(119 days)
No
The summary does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies. The device is described as a thermoelectric cooling and heating system with vacuum and surface applicators.
Yes.
The device is indicated for cold-assisted lipolysis, to minimize pain and thermal injury, act as a local anesthetic, provide localized thermal therapy to minimize pain post-trauma and post-surgery, and for temporary relief of minor aches, pains, muscle spasms, and temporary improvement in local circulation and temporary reduction in the appearance of cellulite, all of which are therapeutic uses.
No
The device is intended for cold-assisted lipolysis, minimizing pain, and providing thermal therapy, which are all therapeutic or aesthetic treatments, not diagnostic functions. It affects the appearance of fat bulges and provides symptomatic relief, rather than identifying or diagnosing medical conditions.
No
The device description explicitly states it is a "portable thermoelectric cooling and heating device" comprised of a control unit, applicators, and supplies, indicating it is a hardware-based system.
Based on the provided information, the CoolSculpting System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. This includes things like blood, urine, tissue samples, etc., to provide information for diagnosis, monitoring, or screening.
- The CoolSculpting System is a physical therapy device. Its intended use is to apply controlled cooling or heating to the skin for purposes like fat reduction, pain relief, and temporary improvement in circulation and cellulite appearance. It directly interacts with the patient's body externally and does not analyze biological samples.
The description of the device, its intended use, and the performance studies all point to it being a therapeutic device, not a diagnostic one that analyzes in vitro samples.
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, 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.
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 and surface applicators and supplies such as liners, gel/gelpads, cycle cards, geltraps, foam borders and securement system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm, bra fat, banana roll, submental area, thigh, abdomen, flank, or "love handles"
Indicated Patient Age Range
subjects between 22 and 65 years of age
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)
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
Key Results:
- Safety Endpoint: Rate of unanticipated adverse device effects (UADE). 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 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 Endpoints:
- Change in ultrasound-measured upper arm fat from pre-treatment to 12 weeks post-treatment: Data from ultrasound measurements showed significant reduction in the fat layer (0.32 cm) from baseline to 12 weeks post-treatment.
- Subject satisfaction as assessed by 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Correct baseline photograph identification rate by independent panel reviewers: 85.2% [72.9%, 93.4%]
- Significant reduction in fat layer (ultrasound measurement): 0.32 cm
- Subjects finding the procedure comfortable to very comfortable: 72.41%
- Subjects who would recommend the procedure to a friend: 63.3%
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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is simple and recognizable, representing the department's role in promoting health and well-being.
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 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.
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 Drive
Pleasanton, CA 94588 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Shruti Jayakumar
Senior Regulatory Affairs Manager
ZELTIQ Aesthetics, Inc.
Phone: 925-474-2516
Fax: 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.
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,
4
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.
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. |
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.