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.

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 spassms. 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, foam borders and securement system.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: Zeltiq CoolSculpting System (specifically the CoolAdvantage applicator for upper arms)
Indication: Cold-assisted lipolysis of the upper arm in individuals with a BMI of 30 or less.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Endpoint)	Reported Device Performance (Result)
Primary Safety Endpoint: Incidence of unanticipated adverse device effects (UADE).	No unanticipated adverse device effects, or serious device or procedure-related adverse effects occurred. All device- and/or procedure-related adverse events resolved spontaneously. (Anticipated side-effects, such as prolonged numbness in 4 patients, were noted).
Primary Efficacy Endpoint: Correct identification of pre-treatment vs. 12-week post-treatment images by at least two out of three blinded, independent reviewers.	For the per-protocol population, the correct baseline photograph identification rate by the independent panel reviewers was 85.2% [72.9%, 93.4%]
Secondary Efficacy (Ultrasound): Significant reduction in fat layer as measured by ultrasound from baseline to 12 weeks post-treatment.	Significant reduction in the fat layer (0.32 cm) from baseline to 12 weeks post-treatment.
Secondary Efficacy (Subject Satisfaction): Percentage of subjects finding the procedure comfortable and recommending it.	72.41% of subjects found the procedure to be comfortable to very comfortable. 63.3% of subjects reported they would recommend the procedure to a friend.

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

Sample Size: 30 subjects, with each subject treated on both upper arms (60 treatments total).
Data Provenance: The study was a "Prospective, multicenter, non-randomized, interventional cohort study" conducted at "two clinical sites." The country of origin is not explicitly stated, but given the FDA submission, it's typically assumed to be the United States unless otherwise specified.

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

Number of Experts: Three blinded, independent reviewers.
Qualifications: Not explicitly stated, but they are referred to as "independent panel reviewers," suggesting they are qualified professionals in assessing aesthetic outcomes.

4. Adjudication Method for the Test Set

Adjudication Method: A majority consensus approach was used for the primary efficacy endpoint. "Correct identification of pre-treatment vs 12 Week post-treatment images by at least two out of three blinded, independent reviewers." This is a 2-out-of-3 consensus method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted or described in this document. This study focuses on the standalone performance of the device and its treatment outcome, not on AI assistance for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This document describes a clinical study evaluating a medical device (CoolSculpting System), not an AI algorithm. Therefore, no standalone (algorithm only) performance study was conducted or reported. The efficacy endpoints directly assess the physical outcomes on patients from the device's application.

7. Type of Ground Truth Used

Primary Efficacy: Expert consensus (2-out-of-3 blinded independent reviewers) on photographic evidence of fat reduction.
Secondary Efficacy:
- Objective measurements (ultrasound-measured upper arm fat reduction).
- Subjective patient-reported outcomes (questionnaire for satisfaction).
Safety: Clinical safety assessment by investigators and follow-up for adverse events.

8. Sample Size for the Training Set

This document describes a clinical investigation for device clearance, not the development of an AI model. Therefore, there is no mention of a training set sample size.

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

As this is a device clearance document and not an AI model development report, there is no discussion of a training set or how its ground truth was established.

Summary

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

November 21, 2016

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

Re: K162050

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: October 20, 2016 Received: October 21, 2016

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 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 devicerelated 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 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,

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) K162050

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)

	X Prescription Use (Part 21 CFR 801 Subpart D)		Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY

COOLSCULPTING SYSTEM

Submitted by:	ZELTIQ™ Aesthetics, Inc.4410 Rosewood DrivePleasanton, CA 94588
CONTACT:	Shruti JayakumarSenior Regulatory Affairs ManagerZELTIQ Aesthetics, Inc.Phone: 925-474-2516Fax: 925-474-8028
DATE PREPARED:	November 21, 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
PREDICATE DEVICES:	The ZELTIQ CoolSculpting System (K160259)

INDICATION 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, 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 flank.

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,

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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:

TECHNOLOGICAL CHARACTERISTICS:

The CoolSculpting System is a thermoelectric cooling and heating device that applies controlled cooling or heating to a treatment site. This submission expands the CoolSculpting System's indications for use to include treatment of the upper arm and also introduces a new vacuum applicator known as CoolAdvantage.

This CoolSculpting 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. As part of its suite of vacuum applicators, ZELTIQ has also developed a new applicator known as CoolAdvantage. CoolAdvantage has the same cup design as CoolMini and features interchangeable contours to accommodate body areas of different curvature. The contours are in the shapes of previously cleared vacuum applicators (CoolCurve+, CoolFit, and CoolCore cleared in DEN090002 and K133212). The treatment parameters for CoolAdvantage are within the previously cleared parameters for vacuum applicators (K142491). Treatment of the upper arm is cleared for -11°C for 35 minutes.

SUMMARY OF SUBSTANTIAL EQUIVALENCE:

The ZELTIQ CoolSculpting System is substantially equivalent to the device cleared in K160259. Clinical data demonstrates that cold-assisted lipolysis of the upper arms is substantially equivalent to coldassisted lipolysis of the abdomen, flanks, thighs, submental area, back fat, bra fat, and banana roll which were cleared under K160259.

As stated previously, this submission also introduced a new vacuum applicator known as CoolAdvantage. CoolAdvantage has the same cup design as CoolMini and features interchangeable contours to accommodate body areas of different curvature. The contours are in the shapes of previously cleared vacuum applicators (CoolCurve+, CoolFit, and CoolCore cleared in DEN090002 and K133212). The CoolAdvantage applicator is also provided with disposable gaskets which provide a tight seal between the applicator cup and the contour. The treatment parameters for CoolAdvantage are within the previously cleared parameters for vacuum applicators (K142491). Treatment of the upper arm is cleared for -11°C for 35 minutes.

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Clinical data: ZELTIQ conducted a clinical investigation to evaluate the safety and efficacy of cryolipolysis for non-invasive reduction of upper-arm fat. In this study, 30 subjects were enrolled at two clinical sites. Sixty initial treatments were performed with a prototype CoolAdvantage applicator (CoolFit applicator with aluminum Insert). The average age of the 30 subjects enrolled in the study was 45.7 years with an average Body Mass Index (BMI) of 28.2. All subjects were female. Each subject was treated once on each upper arm, at -11°C for 35 minutes. Follow-up data is available through 12 weeks post-treatment. Subject safety was assessed throughout the study. Follow-ups were required at 1 week, and 12 weeks post-treatment. All 30 subjects completed the 12 week follow-up.

The primary safety endpoint was the incidence of unanticipated adverse device effects. Clinical safety assessment showed anticipated side-effects. There were 4 patients with prolonged numbness lasting greater than 12 weeks. No unanticipated adverse device effects, or serious device or procedure-related adverse effects occurred. All device- and/or procedure-related adverse events have resolved spontaneously.

The primary efficacy endpoint involved independent panel review of pre- and 12-Week post-treatment photographs of the treatment area for discernible fat layer reduction. The per protocol population consisted of all the treated subjects followed for 12 weeks with weight change of no more than 5% of total body weight at the time the 12 week images were taken. For the per protocol population, the correct baseline photograph identification rate by the independent panel reviewers was 85.2% [72.9%, 93.4%].

Further evidence of treatment efficacy is found in the data from ultrasound measurements of fat reduction at the treated areas, with significant reduction in the fat layer (0.32 cm) from baseline to 12 weeks post-treatment.

The secondary efficacy endpoint for subject satisfaction was assessed by an IRB-approved questionnaire administered at 12 weeks post-treatment. 72.41% of the subjects found the procedure to be comfortable to very comfortable, and 63.3% of the subjects reported that they would recommend the procedure to a friend.

Study Design	Prospective, multicenter, non-randomized, interventional cohort study
Sample Size	30 subjects treated on both upper arms (60 treatments total) across two clinical sites
Principal Eligibility Criteria	Clearly visible fat sufficient for treatment on the upper arm No weight change exceeding 5% in the preceding month Male or female subjects between 22 and 65 years of age
Follow up Intervals	1 week, 4 weeks, and 12 weeks
Endpoints	Primary endpoints: Safety endpoint – Rate of unanticipated adverse device effects (UADE).

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

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	Efficacy endpoint: Correct identification pf pre-treatment vs 12 Week post-treatment images by at least two out of three blinded, independent reviewers Secondary endpoints: Subject satisfaction as assessed by questionnaire administered at 12 weeks post-treatment Change in ultrasound-measured upper arm fat from pre-treatment to 12 weeks post-treatment
Effectiveness Results	The per protocol population consisted of all the treated subjects followed for 12 weeks with weight change of no more than 5% of total body weight at the time the 12 week images were taken. For the per protocol population, the correct baseline photograph identification rate by the independent panel reviewers was 85.2% [72.9%, 93.4%].Data from ultrasound measurements showed significant reduction in the fat layer (0.32 cm) from baseline to 12 weeks post-treatment.Subject satisfaction: 72.41% of the subjects found the procedure to be comfortable to very comfortable, and 63.3% of the subjects reported that they would recommend the procedure to a friend.
Safety Results	Clinical safety assessment showed anticipated side-effects. There were 4 patients with prolonged numbness lasting greater than 12 weeks. All adverse events have resolved. No unanticipated adverse device effects, or serious device or procedure-related adverse effects occurred. All device- and/or procedure-related adverse events have resolved spontaneously.

Efficacy endpoint: Correct identification pf pre-treatment vs 12 Week post-treatment images by at least two out of three blinded, independent reviewers Secondary endpoints: Subject satisfaction as assessed by questionnaire administered at 12 weeks post-treatment Change in ultrasound-measured upper arm fat from pre-treatment to 12 weeks post-treatment

Effectiveness Results

The per protocol population consisted of all the treated subjects followed for 12 weeks with weight change of no more than 5% of total body weight at the time the 12 week images were taken. For the per protocol population, the correct baseline photograph identification rate by the independent panel reviewers was 85.2% [72.9%, 93.4%].Data from ultrasound measurements showed significant reduction in the fat layer (0.32 cm) from baseline to 12 weeks post-treatment.Subject satisfaction: 72.41% of the subjects found the procedure to be comfortable to very comfortable, and 63.3% of the subjects reported that they would recommend the procedure to a friend.

Safety Results

Clinical safety assessment showed anticipated side-effects. There were 4 patients with prolonged numbness lasting greater than 12 weeks. All adverse events have resolved. No unanticipated adverse device effects, or serious device or procedure-related adverse effects occurred. All device- and/or procedure-related adverse events have resolved spontaneously.

This clinical investigation demonstrates that use of the ZELTIQ CoolSculpting System can safely and effectively induce cold-assisted lipolysis as the predicate device.

CONCLUSION:

Testing of the CoolSculpting System, which includes the CoolAdvantage applicator, demonstrated that the device performs as intended. As such, the CoolSculpting System with CoolAdvantage applicator is substantially equivalent to the predicate device.

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.