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 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 applicators and supplies such as liners, gelpads, and cycle cards.

AI/ML Overview

The ZELTIQ CoolSculpting System is a device designed for cold-assisted lipolysis of the thigh, abdomen, and flank. The provided document details the clinical investigations conducted to demonstrate its safety and efficacy, particularly regarding its application to the thigh region.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ZELTIQ CoolSculpting System primarily focused on the visible reduction of fat in target treatment areas, as assessed by blinded evaluators based on photographic evidence.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Efficacy - Visible Fat Reduction	Overall correct identification rate by three blinded evaluators of pre-treatment photographs from a series against post-treatment photographs.	Inner Thigh Study: 90.5% correct identification rate.Outer Thigh Study: 83.9% correct identification rate.
	At least two out of three blinded evaluators correctly identify pre-treatment photographs from a series against post-treatment photographs.	Inner Thigh Study: 90.5% identified correctly by at least two evaluators.Outer Thigh Study: 87.1% identified correctly by at least two evaluators.
Safety - Adverse Events	Resolution of adverse events by 16-week follow-up.	All adverse events (numbness, mild contour irregularity) but one resolved by the 16-week follow-up.One mild case of hyperpigmentation persisted, which is noted as a rare side effect that typically resolves spontaneously.

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

The test set for evaluating the device's performance consisted of patient photographs.

Sample Size:
- Inner Thigh Study: 90 treatments completed. Each treatment likely corresponds to a unique subject/area, resulting in 90 sets of pre and post-treatment photos.
- Outer Thigh Study: 40 treatments completed. Each treatment likely corresponds to a unique subject/area, resulting in 40 sets of pre and post-treatment photos.
Data Provenance: The document does not explicitly state the country of origin. However, the FDA 510(k) submission process is for devices marketed in the United States, suggesting the studies were likely conducted in the US or in a manner compliant with US regulatory standards. The studies appear to be prospective clinical investigations conducted specifically to determine the safety and efficacy of the device for cold-assisted lipolysis in the thigh region.

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

Number of Experts: Three blinded evaluators.
Qualifications of Experts: The document does not explicitly state the specific qualifications (e.g., radiologist, dermatologist, years of experience) of the "three blinded evaluators." It only identifies them as "blinded evaluators." Their role was to assess photographic evidence of fat reduction.

4. Adjudication Method for the Test Set

The adjudication method used was based on agreement among the blinded evaluators:

Method: The evaluators were presented with series of photographs (pre- and post-treatment) and asked to identify the pre-treatment photographs for each subject.
Reporting: The "overall correct identification rate by the three evaluators" and "At least two out of three evaluators correctly identified" rates were reported, indicating a form of majority or consensus adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. The study described involves human evaluators assessing photographic outcomes directly, not evaluating an AI's output or being assisted by AI.

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

No, a standalone (algorithm only) performance study was not done. The performance assessment relies entirely on human evaluators' interpretation of photographic evidence. This device is not an AI algorithm; it is a physical cooling device.

7. The Type of Ground Truth Used

The ground truth used was expert consensus interpretation of photographic evidence of visible fat reduction. The three blinded evaluators' assessment of "visible reduction of fat" in the treatment areas from photographs served as the primary measure of efficacy.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or AI. The clinical investigations described are for evaluating the actual physical device's performance on human subjects, not for training a model.

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

As there was no "training set" for an algorithm, the concept of establishing ground truth for a training set is not applicable here. The clinical studies directly demonstrated the device's effect on subjects.

Summary

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K133212 Page 1 of 3

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[ZELTIQ CoolSculpting Device 510(k)]

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.

APPLICANT:	ZELTIQ™ Aesthetics, Inc.4698 Willow RoadPleasanton, CA 94588
CONTACT:	Shruti JayakumarZELTIQ Aesthetics, Inc.Phone: 925-621-2516Fax: 925-621-7376
DATE PREPARED:	April 7, 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 device (K080521 and K120023)

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 K080521 and for the abdomen under K120023.

Clinical testing has demonstrated the ability of the CoolSculpting System to cause lipolysis of the subcutaneous fat in the thigh in the same way that lipolysis occurs when the device is used in the flank

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and abdomen. The applicators all share the same technological characteristics, mechanism of action, and intended use.

INDICATION FOR USE:

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 controlled cooling or heating to a treatment site. This system features vacuum applicators of various sizes and a nonvacuum belt 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:

Clinical testing demonstrates that the CoolSculpting System can cause lipolysis with a subsequent removal of fat. Clinical results for the flank, abdomen, and thigh, support the safe and effective use of the device for this indication.

ZELTIQ conducted two clinical investigations to determine the safety and efficacy of cold-assisted lipolysis in the thigh region. In the inner thigh study, 90 treatments were completed with the flat cup vacuum applicator; in the outer thigh study, 40 treatments were completed with the belt applicator. Follow-up data is available for both studies up to 16 weeks post-treatment. Three blinded evaluators assessed the photos for visible reduction of fat in the treatment areas at the 16-week follow-up visit. The evaluators were presented with the series of photographs and were asked to identify the pretreatment photographs for each subject.

The overall correct identification rate by the three evaluators was 90.5% for the inner thigh study and 83.9% for the outer thigh study. At least two out of three evaluators correctly identified 90.5% of all

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photo pairs for the inner thigh study and 87.1% for the outer thigh study. The results demonstrate that the ZELTIQ CoolSculpting System affects the appearance of the thighs.

Adverse events reported during the studies included numbness and mild contour irregularity. All adverse events but one resolved by the 16 week follow-up. A mild case of hyperpigmentation in the treatment area persisted beyond the 16 week follow-up. This is a rare side effect that typically resolves spontaneously. The clinical investigations demonstrate that use of the ZELTIQ CoolSculpting System can safely and effectively induce cold-assisted lipolysis in the same manner as in the abdomen and flanks.

The materials used in this device are the same as previously cleared in K080521 and K120023. No new biocompatibility risks have been identified.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 9, 2014

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

Re: K133212

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: February 21, 2014 Received: February 24, 2014

Dear Ms. 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (2 l CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Ms. Shruti Jayakumar

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 Small Manufacturers. International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance 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 yours,

David Krause -S

for

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

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K133212

ZELTIQ CoolSculpting Device Name:

Indications for Use:

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

Prescription Use __ x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

and the state of the state of the success and and and and and and and and the many of the many of

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joshua C. Nipper -S

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.