(102 days)
The Cynosure is intended for non-invasive lipolysis of the flanks to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired affect. Intended for individuals with a Body Mass Index (BMI) of 30 or less.
The Cynosure SculpSure is a diode laser system. Electrically efficient semiconductors generate optical radiation (1064 nm) which is used to directly irradiate the skin's surface. The Sculpsure is intended for non-invasive lipolysis of the flanks to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. The main components of SculpSure are a console and applicator.
Here's a breakdown of the acceptance criteria and the study that proves the device (Cynosure SculpSure) meets these criteria, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Endpoint: Correct identification of pre-treatment vs. post-treatment images by blinded evaluators. | In 88% of total individual evaluations, blinded board-certified dermatologists correctly identified the before and after images. The study states "all endpoints were met." |
| Secondary Endpoint: Change from baseline in adipose layer thickness between device and control based on ultrasound measurements. | An average of 13% normalized fat reduction was observed based on ultrasound measurements at 12 weeks. The study states "all endpoints were met." |
| Tertiary Endpoint: Subject satisfaction survey. | 98% of patients rated the treatment as "satisfied" on the Likert Satisfaction scale. The study states "all endpoints were met." |
| Safety: No deaths, serious adverse events (SAEs), or unanticipated adverse device effects (UADEs). | No deaths, SAEs, or UADEs were reported. Events logged (edema, bruising, pain, blistering, erythema, nodule, hardness) were typical, transient, and resolved without medical intervention. |
| Pre-clinical: Device elevates tissue temperature to 42-47°C. (Implicitly a criterion for the hyperthermic treatment's mechanism of action to cause adipocyte injury comparable to hypothermic.) | Pre-clinical testing demonstrated that the device would elevate the temperature of the tissue to 42-47 °C. This was concluded to result in comparable adipocyte injury and fat reduction to hypothermic treatment. |
Study Details
- Sample Size used for the test set and the data provenance:
- Sample Size: 49 subjects initially, with 43 subjects returning for the 12-week post-treatment photographic evaluations.
- Data Provenance: The study was a prospective clinical study conducted at two centers. The countries of origin are not specified, but the governing body (FDA) is US-based, suggesting it was likely conducted in the US.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Three blinded evaluators.
- Qualifications: Board-certified dermatologists.
- Adjudication method for the test set:
- The text states that photographs "were evaluated individually by three blinded evaluators." It doesn't explicitly mention an adjudication method like 2+1 or 3+1 for discrepancies. However, the reported 88% correct identification is presented as a singular consensus or aggregate result across all individual evaluations.
- 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:
- No, an MRMC comparative effectiveness study involving human readers improving with AI vs. without AI assistance was not done. This study focuses on the effectiveness of the SculpSure device for lipolysis, not on software/AI interpretation.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this device is a laser system for medical treatment. The "performance" being evaluated is the physical effect of the laser on target tissue, and the subsequent aesthetic and physiological changes, not the performance of an algorithm.
- The type of ground truth used:
- For Primary Endpoint (Photographic Evaluation): Expert consensus (specifically, correct identification by blinded evaluators) implicitly serves as the ground truth for aesthetic improvement.
- For Secondary Endpoint (Adipose Layer Thickness): Objective quantitative measurement via ultrasound scans serves as the ground truth for fat reduction.
- For Tertiary Endpoint (Satisfaction): Subjective patient satisfaction surveys.
- For Pre-Clinical (Mechanism of Action): Histologic examination and quantitative measurements comparing hyperthermic and hypothermic (predicate) treatments, suggesting a pathology-based ground truth for cellular injury and fat reduction comparability.
- The sample size for the training set:
- The document describes a single clinical study that serves as the basis for performance evaluation. It does not explicitly mention a separate "training set" in the context of machine learning or AI algorithm development. The study described is a clinical validation study for the device's efficacy and safety.
- How the ground truth for the training set was established:
- As there's no explicitly mentioned training set for an AI algorithm, this question is not directly applicable. The "ground truth" for the overall device effectiveness and safety was established through a clinical trial with the methodologies described above (photographic evaluation by experts, ultrasound measurements, patient surveys, and pre-clinical histologic analysis).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2015
Cynosure, Inc. % Kevin O' Connell Director Regulatory Affairs 5 Carlisle Road Westford, Massachusetts 01886
Re: K150230 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: January 30, 2015 Received: February 4, 2015
Dear Mr. O' Connell,
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
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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 yours,
Jennifer R. Stevenson -S
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) K150230
Device Name Cynosure SculpSure
Indications for Use (Describe)
Indications for use: The Cynosure is intended for non-invasive lipolysis of the flanks to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired affect. Intended for individuals with a Body Mass Index (BMI) of 30 or less.
| 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
| 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 | |
|---|---|
| Name | Cynosure, Inc. |
| Address | 5 Carlisle RoadWestford, MA 01886USA |
| Phone number | 978-367-8736 |
| Fax number | 978-256-6556 |
| Establishment Registration Number | 1222993 |
| Name of contact person | Kevin J. O'Connell |
| Date prepared | May 14, 2015 |
| 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 and Plastic Surgery |
| Regulation | 21 CFR 878.5400 |
| Product Code(s) | PKT |
| 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed | |
| Zeltiq Coolsculpting Device K133212Cynosure Smartlipo MPX Laser K083795Cynosure 1064 nm Diode Laser K123971 | |
| 807.92(a)(4) - Device description | |
| The Cynosure SculpSure is a diode laser system. Electrically efficient semiconductors generate optical radiation (1064 nm) which is used to directly irradiate the skin's surface. The Sculpsure is intended for non-invasive lipolysis of the flanks to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. The main components of SculpSure are a console and applicator. | |
| 807.92(a)(5) Intended use of the device | |
| Indications for use | The Cynosure SculpSure is intended for non-invasive lipolysis of the flanks to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. Intended for individuals with a Body Mass Index (BMI) of 30 or less |
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| 807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate | ||||
|---|---|---|---|---|
| Characteristic | SculpSure | Zeltiq CoolsculptingDevice K133212 | Cynosure Smartlipo MPXLaser K083795 | Cynosure 1064 nm DiodeLaser K123971 |
| Lipolysis Method | heat - assisted | cold - assisted | heat - assisted | n/a |
| Laser Type | Diode | N/A | Nd:YAG | Diode |
| Wavelength | 1064 nm | n/a | 1064 nm | 1064 nm |
| Power Density | 1.7 W/cm2 | n/a | n/a | 5 W/ cm2 |
| Power Modes | Continuous with dutycycle | Continuous, PulseModulation | ||
| Pulse Length | 1s to 20 s | n/a | 0.1 - 300 ms | 100ms - 500ms |
| Applicator size | 4 x 6 cm2 (3X) | 4.5 x 7 cm2 (2x)approximate | 300,600,1000 μm | 3 x 10 cm2 |
| Attachment topatient | Belt | belt | n/a – fiber is manipulatedby operator | belt |
| 807.92(b)(1) NONCLINICAL TESTS SUBMITTED | ||||
| Discussion of nonclinicaltests: | Software verification and validation was performed, and demonstrated that the software performs asintended.Electromagnetic compatibility and electrical safety testing was performed per standards IEC 60601-1, IEC60601-1-2, IEC 60825-1 and IEC. Results confirmed the device met the standards. | |||
| 807.92(b)(2) CLINICAL TESTS SUBMITTED | ||||
| Discussion of ClinicalStudy: | A preliminary study was performed to demonstrate the use of hyperthermic treatment to cause the sametype of injury to adipocytes as hypothermic treatment (predicate). It was concluded that histologic,quantitative measurements, as well as aesthetic level of improvement show comparable results betweenhyperthermic and hypothermic treatment of adipocytes resulting in fat reduction. | |||
| Pre-clinical testing was performed to demonstrate that the device would elevate the temperature of thetissue to 42 – 47 °C.The clinical study was performed at two centers using 49 subjects ages 25 - 61 with unwanted fat in theflanks. Racial demographics of the subjects included: Caucasian, African American, Hispanic, Indian andAsian. The BMI of the subjects ranged from 21.6 to 35. Subjects include all Fitzpatrick skin types (I - | ||||
| VI). 42 of the subjects were female and 7 were male. |
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| The primary endpoint was photographic evaluations with correct identification of pre-treatment imagescompared to post treatment images. Secondary endpoint was a change from baseline in adipose layerthickness between device and control based on ultrasound measurements. The third endpoint was subjectsatisfaction survey. | |
|---|---|
| Before treatment each subject was photographed, ultrasound images taken and weight recorded. Eachsubject received one treatment with the device. Post treatment follow up was at 1 week (optional), 6weeks and 12 weeks. | |
| Before and after (12 week post treatment) photographs of the 43 of 49 subjects that returned were evaluatedindividually by three blinded evaluators. In 88% of the total individual evaluations the evaluators correctlyidentified the before and after images. The blinded evaluators were board certified dermatologists. Therewas an average of 13% normalized fat reduction based on ultrasound measurements at 12 weeks. Ninetyeight percent of the patients rated the treatment satisfied on the Likert Satisfaction scale. Therefore allendpoints were met. | |
| Patients were evaluated for adverse events immediately after treatment and at all follow up visits. Therewere no deaths, serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) reported inthis study. The events that were logged were typical reactions to laser treatments including edema,bruising, pain, blistering, and erythema; nodule and hardness due to inflammation. All eventstransient and resolved without medical intervention. | |
| 807.92(b)(3) Conclusion |
Nonclinical testing performed confirmed that the device met its specifications. Clinical testing performed that the device achieved disruption of adipocyte cells which achieved a desired affect without any serious adverse events or unanticipated adverse device effects
§ 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.