(88 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, banana roll, 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 upper arm, bra fat, banana roll, 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 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 and surface applicators and supplies such as liners, gel/gelpads, cycle cards, geltraps, gaskets, foam borders and securement system.
As part of the CoolSculpting System suite of applicators, ZELTIQ has developed two new vacuum applicators known as CoolAdvantage Plus and CoolAdvantage Petite. Both applicators feature the curved aluminum cup design with interchangeable silicone contours that is identical to the previously cleared CoolAdvantage applicator (K162050). They have been modified in size to accommodate different sizes of fat bulges. All other technological characteristics, including mechanism of action, and performance remain identical for the CoolAdvantage family of applicators.
The CoolAdvantage family of applicators is also provided with a new gelpad known as CoolAdhesive Pad. The CoolAdhesive Pad is comprised of fructose and glycerin in a pad made of rayon and spandex. This material is commonly used in the garment industry. It has the identical functionality as the previously cleared gelpads and is intended to provide consistent thermal contact during treatments with the CoolAdvantage family of applicators. Fructose and glycerin are considered safe ingredients and are found in commonly used products. Fructose is generally used as a food additive and glycerin is typically found in common cosmetic products such as lotion and soap. Glycerin is generally recognized as safe (GRAS per CFR §182.1320). The CoolAdhesive Pad has been tested for biocompatibility and is considered biocompatible. The performance remains the same for CoolAdhesive Pad as for the previously cleared gelpads.
The provided text describes the 510(k) summary for the ZELTIQ CoolSculpting System, specifically focusing on the introduction of two new applicators (CoolAdvantage Plus and CoolAdvantage Petite) and a new gelpad (CoolAdhesive Pad). The document explicitly states that no clinical studies were performed in support of this specific submission. Therefore, it is impossible to provide information regarding a study that proves the device meets acceptance criteria based on the provided text alone, as such a study was not part of this submission process.
The FDA's decision of substantial equivalence (K171069) for this device relies heavily on its similarity to a previously cleared predicate device (ZELTIQ CoolSculpting System, K162050), which presumably underwent clinical testing for its initial clearance or was cleared through other pathways.
However, based on the information provided, I can construct parts of the answer regarding acceptance criteria and the types of testing performed for this specific submission, even though they do not involve clinical performance data.
Here's an analysis of the provided text in relation to your questions, highlighting where information is absent due to the lack of clinical studies in this specific submission:
1. A table of acceptance criteria and the reported device performance
The document details various tests conducted and generally states that the device "passed successfully by meeting the acceptance criteria." Specific numerical performance data or detailed acceptance criteria from these tests are not provided in this summary.
Acceptance Criteria and Reported Device Performance (Based on provided text, non-clinical):
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Passed Cytotoxicity, Sensitization, and Irritation tests consistent with ISO 10993 standards. |
| Electrical Safety and Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1 (2005+A1:2012) for safety and IEC 60601-1-2 (2007) for EMC. |
| Software Verification and Validation | Tests conducted per FDA's "General Principles of Software Validation" (2002); device software considered "moderate level of concern." |
| Bench Performance Testing | Design verification and usability tests were passed successfully by meeting acceptance criteria (e.g., thermal performance, thermal range, reuse, physical specifications, compatibility with use environment, treatment parameters, power and operational control, labeling, interface, and support requirements). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable for clinical performance as "no preclinical or clinical testing was performed" for this specific submission. For bench testing, sample sizes are not explicitly mentioned.
- Data Provenance: Not applicable for clinical performance. For bench testing, the data origin is from ZELTIQ Aesthetics, Inc.'s internal testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. As no clinical performance study was conducted for this submission, there was no ground truth established by experts in the context of clinical efficacy or safety.
4. Adjudication method for the test set
- Not applicable. No clinical test set.
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. No clinical studies, let alone MRMC studies, were performed or described for this specific submission. The device is a physical system for aesthetic treatment, 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, not an algorithm. Bench testing demonstrated the device's technical performance in a standalone manner (without patient interaction) against specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for clinical ground truth. For the non-clinical performance and safety data:
- Biocompatibility: Ground truth is established by the specified ISO 10993 standards and their inherent scientific principles for evaluating biological compatibility.
- Electrical Safety & EMC: Ground truth is defined by the requirements of IEC 60601-1 and IEC 60601-1-2 standards.
- Software V&V: Ground truth is adherence to the "General Principles of Software Validation" guidance and internal software requirements.
- Bench Performance: Ground truth is defined by the internal design specifications and defined performance parameters of the device.
8. The sample size for the training set
- Not applicable. The device is not an AI/ML model that requires a training set in the typical sense.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Device Performance Assessment in this Submission:
The ZELTIQ CoolSculpting System's K171069 submission primarily focuses on demonstrating substantial equivalence to its predicate device (K162050) by highlighting that the new applicators and gelpad maintain the same indications for use, mechanism of action, and performance characteristics. The acceptance criteria for this specific submission were met through:
- Biocompatibility testing of the new gelpad.
- Electrical safety and EMC testing of the overall system.
- Software verification and validation (since the software remained unchanged from the predicate, ensuring its continued proper function).
- Bench performance testing to ensure the new applicators and gelpad performed as expected and within previously cleared parameters (e.g., maintaining the target temperature, durability, etc.).
The key takeaway is that for this 510(k) submission, the "study that proves the device meets the acceptance criteria" refers to the non-clinical performance and safety testing outlined, rather than a clinical trial with human subjects. The substantial equivalence argument negates the need for new clinical data if the technological characteristics are sufficiently similar and safety/performance are demonstrated through non-clinical means.
§ 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.