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.

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.

AI/ML Overview

The provided text describes a 510(k) submission for the "Cool Renewal" cryosurgical device, seeking substantial equivalence to a predicate device. This submission focuses on comparing the new device to an existing one, rather than establishing de novo performance criteria. Therefore, the information provided does not contain traditional "acceptance criteria" and "reported device performance" in the way one might expect for a novel device with specific quantitative metrics for sensitivity, specificity, etc.

Instead, the core of the submission revolves around demonstrating that the Cool Renewal device is substantially equivalent to its predicate device, the Nuance Freeze Spray (K130995), for the same Indications for Use.

Here's an attempt to extract and present the information in the requested format, interpreting "acceptance criteria" through the lens of substantial equivalence and the comparative non-clinical study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (based on predicate equivalence)	Reported Device Performance (Cool Renewal)
Cryogen Composition: Same type of cryogen gas (R404A: 1,1,1,2-tetrafluoroethane, Pentafluoroethane, and 1,1,1-trifluoroethane) as the predicate.	Uses R404A: 1,1,1,2-tetrafluoroethane (CAS 354-33-6); Pentafluoroethane (CAS 420-46-2); 1,1,1- trifluoroethane (CAS 811-97-2). Meets criterion.
Mechanism of Action: Same as the predicate device (application of extreme cold causing tissue destruction due to direct effects of freezing on cells and vascular stasis after thawing).	Mechanism of action is identical to the predicate device. Meets criterion.
Freeze Time: Capable of achieving an effective freeze time comparable to the predicate device (15-40 seconds).	Freeze time is 15-40 seconds, identical to the predicate device. Meets criterion.
Temperature Drop & Effectiveness: Capable of generating a degree of cold and maintaining "effective temperatures" for cryosurgery comparable to the predicate device, reaching the minimum desired temperature for the maximum treatment time of 40 seconds. Affects equal surface area and depth during application compared to the predicate.	Comparative bench testing on a "phantom skin model" showed that Cool Renewal® cryogen and applicators perform equivalently to Nuance Freeze Spray cryogen and applicators by affecting equal surface area and depth during application. Demonstrated capability of reaching the minimum desired temperature for the maximum treatment time of 40 seconds and performed comparably to the predicate device. Meets criterion.
Safety and Efficacy Concerns: No new questions regarding safety or effectiveness compared to the predicate device, despite minor design differences (applicators).	Minor differences (double-ended foam tipped applicators, third applicator for skin tags) do not raise any new questions about safety or effectiveness. Meets criterion.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: The text mentions "comparative testing was performed on a 'phantom skin model'". It does not specify the number of tests conducted, the number of applicators, or the number of cryogen canisters used.
Data Provenance: Not explicitly stated, but it's a non-clinical, bench testing study. The location of the testing is not mentioned, and it is a prospective comparative bench test designed to demonstrate equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was a non-clinical bench test on a "phantom skin model" measuring physical properties (temperature drop over time, surface area, depth of effect). There was no "ground truth" to be established by human experts in the context of diagnostic or clinical evaluation for this specific non-clinical test.

4. Adjudication method for the test set

Not applicable. As this was a non-clinical bench test measuring physical parameters, there was no expert adjudication process for the test set results. The measurements likely followed a pre-defined protocol.

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

Not applicable. This device is a cryosurgical unit, not an AI-powered diagnostic or assisted reading device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a manual cryosurgical unit, not an algorithm or AI system.

7. The type of ground truth used

For the non-clinical performance data, the "ground truth" was established through physical measurements of temperature and impact on a "phantom skin model" against expected performance parameters for cryotherapy, and in comparison to the predicate device. It's a technical ground truth based on physical properties and known cryosurgical principles, not expert consensus, pathology, or outcomes data in a clinical sense for this specific study.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI that would require a "training set." The submission relies on comparative bench testing and the established safety and efficacy of the predicate device and cryosurgery in general.

9. How the ground truth for the training set was established

Not applicable, as no training set was used.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known)

K161296

Device Name Cool Renewal

Indications for Use (Describe)

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)

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510(k) Summary — K161296

1. Submission Sponsor

Name:	Cool Renewal, LLC
Address:	2515 Eugenia Ave, Suite 103Nashville, Tennessee 37211United States
Telephone:	615-844-0132
Fax:	615-544-1411
Contact person:	Ashley Rains, President

2. Submission Correspondent

Name:	Emergo
Address:	816 Congress Avenue, Suite 1400Austin, Texas 78701United 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.

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6. Device Description

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:

1. The direct effects of freezing on the cells, and
1. 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).

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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
RegulationNumber	878.4350	878.4350	Same
RegulationName	Cryosurgical unit andaccessories	Cryosurgical unitand accessories	Same
Indications forUse	1,1,1,2-tetrafluoroethane,Pentafluoroethane, and 1,1,1-trifluoroethane is to be usedfor the treatment of verruca(warts) including plantarwarts, seborrheic keratosis,actinic keratosis,achrochordon, molluscumcontagiosum, age spots,dermatofibroma, smallkeloids, granuloma annulare,porokeratosis plantaris,angiomas, keratoacanthoma,chondrodermatitis, epithelialnevus, leukoplakia,granuloma pyogenicum, andpyogenic granuloma.	1,1,1,2-tetrafluoroethane,Pentafluoroethane, and 1,1,1-trifluoroethane is to be usedfor the treatment of verruca(warts) including plantarwarts, seborrheic keratosis,actinic keratosis,achrochordon, molluscumcontagiosum, age spots,dermatofibroma, smallkeloids, granuloma annulare,porokeratosis plantaris,angiomas, keratoacanthoma,chondrodermatitis, epithelialnevus, leukoplakia, granulomapyogenicum, and pyogenicgranuloma.	Same
Mechanism ofAction	Application of extreme coldcausing tissue destruction dueto:1) Direct effects of freezingon the cells,2) Vascular stasis whichdevelops in the tissue afterthawing.	Application of extreme coldcausing tissue destructiondue to:1) Direct effects of freezingon the cells,2) Vascular stasis whichdevelops in the tissue afterthawing.	Same
Cryogen GasMaterial	R404A: 1,1,1,2-tetrafluoro-ethane (CAS 354-33-6);Pentafluoroethane (CAS420-46-2);1,1,1- trifluoroethane(CAS 811-97-2)	R404A: 1,1,1,2-tetrafluoro-ethane (CAS 354-33-6);Pentafluoroethane (CAS420-46-2);1,1,1- trifluoroethane(CAS 811-97-2)	Same
Freeze time	15-40 seconds	15-40 seconds	Same.
Applicators	Foam Tipped ApplicatorPlastic Isolation FunnelFoam Tipped Skin Tag Tweezer	BudsDosing Cones	Similar. Cool Renewal®is supplied with a thirdapplicator. CoolRenewal® Funnels aredisposable. Does notadd new safety orefficacy concerns.
Sterile	No	No	Same

Table 5A – Comparison of Characteristics

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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.

Regulation Number and Section

§ 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.