Predicate Devices

Cynosure TempSure (K171262), Cynosure dba Ellman Surgitron 4.0 Dual RF S5 - Pelleve (K123366), ValleyLab ForceTriad (K051644)

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a radiofrequency generator with various handpieces and surgical modes. There is no mention of AI or ML in the intended use, device description, or performance studies. The control is described as a "guided user interface (GUI)" and physical switches, not AI-driven algorithms.

Therapeutic

Yes
The device is indicated for various medical conditions, including the temporary relief of pain, muscle spasms, increased local circulation, treatment of facial wrinkles, and a wide range of surgical procedures. These uses align with the definition of a therapeutic device designed to treat or alleviate medical conditions or symptoms.

Diagnostic

No

The device description and intended use indicate that the Cynosure TempSure System is for non-ablative treatment, heating, temporary pain relief, temporary reduction of cellulite, and various surgical procedures (coagulation, cutting, blended cutting and coagulation, fulguration, bipolar). These are all therapeutic or surgical interventions, not diagnostic ones.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including a generator, handpieces, power cord, footswitch, and various cables and electrodes. The software (GUI) is described as controlling the output of energy from the hardware.

IVD (In Vitro Diagnostic)

Based on the provided text, the Cynosure TempSure™ System is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended uses described are for treating various medical conditions and performing surgical procedures directly on the patient's body (in vivo). This includes treating wrinkles, pain, muscle spasms, cellulite, and performing surgical cutting, coagulation, and other procedures.
Device Description: The device is a radiofrequency generator that applies energy to the patient's tissue.
Lack of In Vitro Activities: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or treatment. The testing described is on ex-vivo tissue samples, which is for performance evaluation, not for diagnostic purposes in a clinical setting.

IVD devices are specifically designed to be used in vitro (outside the living body) to analyze samples and provide diagnostic information. The TempSure™ System operates in vivo (within the living body) for therapeutic and surgical purposes.

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 handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids.

The 25mm, and 30mm handpieces 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 TempSure generator has been upgraded to include additional surgical modes – Cut, Bipolar, Fulgurate, and Blend, along with the existing Coag. The power of the device for Surgical applications is a maximum of 300W. There have been no changes to the Smart Handpiece treatment with temperature sensitive handpieces.

TempSure system is used with the same existing Ellman electrosurgical accessories.

The TempSure™ System includes:
• TempSure™ Generator
• Temperature Sensing Handpieces
• IEC Power Cord
• Footswitch
• Disposable/Reusable Neutral Pad
• Surgical Fingerswitch/Foot Controlled Handpieces
• Monopolar Cables
• Disposable/Reusable Electrodes, Forceps

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Facial (for wrinkles and rhytids); various anatomical sites typical for general surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures; palatal, myringotomy, turbinate, skin, cysts, abscesses, tumors, nose (epistaxis), papilloma, keloids, verrucae, basal cell carcinoma, nevi, fistulas; and also implied areas for pain, muscle spasms, and local circulation increase.

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

Not Found

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

Non-clinical tests were submitted, including:
Thermal Effects on Tissue: Testing performed on ex-vivo tissue samples (liver, kidney, and muscle) in triplicate on three tissue samples and three power settings. The thermally affected zone (TAZ) of TempSure was compared to predicate devices (ForceTriad and Surgitron). Results showed that TempSure created a similar TAZ to the predicate devices, leading to the conclusion of substantial equivalence.

Electromagnetic Compatibility and Electrical Safety: Test reports were provided in accordance with FDA Guidance and IEC standards (60601-1, 60601-1-2, 60601-2-2). These tests demonstrated that the device is safe to use and meets required standards.

No clinical tests were submitted.

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

Not Found

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 (K171262), Cynosure dba Ellman Surgitron 4.0 Dual RF S5 - Pelleve (K123366), ValleyLab ForceTriad (K051644)

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 logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 24, 2018

Cynosure, Inc Amy Tannenbaum Regulatory Affairs Specialist III 5 Carlisle Road Westford, Massachusetts 01886

Re: K182365

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 Dated: August 29, 2018 Received: August 30, 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/cfdocs/cfpmr/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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 entiled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding 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 medical devices and radiation-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 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) K182365

Device Name TempSure System

Indications for Use (Describe)