(58 days)
Not Found
No
The device description and performance studies focus on a standard cryogen spray system and bench testing of temperature performance, with no mention of AI or ML.
Yes
The device is intended for the treatment of various medical conditions such as warts, sebortheic keratosis, and skin tags, indicating its therapeutic purpose.
No
Explanation: The device is described as being used for 'treatment' of various skin lesions, specifically using a cryogen spray system to freeze them. There is no mention of it being used to diagnose conditions or provide diagnostic information.
No
The device description clearly states the main device component is an aerosol canister containing cryogen spray and includes physical applicators. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of various skin lesions (warts, skin tags, etc.) using cryosurgery. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a cryogen spray system used to freeze skin lesions. It's a physical treatment method.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment. The performance studies described are bench tests on a "phantom skin model" and comparative testing of the cryogen's temperature effects, not tests on human samples.
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., to help diagnose diseases or conditions. This device directly treats a condition on the body.
N/A
Intended Use / Indications for Use
1,1,1,2-tetrafluoroethane, Pentafluoroethane, and 1,1,1- trifluoroethane is to be used for the treatment of verruca (warts) including plantar warts, sebortheic keratosis, actinic keratosis, achrochordon (skin tags), molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenic granuloma.
Product codes (comma separated list FDA assigned to the subject device)
GEH
Device Description
Cool Renewal® is used in the practice of dermatology in the treatment of benign skin lesions using a cryogen spray system. This methodology is an accepted practice used by physicians for decades using accepted procedures and techniques. It utilizes a standard cryogen composition profile to freeze common skin lesions.
The main device component is the aerosol canister containing cryogen spray. The device is used with non-sterile, single-patient applicators which are disposed after use. The applicators are available in Foam Tipped Applicators, Foam Tipped Skin Tag Tweezers, and Plastic Isolation Funnels. The device is provided in a kit containing the canisters, extender tubes, assorted applicators, Instructions for Use, Patient Instruction Tear Pad, and Applicator Practice Pad.
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
Used in the practice of dermatology.
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 Performance Data: Comparative testing was performed on a "phantom skin model" to determine the degree of cold generated by the cryogen and the time frame that such temperatures are deemed "effective temperatures" for using cryosurgery. The comparison bench test studied temperature drop over time for the subject and predicate device applicators, measuring the temperature drop on the surface of the applicator portion placed over the wart or skin lesion after dispensing the applicator. The test determined that Cool Renewal® cryogen and applicators perform equivalently to Nuance Freeze Spray cryogen and applicators by affecting equal surface area and depth during application. Further, it demonstrated that the device is capable of reaching the minimum desired temperature for the maximum treatment time of 40 seconds and performed comparably to the predicate device.
Clinical Performance Data: There was no clinical testing required to support the medical device as the indications for use are equivalent to those of the predicate devices. These types of devices have been on the market for decades and their clinical safety and efficacy has been established. The nonclinical testing detailed in this submission supports the substantial equivalence of the 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.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, connected by flowing lines, creating a sense of unity and forward movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 6, 2016
Cool Renewal, LLC % Ms. Audrey Swearingen Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, Texas 78701-2631
Re: K161296
Trade/Device Name: Cool Renewal Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: May 6, 2016 Received: May 9, 2016
Dear Ms. Swearingen:
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. 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Cool Renewal
Indications for Use (Describe)
1,1,1,2-tetrafluoroethane, Pentafluoroethane, and 1,1,1- trifluoroethane is to be used for the treatment of verruca (warts) including plantar warts, sebortheic keratosis, actinic keratosis, achrochordon (skin tags), molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenic granuloma.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."
3
510(k) Summary — K161296
1. Submission Sponsor
| Name: | Cool Renewal, LLC |
|---|---|
| Address: | 2515 Eugenia Ave, Suite 103 |
| Nashville, Tennessee 37211 | |
| United States | |
| Telephone: | 615-844-0132 |
| Fax: | 615-544-1411 |
| Contact person: | Ashley Rains, President |
2. Submission Correspondent
| Name: | Emergo |
|---|---|
| Address: | 816 Congress Avenue, Suite 1400 |
| Austin, Texas 78701 | |
| United States | |
| Telephone: | 512-327-9997 |
| Fax: | 512-327-9998 |
| Contact person: | Audrey Swearingen (RAC), Director Regulatory Affair |
| Email: | project.management@emergogroup.com |
3. Date Prepared
July 5, 2016
4. Device Identification
| Trade/Proprietary Name: | Cool Renewal® |
|---|---|
| Common/Usual Name: | Portable aerosol cryosurgery device |
| Classification Name: | Unit, Cryosurgical, Accessories |
| Classification Regulation: | 878.4350 |
| Product Code: | GEH |
| Device Class: | Class II |
| Classification Panel: | General & Plastic Surgery |
5. Legally Marketed Predicate Device(s)
Nuance Freeze Spray (K130995) manufactured by Nuance Medical, LLC is the primary predicate device.
4
6. Device Description
Cool Renewal® is used in the practice of dermatology in the treatment of benign skin lesions using a cryogen spray system. This methodology is an accepted practice used by physicians for decades using accepted procedures and techniques. It utilizes a standard cryogen composition profile to freeze common skin lesions.
The main device component is the aerosol canister containing cryogen spray. The device is used with non-sterile, single-patient applicators which are disposed after use. The applicators are available in Foam Tipped Applicators, Foam Tipped Skin Tag Tweezers, and Plastic Isolation Funnels. The device is provided in a kit containing the canisters, extender tubes, assorted applicators, Instructions for Use, Patient Instruction Tear Pad, and Applicator Practice Pad.
The mechanisms of action for any cryotherapy using R404A gas, including Cool Renewal® and the predicate device, Nuance Freeze Spray, are:
-
- The direct effects of freezing on the cells, and
-
- The vascular stasis which develops in the tissue after thawing.
During cryosurgery, both extracellular and intracellular ice formation occur, with fast freezing in the center of the lesion, and slow freezing on the outside border. The loss of blood supply to the treated area eradicates the likelihood of survival of the cells in the frozen tissue.
7. Indications for Use Statement of Cool Renewal®
1,1,2-tetrafluoroethane, Pentafluoroethane, and 1,1,1- trifluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratosis, actinic keratosis, achrochordon, molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyrogenic granuloma.
8. Substantial Equivalence Discussion
The Cool Renewal® intended use, indications and clinical application as well as device design, materials and overall technical characteristics are substantially equivalent to the predicate device. The below table compares the Cool Renewal® to the predicate device with respect to intended use, technological characteristics and principles of operation and provides detailed information regarding the basis for the determination of substantial equivalence (see Table 5A).
Differences between Cool Renewal® and the predicate device are related to minor design elements. The Cool Renewal® Foam Tipped Applicators are double-ended (strictly cosmetic difference). Cool Renewal® is provided with a third applicator (Foam Tipped Skin Tag Tweezers) which has been developed to effectively address the treatment of "skin tags" that tend to hang from the patient's skin. The Cool Renewal® applicators are also disposable and intended for singlepatient use. None of these differences raise any new questions about safety or effectiveness. It is concluded that Cool Renewal® is substantially equivalent to the predicate device manufactured by and Nuance Medical, LLC (Nuance Freeze Spray).
5
| Manufacturer | Cool Renewal, LLC | Nuance Medical, LLC | Significant Differences |
|---|---|---|---|
| Trade Name | Cool Renewal® | Nuance Freeze Spray | |
| 510(k) | |||
| Number | - | K130995 | - |
| Product Code | GEH | GEH | Same |
| Regulation | |||
| Number | 878.4350 | 878.4350 | Same |
| Regulation | |||
| Name | Cryosurgical unit and | ||
| accessories | Cryosurgical unit | ||
| and accessories | Same | ||
| Indications for | |||
| Use | 1,1,1,2-tetrafluoroethane, | ||
| Pentafluoroethane, and 1,1,1- | |||
| trifluoroethane is to be used | |||
| for the treatment of verruca | |||
| (warts) including plantar | |||
| warts, seborrheic keratosis, | |||
| actinic keratosis, | |||
| achrochordon, molluscum | |||
| contagiosum, age spots, | |||
| dermatofibroma, small | |||
| keloids, granuloma annulare, | |||
| porokeratosis plantaris, | |||
| angiomas, keratoacanthoma, | |||
| chondrodermatitis, epithelial | |||
| nevus, leukoplakia, | |||
| granuloma pyogenicum, and | |||
| pyogenic granuloma. | 1,1,1,2-tetrafluoroethane, | ||
| Pentafluoroethane, and 1,1,1- | |||
| trifluoroethane is to be used | |||
| for the treatment of verruca | |||
| (warts) including plantar | |||
| warts, seborrheic keratosis, | |||
| actinic keratosis, | |||
| achrochordon, molluscum | |||
| contagiosum, age spots, | |||
| dermatofibroma, small | |||
| keloids, granuloma annulare, | |||
| porokeratosis plantaris, | |||
| angiomas, keratoacanthoma, | |||
| chondrodermatitis, epithelial | |||
| nevus, leukoplakia, granuloma | |||
| pyogenicum, and pyogenic | |||
| granuloma. | Same | ||
| Mechanism of | |||
| Action | Application of extreme cold | ||
| causing tissue destruction due | |||
| to: |
- Direct effects of freezing
on the cells, - Vascular stasis which
develops in the tissue after
thawing. | Application of extreme cold
causing tissue destruction
due to: - Direct effects of freezing
on the cells, - Vascular stasis which
develops in the tissue after
thawing. | Same |
| Cryogen Gas
Material | R404A: 1,1,1,2-tetrafluoro-
ethane (CAS 354-33-6);
Pentafluoroethane (CAS
420-46-2);
1,1,1- trifluoroethane
(CAS 811-97-2) | R404A: 1,1,1,2-tetrafluoro-
ethane (CAS 354-33-6);
Pentafluoroethane (CAS
420-46-2);
1,1,1- trifluoroethane
(CAS 811-97-2) | Same |
| Freeze time | 15-40 seconds | 15-40 seconds | Same. |
| Applicators | Foam Tipped Applicator
Plastic Isolation Funnel
Foam Tipped Skin Tag Tweezer | Buds
Dosing Cones | Similar. Cool Renewal®
is supplied with a third
applicator. Cool
Renewal® Funnels are
disposable. Does not
add new safety or
efficacy concerns. |
| Sterile | No | No | Same |
Table 5A – Comparison of Characteristics
6
9. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of Cool Renewal®, and substantial equivalence to the predicate device, comparative testing was performed on a "phantom skin model" to determine the degree of cold generated by the cryogen and the time frame that such temperatures are deemed "effective temperatures" for using cryosurgery. The comparison bench test studied temperature drop over time for the subject and predicate device applicators, measuring the temperature drop on the surface of the applicator portion placed over the wart or skin lesion after dispensing the applicator. The test determined that Cool Renewal® cryogen and applicators perform equivalently to Nuance Freeze Spray cryogen and applicators by affecting equal surface area and depth during application. Further, it demonstrated that the device is capable of reaching the minimum desired temperature for the maximum treatment time of 40 seconds and performed comparably to the predicate device.
10. Clinical Performance Data
There was no clinical testing required to support the medical device as the indications for use are equivalent to those of the predicate devices. These types of devices have been on the market for decades and their clinical safety and efficacy has been established. The nonclinical testing detailed in this submission supports the substantial equivalence of the device.
11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. While there are minor differences between the Cool Renewal® and its predicate device, these are related to cosmetic design. These differences do not affect the principle of operation or mode of action of the Cool Renewal®. Existing differences do not raise new questions regarding safety and effectiveness as compared to the predicate device.
It has been shown in this 510(k) submission that the minor differences between the Cool Renewal® and the predicate device do not raise any questions regarding its safety and effectiveness. The Cool Renewal® device is determined to be substantially equivalent to the predicate device, Nuance Freeze Spray.
12. Conclusion
The Cool Renewal® device, based on comparison to the predicate and the results of performance testing, is substantially equivalent to the predicate device, Nuance Freeze Spray.