(308 days)
The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures.
When the Dermal Cooling System is used with the R2 Dermabrasion Tips, the intended use includes general dermabrasion, scar revision, acne scar revision, and tattoo removal.
The Dermal Cooling System is intended to be used by trained healthcare professionals.
The Dermal Cooling System is a cryosurgical device used to cool the skin, without the use of cryogenic gases or liquids, for the removal of benign skin lesions and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. Surface contact cooling is achieved using a thermoelectric cooler (TEC), with an integrated aluminum plate, to lower the temperature of the skin. For dermabrasion, the Dermal Cooling System handpiece is intended to serve as a handle to facilitate manual movement of the R2 Dermabrasion Tips.
The R2 Dermabrasion Tips are optional accessories for the Dermal Cooling System that may be attached to the distal end of the handpiece to facilitate manual dermabrasion. The R2 Dermabrasion Tips may be used with a commercially available topical or water to facilitate movement of the handpiece across the treatment area.
This document describes a 510(k) premarket notification for the Dermal Cooling System and its accessory, R2 Dermabrasion Tips. The primary purpose of the submission is to expand the indications for use of the Dermal Cooling System to include general dermabrasion, scar revision, acne scar revision, and tattoo removal when used with the R2 Dermabrasion Tips.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Test Method/Requirement | Acceptance Criteria | Results |
|---|---|---|---|
| Accessories Validation | |||
| Dermabrasion Performance Test | 3 subjects tested with the R2 Dermabrasion Tips (20 Amps EDM) and 3 subjects tested with (80 Amps EDM) | No unexpected side effects observed immediately post test, and 2-days post test | Passed |
| Thermal Insulation Test | 3 subjects tested with the R2 Dermabrasion Tips (20 Amps EDM and 80 Amps EDM) | Skin temperature to remain at or above +20 °C for the full duration | Passed |
2. Sample Size Used for the Test Set and Data Provenance
- Dermabrasion Performance Test: 6 subjects (3 at 20 Amps EDM, 3 at 80 Amps EDM)
- Thermal Insulation Test: 6 subjects (3 at 20 Amps EDM, 3 at 80 Amps EDM)
- Data Provenance: The document does not specify the country of origin of the data. It appears to be a prospective study as tests were conducted on subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish a ground truth for the test set. The acceptance criteria for the performance tests (e.g., "no unexpected side effects observed") would likely have been evaluated by the researchers or medical staff conducting the study.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The study focused on the performance of the device (Dermal Cooling System with R2 Dermabrasion Tips) itself, not on the improvement of human readers with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This device is not an AI algorithm. It is a physical medical device (Dermal Cooling System with R2 Dermabrasion Tips). The performance tests described demonstrate the device's physical functionality and safety, not an algorithm's standalone performance.
7. The Type of Ground Truth Used
The ground truth for the performance tests was based on direct observation of subjects for:
- Absence of unexpected side effects (Dermabrasion Performance Test).
- Maintenance of skin temperature above a certain threshold (Thermal Insulation Test).
This is akin to objective clinical observations rather than established "ground truth" in the context of image analysis or diagnostic AI.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI/ML device that requires a training set.
§ 878.4340 Contact cooling system for aesthetic use.
(a)
Identification. A contact cooling system for aesthetic use is a device that is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption of adipocyte cells intended for non-invasive aesthetic use.(b)
Classification. Class II (special controls). The special controls for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.