Predicate Devices

Cynosure TempSure™ (K190678)

Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a radiofrequency generator and its accessories for aesthetic and surgical procedures. There is no mention of AI or ML technology in the intended use, device description, or performance studies. The control is described as being via a guided user interface and foot/hand-switch, which are standard controls for such devices.

Therapeutic

Yes

Explanation: The device is indicated for non-ablative treatment of mild to moderate facial wrinkles, temporary relief of pain, muscle spasms, increased local circulation, general surgical procedures, and reduction in the appearance of cellulite, all of which are therapeutic applications.

Diagnostic

No

The device is described as a radiofrequency generator with applications for aesthetic and surgical procedures, providing treatment for various conditions and performing surgical functions like cutting and coagulation. It does not mention any diagnostic capabilities.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a system that includes a radiofrequency generator, handpieces, applicators, power cords, footswitches, and other physical components. While it mentions a guided user interface (GUI), the core functionality and intended use are based on the delivery of radiofrequency energy through hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
Device Description and Intended Use: The description and intended use of the TempSure™ System clearly indicate it is a radiofrequency generator used for direct treatment of the patient's body through the application of energy. Its applications are aesthetic and surgical procedures performed on the patient, not on specimens from the patient.
Lack of Specimen Handling: There is no mention of the device being used to analyze or process biological specimens.

The device's functions, such as wrinkle treatment, pain relief, cellulite reduction, and various surgical procedures (coagulation, cutting, etc.), are all performed directly on the patient's tissues.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The TempSure™ System has the following indications for use:

The 10mm, 15mm, and 20mm Smart Handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids.

The 18mm, 25mm, 30mm, 60mm Smart Handpieces and FlexSure™ applicators provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The massage device is intended to provide a temporary reduction in the appearance of cellulite

The following surgical modes are applicable to the generator.

Coagulation/Hemostasis: General surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures where electrosurgical coagulation of tissue is performed

Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control. epistaxis treatment, turbinate shrinkage. skin incisions, biopsy, cysts, abscesses. tumors. cosmetic repairs, development of' skin flaps. skin tags and blepharoplasty.

Blended Cutting and Coagulation: submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP). myringotomy with effective hemorrhage control. epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids. keratosis, verrucae, basal cell carcinoma. nevi. fistulas. epithelidma. cosmetic repairs. cysts. abscesses. and development of skin flaps.

Fulguration: basal cell carcinoma. papilloma. cyst destruction, tumors. verrucae, hemostasis.

Bipolar: pinpoint precise coagulation. pinpoint hemostasis in any, field (wet or dry). snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control. epistaxis treatment and turbinate shrinkage

Product codes (comma separated list FDA assigned to the subject device)

GEI, PBX

Device Description

The Cynosure TempSure™ System is a radiofrequency generator with a variety of applications both aesthetic and surgical procedures. The intended action is achieved through application of radiofrequency energy to the patient which results in minimization of heat dissipation and cellular alteration. Output of energy is controlled via the guided user interface (GUI) and the foot and/or hand-switch.

The FlexSure TM Applicators are now included for the purpose of tissue heating for selected medical conditions. The applicator comes in 2 sizes (large and medium) and has the same maximum output power of 300W in the Smart Handpiece Mode. The FlexSure applicator utilizes the larger disposable neutral pad. There have been no changes to the existing handpieces (10, 15, 18, 20, 25, 30 or 60mm) or Surgical modes (COAG, Cut, Blend, Bipolar, Fulgurate) of the system. The TempSure system is still used with the same existing electrosurgical accessories.

The TempSure™ System includes:
TempSure™ Generator
Temperature Sensing Handpieces (10, 15, 18, 20, 25, 30, and 60mm)
Temperature Sensing single use applicator (FlexSure)
Massage Heads (25, 30, and 60mm)
IEC Power Cord
Footswitch
Disposable/Reusable Neutral Pads
Surgical Fingerswitch/Foot Controlled Handpieces
Monopolar Cables
Disposable/Reusable Electrodes, Forceps

New Additions to the Tempsure System include:
• FlexSure™ Large Applicator
• FlexSure™ Medium Applicator

Mentions image processing

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Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench testing was conducted to show that the new FlexSure single use applicator and large neutral pad, when used in a simulated clinical condition, was able to heat and maintain temperature of the treatment area for 10 minutes.

Electrical safety testing for the Cynosure TempSure was also completed to prove the safe use of the device. These test reports are provided in accordance with FDA Guidance "Premarket Notification 510k Submissions for Electrosurgical Devices for General Surgery" - Section XII - Electrical Safety and Electromagnetic Compatibility". The following test reports are available in Section 17 – Electromagnetic Compatibility and Electrical Safety.

IEC 60601-1, Medical Electrical Equipment Part 1: General requirements for basic safety . and essential performances
IEC 60601-1-2. Medical Electrical Equipment Part 1 -2: General requirements for basic ● safety and essential performance - Collateral standard: Electromagnetic disturbances requirements and tests
IEC 60601-2-2, Medical electrical equipment Part 2 -2: Particular requirements for the basic ● safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

No clinical tests submitted.

The non-clinical tests demonstrate that the TempSure generator with the FlexSure™ single use applicators is safe and effective and performs as well or better than the legally marketed predicate device. The Tissue Heating bench test demonstrated that the device is able to maintain temperature for at least the 10-minute treatment time when used as intended under clinical conditions at various treatment areas and settings. In addition, the Electromagnetic Compatibility and Electrical Safety testing shows that the device is safe to use and meets required standards. These non-clinical tests show that the TempSure generator using the FlexSure™ applicators meets design specifications as well as performance requirements.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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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.

Cynosure TempSure™ (K190678)

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.

Not Found

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

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & 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 agency's name, "U.S. Food & Drug Administration."

March 25, 2020

Cynosure, LLC Kevin O'Connell Director of Regulatory Affairs 5 Carlisle Road Westford, Massachusetts 01886

Re: K200241

Trade/Device Name: TempSure System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, PBX Dated: January 29, 2020 Received: January 31, 2020

Dear Kevin 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. 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/cfdocs/cfpmn/pmn.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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200241

Device Name TempSure™ System

Indications for Use (Describe) The TempSure™ System has the following indications for use: