(107 days)
K171069, OOK
No
The document describes a physical device for cooling and heating tissue and mentions photographic analysis for evaluating treatment outcomes, but there is no mention of AI or ML being used within the device's operation or analysis process.
Yes
The "Intended Use / Indications for Use" section clearly states that the device is indicated for various therapeutic purposes, including cold-assisted lipolysis, minimizing pain and thermal injury during other treatments, acting as a local anesthetic, providing localized thermal therapy to minimize pain, and for temporary relief of minor aches, pains, and muscle spasms.
No
The device is indicated for cold-assisted lipolysis, localized thermal therapy, and pain/spasm relief, which are therapeutic and aesthetic purposes, not diagnostic.
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 Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- CoolSculpting's Intended Use: The CoolSculpting System's intended use is for cold-assisted lipolysis (breakdown of fat) and localized thermal therapy applied directly to the patient's skin. It is a therapeutic device, not a diagnostic one.
- Device Description: The device description confirms it's a thermoelectric cooling and heating device with applicators for direct skin contact.
- Performance Studies: The performance studies described involve photographic analysis of the patient's physical appearance, not analysis of biological specimens.
Therefore, the CoolSculpting System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
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. 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 and surface applicators and supplies such as liners, gel/gelpads, cycle cards, geltraps, gaskets, 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
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
This retrospective study used the per-protocol population (n=58) for analysis. One subject was excluded from the analysis due to excessive hair in the submental region, therefore the number of subjects used for analysis was 57. Right and left lateral photographic views of the submental area taken at baseline and at the 12-week post final treatment visit were included in the analysis. Each photo was cropped and masked prior to evaluation. A board certified plastic surgeon identified the following anatomical points on each photograph: the lateral canthus, the anterior most point where the nostril meets the columella, and the point where the chin meets the neck (submental crease). A series of lines were drawn on the photo using AutoCAD software and areas in the submental region were measured. A responder analysis was performed with the criteria being >= 20 mm² decrease in area as measured on both the right lateral and left lateral views of the region. A second analysis was performed comparing the responders with results from the independent physician review panel of photos conducted for the previous study.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Retrospective photo analysis study
Sample Size: 57
Key Results: ZELTIQ conducted a retrospective photo analysis study examining the effectiveness of the cryolipolysis system to affect the appearance of lax tissue in the submental area. The photographic analysis was based on the methodology used to obtain clearance of the reference device (Ulthera System, K121700).
Sixty subjects were enrolled in an original IDE approved study that was used for the submental clearance in K151179. Two of the 60 subjects did not receive full treatments and were excluded from the per-protocol population. Subjects received treatment with the ZELTIQ CoolSculpting System on the submental area, and were followed through a 12-week post-treatment visit.
The primary safety endpoint in the original IDE approved study was met and remains unchanged since the close of the study and was previously submitted in K151179.
The primary effectiveness endpoint in the original IDE involved independent panel review of pre- and 12-week post-treatment photographs of the treatment area. For the per protocol population, the correct baseline photograph identification rate by the independent panel reviewers was 91.4%. This data remains unchanged since the close of the study and was previously submitted in K151179.
The secondary effectiveness endpoint for subject satisfaction was assessed by an IRB-approved questionnaire administered at 12-week post-treatment. Seventy-five percent of the subjects reported that they agree or strongly agree that the treatment made their chin look more toned. This data remains unchanged since the close of the study and was previously submitted in K151179.
Further evidence of treatment effectiveness found the data from photographic analysis of the treated areas indicates 77.2% (44/57) of subjects exhibited a >= 20 mm² area reduction in the submental area and neck. Of those 44 subjects, 42 (95.5%) were correctly identified by the physician panel as having a visible response. The results of this photographic analysis indicate that the CoolSculpting procedure on the submental area can also affect the appearance of lax tissue in the submental area.
Summary of Retrospective Study for effect on the appearance of lax tissue in the Submental area:
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 91.4%.
Data from photographic analysis showed effect on the appearance of lax tissue (>= 20 mm²) from baseline to 12 weeks post-treatment in 77.2% (44/57) of subjects. Of those 44 subjects, 42 (95.5%) were correctly identified by the physician panel as having a visible response.
Subject satisfaction data from original IDE: 75% of the subjects reported that they agreed that the treatment made their chin look more toned.
Safety Results: The primary safety endpoint of the original IDE approved study was met and remains unchanged since the close of the study. All device- and/or procedure-related adverse events have resolved spontaneously.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correct baseline photograph identification rate by the independent panel reviewers: 91.4%
Subjects exhibiting >= 20 mm² area reduction in the submental area and neck: 77.2% (44/57)
Subjects correctly identified by physician panel as having a visible response (out of 44): 95.5% (42)
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.
CoolSculpting System (K171069, OOK)
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.
Ulthera System (K121700, OHV)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration."
November 1, 2017
ZELTIQ Aesthetics, Inc. Ewald Riechert Director of Regulatory Affairs 4410 Rosewood Road Pleasanton, California 94588
Re: K172144
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: September 28, 2017 Received: September 29, 2017
Dear Ewald 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 pror 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, 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 device-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.
1
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 (DICE) 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 (DICE) 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 -S3 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
2
Indications for Use
510(k) Number (if known) K172144
Device Name Zeltiq 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. 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.
| 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.
| I. SUBMITTER: | ZELTIQ™ Aesthetics, Inc.
4410 Rosewood Drive
Pleasanton, CA 94588 |
|-------------------------|----------------------------------------------------------------------------------------------------------|
| CONTACT: | Ewald Riechert
Director of Regulatory Affairs
ZELTIQ Aesthetics, Inc.
Phone: 925-568-2977 |
| DATE PREPARED: | July 14, 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 DEVICES: | Predicate Device: CoolSculpting System (K171069, OOK)
Reference Device: Ulthera System (K121700, OHV) |
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 and surface applicators and supplies such as liners, gel/gelpads, cycle cards, geltraps, gaskets, foam borders and securement system.
V: INDICATION FOR USE:
The CoolSculpting System is a skin cooling or heating device. The 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
4
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 ZELTIQ CoolSculpting System is the same as the device cleared in K171069. No changes have been made to the device to accommodate this new indication.
The CoolSculpting System has been established as safe and effective through many prior clearances (the most recent is K171069). It was demonstrated to be safe and effective for the submental area in K151179.
VII. PERFORMANCE DATA:
Biocompatibility testing
The ZELTIQ CoolSculpting System is the same as the previously cleared predicate device (K171069).
Electrical safety and electromagnetic compatibility (EMC)
The ZELTIQ CoolSculpting System is the same as the previously cleared predicate device (K171069).
Software Verification and Validation Testing
The ZELTIQ CoolSculpting System is the same as the previously cleared predicate device (K171069).
Performance testing
The ZELTIQ CoolSculpting System is the same as the previously cleared predicate device (K171069).
5
Clinical Study
ZELTIQ conducted a retrospective photo analysis study examining the effectiveness of the cryolipolysis system to affect the appearance of lax tissue in the submental area. The photographic analysis was based on the methodology used to obtain clearance of the reference device (Ulthera System, K121700).1
Sixty subjects were enrolled in an original IDE approved study that was used for the submental clearance in K151179. Two of the 60 subjects did not receive full treatments and were excluded from the per-protocol population. Subjects received treatment with the ZELTIQ CoolSculpting System on the submental area, and were followed through a 12-week post-treatment visit.
The primary safety endpoint in the original IDE approved study was met and remains unchanged since the close of the study and was previously submitted in K151179.
The primary effectiveness endpoint in the original IDE involved independent panel review of pre- and 12-week post-treatment photographs of the treatment area. For the per protocol population, the correct baseline photograph identification rate by the independent panel reviewers was 91.4%. This data remains unchanged since the close of the study and was previously submitted in K151179.
The secondary effectiveness endpoint for subject satisfaction was assessed by an IRBapproved questionnaire administered at 12-week post-treatment. Seventy-five percent of the subjects reported that they agree or strongly agree that the treatment made their chin look more toned. This data remains unchanged since the close of the study and was previously submitted in K151179.
This retrospective study used the per-protocol population (n=58) for analysis. One subject was excluded from the analysis due to excessive hair in the submental region, therefore the number of subjects used for analysis was 57. Right and left lateral photographic views of the submental area taken at baseline and at the 12-week post final treatment visit were included in the analysis. Each photo was cropped and masked prior to evaluation. A board certified plastic surgeon identified the following anatomical points on each photograph: the lateral canthus, the anterior most point where the nostril meets the columella, and the point where the chin meets the neck (submental crease). A series of lines were drawn on the photo using AutoCAD software and areas in the submental region were measured. A responder analysis was performed with the criteria being ≥ 20 mm² decrease in area as measured on both the right lateral and left lateral views of the region. A second analysis was performed comparing the responders with results from the independent physician review panel of photos conducted for the previous study.
1 Oni, G, Hoxworth R, Teotia, S, et al. Evaluation of a Microfocused Ultrasound System for Improving Skin Laxity and Tightening in the Lower Face. Aesthetic Surgery Journal 2014;34(7):1099-1110.
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Further evidence of treatment effectiveness found the data from photographic analysis of the treated areas indicates 77.2% (44/57) of subjects exhibited a ≥ 20 mm² area reduction in the submental area and neck. Of those 44 subjects, 42 (95.5%) were correctly identified by the physician panel as having a visible response. The results of this photographic analysis indicate that the CoolSculpting procedure on the submental area can also affect the appearance of lax tissue in the submental area.
The study design and results are summarized in the table below:
| Study Design | Retrospective |
|---|---|
| Sample Size for | |
| analysis | 57 |
| 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 91.4%. |
Data from photographic analysis showed effect on the
appearance of lax tissue (≥ 20 mm²) from baseline to 12
weeks post-treatment in 77.2% (44/57) of subjects. Of those
44 subjects, 42 (95.5%) were correctly identified by the
physician panel as having a visible response.
Subject satisfaction data from original IDE: 75% of the
subjects reported that they agreed that the treatment made
their chin look more toned. |
| Safety Results | The primary safety endpoint of the original IDE approved
study was met and remains unchanged since the close of the
study. All device- and/or procedure-related adverse events
have resolved spontaneously. |
Table 5.1. Summary of Retrospective Study for effect on the appearance of lax tissue in the Submental area
The data provides reasonable assurance of safety and effectiveness to demonstrate substantial equivalence of the CoolSculpting System for the additional indication for use of affecting the appearance of lax tissue in the submental area.
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VIII. CONCLUSION:
The ZELTIQ CoolSculpting System is the same as the device cleared in K171069. No changes have been made to the device to accommodate this indication of affecting the appearance of lax tissue in the submental area.
The CoolSculpting System is substantially equivalent to the predicate device for the revised indications for use. The clinical data shows visible effect in the appearance of lax tissue meeting both the safety and effectiveness endpoints.
The CoolSculpting System has been established as safe and effective through many prior clearances (the most recent is K171069). It was demonstrated to be safe and effective for the submental area in K151179.
The CoolSculpting System has not changed to accommodate this expanded indication. The clinical data indicates the same safety and effectiveness for the CoolSculpting System for this expanded intended use. As such, the CoolSculpting System is substantially equivalent to the predicate device (previously cleared CoolSculpting System, K171069).