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 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.

As part of the CoolSculpting System suite of applicators, ZELTIQ has developed two new vacuum applicators known as CoolAdvantage Plus and CoolAdvantage Petite. Both applicators feature the curved aluminum cup design with interchangeable silicone contours that is identical to the previously cleared CoolAdvantage applicator (K162050). They have been modified in size to accommodate different sizes of fat bulges. All other technological characteristics, including mechanism of action, and performance remain identical for the CoolAdvantage family of applicators.

The CoolAdvantage family of applicators is also provided with a new gelpad known as CoolAdhesive Pad. The CoolAdhesive Pad is comprised of fructose and glycerin in a pad made of rayon and spandex. This material is commonly used in the garment industry. It has the identical functionality as the previously cleared gelpads and is intended to provide consistent thermal contact during treatments with the CoolAdvantage family of applicators. Fructose and glycerin are considered safe ingredients and are found in commonly used products. Fructose is generally used as a food additive and glycerin is typically found in common cosmetic products such as lotion and soap. Glycerin is generally recognized as safe (GRAS per CFR §182.1320). The CoolAdhesive Pad has been tested for biocompatibility and is considered biocompatible. The performance remains the same for CoolAdhesive Pad as for the previously cleared gelpads.

AI/ML Overview

The provided text describes the 510(k) summary for the ZELTIQ CoolSculpting System, specifically focusing on the introduction of two new applicators (CoolAdvantage Plus and CoolAdvantage Petite) and a new gelpad (CoolAdhesive Pad). The document explicitly states that no clinical studies were performed in support of this specific submission. Therefore, it is impossible to provide information regarding a study that proves the device meets acceptance criteria based on the provided text alone, as such a study was not part of this submission process.

The FDA's decision of substantial equivalence (K171069) for this device relies heavily on its similarity to a previously cleared predicate device (ZELTIQ CoolSculpting System, K162050), which presumably underwent clinical testing for its initial clearance or was cleared through other pathways.

However, based on the information provided, I can construct parts of the answer regarding acceptance criteria and the types of testing performed for this specific submission, even though they do not involve clinical performance data.

Here's an analysis of the provided text in relation to your questions, highlighting where information is absent due to the lack of clinical studies in this specific submission:

1. A table of acceptance criteria and the reported device performance

The document details various tests conducted and generally states that the device "passed successfully by meeting the acceptance criteria." Specific numerical performance data or detailed acceptance criteria from these tests are not provided in this summary.

Acceptance Criteria and Reported Device Performance (Based on provided text, non-clinical):

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Passed Cytotoxicity, Sensitization, and Irritation tests consistent with ISO 10993 standards.
Electrical Safety and Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1 (2005+A1:2012) for safety and IEC 60601-1-2 (2007) for EMC.
Software Verification and Validation	Tests conducted per FDA's "General Principles of Software Validation" (2002); device software considered "moderate level of concern."
Bench Performance Testing	Design verification and usability tests were passed successfully by meeting acceptance criteria (e.g., thermal performance, thermal range, reuse, physical specifications, compatibility with use environment, treatment parameters, power and operational control, labeling, interface, and support requirements).

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable for clinical performance as "no preclinical or clinical testing was performed" for this specific submission. For bench testing, sample sizes are not explicitly mentioned.
Data Provenance: Not applicable for clinical performance. For bench testing, the data origin is from ZELTIQ Aesthetics, Inc.'s internal testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no clinical performance study was conducted for this submission, there was no ground truth established by experts in the context of clinical efficacy or safety.

4. Adjudication method for the test set

Not applicable. No clinical test set.

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

Not applicable. No clinical studies, let alone MRMC studies, were performed or described for this specific submission. The device is a physical system for aesthetic treatment, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a physical system, not an algorithm. Bench testing demonstrated the device's technical performance in a standalone manner (without patient interaction) against specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for clinical ground truth. For the non-clinical performance and safety data:
- Biocompatibility: Ground truth is established by the specified ISO 10993 standards and their inherent scientific principles for evaluating biological compatibility.
- Electrical Safety & EMC: Ground truth is defined by the requirements of IEC 60601-1 and IEC 60601-1-2 standards.
- Software V&V: Ground truth is adherence to the "General Principles of Software Validation" guidance and internal software requirements.
- Bench Performance: Ground truth is defined by the internal design specifications and defined performance parameters of the device.

8. The sample size for the training set

Not applicable. The device is not an AI/ML model that requires a training set in the typical sense.

9. How the ground truth for the training set was established

Not applicable.

Summary of Device Performance Assessment in this Submission:

The ZELTIQ CoolSculpting System's K171069 submission primarily focuses on demonstrating substantial equivalence to its predicate device (K162050) by highlighting that the new applicators and gelpad maintain the same indications for use, mechanism of action, and performance characteristics. The acceptance criteria for this specific submission were met through:

Biocompatibility testing of the new gelpad.
Electrical safety and EMC testing of the overall system.
Software verification and validation (since the software remained unchanged from the predicate, ensuring its continued proper function).
Bench performance testing to ensure the new applicators and gelpad performed as expected and within previously cleared parameters (e.g., maintaining the target temperature, durability, etc.).

The key takeaway is that for this 510(k) submission, the "study that proves the device meets the acceptance criteria" refers to the non-clinical performance and safety testing outlined, rather than a clinical trial with human subjects. The substantial equivalence argument negates the need for new clinical data if the technological characteristics are sufficiently similar and safety/performance are demonstrated through non-clinical means.

Summary

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

July 7, 2017

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

Re: K171069

Trade/Device Name: ZELTIO CoolSculpting System Regulation Number: 21 CFR 878.4340 Regulation Name: Contact Cooling System for Aesthetic Use Regulatory Class: Class II Product Code: OOK Dated: April 7, 2017 Received: April 10, 2017

Dear Mr. 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 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 Actinclude 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 (reporting of medical device

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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 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,

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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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K171069

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)	☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(K) SUMMARY 6.

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: 925-568-2977Fax: 925-568-2770
DATE PREPARED:	April 7, 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 DEVICE:	The ZELTIQ CoolSculpting System (K162050)

IV. DEVICE DESCRIPTION:

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mechanism of action, and performance remain identical for the CoolAdvantage family of applicators.

V. INDICATION FOR USE:

The indications for use are unchanged from the legally marketed device, the CoolSculpting System (K162050).

The CoolSculpting System is a skin cooling or heating device. The device is indicated for coldassisted 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, back 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.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

The ZELTIQ CoolSculpting System is the same as the device cleared in K162050. The indication and mechanism of action remain identical. This submission includes two new applicators, CoolAdvantage Plus and CoolAdvantage Petite. The CoolAdvantage Plus and CoolAdvantage Petite applicators are the same as the previously cleared CoolAdvantage applicator (K162050). Both applicators have the identical curved cup design with interchangeable contours as the previously cleared CoolAdvantage applicator (K162050). They have been modified in size to accommodate different bulges of fat. The dimensions of the applicators are within previously cleared specifications. The CoolAdvantage Plus applicator is provided with a treatment profile of -11°C for 45 minutes and the CoolAdvantage Petite is provided with a treatment profile of -11°C for 35 minutes. Both profiles are within previously cleared treatment parameters (K142491).

In addition, this submission includes a new gelpad known as CoolAdhesive Pad. CoolAdvantage Plus is provided with a larger version of this gelpad, known as CoolAdhesive Plus Pad. The CoolAdhesive Pad has the identical intended use to the previously cleared gelpads (K162050) and is intended to facilitate thermal contact of the device with a patient's skin by mitigating minor variances in deviceto-skin contact. It has the identical duration of contact (less than 24 hours) and is used on intact skin during treatments. The CoolAdhesive Pad is comprised of fructose and glycerin in a pad made of rayon and spandex. This material is commonly used in the garment industry. Fructose and glycerin are considered safe ingredients and are found in commonly used products. Fructose is generally used as a food additive and glycerin is typically found in common cosmetic products such as lotion and soap. Glycerin is generally recognized as safe (GRAS per CFR §182.1320). The pad has been tested for biocompatibility and is considered biocompatible.

VII. PERFORMANCE DATA:

The following performance data were generated in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and international Standard ISO10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The CoolSculpting System is considered a skin contacting surface device for a limited duration of (≤ 24hours). The following tests were conducted: Cytotoxicity, Sensitization, and Irritation.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Zeltig CoolSculpting System, consisting of the control unit and the detachable vacuum and surface applicators. The system complies with the IEC 60601-1 (2005+A1:2012) standard for safety and the IEC 60601-1-2 (2007) standard for EMC.

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Software Verification and Validation Testing

The new applicators CoolAdvantage Plus and CoolAdvantage Petite use the same software as the predicate applicator CoolAdvantage. There is no change to the Control Unit and the GUI since the workflow remains identical to the predicate. Software verification and validation testing were conducted per FDA's "General Principles of Software Validation: Final Guidance for Industry and FDA Staff" (January 2002).

The software for this device is considered a moderate level of concern.

Performance testing

Bench testing to controlled protocols, with calibrated equipment, was used to demonstrate the ability of the CoolSculpting System to meet performance specifications, and to demonstrate substantial equivalence. These tests included design verification, usability, and surface temperature measurements.

Verification testing was completed to demonstrate:

thermal performance ●
. thermal range
reuse
physical specifications ●
compatibility with use environment
treatment parameters (i.e. minimum and maximum temperature settings, treatment duration, active cooling and warming)
power and operational control
labeling, interface, and support requirements ●

All design verification and validation tests were passed successfully by meeting the acceptance criteria.

Clinical Studies

No preclinical or clinical testing was performed.

VIII. CONCLUSION:

The intended use, mechanism of action, technical characteristics and performance of the new CoolAdvantage Plus and CoolAdvantage Petite applicators are the same as the previously cleared CoolAdvantage applicator (K162050). The CoolAdhesive Pad family has the identical intended use, mechanism of action, and performance as the previously cleared CoolGel Max gelpads (K162050). The performance data demonstrate that the device performs to specifications and is expected to be equivalent to the predicate devices cleared in K162050, in safety and effectiveness, for the specified use.

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.