(510 days)
The Cynosure Cellulaze Laser is intended for the short term improvement in the appearance of cellulite.
The Cynosure Cellulaze laser is an Nd: Y AG laser, with a wavelength of 1440nm. The energy delivering laser optical fiber is housed within a cannula and is combined with the temperature monitoring guide functioning as a safety feature that prevents the laser from generating temperature above the safety range.
Here's a breakdown of the acceptance criteria and study information for the Cynosure Cellulaze Laser, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Endpoint 1: Blinded Identification of Baseline PhotographsAt least 80% of photographs correctly identified as baseline by blinded evaluators. | Endpoint 1: Blinded Identification of Baseline PhotographsRange for the 3 evaluators was 91-95% correctly identified, which exceeded the predetermined success criteria. |
| Endpoint 2: Improvement in Cellulite Appearance80% of the sites showing a pre-specified improvement on a validated scale (assessed by blinded evaluators of pre and post-treatment photographs). | Endpoint 2: Improvement in Cellulite AppearanceBlinded evaluation showed 91% of sites meeting this requirement, which exceeded the predetermined success criteria. |
Study Details
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Sample Size used for the test set and the data provenance:
- Test Set Sample Size: 57 subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin). However, it was a "clinical study" that enrolled subjects, implying a prospective and controlled environment.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: 3 blinded evaluators were used for Endpoint 1 (identification of baseline photographs) and Endpoint 2 (improvement in cellulite appearance).
- Qualifications of Experts: Not specified. They are referred to as "blinded evaluators."
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Adjudication method for the test set:
- The text describes "3 evaluators" for Endpoint 1, with a "range for the 3 evaluators" provided. This suggests independent evaluation by each expert, and their individual results were reported. There is no explicit mention of an adjudication method (like 2+1 or 3+1) to reach a consensus if disagreements arose. It appears each expert's performance was noted.
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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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This study assesses the device's standalone performance in improving the appearance of cellulite, not its role as an AI assistant to human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this study represents a standalone performance evaluation of the Cynosure Cellulaze Laser. The "blinded evaluators" are assessing the effect of the device on subjects, not the performance of an algorithm. However, the device itself (the laser system) is performing the intervention, with human evaluators assessing the outcome of that intervention. If we interpret "standalone" as the device's efficacy without human intervention in the therapeutic process, then yes. If it refers to an AI algorithm, then no, this is a physical device study.
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The type of ground truth used:
- The ground truth for Efficacy Endpoint 1 (identification of baseline photographs) is directly tied to the actual baseline photographs. The evaluators' task was to correctly identify these.
- The ground truth for Efficacy Endpoint 2 (improvement in cellulite appearance) was based on expert evaluation/consensus using a "validated scale." The "pre-specified improvement on a validated scale" by blinded evaluators served as the ground truth for success in this endpoint.
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The sample size for the training set:
- The provided text does not mention a "training set" in the context of an algorithm. The 57 subjects are part of the clinical study to support the efficacy of the device performing the intervention.
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How the ground truth for the training set was established:
- Not applicable, as no training set for an algorithm is mentioned. The study is a clinical trial evaluating a physical medical device.
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510(K) Summary
Submitter:
Contact:
Cynosure, Inc. 5 Carlisle Road Westford, MA 01886
Irina Kulinets Vice President of Regulatory Affairs and Quality Systems
October 3. 2012
Cynosure Cellulaze Laser
Medical Laser System
Laser surgical instrument for use in general and plastic surgery and in dermatology
21 CFR 878.4810
SmartLipo Multiwavelength with 1440nm Wavelength, K091537
The Cynosure Cellulaze laser is an Nd: Y AG laser, with a wavelength of 1440nm. The energy delivering laser optical fiber is housed within a cannula and is combined with the temperature monitoring guide functioning as a safety feature that prevents the laser from generating temperature above the safety range.
The Cellulaze Laser is intended for the short term improvement in the appearance of cellulite.
The Cynosure Cellulaze Laser has similar intended use, the same principle of operation, and the same performance specifications as the predicate device. Additionally the same temperature monitoring device as in the predicate device is utilized to ensure temperature within the specified range.
The use of the temperature monitoring device to control site temperature is identical to how this same laser system is used for the prior clearance of fat lipolysis, both predicate device and Cellulaze rely on control temperature to produce fat melting without causing adverse effects associated with higher temperatures.
None
Clinical Performance Data:
Nonclinical Performance Data:
Data from two clinical studies enrolling a total of 106 subjects were provided to support safety and efficacy of the device.
JAN 2 6 2012
Common Name: Classification Name:
Equivalent Device:
Date Summary Prepared:
Device Trade Name:
Device Description:
Intended Use:
Comparison:
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| The clinical dataset used to support the efficacy of the specific indicationfor use was collected in a clinical study that enrolled 57 subjects. Thecompany provided data from two co-primary endpoints, ability ofblinded evaluators to correctly identify baseline photographs andevaluation of improvement in the appearance of cellulite by blindedevaluator scoring of pre and post treatment photographs. The blindedevaluation was made using 3 month post-treatment photographs.Success for identification of baseline photographs was at least 80% ofthe photographs being correctly identified. For this endpoint the rangefor the 3 evaluators was 91-95% which exceeded the predeterminesuccess criteria. | |
|---|---|
| For the endpoint that evaluated improvement, success was established as80% of the sites showing a pre-specified improvement on a validatedscale. Blinded evaluation of this endpoint showed 91% of the sitesmeeting this requirement. | |
| A total of 103 subjects were evaluated for safety. Adverse eventsreported in the two studies included pain, redness, swelling, purpura,itching, numbness, blistering, hardness, seroma, and necrosis. Thesetypes of adverse events are common to this type of procedure. All ofthese events did resolve without need for medical intervention. | |
| Conclusion: | The similarity in technical characteristics combined with the clinicalsafety and effectiveness data demonstrate that the Cynosure CellulazeLaser is substantially equivalent to the predicate device for theindication for use specified. |
| Additional Information: | None |
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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with outstretched wings. The bird is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" surrounding it.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 6 2012
Cynosure, Inc. % Mr. George Cho Vice President, Medical Technology and Regulatory Affairs 5 Carlisle Road Westford, Massachusetts 01886
Re: K102541
Trade/Device Name: Cynosure Cellulaze Laser and Cellulaze Delivery Kit Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: OYW Dated: January 20, 2012 Received: January 23, 2012
Dear Mr. Cho:
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.
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Page 2 - Mr. George Cho
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erin Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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Indications For Usc
510(k) Number (if known): K102541
Device Name: Cynosure Cellulaze Laser
Indications For Use:
The Cynosure Cellulaze Laser is intended for the short term improvement in the appearance of cellulite.
Prescriptive Use _ X ( 21 CFR 801 Subpart D) OR, Over-The-Counter Use ( 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ÀNOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Niels. Ryden for mkn
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102541
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.