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 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.

AI/ML Overview

This document is a 510(k) summary for the CryoDose V50/50, a cryosurgical unit. It focuses on demonstrating substantial equivalence to a predicate device, the Nuance Freeze Spray System (K130995). The primary difference highlighted is the cryogen composition, with the new device using a blend of HFC-32 and HFO-1234ze, which has a significantly lower Global Warming Potential (GWP) than the predicate's HFC blend (R-404a).

Acceptance Criteria and Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of a clinical study, but rather a "Comparison of Technological Characteristics" that serves as the basis for demonstrating substantial equivalence. The "acceptance criteria" here are implied to be performance characteristics that are "similar" or "identical" to the predicate device, ensuring equivalent safety and effectiveness.

Here's a table based on the provided comparison, indicating the "acceptance criteria" (which are performance targets based on the predicate) and the "reported device performance":

Acceptance Criteria (Target based on Predicate)	Reported Device Performance (Subject Device)
Device Name	Nuance Freeze Spray System
Manufacturer	Nuance Medical, Inc.
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.
Target Population	Adults
Anatomical Sites	Skin
Chemical Name	HFC blend (R-404a)
Chemical Composition	1,1,1,2-tetrafluoroethane (4%), pentafluoroethane (44%), 1,1,1-trifluoroethane (54%)
Molecular Weight	71.4
Boiling Point	-46.2°C
Liquid Density @ 25°C	1.05 g/cc
Heat of Vaporization	202.1 kj/kg
Global Warning Potential (CO2=1)	3260
Flammability	Non-flammable
Mechanism of Action	Freezing by application of cryogen
Application Method	Handheld spray cannister with applicators
Temperature at application site @ 3- & 7-seconds spray /3" distance	Surface: -60°C, Subcutaneous: -5°C, Intramuscular: 30°C
Temperature at application site @ 7-seconds spray/ 6" distance	Surface: -65°C, Subcutaneous: -8°C, Intramuscular: 32°C
Spray weight with 5 second spray	0.015 lb.
Mechanical Safety	Positive shut-off release
Cannister Fill Size	162, 236 ml
Kit Components	Device cannister, Cones, Swabs
EMI Radiation Safety	N/A

The document states: "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."

Study Information

This 510(k) submission does not concern a clinical study involving human patients or complex AI algorithms necessitating large test sets, expert readers, or MRMC studies. Instead, it focuses on demonstrating substantial equivalence of a medical device (a cryosurgical unit) through non-clinical performance testing and comparison of technical specifications to a previously cleared predicate device.

Therefore, many of the requested points regarding sample size, data provenance, expert ground truth, adjudication, and MRMC studies are not applicable to this type of device submission.

Here's the information that is applicable based on the document:

Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated as a "test set" in the context of a clinical trial. The testing involved parameters like temperature, spray rate, pressure, flammability/ignition, and visual freezing. The sample size for these specific engineering/performance tests is not provided in this summary.
- Data Provenance: The tests were "performed" on the subject device. The origin (e.g., country) of these performance test results is not specified, but it's presumed to be from the manufacturer's internal testing or a contracted lab. The data is from non-clinical, benchtop performance testing. It is not prospective or retrospective in the clinical sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission relies on objective physical measurements (temperature, pressure, etc.) and comparison to a predicate device's established performance, rather than subjective expert interpretation of data points that would require "ground truth" establishment in a diagnostic context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no human "adjudication" in the sense of resolving discrepancies in expert interpretation, as this was not a clinical or image-based diagnostic study.
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 tool. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth," if one can use the term loosely here, for this type of submission is the established performance characteristics of the legally marketed predicate device and accepted engineering/physical standards for the measured parameters. The goal is to show that the subject device's performance metrics are "similar" or "equivalent" to those of the predicate device, implying comparable safety and effectiveness.
The sample size for the training set:
- Not applicable. This is a hardware device, not an algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable. See point 8.

Summary

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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 (1-800-638-2041 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)

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

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.5931 Sea Lion Place, Suite 113Carlsbad, CA 92010
Company Phone:	(760) 585-9548
Company Facsimile:	(760) 235-4572
Contact Person No. 1:	Marc S. LiebermanChief Executive Officermarc@cryodose.com
Contact Person No. 2:	Neal HartmanRegulatory Affairs/ Quality Assurance892 Summer Moon RoadSan Marcos, CA 92078858.382.6550nealenhartman@gmail.com
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	ProductCode	510(K)Number	ClearanceDate
Nuance FreezeSpray System	878.4350 - Cryosurgical unit and accessories	GEH	K130995	6/14/2013

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K210310

Device Description

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)including plantar warts, seborrheickeratoses, actinic keratosis,achrochorodon, molluscum,contagiosum, age spots, dermatofibroma,small keltoids, granuloma annulare,porokeratosis plantaris, angiomas,keratoacanthoma, chrondrodermatitis,epithelial nevus, leukoplakia, granulomapyogenicum, and pyrogenic granuloma.	1,1,1,2-tetrafluoroethane,pentafluoroethane, and 1,1,1-trifluorethaneis to be used for the treatment of verruca(warts) including plantar warts, seborrheickeratoses, actinic keratosis,achrochorodon, molluscum, contagiosum,age spots, dermatofibroma, small keltoids,granuloma annulare, porokeratosisplantaris, angiomas, keratoacanthoma,chrondrodermatitis, epithelial nevus,leukoplakia, granuloma pyogenicum, andpyrogenic granuloma.
Target Population	Adults	Adults
Anatomical Sites	Skin	Skin
Chemical Name	HFC-32/HFO-1234ze Blend	HFC blend (R-404a)
Chemical Composition	difluoromethane (50%)trans-1,3,3,3-tetrafluoroprop-1-ene (50%)	1,1,2-tetrafluoroethane (4%)pentafluoroethane (44%)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(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 withapplicators	Handheld spray cannister with applicators
Temperature atapplication site @ 3- & 7-seconds spray /3"distance	Surface: -60°CSubcutaneous -5°CIntramuscular: 30°C	Surface: -60°CSubcutaneous -5°CIntramuscular: 30°C
Temperature atapplication site @ 7seconds spray/ 6"distance	Surface: -60°CSubcutaneous -5°CIntramuscular: 28°C	Surface: -65°CSubcutaneous -8°CIntramuscular: 32°C
Spray weight with 5second 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.

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.