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, 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, 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 dermatoms 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 spassne. 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.

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, gel/gelpads, cycle cards, geltraps, gaskets, foam borders and securement system.

AI/ML Overview

The ZELTIQ CoolSculpting System's acceptance criteria and the study proving it meets them are described below, focusing on the expanded indication for cold-assisted lipolysis in the submandibular area and clarification of BMI for submental and submandibular treatments.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Effectiveness Endpoints)	Reported Device Performance (Mean and Range)
Fat layer reduction measured by ultrasound	2.4 mm (range: 2.0 to 2.8 mm)
Fat layer reduction measured by caliper	3.17 mm (around 33%) (range: 2.3 to 4.0 mm)
Subcutaneous fat layer reduction measured by MRI	17%
Fat volume reduction measured by 3D quantification	8.5 mL (one study) 4.82 cm³ (another study)
Reduction in submental laxity measured by 3D quantification (for submental area)	2.25 mm
Blinded, independent review of clinical photographs (correct identification of baseline)	77% (range: 60% to 91%)
Patient satisfaction	85% (range: 80% to 93%)
Safety: No procedure or device-related serious adverse events; common procedural side effects are transient and resolve.	No procedure or device-related serious adverse events reported. Common procedural side effects were transient and resolved without long-term effect. Clinical study literature indicates a low-risk safety profile.

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

The study was a review of published literature and clinical studies. The sample size for the combined "test set" (across various studies and publications) was 228 cryolipolysis treatment cycles during clinical studies of the submental and submandibular areas.

The data provenance is from clinical studies of the submental and submandibular areas and "published literature." The document doesn't specify countries of origin, but clinical publications generally encompass international research. The data appears to be retrospective as it's a review of existing studies and literature.

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

The document mentions "Blinded, independent review of clinical photographs." This implies that experts (likely dermatologists or plastic surgeons, given the nature of the procedure) were used to assess the visual changes. However, the exact number of experts and their specific qualifications (e.g., "radiologist with 10 years of experience") are not specified in the provided text.

4. Adjudication Method for the Test Set

For the blinded, independent photo review, the specific adjudication method is not explicitly stated. Typically, for such reviews, multiple experts independently assess images, and consensus or majority vote might be used, but this detail is missing.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physical medical device (CoolSculpting System) for cosmetic and pain relief applications, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable.

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 device, and its performance relies on its direct application to the patient, not on an algorithm operating independently without human intervention.

7. The Type of Ground Truth Used

The ground truth used for effectiveness was a combination of:

Quantitative measurements: Ultrasound measurement, caliper measurement, Magnetic Resonance Imaging (MRI), and three-dimensional (3D) quantification of volume reduction.
Expert assessment: Blinded, independent review of clinical photographs (implicitly by experts).
Patient-reported outcomes: Patient satisfaction.
Clinical observation/Adverse Event reporting: For safety outcomes.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an algorithm or AI. The CoolSculpting System is a physical device. The studies reviewed were for demonstrating the device's clinical performance, not for training an algorithm. Therefore, this question is not applicable in the context of this device.

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

As there is no "training set" for an algorithm, this question is not applicable. The effectiveness and safety were established through clinical studies and literature reviews as described in section 7.

Summary

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August 29, 2018

ZELTIQ Aesthetics, Inc. Mr. Alex Chang Sr. Manager, Regulatory Affairs 4410 Rosewood Drive Pleasanton, California 94588

Re: K181740

Trade/Device Name: ZELTIQ CoolSculpting System Regulation Number: 21 CFR 878.4340 Regulation Name: Contact Cooling System For Aesthetic Use Regulatory Class: Class II Product Code: OOK Dated: June 29, 2018 Received: July 2, 2018

Dear Mr. Chang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmr/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jennifer R. Stevenson -S3

For 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) K181740

Device Name CoolSculpting System

Indications for Use (Describe)

Cooling with the device may also be used to minimize pain and thermal injury during laser and dermatoms and act as a local anesthetic for procedures that induce minor local discomfort.

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.

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

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

I.SUBMITTER:	ZELTIQ™ Aesthetics, Inc.4410 Rosewood DrivePleasanton, CA 94588
CONTACT:	Alex ChangSr. Manager, Regulatory AffairsZELTIQ Aesthetics, Inc.Phone: 925-621-7415
DATE PREPARED:	June 29, 2018
II. DEVICE:
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
III. PREDICATE DEVICES:	Predicate Device: CoolSculpting System (K172144, OOK)

IV. DEVICE DESCRIPTION:

V. INDICATIONS FOR USE:

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, submentibular areas, thigh, abdomen and flank. When

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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.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

The ZELTIQ CoolSculpting System is the same as the device cleared in K172144. No changes have been made to the device to accommodate the indication of the submandibular area or clarification of BMI.

The CoolSculpting System has been established as safe and effective through many prior clearances (the most recent is K172144).

VII. PERFORMANCE DATA:

Biocompatibility testing

The ZELTIQ CoolSculpting System is the same as the previously cleared predicate device (K172144).

Electrical safety and electromagnetic compatibility (EMC)

The ZELTIQ CoolSculpting System is the previously cleared predicate device (K172144).

Software Verification and Validation Testing

The ZELTIQ CoolSculpting System is the previously cleared predicate device (K172144).

Performance testing

The ZELTIQ CoolSculpting System is the same as the previously cleared predicate device (K172144).

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Clinical Performance Data:

Clinical publications demonstrated the safety and effectiveness of the CoolSculpting System for treatment of the submandibular area.

A review of published literature and clinical studies revealed 228 cryolipolysis treatment cycles during clinical studies of the submental and submandibular areas in a population with a BMI ranging from 22.8 to 46.2.

Effectiveness was measured by several techniques including ultrasound measurement, caliper measurement, Magnetic Resonance Imaging (MRI), three-dimensional (3D) quantification of volume reduction, patient satisfaction, and blinded, independent review of clinical photographs. The mean ultrasound measurement of fat layer reduction was 2.4 mm with a range from 2.0 to 2.8 mm. The mean caliper measurement of fat layer reduction was 3.17 mm (around 33%) with a range from 2.3 to 4.0 mm. The single study using MRI imaging showed mean reduction of 17% subcutaneous fat layer reduction. The 3D imaging showed a mean calculated reduction of 8.5 mL fat volume, and calculated reduction in submental laxity by 2.25 mm (Li, DaSilva, Canfield, & McDaniel, Use of 3-Dimensional Imaging in Submental Fat Reduction After Cryolipolysis, 2018). Three-dimensional volumetric measurement showed a fat reduction of 4.82 cm³ (Bernstein & Bloom, 2017). Blinded, independent photo review was conducted in several studies with correct identification of baseline photographs ranging from 60% to 91% averaging 77%. Patient satisfaction ranged from 80% to 93% averaging 85%.

There were no procedure or device related serious adverse events reported. Common procedural side effects were transient and resolved without long term effect. The clinical study literature indicates that cryolipolysis is a safe and effective non-surgical procedure for subcutaneous fat reduction in the submental and submandibular areas. Clinical literature review and post-market data have demonstrated the same low-risk safety profile. The published data provided in this submission clearly demonstrate the safety and effectiveness profile of the CoolSculpting System for the indication of treatment of the submandibular and submental areas in a population with a BMI ranging from 22.8 to 46.2.

VIII. CONCLUSION:

The ZELTIQ CoolSculpting System is the same as the device cleared in K172144. No changes have been made to the device to accommodate this indication of cold-assisted lipolysis in the submandibular area and clarification of BMI in this patient population.

The CoolSculpting System is substantially equivalent to the predicate device for this new indication for use. The clinical data shows results from cryolipolysis in the submandibular area meeting both the safety and effectiveness endpoints.

The CoolSculpting System has been established as safe and effective through many prior clearances (the most recent is K172144).

The CoolSculpting System has not been changed to accommodate this expanded indication for treatment of the submandibular area and increased BMI for submental and submandibular patients. The

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clinical data indicates the same safety and effectiveness for the CoolSculpting System for this expanded indications for use for the submandibular area and increased BMI for submental and submandibular treatments. As such, the CoolSculpting System is substantially equivalent to the predicate device (previously cleared CoolSculpting System, K172144).

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.