(27 days)
The CoolSculpting System is a skin cooling or heating device is indicated for cold-assisted lipolysis (breakdown of fat) of the upper arm, bra fat, back fat, banana roll, thigh, abdomen, and flank, or "love handles" in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the device is intended for cold-assisted lipolysis of the submental and submandibular areas in individuals with a BMI up to 46.2. The device is intended to affect the appearance of visible fat bulges in the upper arm, bra fat, back fat, banana roll, submental and submandibular areas, thigh, abdomen and flank. When used for cold-assisted lipolysis of the submental area, the device can also affect the appearance of lax tissue in the submental area.
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 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 is comprised of a control unit, detachable vacuum applicators and accessories such as gelpads, cycle cards, geltraps, and gaskets.
The provided document describes the ZELTIQ CoolSculpting System, a skin cooling or heating device used for cold-assisted lipolysis. Here's a breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Requirement | Reported Device Performance |
|---|---|
| Electrical safety and electromagnetic compatibility (EMC) | System complies with IEC 60601-1 (Third Edition, 2005) and IEC 60601-1-2 (Fourth Edition, 2014). |
| Software Verification and Validation | Conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "moderate" level of concern. |
| Interface temperature steady state accuracy (as per "Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use") | Within +/- 0.5°C of the target value. |
| Feedback and control of cooling mechanism (as per "Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use") | Active during treatment. |
| Mechanism to ensure device does not exceed safe cooling limit (as per "Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use") | Incorporated into the device. |
| Vacuum system accuracy and performance | Bench testing performed to verify accuracy and performance. |
| CoolAdvantage and CoolAdvantage Petite applicator performance | Bench testing reports demonstrate performance at treatment parameters of -11 °C for 35 minutes. Demonstrated substantial equivalence to previously-cleared versions via design verification and validation testing. |
| Overall workflow or efficacy of the CoolSculpting System | Unchanged as a result of modifications. |
2. Sample size used for the test set and the data provenance
The document specifies that no clinical testing was conducted for this particular submission (K183514). The testing performed was primarily benchtop and verification/validation testing for hardware and software changes. Therefore, there is no "test set" in the context of patient data or clinical imagery. The provenance of any data used for bench testing is not specified beyond being internal company testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Since no clinical testing was conducted, there were no experts establishing ground truth for a clinical test set. The performance criteria are based on regulatory guidance and engineering specifications.
4. Adjudication method for the test set
Not applicable, as no clinical test set was used.
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 direct treatment device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical system for cold/heat therapy, not an algorithm.
7. The type of ground truth used
For the performance testing, the "ground truth" was established by engineering specifications, regulatory guidance (e.g., "Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use"), and validated design control processes for components like applicators. For example, steady-state accuracy within +/- 0.5°C is an engineering specification, and the presence of a safe cooling limit is a regulatory requirement.
8. The sample size for the training set
Not applicable. The device is not an AI/machine learning model that requires a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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.