(111 days)
No
The device description focuses on thermoelectric cooling and real-time temperature display, with no mention of AI or ML for decision-making or analysis.
Yes.
The device is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma, and for the surgical destruction of target tissue, which are all therapeutic applications.
No
The device is indicated for therapeutic purposes (reduction of pain, swelling, inflammation, hematoma, and surgical destruction of target tissue) rather than for diagnosing a condition or disease.
No
The device description explicitly states that TargetCool™ is a handheld device consisting of hardware components such as a main device, nozzle, guard, filter, and cartridge, and it utilizes thermoelectric cooling. This indicates it is a physical device, not software only.
Based on the provided information, the TargetCool™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The definition of an IVD involves testing samples like blood, urine, or tissue outside of the body to provide information about a person's health.
- TargetCool™ is applied directly to the skin. The device description and intended use clearly state that TargetCool™ is a handheld device that delivers cooling directly to the skin tissue for therapeutic purposes (pain reduction, tissue destruction). It does not involve the analysis of any biological specimens.
Therefore, TargetCool™ falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
TargetCool™ (Cooling mode / Boosting 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).
TargetCool™ (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
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, nozzle, a guard, a filter, and a cartridge.
The main device produces controlled cooling based on thermoelectric cooling, which controls the temperature of the targeted area. TargetCool™ displays the skin temperature measured in real time, the set cooling temperature 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 decreases, increasing 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.
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 contains 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.
June 22, 2023
RecensMedical, Inc. Lee Yeonui Regulatory Affairs Manager #507, #908, SK V1 center, 830 Dongtansunhwan-daero Hwaseong-si, Gyeonggi-do 18468 Korea. South
Re: K230599
Trade/Device Name: TargetCool™ Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH, MLY Dated: Mav 26, 2023 Received: May 26, 2023
Dear Lee Yeonui:
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
1
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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
Image /page/1/Picture/6 description: The image shows the name "Mark Trumbore -S" in a large font on the left side of the image. On the right side of the image, it says "Digitally signed by Mark Trumbore -S" and "Date: 2023.06.22 11:57:21 -04'00'". The text on the right side of the image is smaller than the text on the left side of the image.
Mark Trumbore Assistant Director, THT4A1: Robotically-Assisted Surgical Devices Team 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) K230599
Device Name TargetCool™
Indications for Use (Describe)
TargetCool™ (Cooling mode / Boosting 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).
TargetCool™ (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
| 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
1. ADMINISTRATIVE INFORMATION
| Manufacturer Name | RecensMedical, Inc. |
|---|---|
| #507, #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 | March 01, 2023 |
| Contact person: | Yeonui Lee / Regulatory Affairs Manager |
| yui.lee@recensmedical.com |
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: | K203481 |
|---|---|
| Trade name: | CryoVIVE |
| Classification name: | Cryosurgical Unit and Accessories |
| Classification Regulations: | 21 CFR 878.4350 |
| Class: | Class II |
| Classification Panel: | General & Plastic Surgery |
| Product code: | GEH, MLY |
4. SECOND PRIDICATE DEVICE
510(k) Number: Trade name: Classification name:
K221234 TargetCool™ Cryosurgical Unit and Accessories
4
Image /page/4/Picture/0 description: The image shows the logo for "TargetCool" with the word "Target" in a bright blue color and the word "Cool" in a light gray color. The letters are in a sans-serif font. There is a trademark symbol in superscript next to the word "Cool".
| Classification Regulations: | 21 CFR 878.4350 |
|---|---|
| Class: | Class 11 |
| Classification Panel: | General & Plastic Surgery |
| Product code: | GEH, MLY |
5. INDICATIONS FOR USE
TargetCool™ (Cooling mode, Boosting) 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™ (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
6. 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, nozzle, a guard, a filter, and a cartridge.
The main device produces controlled cooling based on thermoelectric cooling, which controls the temperature of the targeted area. TargetCool™ displays the skin temperature measured in real time, the set cooling temperature 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 decreases, increasing 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.
5
7. 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.
8. 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 TM
(Subject Device) | TargetCool TM
(K221234) | Comparison |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for Use / Intended Use | TargetCoolTM 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). | TargetCoolTM 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, Control button, LCD,
Cooling nozzle, Freezing nozzle,
Cooling guard, filter, CO2 cartridge
and Boosting accessories (Boosting
nozzle, a Boosting guard, and a | Main system, Trigger, LCD Display,
Cooling-Nozzle, Guard, Filter, CO2
Cartridge | Difference |
[TargetCool™-Cooling mode, Boosting mode]
6
| Boosting Container). | ||||
|---|---|---|---|---|
| Mechanism of | ||||
| Action | The unit blows very low-temperature | |||
| gas and cold-water 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 | Similar | |||
| Mode type | Cooling Mode, Boosting Mode | Cooling mode | Difference | |
| Cryogen Type | CO2, Cold-water (Saline solution) | CO2 | Same | |
| Temperature | 2-4 °C within 5 sec | 2-4 °C within 5 sec | Same | |
| Treatment | ||||
| Duration | Cooling Mode | Continuous (0 sec) | ||
| PL (2 sec pre-set) | ||||
| 1~60sec | 0~60 sec | Similar | ||
| Boosting Mode | 3~4 min | |||
| 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 determined to | ||||
| be less than -1 °C for 1 second. | Same |
The Cooling mode & Boosting mode of TargetCool™ is equivalent in intended use, principles of operation, and performance temperature to TargetCool™ (K221234) and raises no new issues of safety or effectiveness.
The differences are the Boosting mode and the Boosting accessories for the Boosting mode.
In Boosting mode, saline cooled by CO2 gas is sprayed onto the skin. The saline solution is used for the purpose of keeping the skin temperature constant at 2-4℃ for 3-4 minutes and for safety purposes to prevent the skin temperature from dropping below freezing.
Cooling mode uses CO2 gas and Boosting mode uses cold-water, but the temperature of Cooling mode and Boosting mode is the same (2~4℃). Therefore, the difference does not raise new questions of safety and effectiveness
| Product Name | TargetCool™
(Subject Device) | CryoVIVE
(K203481) | Comparison |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Indications for
Use
/ Intended Use | TargetCool™ are 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 CryoVIVE are 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 | Same |
| | Component | Main system, Control button, LCD,
Cooling nozzle, Freezing nozzle,
Cooling guard, filter, CO2 cartridge
and Boosting accessories (Boosting
Nozzle, a Boosting guard, and a | Main system, Control button, LCD,
Nozzle (Cooling and Freezing), Guide
tip, filter, CO2 cartridge |
[TargetCoolTM-Freezing mode]
7
| Boosting Container). | |||
|---|---|---|---|
| Mechanism of | |||
| Action | Cryogen, CO2 is delivered to the | ||
| treatment site to effect cellular | |||
| destruction | Cryogen, CO2 is delivered to the | ||
| treatment site to effect cellular | |||
| destruction | Same | ||
| Temperature | CO2 (-79°C) | CO2 (-79°C) | Same |
| Gas dispensing | |||
| rate | 0.578 g/sec | 0.578 g/sec | Same |
| Gas Volume | 65g cartridge | 65g cartridge | Same |
| Tissue damage | Cell necrosis occurs only inside the ice | ||
| ball | Cell necrosis occurs only inside the ice | ||
| ball | Same |
Cryoablation is the fundamental technological principle for the freezing mode of the subject device, TargetCool™, and the predicate devices (CryoVIVE).
The Freezing mode of TargetCool™ is equivalent in intended use, principles of operation, and performance temperature to TargetCool™ (K221234) and raises no new issues of safety or effectiveness. The only difference is that the freezing nozzle's length is shortened and the guard is not inserted during the procedure in the freezing mode. Because of this the device can be placed closer to the lesion, so that it can be applied to smaller lesion sizes. However, these differences do not significantly affect safety and/or effectiveness.
8. CONCLUSION
TargetCool™ and the legally marketed predicate devices have the same intended use, Indications for Use statement and the technological characteristics. While the technological characteristics differ between the two systems, the differences are minor. Performance testing data established that the TargetCool™ is safe and effective as the legally marked predicate devices and that the TargetCool™ does not raise any different questions of safety and effectiveness than the predicate.
On this basis and in accordance with 21 CFR$ 807.100(b), TargetCool™ is substantially equivalent to the predicate device.