The CoolSculpting System is a skin cooling or heating device is indicated for cold-assisted lipolysis (breakdown of fat) of 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 bra fat, back 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.

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, 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

The document does not explicitly state formal "acceptance criteria" in a typical quantitative pass/fail format for device performance. Instead, it relies on a compilation of clinical study results to demonstrate safety and efficacy, implying that these results meet an unstated threshold for acceptability.

Metric (Implied Acceptance Standard)	Reported Device Performance (Mean)
Ultrasound fat layer reduction (Efficacy)	Ranged from 10.3% to 25.5% (average 20.6%) and 1.9 mm to 8.3 mm (average 3.9 mm)
Caliper fat layer reduction (Efficacy)	Ranged from 14.7% to 23.0% (average 22.3%)
Circumferential reduction (Efficacy)	Inner thigh: 0.9 cm; Flanks: 2.4 cm; Abdomen: 6.8 cm
Volumetric reduction (Efficacy)	Flanks: 39.6 cm³
Independent photo review correctness (Efficacy)	89.7% correct, on average
Serious Adverse Events (Safety)	0.13% incidence rate (6 cases out of 4,792 treatments)
Common Procedural Side Effects (Safety)	Erythema, bruising, and numbness, typically resolve within one month of treatment (no specific rate)

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

The document uses a compilation of previously published clinical studies as its "test set" or evidence for performance.

Sample Size for Test Set: 4,792 cryolipolysis treatments.
- Abdomen: 1,695 treatments
- Flanks: 1,987 treatments
- Back: 501 treatments
- Inner thigh: 323 treatments
- Lateral thigh: 150 treatments
- Anterior thigh: 3 treatments
- Submental area: 119 treatments
- Banana roll region: 14 treatments
Data Provenance: The data is compiled from "published scientific literature" and "clinical data from ZELTIQ." The country of origin is not specified, but the context of an FDA submission suggests an intent for use in the USA. The studies are retrospective as they are described as a "compilation of data from these studies" and a "literature review."

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

The document mentions "blinded, independent review of clinical photographs" as one method of efficacy measurement.
Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

For the "blinded, independent review of clinical photographs," the specific adjudication method is not detailed. It's unclear how discrepancies among reviewers (if more than one was used) were resolved. For other metrics like ultrasound and caliper measurements, the ground truth is objective measurement, so multi-expert adjudication isn't applicable in the same way.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not explicitly done in the context of human readers improving with AI vs. without AI assistance. The Zeltiq Coolsculpting System is a physical device used for fat reduction, not a diagnostic AI algorithm that assists human readers.

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

N/A. The Zeltiq Coolsculpting System is a physical medical device, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device's efficacy and safety includes a combination of:

Objective Measurements: Ultrasound and caliper measurements of fat layer reduction, circumferential measurements, and 3D quantification of volume reduction.
Expert Review (Semi-Objective): Blinded, independent review of clinical photographs.
Adverse Event Reporting: Incidence of serious adverse events and a description of common side effects, which would be based on clinical observation and reporting.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" in the context of an AI/algorithm-based device. The evidence for the device's performance is drawn from a compilation of diverse clinical studies, which collectively serve as the basis for demonstrating efficacy and safety. All 4,792 treatments discussed are presented as the data used to demonstrate performance, not a separate training set.

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

N/A. As there's no explicitly defined "training set" for an AI algorithm, the concept of establishing ground truth for it doesn't apply directly in this document. The "ground truth" for the overall clinical performance demonstrated in the compiled studies was established through the various measurement techniques and expert assessments mentioned in point 7.

Summary

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

March 23, 2016

Zeltiq Aesthetics, Inc. Shruti Jayakumar Regulatory Affairs Manager 4698 Willow Road Pleasanton, California 94588

Re: K160259

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: January 29, 2016 Received: February 1, 2016

Dear 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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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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 and Part 809), 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/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 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.

Jennifer R. Stevenson -A

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) K160259

Device Name 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.

APPLICANT:	ZELTIQ™ Aesthetics, Inc.4698 Willow RoadPleasanton, CA 94588
CONTACT:	Shruti JayakumarRegulatory Affairs ManagerZELTIQ Aesthetics, Inc.Phone: 925-474-2516Fax: 925-474-8028
DATE PREPARED:	March 14, 2016
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

DESCRIPTION OF THE DEVICE SUBJECT TO IDENTIFICATION

PREDICATE DEVICES: The ZELTIQ CoolSculpting System (K151179)

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), abdomen, thighs and submental area (K151179).

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Clinical data from ZELTIQ and data from published scientific literature indicates that the CoolSculpting System has the same mechanism of action regardless of treatment site. The safety and efficacy profile remains the same.

INDICATION FOR USE:

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

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.

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 non-vacuum surface applicators that are 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. There is no change required to the device to accommodate additional treatment sites. The same as has been previously cleared.

PERFORMANCE DATA:

A review of clinical publications revealed 4,792 cryolipolysis treatments during clinical studies. From these studies, we compiled the numbers of treatments in several anatomical areas: 1,695 treatments in the abdomen, 1,987 treatments in the flanks, 501 treatments in the back, 323 treatments in the inner thigh, 150 treatments in the lateral thigh, 3 treatments in the anterior thigh, 119 treatments in the submental area, and 14 treatments in the banana roll region.

Efficacy was measured by several techniques including ultrasound and caliper measurements, circumferential measurements, 3D quantification of volume reduction, and blinded, independent review of clinical photographs. Based on the compilation of data from these studies, the overall mean

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ultrasound fat layer reduction ranged from 10.3 to 25.5% and 1.9 to 8.3 mm. Compiled mean caliper fat layer reduction ranged from 14.7 to 23.0%. Single studies showed mean 0.9 cm circumferential reduction in the inner thigh, 2.4 cm circumferential reduction in the flanks, 6.8 cm circumferential reduction in the abdomen, and 39.6 cm³ volumetric reduction in the flanks.

Based on the compilation of these various studies, the overall mean ultrasound fat layer thickness reduction was 20.6% and 3.9 mm. Compiled mean caliper fat layer reduction was 22.3%. The independent photo review was 89.7% correct, on average.

As shown by multiple clinical studies submitted for clearance to the agency, the summary of published data shows a similarly high safety and efficacy profile for the cryolipolysis procedure. Common procedural side effects include erythema, bruising, and numbness, which typically resolve within one month of treatment. Based on the literature review, 6 cases would be considered serious adverse events. These serious adverse events include three cases of paradoxical hyperplasia in the abdomen, one case of paradoxical hyperplasia in the abdomen, back, and flanks, one case of contour irregularity in the abdomen, and one case of contour irregularity in the flank. For 4,792 treatments in published studies, the incidence of serious adverse events is very low (0.13%). Given the fact that 76.8% of treatments were to the abdomen and flanks, this incidence rate shows no clear indication of treatment site specificity. The clinical publications indicate that cryolipolysis is a safe and effective non-surgical procedure for subcutaneous fat reduction.

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.