(56 days)
Not Found
No
The device description focuses on the physical mechanism of cryotherapy using CO2 and basic sensor feedback (temperature, timer, CO2 volume). There is no mention of AI or ML algorithms for data analysis, decision-making, or adaptive control. The temperature monitoring and automatic shut-off are based on simple thresholds, not complex learning or inference.
Yes.
The device is intended for therapeutic purposes like temporary reduction of pain, swelling, and inflammation, and as an adjunct to rehabilitative treatment using cold therapy.
No
The device is for use when cold therapy is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma. It is a therapeutic device that applies cold therapy, not a device that diagnoses medical conditions. While it monitors temperature, this is for treatment application, not diagnosis.
No
The device description clearly outlines multiple hardware components including a hand-piece, touchscreen console, infrared temperature sensor, and a CO2 cylinder. It is a physical device that utilizes software for operation and display, but it is not solely software.
Based on the provided information, the FROZEN C hyperbaric CO2 cryotherapy device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for topical application to the skin for therapeutic purposes (reducing pain, swelling, inflammation, hematoma). It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a device that delivers a cold spray to the skin surface. It measures skin temperature and controls the application of the cryogen. This is a physical therapy device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples or providing diagnostic information based on such analysis.
- Anatomical Site: The anatomical site is the "treatment site (skin surface)," which aligns with a topical therapeutic device.
- Performance Studies: The performance studies focus on the device's ability to deliver the intended temperature and comply with safety standards, not on diagnostic accuracy or performance metrics like sensitivity or specificity.
In summary, the FROZEN C device is a therapeutic device used for applying cold therapy to the skin, not a device used for in vitro diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The FROZEN C, 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).
Product codes
GEH, MLY
Device Description
The FROZEN C Cryotherapy Device uses a compressed medical-grade liquid carbon dioxide as cryogen to deliver a topical refrigerant. Using the natural expansion of liquid CO2, it creates a cold spray of microcrystals delivered under pressure. The FROZEN C Cryotherapy Device consists of a cylindrical grip hand-piece, touchscreen console for operation and display, infrared temperature sensor, and a cylinder of compressed medical-grade carbon dioxide gas (sold separately). The touchscreen provides continuous monitoring by displaying the measured skin temperature, treatment duration by timer set, and residual volume of CO2 gas. The user applies the CO2 spray to the treatment site for 30-60 seconds at a distance of 7cm through a gradual circular motion of handpiece. Rapid cooling (thermal shock) occurs when the spray sublimates (passes directly from solid (ice) phase to gas phase) as it contacts the skin.
The contact point where the two laser pointers meet is designed to guide the appropriate distance from the skin surface where the skin temperature is measured. If the laser pointer is not required by use environment, it is easy to deactivate by using on/off button in the touch screen. The LED on the hand-piece flickers when the measured temperature drops below 5℃ and the device automatically shut down when the measured temperature stays below (0℃ for 1 seconds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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. ±2ºC.
The temperature of a treatment area on skin dropped to 2 ~ 4℃ within 30s as intended. The FROZEN C complies with voluntary standards for electrical safety and EMC testing.
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 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 C to its predicate device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 30, 2018
B.M. Tech. Worldwide Co., Ltd. % Mr. Dave Kim MTech Group 8310 Buffalo Speedway Houston, Texas 77025
Re: K182392
Trade/Device Name: Frozen C Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH, MLY Dated: August 24, 2018 Received: September 4, 2018
Dear Mr. 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 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the logo for the Food and Drug Administration (FDA). The logo consists of the letters "FDA" in a simple, sans-serif font. The letters are large and take up most of the image. The color of the letters is a light blue or gray, and the background is white.
Lona H. Chen -S 2018.10.30 13:55:41 -04'00'
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
2
Indications for Use
510(k) Number (if known) K182392
Device Name FROZEN C
Indications for Use (Describe)
The FROZEN C, 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).
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for BM Tech, which stands for Bio Medical Technology. The logo features a stylized, bold, blue "BM" with the word "TECH" in a lighter, faded gray behind it. Below the logo, the words "Bio Medical Technology" are written in a smaller, sans-serif font.
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: October 24, 2018
I. SUBMITTER
| Owner: | B.M.Tech Worldwide 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@bmtech21.com) / RA Team Manager |
| Official Correspondent: | Dave Kim (davekim@mtech-inc.net) |
| 8310 Buffalo Speedway, Houston, TX 77025 | |
| Tel.: +713-467-2607 |
II. DEVICE
| Trade/proprietary Name | FROZEN C |
|---|---|
| Classification Name | Unit, Cryosurgical, Accessories |
| Common/Usual Name | Cryotherapy Device |
| Regulation & product code | 21 CFR 878.4350 (GEH, MLY) |
| Regulatory Class | Class II |
| 510(k) Review Panel | General & Plastic Surgery |
III. PREDICATE DEVICE
| Trade/proprietary Name | CRYOFOS & Accessories |
|---|---|
| Manufacturer | CRYOFOS Medical Gmbh |
| 510(k) Number | K170810 |
| Regulation & product code | 21 CFR 878.4350 (GEH, MLY) |
| Regulatory Class | Class II |
| 510(k) Review Panel | General & Plastic Surgery |
Prescription Use only.
Predicate device has not been subject to a design-related recall.
4
Image /page/4/Picture/0 description: The image shows a logo for a company called BM Tech - Bio Medical Technology. The logo features a stylized letter 'B' in a dark blue color, with the letters 'M TECH' in a lighter blue color behind it. The words 'Bio Medical Technology' are written in a smaller font below the logo.
IV. DEVICE DESCRIPTION
The FROZEN C Cryotherapy Device uses a compressed medical-grade liquid carbon dioxide as cryogen to deliver a topical refrigerant. Using the natural expansion of liquid CO2, it creates a cold spray of microcrystals delivered under pressure. The FROZEN C Cryotherapy Device consists of a cylindrical grip hand-piece, touchscreen console for operation and display, infrared temperature sensor, and a cylinder of compressed medical-grade carbon dioxide gas (sold separately). The touchscreen provides continuous monitoring by displaying the measured skin temperature, treatment duration by timer set, and residual volume of CO2 gas. The user applies the CO2 spray to the treatment site for 30-60 seconds at a distance of 7cm through a gradual circular motion of handpiece. Rapid cooling (thermal shock) occurs when the spray sublimates (passes directly from solid (ice) phase to gas phase) as it contacts the skin.
The contact point where the two laser pointers meet is designed to guide the appropriate distance from the skin surface where the skin temperature is measured. If the laser pointer is not required by use environment, it is easy to deactivate by using on/off button in the touch screen. The LED on the hand-piece flickers when the measured temperature drops below 5℃ and the device automatically shut down when the measured temperature stays below (0℃ for 1 seconds.
V. INDICATIONS FOR USE
The FROZEN C, 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).
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 C
Subject device | CRYOFOS & Accessories
(K170810) |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use and
Intended use | The FROZEN C, 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 | The CRYOFOS and Accessories
indicated 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 |
| | to rehabilitative treatment (e.g.,
intermittent cold with stretch). | treatment (e.g., intermittent cold
with stretch). |
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Image /page/5/Picture/0 description: The image shows the logo for BM Tech Bio Medical Technology. The logo features a stylized "BM" in a bold, dark blue font, with "TECH" in a lighter gray font extending from the top right of the "M". Below the logo, the words "Bio Medical Technology" are written in a smaller, dark font.
| Product design | 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 | Pistol-grip hand-piece, electronic console for controlling operation, rechargeable battery, CO2 gas cylinder (sold separately) and | |
|---|---|---|---|
| Mobility | Housed in a mobile cart | Housed in a mobile cart | |
| Patient contact | None | None | |
| Energy delivered | Thermal energy via refrigerant spray | Thermal energy via refrigerant spray | |
| Cryogen | Compressed medical-grade carbon dioxide gas (Sold separately) | Compressed medical-grade carbon dioxide gas (Sold separately) | |
| Mechanism of action | CO2 gas is delivered to the treatment site at -78.5°C to effect thermal shock | CO2 gas is delivered to the treatment site at -78.5°C to effect thermal shock | |
| Working | |||
| principle | Treatment | ||
| duration | 30-60 seconds | 30-60 seconds | |
| Distance of | |||
| topical spray | 7 cm | 7 cm | |
| Treatment | |||
| temperature | 2-4°C | 2-4°C | |
| Measurement | Skin temperature by infrared | ||
| temperature sensor | Skin temperature by infrared | ||
| temperature sensor |
Substantial Equivalence
The predicate device is a legally marketed device. The subject device has the same intended use (Indications for Use) as the predicate device. There is demonstrated equivalency in basic product design and fundamental technology, indication for use, mechanism of action and working principle. The subject device and the predicate device have the same structural composition with minor differences. They all are consist 3 basic product components of hand-piece to deliver the CO2 spray, electronic console to control the operation and the compressed medical-grade CO2 gas cylinder (sold separately). The measured skin temperature is continuously displayed on the console (LCD) during treatment, same as the predicate device, but the colored indication on LCD screen is provided along with beep sound and the blue LED on hand-piece flashes when the skin surface temperature falls below 5℃. To improve protection function from the cold stress, coolant spray automatically shut down if the measured temperature drops below 0℃ for 1 seconds.
There are two differences between the predicate and subject devices. One of the differences is change of handpiece appearance from pistol grip to cylindrical grip. And the other difference is that our products do not use batteries, unlike comparison devices. However, these differences do not significantly affect safety and/or effectiveness.
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Image /page/6/Picture/0 description: The image shows a logo for a company called BM Tech - Bio Medical Technology. The logo features a stylized letter 'B' in a dark blue color, with the letters 'M TECH' in a lighter blue color behind it. The words 'Bio Medical Technology' are written in a smaller font below the logo.
VII. PERFORMANCE DATA
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. ±2ºC.
The temperature of a treatment area on skin dropped to 2 ~ 4℃ within 30s as intended. The FROZEN C 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 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 C to its predicate device
VIII. CONCLUSIONS
Based on the label and technology comparison as well as the performance testing, the subject device FROZEN C is substantially equivalent to the predicate device listed above.