(149 days)
Not Found
No
The device description details a system based on physical principles (heating liquid nitrogen, pressure differences, temperature sensing) and simple control logic (heater operation time, bimetallic thermometer, temperature thresholds, timers, distance lasers). There is no mention of algorithms that learn from data or adapt their behavior based on complex patterns, which are characteristic of AI/ML.
Yes
The device's intended use clearly states it 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," which directly describes a therapeutic application.
No
Explanation: The device description and intended use clearly state that it is a cryotherapy device used to apply cold therapy for temporary reduction of pain, swelling, and inflammation. There is no mention of it being used to diagnose conditions or process diagnostic data.
No
The device description clearly outlines a physical device with hardware components such as a vessel, immersion heater, hose, nozzle, handpiece, movable cart, weighing system, LCD touch screen, aiming beams, and LEDs. It is not solely software.
Based on the provided information, the FROZEN N device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "local cryotherapy device used for cooling down tissues by means of nitrogen vapors" for therapeutic purposes (pain, swelling, inflammation reduction, etc.). This is a physical therapy/treatment application, not a diagnostic one.
- Device Description: The description details the mechanism of generating cold vapor and applying it to the body surface. It does not involve analyzing biological samples (blood, urine, tissue, etc.) which is the hallmark of IVD devices.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, measure a biological marker, or provide information about a patient's health status based on in vitro analysis.
- Anatomical Site: The device is applied to the "body surface," which is consistent with a topical treatment device, not an IVD.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The FROZEN N device does not perform any such function.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
GEH, MLY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
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
1
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)
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).
| 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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3
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, 137 | |||
| Sagimakgol-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 77054 | |||
| Tel.: +713-467-2607 | |||
| II. | DEVICE | ||
| Trade/proprietary Name | |||
| Classification Name | |||
| Common/Usual Name | |||
| Regulation & product code | |||
| Regulatory Class | |||
| 510(k) Review Panel | FROZEN N | ||
| Unit, Cryosurgical, Accessories | |||
| Cryotherapy Device | |||
| 21 CFR 878.4350 (GEH, MLY) | |||
| Class II | |||
| General & 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 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.
V. INDICATIONS FOR USE
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).
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 N
K193665 | FROZEN C
K182392 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use
and Intended use | 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). | The FROZEN hyperbaric CO2
cryotherapy device, 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). |
5
| 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.