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. 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.

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

Here's a breakdown of the acceptance criteria and study information for the ZELTIQ CoolSculpting System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Effectiveness)	Reported Device Performance
Primary Effectiveness Endpoint (from original IDE study for submental area - K151179): Independent panel review to correctly identify baseline photographs of the treatment area.	Correct baseline photograph identification rate by the independent panel reviewers was 91.4% (for the per protocol population).
Secondary Effectiveness Endpoint (from original IDE study for submental area - K151179): Subject satisfaction regarding the treatment making their chin look more toned.	75% of subjects reported that they agree or strongly agree that the treatment made their chin look more toned.
New Effectiveness Endpoint (for lax tissue appearance in submental area - based on retrospective photo analysis): ≥ 20 mm² decrease in area as measured on both the right lateral and left lateral views of the submental region.	77.2% (44/57) of subjects exhibited a ≥ 20 mm² area reduction in the submental area and neck.
Concordance with physician panel review (for lax tissue appearance): For subjects showing ≥ 20 mm² area reduction, physician panel should correctly identify a visible response.	Of the 44 subjects showing ≥ 20 mm² area reduction, 42 (95.5%) were correctly identified by the physician panel as having a visible response.
Primary Safety Endpoint (from original IDE study for submental area - K151179): (Not explicitly defined in terms of a specific metric but implied to be met and remain unchanged).	The primary safety endpoint of the original IDE approved study was met and remains unchanged since the close of the study. All device- and/or procedure-related adverse events have resolved spontaneously.

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

Sample Size for Effectiveness Analysis: 57 subjects (per-protocol population of an original IDE study, with one exclusion due to excessive hair).
Data Provenance: The study was a retrospective photo analysis of data from an original IDE approved study. While the country of origin isn't explicitly stated, the context of FDA submission suggests a US-based study or one adhering to US regulatory standards.

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

For the "original IDE study" (K151179): An "independent panel reviewers" performed photographic identification. The number and specific qualifications of these reviewers are not explicitly stated in this document.
For the "retrospective photo analysis" of lax tissue: The photographic analysis involved:
- One board-certified plastic surgeon who identified anatomical points and performed measurements.
- A "physician panel" (presumably the same "independent panel reviewers" from the original IDE study, but not explicitly confirmed) who reviewed photographs for a visible response. The number and specific qualifications of this panel are not explicitly stated in this document beyond being "physician."

4. Adjudication Method for the Test Set

For the original IDE study's primary effectiveness endpoint (photographic identification): It was a review by an "independent panel reviewers." No specific adjudication method (e.g., 2+1) is mentioned, only that a "correct baseline photograph identification rate" was reported.
For the retrospective photo analysis (lax tissue appearance):
- A single board-certified plastic surgeon performed the quantitative measurements (≥ 20 mm² decrease). This wasn't an adjudication but a direct measurement by an expert.
- A "physician panel" retrospectively evaluated visible response, and their agreement (or lack thereof) with the quantitative findings was noted. The exact adjudication method used by this panel is not specified.

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, an MRMC comparative effectiveness study involving AI assistance was not performed. This submission describes the performance of a physical medical device (CoolSculpting System) based on human expert review of photographic evidence, not an AI diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, this is not applicable. This document describes a physical medical device, not an algorithm or AI system. The "performance data" section mentions "Software Verification and Validation Testing" but states it's the same as a previously cleared predicate device and does not involve AI for diagnostic purposes.

7. The Type of Ground Truth Used

Expert Consensus/Measurement:
- For the original IDE study's primary effectiveness endpoint, the ground truth was based on the "correct baseline photograph identification" by independent panel reviewers.
- For the retrospective study on lax tissue, the primary measure of effectiveness (>20 mm² reduction) was derived from measurements performed by a board-certified plastic surgeon on anatomical points. This was then corroborated by an "independent physician review panel" confirming a "visible response."
Subject Reported Outcomes: For the secondary effectiveness endpoint in the original IDE study, subject satisfaction (agreement that the treatment made their chin look more toned) served as a ground truth measure.

8. The Sample Size for the Training Set

Not applicable / Not specified. This submission is for an updated indication for a physical medical device. There is no mention of a "training set" in the context of an AI algorithm learning from data. The effectiveness study relies on an independent panel review and expert measurement on a test set, not on a machine learning model trained on a separate dataset. The "original IDE approved study" involved 60 enrolled subjects, but this served as the source for the test set for the retrospective analysis, not a training set.

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

Not applicable. As there is no training set for an AI algorithm mentioned in this document, the method for establishing its ground truth is not relevant. The ground truth for the test set was established as described in point 7.

Summary

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November 1, 2017

ZELTIQ Aesthetics, Inc. Ewald Riechert Director of Regulatory Affairs 4410 Rosewood Road Pleasanton, California 94588

Re: K172144

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: September 28, 2017 Received: September 29, 2017

Dear Ewald Riechert:

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 pror 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, 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 of medical 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.

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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 (DICE) 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE) 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.

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) K172144

Device Name Zeltiq CoolSculpting System

Indications for Use (Describe)

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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5. 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:	Ewald RiechertDirector of Regulatory AffairsZELTIQ Aesthetics, Inc.Phone: 925-568-2977
DATE PREPARED:	July 14, 2017
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 (K171069, OOK)Reference Device: Ulthera System (K121700, OHV)

IV. DEVICE DESCRIPTION:

V: INDICATION FOR USE:

The CoolSculpting System is a skin cooling or heating device. The device is indicated for cold-assisted lipolysis (breakdown of fat) of the upper arm, bra fat, back 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, back fat, banana roll, submental area, thigh, abdomen and

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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.

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 K171069. No changes have been made to the device to accommodate this new indication.

The CoolSculpting System has been established as safe and effective through many prior clearances (the most recent is K171069). It was demonstrated to be safe and effective for the submental area in K151179.

VII. PERFORMANCE DATA:

Biocompatibility testing

The ZELTIQ CoolSculpting System is the same as the previously cleared predicate device (K171069).

Electrical safety and electromagnetic compatibility (EMC)

The ZELTIQ CoolSculpting System is the same as the previously cleared predicate device (K171069).

Software Verification and Validation Testing

The ZELTIQ CoolSculpting System is the same as the previously cleared predicate device (K171069).

Performance testing

The ZELTIQ CoolSculpting System is the same as the previously cleared predicate device (K171069).

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Clinical Study

ZELTIQ conducted a retrospective photo analysis study examining the effectiveness of the cryolipolysis system to affect the appearance of lax tissue in the submental area. The photographic analysis was based on the methodology used to obtain clearance of the reference device (Ulthera System, K121700).1

Sixty subjects were enrolled in an original IDE approved study that was used for the submental clearance in K151179. Two of the 60 subjects did not receive full treatments and were excluded from the per-protocol population. Subjects received treatment with the ZELTIQ CoolSculpting System on the submental area, and were followed through a 12-week post-treatment visit.

The primary safety endpoint in the original IDE approved study was met and remains unchanged since the close of the study and was previously submitted in K151179.

The primary effectiveness endpoint in the original IDE involved independent panel review of pre- and 12-week post-treatment photographs of the treatment area. For the per protocol population, the correct baseline photograph identification rate by the independent panel reviewers was 91.4%. This data remains unchanged since the close of the study and was previously submitted in K151179.

The secondary effectiveness endpoint for subject satisfaction was assessed by an IRBapproved questionnaire administered at 12-week post-treatment. Seventy-five percent of the subjects reported that they agree or strongly agree that the treatment made their chin look more toned. This data remains unchanged since the close of the study and was previously submitted in K151179.

This retrospective study used the per-protocol population (n=58) for analysis. One subject was excluded from the analysis due to excessive hair in the submental region, therefore the number of subjects used for analysis was 57. Right and left lateral photographic views of the submental area taken at baseline and at the 12-week post final treatment visit were included in the analysis. Each photo was cropped and masked prior to evaluation. A board certified plastic surgeon identified the following anatomical points on each photograph: the lateral canthus, the anterior most point where the nostril meets the columella, and the point where the chin meets the neck (submental crease). A series of lines were drawn on the photo using AutoCAD software and areas in the submental region were measured. A responder analysis was performed with the criteria being ≥ 20 mm² decrease in area as measured on both the right lateral and left lateral views of the region. A second analysis was performed comparing the responders with results from the independent physician review panel of photos conducted for the previous study.

1 Oni, G, Hoxworth R, Teotia, S, et al. Evaluation of a Microfocused Ultrasound System for Improving Skin Laxity and Tightening in the Lower Face. Aesthetic Surgery Journal 2014;34(7):1099-1110.

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Further evidence of treatment effectiveness found the data from photographic analysis of the treated areas indicates 77.2% (44/57) of subjects exhibited a ≥ 20 mm² area reduction in the submental area and neck. Of those 44 subjects, 42 (95.5%) were correctly identified by the physician panel as having a visible response. The results of this photographic analysis indicate that the CoolSculpting procedure on the submental area can also affect the appearance of lax tissue in the submental area.

The study design and results are summarized in the table below:

Study Design	Retrospective
Sample Size foranalysis	57
Effectiveness Results	The per protocol population consisted of all the treatedsubjects followed for 12 weeks with weight change of nomore than 5% of total body weight at the time the 12 weekimages were taken. For the per protocol population, thecorrect baseline photograph identification rate by theindependent panel reviewers was 91.4%.Data from photographic analysis showed effect on theappearance of lax tissue (≥ 20 mm²) from baseline to 12weeks post-treatment in 77.2% (44/57) of subjects. Of those44 subjects, 42 (95.5%) were correctly identified by thephysician panel as having a visible response.Subject satisfaction data from original IDE: 75% of thesubjects reported that they agreed that the treatment madetheir chin look more toned.
Safety Results	The primary safety endpoint of the original IDE approvedstudy was met and remains unchanged since the close of thestudy. All device- and/or procedure-related adverse eventshave resolved spontaneously.

Table 5.1. Summary of Retrospective Study for effect on the appearance of lax tissue in the Submental area

The data provides reasonable assurance of safety and effectiveness to demonstrate substantial equivalence of the CoolSculpting System for the additional indication for use of affecting the appearance of lax tissue in the submental area.

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VIII. CONCLUSION:

The ZELTIQ CoolSculpting System is the same as the device cleared in K171069. No changes have been made to the device to accommodate this indication of affecting the appearance of lax tissue in the submental area.

The CoolSculpting System is substantially equivalent to the predicate device for the revised indications for use. The clinical data shows visible effect in the appearance of lax tissue meeting both the safety and effectiveness endpoints.

The CoolSculpting System has not changed to accommodate this expanded indication. The clinical data indicates the same safety and effectiveness for the CoolSculpting System for this expanded intended use. As such, the CoolSculpting System is substantially equivalent to the predicate device (previously cleared CoolSculpting System, K171069).

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.