(111 days)
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
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.
The provided text describes the 510(k) premarket notification for the TargetCool™ device. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria with performance metrics, sample sizes, or ground truth establishment relevant to AI/ML device evaluations.
The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety. The performance data section refers to bench testing (compliance with standards, biocompatibility, hazard analysis) and mentions "Clinical publications and clinical data demonstrated the safety and effectiveness of the TargetCoolTM for treatment of pediatric patient," but it does not provide specifics about these clinical studies in the context of acceptance criteria.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's what can be inferred and what is missing:
1. A table of acceptance criteria and the reported device performance:
| Feature/Test | Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|---|
| Cooling Mode | Temperature of 2-4 °C within 5 seconds | Achieves 2-4 °C within 5 seconds |
| Boosting Mode | Temperature of 2-4 °C, sustained for 3-4 minutes (for saline solution) | Achieves 2-4 °C, sustained for 3-4 minutes (for saline solution) |
| Freezing Mode (CO2 cryoablation) | Temperature of -79°C (using CO2) | Achieves -79°C (using CO2) |
| Gas dispensing rate (Freezing Mode) | 0.578 g/sec | 0.578 g/sec |
| Gas Volume | 65g cartridge capacity | Uses 65g cartridge |
| Safety Feature (Temperature monitoring) | Alarm and status light blinking if skin temperature is determined to be less than -1 °C for 1 second. | Alarm and status light blinks if skin temp is |
§ 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.