(141 days)
The CoolSculpting System is a skin cooling or heating device is indicated for cold-assisted lipolysis (breakdown of fat) of the submental area, thigh, abdomen, and flank, or "love handles" in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the submental area, thigh, abdomen and flank.
Cooling with the device may also be used to minimize pain and thermal injury during laser and dermatological treatments and act as a local anesthetic for procedures that induce minor local discomfort.
The CoolSculpting System is also indicated for use to provide localized thermal therapy (hot or cold) to minimize pain post-trauma and post-surgery, and for temporary relief of minor aches, pains, and muscle spasms. The optional massage function can also be used for the temporary relief of minor muscle aches, pain, and spasm and for temporary improvement in local circulation and temporary reduction in the appearance of cellulite.
The ZELTIO Pretreatment Skin Wipe and Gel/Gelpad facilitate thermal contact of the device with a patient's skin by mitigating minor variances in device-to-skin contact.
The CoolSculpting System is a portable thermoelectric cooling and heating device that applies controlled cooling or heating to a treatment site. The CoolSculpting System consists of a control unit, detachable vacuum and surface applicators, as well as supplies such as liners, gelpads, skin wipes, cycle cards, foam borders and securement system, and software which includes functions to collect patient data, monitor tissue during cooling and minimize the risk of damage to tissue.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Endpoint) | Reported Device Performance (Result) |
|---|---|
| Primary Safety Endpoint: | The primary safety endpoint was met. |
| Incidence of device- and/or procedure-related adverse events. | No device- or procedure-related adverse events were categorized as serious adverse events (SAE) or unanticipated adverse device effects (UADE). Four device- and/or procedure-related adverse events reported: 2 incidents of prolonged erythema, 1 incident of hyperpigmentation, and 1 incident of subject report of fullness sensation in back of throat due to swelling. All adverse events resolved by the final follow-up at 12 weeks post-final treatment. Anticipated and transient side-effects (erythema, edema, numbness) observed, all resolved over the course of the study. |
| Primary Efficacy Endpoint: | The primary efficacy endpoint was met. |
| Correct identification of pre-treatment vs. 12-week post-final treatment images for discernible fat layer reduction by 3 blinded independent reviewers. (Pre-established 80% criterion for success) | Overall correct identification rate by the 3 reviewers was 91% for the per-protocol population (n=58). |
| Secondary Efficacy Endpoint: | |
| Reduction in fat layer thickness as measured by ultrasound at 12 weeks post-final treatment. | Statistically significant (p |
§ 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.