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.

Device Description

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.

AI/ML Overview

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<0.0001) for both as-treated and per-protocol populations.
Secondary Efficacy Endpoint:	Correct identification of pre- vs. 16-week post-treatment images.
Result:	Met. Correct photo pair identification rate was 86% for the per-protocol population, with 85% of all photo pairs being correctly identified by at least two out of three reviewers.
Secondary Efficacy Endpoint:	Subject satisfaction.
Result:	Met. For the as-treated population, 88.37% reported being moderately or very satisfied with the CoolSculpting procedure.
Primary Safety Endpoint:	Device and/or procedure-related adverse events.
Result:	Met. Adverse events (numbness, pain, hyperpigmentation, one first-degree burn) were mild or moderate and all resolved. Three cases of numbness lasted beyond 16 weeks but resolved within 19 days of their respective 16-week visits.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set): 45 subjects.
Data Provenance: The study was described as an "IRB-approved non-significant risk clinical study" but does not explicitly state the country of origin. Given the FDA submission, it's highly likely to be U.S.-based or conducted under equivalent regulatory standards. The study design (treatment followed by follow-up) indicates it was a prospective study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Three reviewers were used for the secondary efficacy endpoint concerning photo pair identification.
Qualifications of Experts: The document does not specify the qualifications of these reviewers (e.g., dermatologists, radiologists, other medical professionals, or lay-reviewers).

4. Adjudication Method for the Test Set

For the secondary efficacy endpoint of photo identification, the adjudication method was:

85% of all photo pairs were correctly identified by at least two out of three reviewers. This suggests a "2 out of 3" (2+1) consensus method was used for determining a "correct" identification among the reviewers.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done in the context of comparing human readers' performance with and without AI assistance. This study focused on the device's efficacy in reducing fat, subject satisfaction, and safety. The photo review aspect was a means to assess the visible effect of the treatment, not to evaluate AI performance or human reader improvement with AI.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not done. The CoolSculpting System is a physical medical device (skin cooling/heating device), not an independent AI algorithm for image analysis or diagnostic assessment. The "algorithm" in this context refers to the device's operational parameters, not a software algorithm that performs diagnostic tasks.

7. The Type of Ground Truth Used

The study utilized multiple types of "ground truth" to assess the device's effects:

Ultrasound data: Used for the primary efficacy endpoint (reduction in fat layer thickness). This is an objective measurement from a medical imaging modality.
Expert Consensus (Photo Review): Used for a secondary efficacy endpoint, where three reviewers identified pre- and post-treatment images.
Subjective Outcome Data: Used for another secondary efficacy endpoint, based on subject satisfaction reports.
Clinical Observation/Reporting: Used for the primary safety endpoint, involving the documentation and resolution of adverse events.

8. The Sample Size for the Training Set

Not Applicable. The provided document describes a clinical study for a physical device, not an AI model requiring a training set for machine learning. The "training" for this device would refer to its design, engineering, and manufacturing process, rather than data-driven machine learning.

9. How the Ground Truth for the Training Set Was Established

Not Applicable, as this is not an AI/machine learning device with a training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 26, 2015

ZELTIQ™ Aesthetics Incorporated Shruti Jayakumar Senior Regulatory Affairs Specialist 4698 Willow Road Pleasanton, California 94588

Re: K142491

Trade/Device Name: CoolSculpting System Regulation Number: 21 CFR 878.4340 Regulation Name: Contact cooling system for aesthetic use Regulatory Class: Class II Product Code: OOK Dated: December 29, 2014 Received: December 30, 2014

Dear Ms. Shruti Jayakumar:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142491

Device Name CoolSculpting System

Indications for Use (Describe)

The ZELTIQ Gelpad facilitates thermal contact of the device with a patient's skin by mitigating minor variances in device-to-skin contact.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	✔
Over-The-Counter Use (21 CFR 801 Subpart C)	☐

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS ப்

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT:	ZELTIQ™ Aesthetics, Inc.
	4698 Willow Road
	Pleasanton, CA 94588
CONTACT:	Shruti Jayakumar
	Senior Regulatory Affairs Specialist
	ZELTIQ Aesthetics, Inc.
	Phone: 925-474-2516
	Fax: 925-474-8028
DATE PREPARED:	September 3, 2014
TRADE NAME:	ZELTIQ CoolSculpting System
COMMON NAME:	Skin Cooling Device
CLASSIFICATION NAME:	Contact Cooling System for Aesthetic Use
DEVICE CLASSIFICATION:	Class II, 21 CFR §878.4340
PRODUCT CODE:	OOK

PREDICATE DEVICES: The ZELTIQ CoolSculpting System (DEN090002, K120023, K133212)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

SUBSTANTIALLY EQUIVALENT TO:

The ZELTIQ CoolSculpting System is substantially equivalent to the ZELTIQ Dermal Cooling Device, also known as the ZELTIQ CoolSculpting System, which has been cleared for the indication of cold-assisted lipolysis of the flank (love handle) under DEN090002, for the abdomen under K120023, and for the thighs under K133212.

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Clinical testing has demonstrated the ability of the CoolSculpting System to cause lipolysis of the subcutaneous fat in the treatment area with flexible treatment parameter ranges in the same way as the predicate device. The mechanism of action remains the same regardless of temperature or treatment duration. The flexible parameters do not raise new issues of safety or effectiveness.

INDICATION FOR USE:

The CoolSculpting System is a skin cooling or heating 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 ZELTIQ Gelpad facilitates thermal contact of the device with a patient's skin by mitigating minor variances in device-to-skin contact.

TECHNICAL CHARACTERISTICS:

The CoolSculpting System is a thermoelectric cooling and heating device that applies cooling or heating to a treatment site. This system features vacuum applicators of various sizes and a nonvacuum surface applicator that is intended to provide clinicians with an additional option when treating a flat area of the body. The technological characteristics are the predicate devices. All share the same mechanism of cooling and heating for the same intended use.

PERFORMANCE DATA:

ZELTIQ conducted an IRB-approved non-significant risk clinical study to evaluate the safety and efficacy of the CoolSculpting System with flexible treatment parameter ranges. The study enrolled 45 subjects who received up to two treatments on the flank in one visit. Follow-up was conducted until 16 weeks post-treatment. Subjects were assessed for efficacy via ultrasound and comparison of before and after photographs.

The primary efficacy endpoint of reduction in fat layer thickness was met. Analysis of ultrasound data showed statistical significance (p<0.0001) for both the as-treated population and per-protocol population. The secondary efficacy endpoint of correct identification of pre- vs 16-week post-treatment images was met. The correct photo pair identification rate was 86% for the per-protocol population, with 85% of all photo pairs being correctly identified by at least two out of three reviewers. The secondary efficacy endpoint of subject satisfaction was also met. For the as-treated population, 88.37%

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reported being moderately or very satisfied with the CoolSculpting procedure. The primary safety endpoint of device and/or procedure-related adverse events was met. Adverse events included numbness, pain, and hyperpigmentation. One treatment was not completed due to a first degree burn. Three cases of numbness lasted beyond the 16 week follow-up and all three had resolved within 19 days of their respective 16-week visits. All device and/or procedure-related adverse events were mild or moderate in nature and all have resolved.

The materials used in this device are the same as previously cleared in DEN090002, K120023, and K133212. No new biocompatibility risks have been identified.

Regulation Number and Section

§ 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.