(167 days)
No
The device description focuses on the physical mechanism of cooling/freezing using CO2 gas and thermoelectric cooling, with temperature monitoring and basic alerts. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
A therapeutic device is one that treats or alleviates a disease, injury, or condition. This device, the CryoVIVE, is indicated for the surgical destruction of various skin lesions and for the temporary reduction of pain, swelling, and inflammation, thereby treating these conditions.
No
The device is indicated for the surgical destruction of tissue or temporary reduction of pain, swelling, inflammation, and hematoma. It treats conditions rather than diagnosing them. Although it displays skin temperature and has an LED/beep for low temperature, these are feedback mechanisms for treatment, not diagnostic functions.
No
The device description clearly outlines a handheld hardware device that delivers cryogenic gases and utilizes thermoelectric cooling, including components like nozzles, guide tips, filters, and CO2 cartridges. It also has an LCD screen and LED indicators. This is not a software-only device.
Based on the provided information, the CryoVIVE is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- CryoVIVE's Function: The CryoVIVE is a device that applies extreme cold directly to the skin tissue on the body (in vivo) for therapeutic purposes (surgical destruction of tissue or temporary reduction of pain/swelling). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes the direct application of cold to the skin for treating various skin conditions and injuries.
- Device Description: The description details a handheld device that delivers cold temperatures to the skin, not a device for analyzing biological samples.
Therefore, the CryoVIVE falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CryoVIVE(Freezing mode) is indicated for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures
- Molluscum Contagiosum
- Skin Tags
- Actinic Keratosis
- Lentigo
- Verruca Plana
- Verruca Vulgaris
- Verruca Lesions
- Genital Lesions
- Seborrheic Keratosis
The CryoVIVE(Cooling mode) 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 CryoVIVE is a handheld device that delivers rapid, precise and controlled cooling temperature to the skin tissue with the use of CO2 gas cartridge. The CryoVIVE consists of main system, nozzles(Cooling nozzle and Freezing nozzle), Guide tip, filter, and CO2 cartridge. The CryoVIVE offers two treatment modes, which can be changed by using different nozzles. In cooling mode, the main device produces controlled cooling based on thermoelectric cooling, which control the temperature (2-4°C) of targeted area. In freezing mode, the main device delivers the CO2 gas of extreme cold temperature (-79°C) , which causes the surgical destruction of target tissue. The CryoVIVE displays the skin temperature measured in real time, the set cooling temperature and time, and the device status through the LCD screen. Also, if the temperature below -1°C lasts for more than 1 second, the front LED blinks in blue with a beep sound.
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)
Bench Testing: The CryoVIVE complies with all applicable standards, including ISO 13485:2003, IEC 60601-1 for electrical safety and IEC 60601-1-2 for electromagnetic compatibility. Biocompatibility (ISO 10993) was also performed to demonstrate conformance with established industry standards. The device Hazard analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the specifications have met the acceptance criteria of each module and interaction of processes. The CryoVIVE passed all testing and supports the claims of substantial equivalence and safe operation.
Clinical Testing: No performance data has been provided since the CryoVIVE is equivalent to the previously cleared predicate devices with no new issues regarding safety and effectiveness.
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.
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 13, 2021
Recens Medical Inc. % Dave Kim President Mtech Group 7707 Fannin Street Ste 200-V111 Houston, Texas 77054
Re: K203481
Trade/Device Name: CryoVIVE Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH, MLY Dated: March 15, 2021 Received: March 15, 2021
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.
1
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 (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-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Leam (https://www.fda.gov/training-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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE website assistance/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
2
Indications for Use
510(k) Number (if known) K203481
Device Name CryoVIVE
Indications for Use (Describe)
The CryoVIVE(Freezing mode) is indicated for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures
- Molluscum Contagiosum
- Skin Tags
- Actinic Keratosis
- Lentigo
- Verruca Plana
- Verruca Vulgaris
- Verruca Lesions
- Genital Lesions
- Seborrheic Keratosis
The CryoVIVE(Cooling mode) 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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3
510(k) Summary K203481
5/12/2021
1. ADMINISTRATIVE INFORMATION
| Manufacturer Name | Recensmedical Inc.
908, SK V1 center, 830 Dongtansunhwan-
daero, Hwaseong-si, Gyeonggi-do,
Republic of Korea |
|-----------------------|------------------------------------------------------------------------------------------------------------------------|
| Phone: | +82 31 8043 3064 |
| Fax: | +82 31 630 2092 |
| Contact person: | Yeonui Lee / Regulatory Affairs Manager
yui.lee@recensmedical.com |
| Office Correspondent: | Dave Kim, MBA
Mtech Group
7505 Fannin St. Ste 610, Houston, TX 77054
+1-713-467-2607
davekim@mtech-inc.net |
2. DEVICE NAME AND CLASSIFICATION
| Trade name: | CryoVIVE |
|---|---|
| Common name : | Cryosurgical Device |
| Classification name: | Cryosurgical Unit and Accessories |
| Classification Regulations: | 21 CFR 878.4350 |
| Class: | Class II |
| Classification Panel: | General & Plastic Surgery |
| Product code: | GEH, MLY |
3. PRIMARY PREDICATE DEVICE
| 510(k) Number: | K190407 |
|---|---|
| Trade name: | CryoLab |
| Classification name: | Cryosurgical Unit and Accessories |
4
| Classification Regulations: | 21 CFR 878.4350 |
|---|---|
| Class: | Class II |
| Classification Panel: | General & Plastic Surgery |
| Product code: | GEH |
4. SECOND PREDICATE DEVICE
| 510(k) Number: | K170810 |
|---|---|
| Trade name: | Cryofos |
| Classification name: | Cryosurgical Unit and Accessories |
| Classification Regulations: | 21 CFR 878.4350 |
| Class: | Class II |
| Classification Panel: | General & Plastic Surgery |
| Product code: | GEH, MLY |
5. REFERENCE DEVICE INFORMATION
| 510(k) Number: | K172769 |
|---|---|
| Trade name: | CryOmega Flexx |
| Classification name: | Cryosurgical Unit and Accessories |
| Classification Regulations: | 21 CFR 878.4350 |
| Class: | Class II |
| Classification Panel: | General & Plastic Surgery |
| Product code: | GEH |
6. INDICATIONS FOR USE
The CryoVIVE(Freezing mode) is indicated for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures
- Molluscum Contagiosum
- Skin Tags
- Actinic Keratosis
- Lentigo
- Verruca Plana
- Verruca Vulgaris
5
- Verruca Lesions
- Genital Lesions
- Seborrheic Keratosis
The CryoVIVE(Cooling mode) 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).
7. DEVICE DESCRIPTION
The CryoVIVE is a handheld device that delivers rapid, precise and controlled cooling temperature to the skin tissue with the use of CO2 gas cartridge. The CryoVIVE consists of main system, nozzles(Cooling nozzle and Freezing nozzle), Guide tip, filter, and CO2 cartridge. The CryoVIVE offers two treatment modes, which can be changed by using different nozzles. In cooling mode, the main device produces controlled cooling based on thermoelectric cooling, which control the temperature (2-4°C) of targeted area. In freezing mode, the main device delivers the CO2 gas of extreme cold temperature (-79°C) , which causes the surgical destruction of target tissue. The CryoVIVE displays the skin temperature measured in real time, the set cooling temperature and time, and the device status through the LCD screen. Also, if the temperature below -1°C lasts for more than 1 second, the front LED blinks in blue with a beep sound.
8. PERFORMANCE DATA
The Company's Performance Data for the CryoVIVE is as follows:
Bench Testing
The CryoVIVE complies with all applicable standards, including ISO 13485:2003, IEC 60601-1 for electrical safety and IEC 60601-1-2 for electromagnetic compatibility.
Biocompatibility (ISO 10993) was also performed to demonstrate conformance with established industry standards. The device Hazard analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the specifications have met the acceptance criteria of each module and interaction of processes.
The CryoVIVE passed all testing and supports the claims of substantial equivalence and safe operation.
Clinical Testing
No performance data has been provided since the CryoVIVE is equivalent to the previously cleared predicate devices with no new issues regarding safety and effectiveness.
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9. SUBSTANTIAL EQUIVALENCE
The comparison chart below provides evidence to facilitate the substantial equivalence determination between the CryoVIVE and the predicate devices (K190407, K172769) as well as the reference device (K170810) with respect to intended use, technological characteristics and principles of operation. The CryoVIVE shares the same indications for use, device operation, technical and functional capabilities, and therefore is substantially equivalent to both devices.
CryoVIVE, the subject device, the predicate and the reference devices are all cryosurgical instruments ; these devices can be used to cool tissue or freeze tissue in dermatologic procedures of the skin. Since the CryoVIVE has two operating modes: Cooling mode and Freezing mode, the predicate device and the reference device were selected and compared for freezing mode and cooling mode, respectively.
| Product Name | CryoVIVE
(K203481) | Cryolab
(K190407) | CryOmega Flexx
(K172769) |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use
/ Intended Use | The CryoVIVE(Freezing
mode) intended for the
surgical destruction of target
tissue by applying cryogenic
gases at extreme low
temperatures
- Molluscum Contagiosum
- Skin Tags
- Actinic Keratosis
- Lentigo
- Verruca Plana
- Verruca Vulgaris
- Verruca Lesions
- Genital Lesions
- Seborrheic Keratosis | The CryoLab® is intended
for the surgical destruction
of target tissue by applying
cryogenic gases at extreme
low temperatures
• Molluscum Contagiosum
• Skin Tags
• Actinic Keratosis
• Lentigo
• Verruca Plana
• Verruca Vulgaris
• Verruca Lesions
• Genital Lesions
• Seborrheic Keratosis | The CryOmega Flexx is
intended for the surgical
destruction of tissue of
target tissue by applying
cryogenic gases at
extreme low
temperatures.
The List below shows
examples of the types of
lesions that may be
treated:
• Molluscum Contagiosum
• Skin Tags
• Actinic Keratosis
• Lentigo
• Verruca Plana
• Verruca Vulgaris
• Verruca Plantaris
• Genital Lesions
• Seborrheic Keratosis |
| Component | Main system, Control button,
LCD, Nozzle(Cooling and
Freezing), Guide tip, filter,
CO2 cartridge | Housing, Filter, O-rings,
Gas(CO2 or N2O) Cylinder | Housing, spray tip
applicator, gas cartridge
(N2O) with internal valve |
| Mechanism of | Cryogen,CO2 is delivered to | Cryogen, N2O or CO2 is | N2O gas is delivered to |
[CryoVIVE - Freezing mode]
7
| action | the treatment site to effect
cellular destruction | delivered to the treatment
site to effect cellular
destruction | the treatment site at -89°C
to effect cellular
destruction |
|------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Temperature | CO2 (-79°C) | N2O (-89°C) , CO2 (-79°C) | N2O (-89°C) |
| Gas Volume | 60g cartridge | 20 oz cylinders | 16g or 25g cartridge |
| Gas dispensing
rate | 0.581 g/sec | Unidentified | Unidentified |
| Tissue damage | Cell necrosis occurs only
inside the ice ball (Ice ball
size is margin(13mm)3mm)
freeze beyond the lesion) | Cell necrosis occurs only
inside the ice ball (Ice ball
size is margin(1
freeze beyond the lesion) | Cell necrosis occurs only
inside the ice ball (Ice ball
size is margin (1~3mm)
freeze beyond the lesion) |
Cryoablation is the fundamental technological principle for the freezing mode of the subject device, CryoVIVE, and the predicate devices (Cryolab and CryOmega Flexx). The subject and marketed predicate devices are used to ablate unwanted tissue by application of extreme cold. The technological differences that exist between the subject device and the predicate devices. However, these differences do not significantly affect safety and/or effectiveness.
[CryoVIVE – Cooling mode]
| Product Name | CryoVIVE
(Subject Device) | CRYOFOS
(K170810) | Comparison |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Indications for
Use
/ Intended Use | The CryoVIVE(Cooling
mode) 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
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 treatment (e.g.,
intermittent cold with stretch). | The intended use of both
devices are similar. |
| Component | Main system, Control button,
LCD, Nozzle(Cooling and
Freezing), Guide tip, filter,
CO2 cartridge | Pistol grip handpiece, control
console, battery and CO2 gas
cylinder | Different (the CryoVIVE
is a handheld device
using CO2 cartridge
while the Cryofos uses a
gas cylinder.) |
| Mechanism of
action | The unit blows very low-
temperature gas at | The unit blows very low-
temperature air onto the | same |
8
| | temperature and time
settings, onto the desired
treatment area | desired treatment area | |
|---------------------|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|---------|
| Cryogen Type | CO2 | CO2 | same |
| Temperature | Reaching 2-4 °C within 5 sec | Reaching 2-4 °C within 30 sec | Similar |
| Treatment duration | 060 sec | 3060 sec | Similar |
| Gas dispensing rate | 0.148g/sec | Unidentified | |
| Safety feature | Alarm and LED blinking if
the temperature of the skin
is -1 °C or less for 1
second. | CRYOFOS shuts down if the
temperature of the skin is
less than -1 °C for 1 second. | Similar |
The Cooling mode of CryoVIVE is substantially equivalent in intended use, principles of operation, and performance temperature to Cryofos (K170810) and raises no new issues of safety or effectiveness. The only difference to the marketed reference is the type of a gas container. The performance benchmark testing confirmed the temperature of 2~4 °C is reached by the subject device while the lowest temperature is -79 °C for the subject device and -78.5 °C for the predicate device. The subject device has a warning alarm when the temperature of the skin is -1 °C or less for 1 second. The principle of pain relief through skin cooling is as follows. As the skin cools by spraying the cryogen onto the skin, the nerve conduction velocity (NCV) of the skin decreases, increasing the Pain threshold (PTH) and pain tolerance (PTO)1. Through this mechanism, pain in the skin is relieved.
The type of a gas container does not affect the pain relief application. It does not raise any new questions of safety and effectiveness. It was proved by the performance test that the temperature range at the target skin area was the same as that of the predicate device and the reference device. Therefore, CryoVIVE, the subject device, is equivalent to the predicate device and the reference device.
8. CONCLUSION
The CryoVIVE and the legally marketed predicated devices have intended use and Indications for Use statement. While the technological characteristics differ between the two systems, the differences are minor. Performance testing data established that the CryoVIVE is safe and effective as the leqally marked predicate devices and that the CryoVIVE does not raise any different questions of safety and effectiveness than the predicate. On this basis and in accordance with 21 CFRS 807.100(b), the CryoVIVE is substantially equivalent to the predicate device and the reference device.