The FROZEN N, cryotherapy device using liquid nitrogen vapor, is for use when cold therapy is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).

Device Description

The FROZEN N is a local cryotherapy device used for cooling down tissues by means of nitrogen vapors. Liquid nitrogen, whose boiling point is -196°C, inside the vessel changes into the gas form by heating from a rod-shaped immersion heater operated by AC power. The appearing difference in pressure between atmospheric pressure and the vessel provokes the flow of nitrogen vapors from the vessel to the hose finished with a nozzle mounted on handpiece. The nozzle discharge volume of nitrogen vapors is controlled in 5 levels by the operation time of heater. As the amount of nitrogen decreases, the device is off automatically when the temperature of the heater reaches 60°C where sensed via bimetallic thermometer embedded in heater module. The structural design of device is the movable cart equipped with a weighing system to check the amount of nitrogen in the vessel. Rapid cooling (thermal shock) in the temperature range of 2~4 ℃ occurs within 30-45 seconds when the spray sublimates as it contacts the skin. The device is controlled via touch screen keys of LCD where displays the timer, measured temperature, operating level and remains of nitrogen. Also, the touch key controls the aiming beams mounted on the nozzle side of handpiece that helps the user keeping a proper distance while the two laser beams meet each other. The LED on the hand-piece flickers when the measured drops below 5℃ and the device automatically shuts down when the measured temperature stays -1 ℃ or below for 1 second.

AI/ML Overview

The provided text describes the 510(k) summary for the FROZEN N cryotherapy device, primarily focusing on its substantial equivalence to a predicate device (FROZEN C, K182392). The information does not detail a clinical study with specific acceptance criteria for diagnostic performance (e.g., sensitivity, specificity) or human reader improvement with AI assistance, as it is a different type of medical device (cryotherapy) and the submission appears to be based on substantial equivalence rather than a new AI diagnostic algorithm.

However, the document does contain information about performance data and various tests. I will address the relevant sections of your request based on the available information.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the performance tests conducted to demonstrate substantial equivalence, particularly concerning temperature.

Acceptance Criteria	Reported Device Performance
Temperature Range for Cold Therapy	Device can generate 2-4°C
Time to Arrive Intended Temperature	Dropped to 2-4°C within 30-45 seconds
Temperature Accuracy (LCD vs. Actual Skin Surface)	Within ±2°C
Auto-off Temperature	Shuts down at -1°C or below for 1 second
Electrical Safety	Complies with AAMI ANSI ES 60601-1:2005/(R) 2012 and A1:2012
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2:2014 (Ed.4), no potential deviation
Software Validation	Software verification testing conducted as recommended in IEC 62304:2006 and FDA Guidance Document

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "skin temperature test on human subjects."

Sample Size: Not explicitly stated beyond "human subjects."
Data Provenance: Not specified, but generally, 510(k) submissions would involve testing conducted by the manufacturer or a contracted lab. The document does not specify country of origin or whether it was retrospective or prospective, though performance testing on a device implies prospective testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable in the context of this device and the type of performance testing described. Ground truth for a cryotherapy device's performance would be the direct temperature measurements, not expert consensus on images.

4. Adjudication Method for the Test Set

Not applicable. This device does not involve subjective assessment or image interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is relevant for AI image analysis or diagnostic support systems where human readers interpret medical images. The FROZEN N is a physical cryotherapy device. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the FROZEN N to its predicate device."

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

This question is not directly applicable to the FROZEN N device as it's a physical cryotherapy unit, not an AI algorithm. Its "standalone" performance is measured by its ability to deliver the intended temperature and operate safely and effectively. The performance tests ("skin temperature test," "temperature accuracy," "auto-off") confirm the device's functional performance.

7. The type of ground truth used

The ground truth for the performance claims (temperature, timing) was established through direct physical measurement. For instance, a "skin temperature test on human subjects" directly measured the skin temperature achieved by the device.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense. Its "training" or development would involve engineering and design, followed by bench and human-subject performance testing.

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

Not applicable as there is no "training set" for an AI/ML algorithm in this context.

Summary

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May 28, 2020

YOZMA BMTECH CO., LTD. % Dave Kim President, MTech Group 7707 Fannin St. Ste 200 Houston, Texas 77054

Re: K193665

Trade/Device Name: Frozen N Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: December 1, 2019 Received: April 3, 2020

Dear Dave Kim:

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/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.

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

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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 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.

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193665

Device Name

FROZEN N

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date 510(k) summary prepared:		May 26, 2020
I.	SUBMITTER
	Owner:	YOZMA BMTECH CO., LTD.#609, #808, #1001~1007, Jungang Induspia 5-cha, 137Sagimakgol-ro, Jungwon-gu, Seongnam-si,Gyeonggi-do, Korea (13202)Tel.: +82 (31) 7395544
	Contact person	Jenny Cho (jennycho@yozma-bmtech.com)/ RA Team Manager
	Official Correspondent	Dave Kim (davekim@mtech-inc.net)7707 Fannin St. Ste 200, Houston, TX 77054Tel.: +713-467-2607
II.	DEVICE
	Trade/proprietary NameClassification NameCommon/Usual NameRegulation & product codeRegulatory Class510(k) Review Panel	FROZEN NUnit, Cryosurgical, AccessoriesCryotherapy Device21 CFR 878.4350 (GEH, MLY)Class IIGeneral & Plastic Surgery
III.	PREDICATE DEVICE

VICI C

Trade/proprietary Name	FROZEN C
Manufacturer	B.M.Tech Worldwide Co., Ltd.(old name of YOZMA BMTECH. CO., LTD)
510(k) Number	K182392
Regulation & product code	21 CFR 878.4350 (GEH, MLY)

Prescription Use only.

Predicate device has not been subject to a design-related recall.

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IV. DEVICE DESCRIPTION

The device is controlled via touch screen keys of LCD where displays the timer, measured temperature, operating level and remains of nitrogen. Also, the touch key controls the aiming beams mounted on the nozzle side of handpiece that helps the user keeping a proper distance while the two laser beams meet each other. The LED on the hand-piece flickers when the measured drops below 5℃ and the device automatically shuts down when the measured temperature stays -1 ℃ or below for 1 second.

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject device has the same or equivalent technical characteristics as the predicate device including materials, design, and energy source. There are no technological differences between the predicate and the submitted device. Refer to the following table for the comparison between the subject device and the predicate:

	FROZEN NK193665	FROZEN CK182392
Indication for useand Intended use	The FROZEN N, cryotherapydevice using liquid nitrogenvapor, is for use when coldtherapy is indicated for thetemporary reduction of pain,swelling, inflammation, andhematoma from minor surgicalprocedures, minor sprains orother minor sports injuries, andas an adjunct to rehabilitativetreatment (e.g., intermittentcold with stretch).	The FROZEN hyperbaric CO2cryotherapy device, is for usewhen cold therapy is indicatedfor the temporary reduction ofpain, swelling, inflammation,and hematoma from minorsurgical procedures, minorsprains or other minorsports injuries, and as anadjunct to rehabilitativetreatment (e.g., intermittentcold with stretch).

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Product design		Cylindrical grip hand-piece, electronic console for controlling operation (7" LCD screen), LN2 gas cylinder (included) and laser pointer mounted on the hand-piece beside nozzle	Cylindrical grip hand-piece, electronic console for controlling operation (7" LCD screen), CO2 gas cylinder (sold separately) and laser pointer mounted on the hand-piece beside nozzle
Energy delivered		Thermal energy via refrigerant spray	Thermal energy via refrigerant spray
Cryogen		Medical-grade Liquid Nitrogen gas (Sold separately)	Medical-grade carbon dioxide gas (Sold separately)
Mechanism of action		LN2 gas is delivered to the treatment site at -196°C to effect thermal shock	CO2 gas is delivered to the treatment site at -78.5°C to effect thermal shock
Firmware		Ver 1.1.0 (FROZENN)	Ver 1.0.0 (FROZENC)
Mobility		Housed in a mobile cart	Housed in a mobile cart
Patient contact		None	None
Working principle	Treatment time per procedure	30-60 seconds	30-60 seconds
	Distance of topical spray	12 cm (about 5 inches)	7 cm (about 3 inches)
	Treatment temperature	2-4°C in 30-45 seconds	2-4°C in 30-45 seconds
	Measurement	Skin temperature by infrared temperature sensor	Skin temperature by infrared temperature sensor
	Auto-off	-1°C	-1°C

Substantial Equivalence

The cryotherapy devices including both of subject and predicate devices use cryogenic liquids, vapor and cold gases to local cooling of the body surface. The subject device FROZEN N is substantially equivalent in design, manufacturing material, intended use, working principle, and technical characteristics to the FROZEN C cryotherapy device (K182392) and raise no new issues of safety or effectiveness.

For the mechanism of action, the predicate device (K182392) does not include the cylinder to be filled with compressed carbon dioxide in liquid state but provide the connector conforming to CGA320, which is the US Carbon Dioxide Cylinder Valve outlet standard. Instead, the subject device uses an unpressurised liquid nitrogen but that is venting at a boiling point of -196°C, thus providing an insulated container designed to withstand rapid temperature changes.

While the design differences of gas discharge method between subject device and predicate, the intended use (indication for use) is identical for cryotherapy which does not require cell destruction by freezing. The difference of cryogenic boiling points between CO2 and LN2 medical grade gases does not raise any new questions of safety and effectiveness since the clinical effect is led from the local cooling of the body surface where its skin temperature of affected area is exposed to 2-4℃ in 30-60 seconds. The safety and performance of subject device has been properly validated throughout the electrical safety testing, EMC testing and bench testing.

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VII. PERFORMANCE DATA

Similar performance tests established in the predicate (K182392) submission was performed to demonstrate the Substantial Equivalence, including but not limited to the skin temperature test on human subjects to verify the device can generate the needed temperature range (2-4 ℃) for cold therapy safely and effectively. Performance bench testing including temperature accuracy and time to arrive intended temperature have been tested. The difference of the temperature on LCD and the actual skin surface was within the tolerance level, ±2℃.

The temperature of a treatment area on skin dropped to 2 ~ 4℃ within 30s as intended. The FROZEN N complies with voluntary standards for electrical safety and EMC testing. The following data were provided to support the substantial equivalence determination:

Electrical Safety and essential performance testing was conducted in accordance with

AAMI ANSI ES 60601-1:2005/(R) 2012 and A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD).

Electromagnetic Compatibility:

Testing was conducted in accordance with IEC 60601-1-2:2014 (Ed.4) Medical Electrical Equipment -Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests. There was no potential deviation.

Software:

Software validation report contains Software verification testing as recommended in IEC 62304:2006 Medical device software -- Software life cycle processes and FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005).

Summary of clinical tests

Clinical testing was not required to demonstrate the substantial equivalence of the FROZEN N to its predicate device

VIII. CONCLUSIONS

Based on the label and technology comparison as well as the performance testing, the subject device FROZEN N is substantially equivalent to the predicate device listed above.

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.