(84 days)
No
The device description focuses on thermoelectric cooling and real-time temperature display, with no mention of AI or ML algorithms for control, analysis, or prediction. The performance studies are standard bench and clinical testing, not related to AI/ML model validation.
Yes.
The device is used to reduce pain, swelling, and inflammation, and is an adjunct to rehabilitative treatment, which are all therapeutic uses.
No
The device is indicated for the temporary reduction of pain, swelling, and inflammation, which are therapeutic actions rather than diagnostic ones. It measures skin temperature, but this is for controlling the cooling effect, not for diagnosing a medical condition.
No
The device description explicitly details hardware components (main device, Cooling-Nozzle, guard, filter, cartridge) and physical mechanisms (thermoelectric cooling) for delivering the intended therapeutic effect. It is a physical device with integrated software for control and display.
Based on the provided information, the TargetCool™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use of TargetCool™ is 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. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description focuses on delivering controlled cooling to the skin tissue for therapeutic purposes. It measures skin temperature in real-time to control the cooling process, but this is for monitoring and controlling the treatment, not for diagnosing a condition.
- Lack of Diagnostic Elements: There is no mention of the device analyzing biological samples (like blood, urine, tissue, etc.) or providing information for the diagnosis of a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. TargetCool™ does not fit this description.
N/A
Intended Use / Indications for Use
TargetCool™ 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
TargetCool™ is a handheld device that can deliver rapid, precise, and controlled cooling to the skin tissue. The TargetCool™ device consists of a main device Cooling-Nozzle, a guard, a filter, and a cartridge.
In Cooling mode, the main device produces controlled cooling based on thermoelectric cooling, which controls the temperature (2-4°C) of the targeted area. TargetCool™ displays the skin temperature measured in real time, the set cooling temperature and time, and the device status through the LCD display. Also, if the measured temperature is below -1 ℃ and lasts for more than 1 second, the status light blinks in blue with a beep sound.
The principle of pain relief through skin cooling is as the skin cools by spraying the cryogen onto the skin, the nerve conduction velocity (NCV) of the skin decreasing the pain threshold (PTH) and pain tolerance (PT). Through this mechanism, pain in the skin is relieved. The advances represented by TargetCool™ lie in the fact that the device executes this process in a precise, controlled, and rapid way.
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:
TargetCool™ complies with all applicable standards, including ISO 13485:2016, 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 only patient-contacting material on TargetCool™ is the guard, which is comprised of polycarbonate. The polycarbonate is the exact same material used in CryoVIVE, which was FDA-cleared under K203481. Therefore, the biocompatibility test is not applicable for the TargetCool™.
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.
TargetCool™ passed all testing and supports the claims of substantial equivalence and safe operation.
Clinical Testing:
Clinical publications and clinical data demonstrated the safety and effectiveness of the TargetCoolTM for treatment of pediatric patient.
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 contains the logo of the U.S. Food & 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.
July 22, 2022
RecensMedical Inc. Yeonui Lee Regulatory Affairs Manager 908, SK V1 center, 830 Dongtansunhwan-daero Hwaseong-si. Gyeonggi-do 18468 Korea. South
Re: K221234
Trade/Device Name: TargetCool Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: May 26, 2022 Received: May 26, 2022
Dear Yeonui Lee:
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/cdth/cfdocs/cfpmn/pmn.cfm 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 801); medical
1
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-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) 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-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,
for 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) K221234
Device Name TargetCool™
Indications for Use (Describe)
TargetCool™ 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 reatment (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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510(k) Summary
K221234
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 |
| Date of the summary preparation | May 23, 2022 |
| Contact person: | Yeonui Lee / Regulatory Affairs Manager
yui.lee@recensmedical.com |
| Office Correspondent: | Dave Kim, MBA
Mtech Group
7707 Fannin St. Ste 200, Houston, TX 77054
+1-713-467-2607 |
2. DEVICE NAME AND CLASSIFICATION
| Trade name: | TargetCool™ |
|---|---|
| Common name: | Cryosurgical Device |
| Classification name: | Cryosurgical Unit and Accessories |
| Classification Regulations: | 21 CFR 878.4350 / 21 CFR 878.4810 |
| Class: | Class II |
| Classification Panel: | General & Plastic Surgery |
| Product code: | GEH, MLY |
3. PRIMARY PREDICATE DEVICE
| 510(k) Number: | K220674 |
|---|---|
| Trade name: | TargetCool |
| Classification name: | Cryosurgical Unit and Accessories |
| Classification Regulations: | 21 CFR 878.4350 |
| Class: | Class II |
| Classification Panel: | General & Plastic Surgery |
| Product code: | GEH, MLY |
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4. INDICATIONS FOR USE
TargetCool™ 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. DEVICE DESCRIPTION
TargetCool™ is a handheld device that can deliver rapid, precise, and controlled cooling to the skin tissue. The TargetCool™ device consists of a main device Cooling-Nozzle, a guard, a filter, and a cartridge.
In Cooling mode, the main device produces controlled cooling based on thermoelectric cooling, which controls the temperature (2-4°C) of the targeted area. TargetCool™ displays the skin temperature measured in real time, the set cooling temperature and time, and the device status through the LCD display. Also, if the measured temperature is below -1 ℃ and lasts for more than 1 second, the status light blinks in blue with a beep sound.
The principle of pain relief through skin cooling is as the skin cools by spraying the cryogen onto the skin, the nerve conduction velocity (NCV) of the skin decreasing the pain threshold (PTH) and pain tolerance (PT). Through this mechanism, pain in the skin is relieved. The advances represented by TargetCool™ lie in the fact that the device executes this process in a precise, controlled, and rapid way.
6. PERFORMANCE DATA
The Company's Performance Data for TargetCool™ is as follows:
Bench Testing
TargetCool™ complies with all applicable standards, including ISO 13485:2016, 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 only patient-contacting material on TargetCool™ is the guard, which is comprised of polycarbonate. The polycarbonate is the exact same material used in CryoVIVE, which was FDA-cleared under K203481. Therefore, the biocompatibility test is not applicable for the TargetCool™.
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.
TargetCool™ passed all testing and supports the claims of substantial equivalence and safe operation.
Clinical Testing
Clinical publications and clinical data demonstrated the safety and effectiveness of the TargetCoolTM for treatment of pediatric patient.
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7. SUBSTANTIAL EQUIVALENCE
The comparison chart below provides evidence to support the equivalence determination between TargetCool™ and the predicate device (K220674) with respect to intended use, technological characteristics and principles of operation. TargetCool™ shares the same indications for use, device operation, technical and functional capabilities, and therefore is substantially equivalent to the predicate device.
| Product Name | TargetCool™
(Subject Device) | TargetCool
(K220674) | Comparison |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for
Use
/ Intended Use | TargetCool™ 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). | TargetCool™ 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). | Same |
| Component | Main system, Trigger, LCD Display,
Cooling-Nozzle, Guard, Filter,
Cartridge | Main system, Trigger, LCD Display,
Cooling-Nozzle, Guard, Filter,
Cartridge | Same |
| Mechanism of
Action | The unit blows very low-temperature
gas at temperature and time settings,
onto the desired treatment area | The unit blows very low-temperature
gas at temperature and time settings,
onto the desired treatment area | Same |
| Cryogen Type | CO2 | CO2 | Same |
| Temperature | Reaching 2-4 °C within 5 sec | Reaching 2-4 °C within 5 sec | Same |
| Treatment
Duration | 060 sec | 060 sec | Same |
| Gas Volume | 65g cartridge | 65g cartridge | Same |
| Safety feature | Alarm and status light blinking if the
temperature of the skin is determined to
be less than -1 °C for 1 second. | Alarm and status light blinking if the
temperature of the skin is less than -
1 °C for 1 second. | Same |
TargetCool™ is the same as the device cleared in K220674. No changes have been made to the device to change the contraindication. TargetCool™, the subject device, is equivalent to the predicate device.
8. CONCLUSION
TargetCool™ and the legally marketed predicate devices have the same intended use, Indications for Use statement and the technological characteristics. While the contraindication differs between the two systems. Clinical literatures and clinical data demonstrate that TargetCool™ is as safe and effective as the legally marketed predicate devices and that TargetCool™ does not raise any different questions of safety or effectiveness than the predicate. On this basis and in accordance with 21 CFR$ 807.100(b), TargetCool™ is substantially equivalent to the predicate device.