(97 days)
The Cynosure SculpSure™ is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the device is intended for non-invasive lipolysis of the submental area in individuals with a Body Mass Index (BMI) of 49 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area. When using the petite mask for non-invasive lipolysis of the submental area, the device can also affect the appearance of lax tissue in the submental area.
The Cynosure SculpSure is a diode laser system. The main components of SculpSure are a console and four applicators that deliver the laser energy to the patient. Electrically efficient semiconductors generate optical radiation (1060 nm) which is used to deliver laser energy to subcutaneous tissue layers.
The document describes a clinical study conducted to evaluate the safety and efficacy of the Cynosure SculpSure laser system with a new petite mask for non-invasive fat reduction and improvement of lax tissue appearance in the submental area.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state the acceptance criteria as a separate table. Instead, it describes the endpoints that were evaluated and the results. I will infer the acceptance criteria from the "met all three endpoints to prove safety and efficacy" statements.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| For Non-Invasive Fat Reduction: | |
| 1. Significant change in adipose tissue thickness from baseline. | Reduction in adipose tissue measured by ultrasound imaging at 12-week post follow-up visit showed a p-value of <0.001 for all subjects, indicating a statistically significant reduction. Average reduction was 1.4mm. (Met) |
| 2. Positive blind evaluation of pre- and post-photographs. | On average, blind evaluators were able to identify 91% (53/58) of all post-treatment photographs. (Met) |
| 3. High patient satisfaction. | The patient satisfaction survey at 12-week post follow-up visit showed a 91% (53/58) satisfaction rate. (Met) |
| For Improvement of Lax Tissue Appearance: | |
| 1. Measurable improvement in lax tissue (quantitative). | 86% of subjects (50/58) showed a measurable improvement in lax tissue in the submental area, defined as a ≥20mm² decrease in lax tissue via photographic analysis. (Met) |
| 2. Positive patient perception of chin toning. | 86% (49/57) patients responded that they agreed that the treatment made their chin look more toned. (Met) |
| For Both Indications (Safety): | |
| Low incidence of significant adverse events. | All subjects (n=61) were included in the safety analysis. Most events were transient, and a majority was mild in nature. No significant safety concerns were identified, and it was concluded that the device is safe. (Met) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): 61 subjects were enrolled in the study. 58 subjects were included in the efficacy analysis for fat reduction and lax tissue improvement (implied by 53/58 and 50/58). 57 subjects were evaluated for patient satisfaction regarding chin toning (49/57). 61 subjects were included in the safety analysis.
- Data Provenance: The study was a prospective, controlled study conducted at 3 study centers. The document does not specify the country of origin, but given the FDA submission, it is likely the US or a region with comparable clinical trial standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- The document states "blind evaluators" were used for assessing pre- and post-treatment photographs for fat reduction. The number and qualifications of these evaluators are not specified.
4. Adjudication Method for the Test Set:
- The document implies a "blind evaluation" for the photographic assessment, suggesting that the evaluators were blinded to the treatment status (pre vs. post). However, it does not explicitly describe an adjudication method (e.g., 2+1, 3+1) if there were multiple evaluators and their assessments differed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This study focused on the performance of the device itself.
6. Standalone (Algorithm Only) Performance:
- This is a medical device (laser system), not an AI algorithm. Therefore, the concept of "standalone performance" of an algorithm is not applicable here. The study evaluated the device's performance directly on human subjects.
7. Type of Ground Truth Used:
- For Fat Reduction:
- Objective/Quantitative: Ultrasound imaging measurements of adipose tissue thickness.
- Subjective/Qualitative: Blind evaluation of pre- and post-treatment photographs.
- Patient-Reported: Patient satisfaction survey (Likert scale).
- For Lax Tissue Improvement:
- Objective/Quantitative: Photographic analysis with anatomical points to measure reduction in submental area and neck lax tissue (defined as ≥20mm² decrease).
- Patient-Reported: Subject questionnaire on 'chin toning'.
8. Sample Size for the Training Set:
- The document describes a clinical study for the evaluation of the device, not the training of an AI model. Therefore, there is no mention of a training set sample size in the context of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established:
- As this is not an AI algorithm study, the concept of a training set and its ground truth establishment is not applicable. The "ground truth" in this context refers to the methods used to assess the efficacy and safety of the device in the clinical trial.
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January 3, 2019
Cynosure Amy Tannenbaum Regulatory Affairs Specialist III 5 Carlisle Road Westford, Massachusetts 01886
Re: K182741
Trade/Device Name: SculpSure Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System For Aesthetic Use Regulatory Class: Class II Product Code: PKT Dated: September 27, 2018 Received: September 28, 2018
Dear Amy Tannenbaum:
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/ofdocs/ofpmn.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
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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.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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,
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
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Indications for Use
510(k) Number (if known) K182741
Device Name SculpSure
Indications for Use (Describe)
The Cynosure SculpSure™ is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the device is intended for non-invasive lipolysis of the submental area in individuals with a BMI of 49 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area. When using the petite mask for non-invasive lipolysis of the submental area, the device can also affect the appearance of lax tissue in the submental area.
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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510(k) Summary for SculpSure Laser System
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| 807.92(a)(1) Submitter Information | |
|---|---|
| Applicant | Cynosure, Inc. |
| Address | 5 Carlisle RoadWestford, MA 01886 |
| Phone Number | (978) 256-4200 |
| Fax Number | (978) 256-6556 |
| Establishment Registration Number | 1222993 |
| Contact Person | Amy Tannenbaum |
| Preparation Date | September 27, 2018 |
| 807.92(a)(2) Name of Device | |
| Trade or Proprietary Name | SculpSure |
| Common or Usual Name | Laser |
| Classification Name | Laser for disruption of adipocyte cells for aesthetic use |
| Classification Panel | General & Plastic Surgery |
| Regulation | 21 CFR 878.5400 |
| Regulatory Class | II |
| Product Code(s) | PKT |
| 807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed | |
| Predicate Devices | Cynosure SculpSure K171992, Zeltiq Coolsculpting K172144The predicate devices have not been subject to a design-relatedrecall |
| 807.92(a)(4) Device Description | |
| The Cynosure SculpSure is a diode laser system. The maincomponents of SculpSure are a console and four applicators thatdeliver the laser energy to the patient. Electrically efficientsemiconductors generate optical radiation (1060 nm) which isused to deliver laser energy to subcutaneous tissue layers. | |
| 807.92(a)(5) Intended Use of the Device | |
| The SculpSure laser system is intended for non-invasivelipolysis of the abdomen, flanks, back, and thighs in individualswith a Body Mass Index (BMI) of 30 or less. In addition, the | |
| device is intended for non-invasive lipolysis of the submentalarea in individuals with a Body Mass Index (BMI) of 49 or less. | |
| The device is intended to affect the appearance of visible fatbulges in the abdomen, flanks, back, thighs, and submental area. | |
| When using the petite mask for non-invasive lipolysis of thesubmental area, the device can also affect the appearance of laxtissue in the submental area. |
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807.92(a)(6) Summary of the Technological Characteristics of the Device Compared to the Predicate
| Proposed SculpSure | Cynosure SculpSure | Zeltiq Coolsculpting | |
|---|---|---|---|
| Laser System | Laser System | Device | |
| 510(k) Number | KPending | K171992 | K172144 |
| Manufacturer | Cynosure, Inc. | Cynosure, Inc. | Zeltiq Aesthetics, Inc. |
| Lipolysis Method | Heat-assisted | Heat-assisted | Cold-assisted |
| Device Type | Diode Laser | Diode Laser | N/A |
| Wavelength | 1060 ±20 nm(infrared) | 1060 ±20 nm(infrared) | N/A |
| Spot Size | 4 x 6 $cm²$ on each ofthe Applicator heads(up to fourapplicators per bodytreatment)14.28 $cm²$ (forstandard submentalmask)10.49 $cm²$ (for petitesubmental mask) | 4 x 6 $cm²$ on each ofthe Applicator heads(up to fourapplicators per bodytreatment)14.28 $cm²$ (oneapplicator head andframe used forSubmental treatment) | 4.5 x 7 $cm²$ (2x)approximate |
| Pulse Width (laserON time) | CW | CW | N/A |
| Power Density | Up to 1.4 W/ $cm²$(body)Up to 3.06 W/ $cm²$(submental) | Up to 1.4 W/ $cm²$(body)Up to 2.35 W/ $cm²$(submental) | N/A |
| Attachment topatient | Belt (body treatment)Headgear and straps(submental treatment) | Belt (body treatment)Headgear and straps(submental treatment) | Belt |
| Voltage | 200-240V~, SinglePhase | 200-240V~, SinglePhase | N/A |
| Current | 20A | 20A | N/A |
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807.92(b)(1) Non-clinical tests submitted
Electromagnetic compatibility and electrical safety was performed per standards IEC 60601-1, Ed 3.1, IEC 60601-1-2 Ed 4, IEC 60601-2-22, Ed 3.1, and IEC 60825-1 Ed 2. Software has been updated and validation was performed. All patient contacting materials were assessed as per ISO 10993-1 and found to be biocompatible. Additional bench testing was performed to demonstrate that the petite submental mask provides beam uniformity to the treatment area with +/- 15% specifications.
807.92(b)(2) Clinical tests submitted
A controlled clinical study was conducted to evaluate the safety and efficacy of treatment in the submental area for adipose tissue reduction using the petite mask.
A prospective, controlled study was conducted at 3 study centers to evaluate the safety and efficacy of the Cynosure SculpSure laser for the non-invasive fat reduction of the submental area, using the new petite mask (10.49cm²). The treatment techniques used and subsequent follow up schedule for the study were kept consistent between the three centers. 61 subjects enrolled in the study. 34 subjects had a BMI of less than 30, and 27 subjects had a BMI of 30 or higher. Each subject received up to 2 treatments with the petite mask in the submental area. There were 4 patients that received 1 treatment, and the rest received 2 treatments. Treatment effectiveness was assessed through blind evaluation of pre- and post- final treatment (12 week) photographs; significant change in adipose tissue thickness from baseline to 12-week follow up measured through ultrasound imaging, and patient satisfaction measured at the 12-week post-final treatment follow up visit through 6-point Likert scale. In addition, an analysis of the safety and adverse events will be conducted. On average, blind evaluators were able to identify 91% (53/58) of all post-treatment photograph. Reduction in adipose tissue was measured by ultrasound imaging at 12-week post follow up visit. Results showed a p-value of <0.001 for all subjects indicating a statistically significant reduction in adipose tissue laver, with average reduction of 1.4mm. Therefore, the secondary efficacy endpoint for statistically significant reduction in adipose tissue was met. The patient satisfaction survey at 12-week post follow up visit showed a 91% (53/58) satisfaction rate. All subjects that were treated in the study (n=61) were included in the safety analysis and adverse events were assessed at all visits. Most events were transient, and a majority was mild in nature. Both the High and Low BMI groups met all three endpoints to prove safety and efficacy of this study. There was no significant difference between the safety and efficacy results of the subjects that had a BMI above 30 as compared to the results of the subjects that had a BMI below 30. This study concluded that the SculpSure is safe and effective for non-invasive fat reduction at the submental area using the petite mask.
In addition, an evaluation of the effectiveness of the SculpSure device to affect the appearance of lax skin in the submental area was conducted.
A prospective, controlled study was conducted at 3 study centers to evaluate the safety and efficacy of the Cynosure SculpSure laser to improve the appearance of lax tissue in the submental area, using the submental mask. In this study, the petite (10.49cm²) mask was used. The treatment techniques used and subsequent follow up schedule for the study were kept consistent between the three centers. 61 subjects were enrolled in the study. 34 subjects had a
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BMI of less than 30, and 27 subjects had a BMI of 30 or higher. Each subject received up to 2 treatments with the petite mask in the submental area. There were 4 patients that received 1 treatment, and the rest received 2 treatments. Treatment effectiveness was assessed through the reduction in submental area and neck lax tissue as measured by photographic analysis at the 12-week post-final treatment follow up, and subject questionnaire on 'chin toning' given at the 12-week post-final treatment follow up. Anatomical points were identified on the images and analyzed using the same protocol as described by 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. Criteria for improvement was a ≥20mm² decrease in lax tissue. 86% of subjects (50/58) showed a measurable improvement in lax tissue in the submental area. 86% (49/57) patients responded that they agreed that the treatment made their chin look more toned. All subjects that were treated in the study (n=61) were included in the safety analysis and adverse events were assessed at all visits. Most events were transient, and a majority was mild in nature. Both the High and Low BMI groups met all three endpoints to prove safety and efficacy of this study. There was no significant difference between the safety and efficacy results of the subjects that had a BMI above 30 as compared to the results of the subjects that had a BMI below 30. This study concluded that SculpSure is safe and effective to affect the appearance of lax tissue in the submental area.
807.92(b)(3) Conclusions drawn from clinical and non-clinical tests submitted
Cynosure believes that SculpSure is substantially equivalent to its predicate devices with same intended use and technological characteristics. The non-clinical data for SculpSure, including biocompatibility, bench testing, hardware, and software documentation shows that the device should perform as intended in the specified use. Additionally, the successful clinical performance of the SculpSure with the petite submental mask proves that the safety and efficacy profile meet that of the predicate devices. Therefore, Cynosure is requesting clearance for use of the petite mask and the indication to affect the appearance of lax tissue in the submental area.
§ 878.5400 Low level laser system for aesthetic use
(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.