(405 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.
The Dermal Cooling System is further indicated to minimize pain, inflammation, and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections.
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. The Dermal Cooling System is further indicated to minimize pain, inflammation, and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections. 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Dermal Cooling System:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| System Performance Test | System is able to hold the internal coldplate temperature to -16.0°C ± 0.5°C for 20 minutes | Passed |
Detailed Information about the Study:
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "No other performance testing was performed for the subject device for this Traditional 510(k)..." and "No preclinical or clinical testing was performed." The only reported test is a "System Performance Test" described as "Bench testing." This implies the "test set" for this specific performance criteria was likely a single or a small number of physical devices tested in a lab setting, rather than a clinical dataset. No information on data provenance (country of origin, retrospective/prospective) is applicable as it's not a clinical study involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. The reported test is a bench test, and the "ground truth" is established by the device's ability to maintain a specific coldplate temperature, not by expert interpretation of clinical data.
4. Adjudication Method for the Test Set:
Not applicable, as it's a bench test against an objective temperature criterion.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states, "No preclinical or clinical testing was performed."
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
This question is not applicable to the Dermal Cooling System. This device is a physical cryosurgical instrument, not an AI algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not relevant.
7. The Type of Ground Truth Used:
The ground truth for the "System Performance Test" was the pre-defined target temperature range for the internal coldplate (-16.0°C ± 0.5°C) maintained over a specific duration (20 minutes). This is a physical performance specification, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set:
Not applicable. There is no mention of a training set as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set mentioned or implied.
§ 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.