
The device description explicitly details physical components: a canister of compressed gases and polyurethane foam swabs. It is a hardware-based cryosurgical system.
Based on the provided information, the Verruca-Freeze® H cryosurgical system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This typically involves testing samples like blood, urine, tissue, etc., outside of the body.
- Verruca-Freeze® H Function: The Verruca-Freeze® H system is a therapeutic device. It is used to treat skin lesions by freezing them directly on the patient's body. It does not involve the examination of specimens derived from the human body in vitro for diagnostic purposes.
The description clearly states its intended use is for the "treatment of the following skin lesions" and describes a procedure performed directly on the patient's skin.
N/A
Intended Use / Indications for Use
The Verruca-Freeze® H cryosurgical system is indicated for use in the treatment of the following skin lesions:
• Actinic Keratosis
• Genital Warts
• Lentigo
• Molluscum Contagiosum
• Seborrheic Keratosis
• Skin Tags
• Verruca Plantaris
• Verruca Vulgaris
• Verruca Plana
Product codes
GEH
Device Description
The Verruca-Freeze® H cryosurgical system is used for treatment of benign skin lesions. The device consists of:
• Canister filled with a liquid mixture of the compressed gases dimethyl ether, propane, and isobutane
• Polyurethane foam swabs
• Detailed instructions including illustrated descriptions
The main component of the device is the pressurized aerosol canister containing cryogen spray. The canister is used with foam swabs, which are non-sterile, single-use applicators that are disposed after each use. The foam swabs allow the cryogen to be localized to a target lesion.
The one- to two-minute procedure begins by spraying cryogen onto a foam swab, which is then placed directly onto held for 15-40 seconds. Upon removal of the swab from the skin, the frozen tissue appears white and begins thaw time is 20-40 seconds.
This treatment methodology is simple and has been an accepted by physicians for decades. It utilizes a standard cryogen composition profile to freeze lesions and destroy the underlying tissue through evaporative cooling. On the cellular level, both extracellular and intracellular ice formation are occurring.
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)
A stability protocol was developed to ensure that the product is maintained throughout its labeled dating period. Testing conducted under controlled conditions at room temperature and under accelerated conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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December 3, 2024
CryoSurgery, Inc. Dr. Ronald McDow CEO and Medical Director 5829 Old Harding Pike Nashville, Tennessee 37205
Re: K243454
Trade/Device Name: Verruca-Freeze H Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: November 7, 2024 Received: November 7, 2024
Dear Dr. 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 (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" (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).
1
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 Rule"). 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-device-advicecomprehensive-regulatory-assistance/unique-device-identification-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 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,
2
Image /page/2/Picture/2 description: The image shows the name "Long H. Chen -S-s" in a large font. Above and to the right of the name, the text "Digitally signed by Long H. Chen" is present. Below this text is the date "Date: 2024.12.03 07:38:42 -05'00'".
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
3
Indications for Use
Submission Number (if known)
K243454
Device Name
Verruca-Freeze H
Indications for Use (Describe)
The Verruca-Freeze® H cryosurgical system is indicated for use in the treatment of the following skin lesions:
- · Actinic Keratosis
- · Genital Warts
- · Lentigo
- · Molluscum Contagiosum
- · Seborrheic Keratosis
- · Skin Tags
- · Verruca Plantaris
- · Verruca Vulgaris
- · Verruca Plana
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
| K243454 | ||
|---|---|---|
| 510(k) #: K243454 | 510(k) Summary | Prepared on: 2024-11-07 |
| Contact Details | 21 CFR 807.92(a)(1) | |
| Applicant Name | CryoSurgery, Inc. | |
| Applicant Address | 5829 Old Harding Pike Nashville TN 37205 United States | |
| Applicant Contact Telephone | 615-354-0414 | |
| Applicant Contact | Dr. Ronald McDow | |
| Applicant Contact Email | info@cryosurgeryinc.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | Verruca-Freeze H | |
| Common Name | Cryosurgical unit and accessories | |
| Classification Name | Unit, Cryosurgical, Accessories | |
| Regulation Number | 878.4350 | |
| Product Code(s) | GEH | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K233347 | Verruca-Freeze H | GEH |
| Device Description Summary | 21 CFR 807.92(a)(4) | |
| The Verruca-Freeze® H cryosurgical system is used for treatment of benign skin lesions. The device consists of: | ||
| • Canister filled with a liquid mixture of the compressed gases dimethyl ether, propane, and isobutane | ||
| • Polyurethane foam swabs | ||
| • Detailed instructions including illustrated descriptions |
The main component of the device is the pressurized aerosol canister containing cryogen spray. The canister is used with foam swabs, which are non-sterile, single-use applicators that are disposed after each use. The foam swabs allow the cryogen to be localized to a target lesion.
The one- to two-minute procedure begins by spraying cryogen onto a foam swab, which is then placed directly onto held for 15-40 seconds. Upon removal of the swab from the skin, the frozen tissue appears white and begins thaw time is 20-40 seconds.
This treatment methodology is simple and has been an accepted by physicians for decades. It utilizes a standard cryogen composition profile to freeze lesions and destroy the underlying tissue through evaporative cooling. On the cellular level, both extracellular and intracellular ice formation are occurring.
Intended Use/Indications for Use
The Verruca-Freeze® H cryosurgical system is indicated for use in the treatment of the following skin lesions:
• Actinic Keratosis
- Genital Warts
- · Lentigo
- Molluscum Contagiosum
- Seborrheic Keratosis
21 CFR 807.92(a)(5)
5
• Skin Tags
• Verruca Plantaris
• Verruca Vulgaris • Verruca Plana
Indications for Use Comparison
The subject device has the same indications for use as the predicate device.
Technological Comparison
The subject device has the same technological characteristics as the same design, ene the same design, energy source, materials, and other features.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
A stability protocol was developed to ensure that the product is maintained throughout its labeled dating period. Testing conducted under controlled conditions at room temperature and under accelerated conditions.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)