CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit

K210310 · Nuance Medical, LLC · GEH · Oct 22, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210310
• Device Name: CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit
• Applicant: Nuance Medical, LLC
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Oct 22, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For the treatment of verruca (warts) including plantar warts, sehorrheic keratosis, achrochorodon, molluscum, contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chrondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyrogenic granualpma.

Device Story

CryoDose V50/50 is a handheld cryosurgical spray system used by physicians in dermatology clinics to treat skin lesions. The device consists of a canister containing a cryogen blend (HFC-32 and HFO-1234ze) and applicators (cones/swabs). Operation involves manual activation of the canister to spray the cryogen onto the target skin lesion. The cryogen freezes the tissue, facilitating the removal or treatment of the lesion. The device is designed to provide equivalent performance to existing cryosurgical systems while utilizing a propellant with lower global warming potential. The healthcare provider applies the spray directly to the lesion; the freezing effect serves as the therapeutic mechanism. The device is non-flammable and features a positive shut-off release for safety.

Clinical Evidence

Bench testing only. Evaluations included temperature profiles at the application site, flammability/ignition testing, spray rate, pressure, and visual freezing performance. Results demonstrate the subject device delivers temperatures and spray weights comparable to the predicate device.

Technological Characteristics

Handheld cryosurgical spray system. Materials: HFC-32 (difluoromethane) and HFO-1234ze (trans-1,3,3,3-tetrafluoroprop-1-ene) blend. Non-flammable. Mechanical operation via positive shut-off release. Dimensions: 175 ml and 236 ml canister sizes. No electronic components or software.

Indications for Use

Indicated for treatment of skin lesions including verruca (warts), plantar warts, seborrheic keratoses, actinic keratosis, achrochorodon, molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyrogenic granuloma in adults.

Regulatory Classification

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.

Predicate Devices

• Nuance Freeze Spray System (K130995)

Submission Summary (Full Text)

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October 22, 2021

Nuance Medical, Inc. Mr. Neal Hartman Regulatory Affair/Quality Assurance 5931 Sea Lion Place, Suite 113 Carlsbad, California 92010

Re: K210310

Trade/Device Name: CryoDose V50/50 Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: October 8, 2021 Received: October 12,2021

Dear Mr. Hartman:

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/cfpm/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.

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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 mediation-emitting products, including information about labeling regulations, please see Device (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 [phone] 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 Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K210310

Device Name CryoDose V 50/50

Indications for Use (Describe)

For the treatment of verruca (warts) including plantar warts, sehorrheic keratosis, achrochorodon, molluscum, contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chrondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyrogenic granualpma.

| Type of Use (Select one or both, as applicable) | <div> <span>☑ Research Use (Part 21 CFR 321.3, Level I)</span> <span>☐ Over-The-Counter Use (21 CFR 331.3, Level I)</span> </div> |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|

> Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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# K210310

# Nuance Medical

# 510(K) SUMMARY

# Submitter Information

| Company Name: | Nuance Medical, Inc. |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Address: | Nuance Medical, Inc.<br>5931 Sea Lion Place, Suite 113<br>Carlsbad, CA 92010 |
| Company Phone: | [phone] |
| Company Facsimile: | [phone] |
| Contact Person No. 1: | Marc S. Lieberman<br>Chief Executive Officer<br>[e-mail] |
| Contact Person No. 2: | Neal Hartman<br>Regulatory Affairs/ Quality Assurance<br>892 Summer Moon Road<br>San Marcos, CA 92078<br>858.382.6550<br>[e-mail] |
| Date: | October 16, 2021 |

## Device Identification

| Device Trade Name: | CryoDose V50/50 |
|-------------------------|-----------------------------------|
| Common Name: | Cryogen Spray |
| Classification Name(s): | Cryosurgical unit and accessories |
| Requlation(s): | 878.4350 |
| Device Class: | Class II |
| Product Code(s): | GEH |
| Advisory Panel: | General & Plastic Surgery |

# ldentification of Predicate Devices

The System Device is substantially equivalent to the following device:

| Device Name | Classification Regulation | Product<br>Code | 510(K)<br>Number | Clearance<br>Date |
|-------------------------------|----------------------------------------------|-----------------|------------------|-------------------|
| Nuance Freeze<br>Spray System | 878.4350 - Cryosurgical unit and accessories | GEH | K130995 | 6/14/2013 |

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# K210310

### Device Description

The Subject Device is used in the practice of dermatology in the treatment of skin lessons using a cryogen spray system. This methodology is an accepted practice used by physicians for decades using accepted procedures and techniques. It utilizes a cryogen composition profile to freeze common skin lessons that is has a lower global warming potential then the predicate device and is safe and provide equivalent performance.

The chemical composition is a blend of HFC-32 and HFO-1234ze. HFC-32, difluoromethane, is a colorless gas typically used as a refrigerant. HFO-1234ze, trans-1,3,3,3-tetrafluoroprop-1-ene, is a colorless gas and a new generation hydrofluoroolefin developed for its low global warming potential.

#### Indications for Use

For the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic keratosis, achrochorodon, molluscum, contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chrondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyrogenic granuloma.

| Comparison Feature | Subject Device | Predicate Device |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | CryoDose V50/50 | Nuance Freeze Spray System |
| Manufacturer | Nuance Medical, Inc. | Nuance Medical, Inc. |
| Indications for Use | For the treatment of verruca (warts)<br>including plantar warts, seborrheic<br>keratoses, actinic keratosis,<br>achrochorodon, molluscum,<br>contagiosum, age spots, dermatofibroma,<br>small keltoids, granuloma annulare,<br>porokeratosis plantaris, angiomas,<br>keratoacanthoma, chrondrodermatitis,<br>epithelial nevus, leukoplakia, granuloma<br>pyogenicum, and pyrogenic granuloma. | 1,1,1,2-tetrafluoroethane,<br>pentafluoroethane, and 1,1,1-trifluorethane<br>is to be used for the treatment of verruca<br>(warts) including plantar warts, seborrheic<br>keratoses, actinic keratosis,<br>achrochorodon, molluscum, contagiosum,<br>age spots, dermatofibroma, small keltoids,<br>granuloma annulare, porokeratosis<br>plantaris, angiomas, keratoacanthoma,<br>chrondrodermatitis, epithelial nevus,<br>leukoplakia, granuloma pyogenicum, and<br>pyrogenic granuloma. |
| Target Population | Adults | Adults |
| Anatomical Sites | Skin | Skin |
| Chemical Name | HFC-32/HFO-1234ze Blend | HFC blend (R-404a) |
| Chemical Composition | difluoromethane (50%)<br>trans-1,3,3,3-tetrafluoroprop-1-ene (50%) | 1,1,2-tetrafluoroethane (4%)<br>pentafluoroethane (44%)<br>1,1,1-trifluoroethane (54%). |
| Molecular Weight | 97.6 | 71.4 |
| Bolling Point | -47.8°C | -46.2°C |
| Liquid Density @ 25°C | ~1.13 g/cc | 1.05 g/cc |
| Heat of Vaporization | ~233 kj/kg | 202.1 kj/kg |
| Global Warning Potential<br>(CO2=1) | ~340 | 3260 |
| Flammability | Non-flammable | Non-flammable |

## Comparison of Technological Characteristics with Predicate and Reference Devices

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| Comparison Feature | Subject Device | Predicate Device |
|-------------------------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------|
| Mechanism of Action | Freezing by application of cryogen | Freezing by application of cryogen |
| Application Method | Handheld spray cannister with<br>applicators | Handheld spray cannister with applicators |
| Temperature at<br>application site @ 3- & 7-<br>seconds spray /3"<br>distance | Surface: -60°C<br>Subcutaneous -5°C<br>Intramuscular: 30°C | Surface: -60°C<br>Subcutaneous -5°C<br>Intramuscular: 30°C |
| Temperature at<br>application site @ 7<br>seconds spray/ 6"<br>distance | Surface: -60°C<br>Subcutaneous -5°C<br>Intramuscular: 28°C | Surface: -65°C<br>Subcutaneous -8°C<br>Intramuscular: 32°C |
| Spray weight with 5<br>second spray | 0.015 lb. | 0.015 lb. |
| Mechanical Safety | Positive shut-off release | Positive shut-off release |
| Cannister Fill Size | 175, 236 ml | 162, 236 ml |
| Kit Components | Device cannister, Cones, Swabs | Device cannister, Cones, Swabs |
| EMI Radiation Safety | N/A | N/A |

Technically, the Subject Device has similar mechanical properties to the predicate as well as its performance. The same patient population and use indications applies between the devices. Identical cannister components and applicators are used with both devices. The main differences between the Subject Device and predicate is that the global warning potential is significantly less with the Subject Device. The differences in the Subject Device does not impact safety, effectiveness, or performance.

## Summary of Testing Performed

Assessments were performed that includes the following:

- Temperature
- Flammability/Ignition ●
- Spray Rate
- Pressure
- Visual Freezing ●

As indicated in the above comparison chart, the Subject Devices in non-flammable, deliveries similar temperatures at the application site, and the spray weight is identical than that of the predicate.

Results of the evaluations demonstrate that the Subject Device met the safety and performance requirements as it relates to its indication for use.

#### Conclusions Drawn from Nonclinical Evaluation

The results of the evaluation demonstrate that the Subject Device is substantially equivalent to the predicate as it pertains to the indications for use and device performance.