(27 days)
Not Found
No
The document describes a thermoelectric cooling and heating device with vacuum applicators and control systems, but there is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The intended uses for the CoolSculpting System include cold-assisted lipolysis, minimizing pain and thermal injury, temporary relief of minor aches, pains, muscle spasms, and temporary improvement in local circulation and reduction in cellulite, all of which fall under therapeutic applications.
No
The device is indicated for cold-assisted lipolysis, localized thermal therapy, and temporary relief of minor aches, pains, and muscle spasms, which are all treatment-oriented uses, not diagnostic.
No
The device description explicitly states it is a "portable thermoelectric cooling and heating device" comprised of a control unit, detachable vacuum applicators, and accessories, indicating it is a hardware-based system.
Based on the provided information, the CoolSculpting System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device that applies controlled cooling or heating to the body for various therapeutic and aesthetic purposes (lipolysis, pain relief, muscle spasm relief, circulation improvement, cellulite reduction). IVD devices are intended for the examination of specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description details a system with a control unit, applicators, and accessories for applying thermal therapy to the skin. This aligns with a physical therapy or aesthetic device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any processes typically associated with in vitro diagnostics.
Therefore, the CoolSculpting System falls under the category of a therapeutic or aesthetic medical device, not an IVD.
N/A
Intended Use / Indications 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, thigh, abdomen, and flank, or "love handles" in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the device is intended for cold-assisted lipolysis of the submental and submandibular areas in individuals with a BMI up to 46.2. The device is intended to affect the appearance of visible fat bulges in the upper arm, bra fat, back fat, banana roll, submental and submandibular areas, 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.
Product codes (comma separated list FDA assigned to the subject device)
OOK
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 applicators and accessories such as gelpads, cycle cards, geltraps, and gaskets.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm, bra fat, back fat, banana roll, thigh, abdomen, flank, submental and submandibular areas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing: No changes have been made to patient contacting components of the biocompatibility testing is not applicable.
Electrical safety and electromagnetic compatibility (EMC): The device has undergone electrical and mechanical safety performance testing and electromagnetic compatibility testing as a result of the changes referenced. The system complies with IEC 60601-1 (Third Edition, 2005) and IEC 60601-1-2 (Fourth Edition, 2014).
Software Verification and Validation Testing: The CoolSculpting System uses a new operating system and new software architecture. The operating system used in the predicate device (K181740) is Windows CE and has been changed to a Windows 10 operating system. The graphic user interface (GUI) is still a touchscreen LCD as in the predicate device. One step in the treatment instructions has changed in respect to the gelpad application, but the overall workflow has not changed. The device has undergone verification testing as a result of the software changes referenced. Software verification and validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
Performance testing: Performance testing demonstrated that the CoolSculpting system met all performance requirements. As required by the "Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use", testing confirmed that the interface temperature has a steady state accuracy within +/- 0.5°C of the target value, that feedback and control of the cooling mechanism is active during treatment, and that there is a mechanism incorporated into the device to ensure the device does not exceed a safe cooling limit. Since the CoolSculpting System has a vacuum system, bench testing was also performed to verify the accuracy and performance of the vacuum.
The following applicators are to be used with the CoolSculpting system: The CoolAdvantage applicator and the CoolAdvantage Petite applicator. The CoolAdvantage and CoolAdvantage Petite were previously cleared in K162050 and K171069, respectively. These two applicators have been modified to accommodate the updated control unit. Version 2 of the CoolAdvantage and CoolAdvantage Petite applicators have been demonstrated substantial equivalence to the previously-cleared versions via design verification and validation testing though ZELTIQ's design control process. The treatment parameters of the subject device operate within the cleared treatment range. The bench testing reports demonstrate the performance of these applicators at the treatment parameters of -11 °C for 35 minutes. The overall workflow or efficacy of the CoolSculpting System has not changed as a result.
The device has undergone performance benchtop testing and shipping validation testing as a result of the changes referenced. The performance standards as set forth in the "Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use", have been met.
Clinical Study: No clinical testing was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Drive
Pleasanton, CA 94588 |
|------------------------|---------------------------------------------------------------------------------------------------------|
| CONTACT: | Katherine Prendergast
Regulatory Affairs Associate
ZELTIQ Aesthetics, Inc.
Phone: 925-568-2976 |
| DATE PREPARED: | December 14, 2018 |
| 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: ZELTIQ CoolSculpting System (K181740)
IV. 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 applicators and accessories such as gelpads, cycle cards, geltraps, and gaskets.
V: 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, thigh, abdomen, and flank,
1
or "love handles" in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the device is intended for cold-assisted lipolysis of the submental and submandibular areas in individuals with a BMI up to 46.2. The device is intended to affect the appearance of visible fat bulges in the upper arm, bra fat, back fat, banana roll, submental and submandibular areas, 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
The technological characteristics and operating principal associated with the treatment remain unchanged from the predicate device. The size and shape of the applicators remain the same. The applicator heating and cooling technology and method remain unchanged utilizing the same Thermoelectric Coolers (TECs) to achieve heating and cooling. The temperature feedback control mechanism remains the same and the device monitoring is through software monitoring.
Changes were made to the predicate's (K181740) system hardware and the software to create the next generation of the CoolSculpting System. The chiller has been changed from a TEC based chiller to a refrigerator-based model. The single board computer and the software operating system were updated to current technology. The size and shape of the control unit have changed to give it a more modern look and feel, and the user interface has been enhanced to include more explanatory text of the preparation steps on the new software touchscreen display.
VII. PERFORMANCE DATA:
Biocompatibility testing
No changes have been made to patient contacting components of the biocompatibility testing is not applicable.
Electrical safety and electromagnetic compatibility (EMC)
2
The device has undergone electrical and mechanical safety performance testing and electromagnetic compatibility testing as a result of the changes referenced. The system complies with IEC 60601-1 (Third Edition, 2005) and IEC 60601-1-2 (Fourth Edition, 2014).
Software Verification and Validation Testing
The CoolSculpting System uses a new operating system and new software architecture. The operating system used in the predicate device (K181740) is Windows CE and has been changed to a Windows 10 operating system. The graphic user interface (GUI) is still a touchscreen LCD as in the predicate device. One step in the treatment instructions has changed in respect to the gelpad application, but the overall workflow has not changed. The device has undergone verification testing as a result of the software changes referenced. Software verification and validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
Performance testing
Performance testing demonstrated that the CoolSculpting system met all performance requirements. As required by the "Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use", testing confirmed that the interface temperature has a steady state accuracy within +/- 0.5°C of the target value, that feedback and control of the cooling mechanism is active during treatment, and that there is a mechanism incorporated into the device to ensure the device does not exceed a safe cooling limit. Since the CoolSculpting System has a vacuum system, bench testing was also performed to verify the accuracy and performance of the vacuum.
The following applicators are to be used with the CoolSculpting system: The CoolAdvantage applicator and the CoolAdvantage Petite applicator. The CoolAdvantage and CoolAdvantage Petite were previously cleared in K162050 and K171069, respectively. These two applicators have been modified to accommodate the updated control unit. Version 2 of the CoolAdvantage and CoolAdvantage Petite applicators have been demonstrated substantial equivalence to the previously-cleared versions via design verification and validation testing though ZELTIQ's design control process. The treatment parameters of the subject device operate within the cleared treatment range. The bench testing reports demonstrate the performance of these applicators at the treatment parameters of -11 °C for 35 minutes. The overall workflow or efficacy of the CoolSculpting System has not changed as a result.
The device has undergone performance benchtop testing and shipping validation testing as a result of the changes referenced. The performance standards as set forth in the "Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use", have been met.
Clinical Study
No clinical testing was conducted.
3
VIII. CONCLUSION:
The Indication for Use for the ZELTIQ CoolSculpting System is the same as the device cleared in K181740. The changes that have been made to the system's hardware and software do not affect the intended use or risk profile of the device. The subject device still utilizes all the same main components as the predicate device.
4
Image /page/4/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font, and "ADMINISTRATION" in a smaller font below.
January 14, 2017
ZELTIO Aesthetics, Inc. Ms. Katherine Prendergast Regulatory Affairs Associate 4410 Rosewood Drive Pleasanton, California 94588
Re: K183514
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: December 14, 2018 Received: December 18, 2018
Dear Ms. Prendergast:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
5
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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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