(84 days)
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 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 provided document is a 510(k) Summary for the medical device TargetCool™ (K221234). It compares this device to a predicate device, also named TargetCool (K220674).
Here's an analysis of the acceptance criteria and the study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents a comparison between the subject device (TargetCool™ K221234) and its predicate (TargetCool K220674) to establish substantial equivalence. While explicit acceptance criteria are not tabulated with numerical performance, the comparison acts as a de facto set of criteria since the subject device is stated to be "Same" as the predicate for all listed characteristics.
| Acceptance Criteria (from Predicate Device K220674) | Reported Device Performance (TargetCool™ K221234) | Satisfied? |
|---|---|---|
| Indications for Use: 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). | 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). | Yes |
| Component: Main system, Trigger, LCD Display, Cooling-Nozzle, Guard, Filter, Cartridge | Main system, Trigger, LCD Display, Cooling-Nozzle, Guard, Filter, Cartridge | Yes |
| 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 | Yes |
| Cryogen Type: CO2 | CO2 | Yes |
| Temperature: Reaching 2-4 °C within 5 sec | Reaching 2-4 °C within 5 sec | Yes |
| Treatment Duration: 0~60 sec | 0~60 sec | Yes |
| Gas Volume: 65g cartridge | 65g cartridge | Yes |
| Safety feature: Alarm and status light blinking if the temperature of the skin is 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. | Yes |
Study Proving Device Meets Acceptance Criteria:
The document states: "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."
This indicates that the "study" proving the device meets the acceptance criteria is primarily a direct comparison and declaration of sameness to a previously cleared device (K220674), rather than new, independent performance testing for the subject device against the listed criteria.
2. Sample size used for the test set and the data provenance
The document does not describe a separate "test set" in the context of a clinical study for the K221234 device. Instead, it relies on the predicate device's clearance. It mentions "Clinical publications and clinical data demonstrated the safety and effectiveness of the TargetCoolTM for treatment of pediatric patient" but does not provide details on the sample size or provenance of this data. Given the context of establishing substantial equivalence to an identical device, new clinical testing specific to K221234 for comparing against acceptance criteria is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new test set for the K221234 device is described, as the substantial equivalence is based on the device being functionally identical to the predicate (K220674). The ground truth for the safety and effectiveness of the predicate device (and thus implicitly the subject device) would have been established during its regulatory review, likely based on scientific principles of cryotherapy and any historical clinical data available for similar devices, but this document does not provide details about that.
4. Adjudication method for the test set
Not applicable. There is no new "test set" with expert adjudication described for K221234 in this document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a cryosurgical unit, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm, so standalone algorithm performance testing is not relevant.
7. The type of ground truth used
The ground truth for the functionality and safety of the subject device (K221234) is established by its direct equivalence to the predicate device (K220674), which itself would have been cleared based on a combination of bench testing, adherence to standards (electrical safety, EMC, biocompatibility), and existing clinical literature/data for cryotherapy devices. The statement "Clinical publications and clinical data demonstrated the safety and effectiveness of the TargetCoolTM" refers to the scientific basis for the predicate device's (and thus the subject device's) application.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
§ 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.