(144 days)
The CoolSculpting System is a skin cooling or heating device. The device is indicated for cold-assisted lipolysis of the 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 the thigh, abdomen and the 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 ZELTIQ Gelpad facilitates 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 is comprised of a control unit, detachable vacuum and surface applicators and supplies such as liners, gelpads, cycle cards, foam borders and securement system.
The provided document is a 510(k) summary for the ZELTIQ CoolSculpting System. It describes the device, its indications for use, and a clinical study conducted to demonstrate its safety and efficacy.
Here's an analysis of the acceptance criteria and study as requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds (e.g., "minimum 70% accuracy"). Instead, it describes meeting "primary efficacy endpoint," "secondary efficacy endpoint," and "primary safety endpoint."
| Acceptance Criteria (Endpoint) | Reported Device Performance |
|---|---|
| Primary Efficacy Endpoint: | Reduction in fat layer thickness. |
| Result: | Met. Analysis of ultrasound data showed statistical significance (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.