TempSure

K171262 · Cynosure, Inc. · GEI · Sep 22, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K171262
• Device Name: TempSure
• Applicant: Cynosure, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 22, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TempSure Generator has the following indications for use: The 10mm, 15mm, and 20mm Portrait handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids. The 18mm, 25mm, and 30mm Portrait 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 Portrait™ massage device is intended to provide a temporary reduction in the appearance of cellulite Coagulation/Hemostasis: Using the surgical handpieces and accessories, general surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures where electrosurgical coagulation of tissue is performed

Device Story

TempSure is a radiofrequency (RF) generator system for aesthetic and electrosurgical procedures. Input: RF energy delivered to patient tissue via temperature-sensing handpieces or surgical accessories. Operation: Generator applies RF energy to induce cellular alteration/heat dissipation; real-time temperature feedback provided by a thermistor at the handpiece tip. Output: Visual display of temperature set point, actual tissue temperature, procedure time, and system status on a GUI. Used in clinical settings by physicians/trained staff. Output affects clinical decision-making by allowing precise control of tissue heating for wrinkle reduction, pain relief, or hemostasis. Benefits: Non-invasive aesthetic improvement and controlled surgical coagulation.

Clinical Evidence

No clinical data submitted. Evidence consists of bench testing: temperature monitoring accuracy (vs. Fluke thermometer, +/- 1.5°C variance) and ex-vivo thermal effects on tissue (TAZ comparison vs. ForceTriad in liver, kidney, muscle samples).

Technological Characteristics

RF generator; 4.0 MHz sine-wave output. Handpieces: 10-30mm sizes; materials include gold-plated brass, polytheramide, Loctite, Delrin. Features real-time thermistor-based temperature feedback (<1s response). Connectivity: GUI display. Power: 50W (Coag), 120W (wrinkle), 300W (tissue heating). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2.

Indications for Use

Indicated for non-ablative treatment of mild to moderate facial wrinkles/rhytids; temporary relief of pain, muscle spasms, and increased local circulation; temporary reduction in cellulite appearance; and electrosurgical coagulation/hemostasis in general surgical procedures (urologic, thoracic, plastic, reconstructive, gynecological).

Regulatory Classification

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.

Predicate Devices

• Cynosure dba Ellman Surgitron 4.0 Dual RF S5 - Pelleve (K132665)
• ValleyLab ForceTriad (K051644)
• Cynosure dba Ellman PelleFirm (K132949)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 22, 2017

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

Re: K171262

Trade/Device Name: TempSure Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, PBX Dated: September 1, 2017 Received: September 5, 2017

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. The general controls provisions of the Actinclude 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 (reporting of medical device

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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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Image /page/1/Picture/9 description: The image shows the name "Jennifer R. Stevenson -S3" in a large, clear font. The text is black and stands out against a background that appears to have a faded watermark of the letters "FDA". The name is split into two lines, with "Jennifer R." on the first line and "Stevenson -S3" on the second.

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) K171262

Device Name TempSure

Indications for Use (Describe)

The TempSure Generator has the following indications for use:

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

The 18mm, 25mm, and 30mm Portrait 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 Portrait™ massage device is intended to provide a temporary reduction in the appearance of cellulite

Coagulation/Hemostasis: Using the surgical handpieces and accessories, general surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures where electrosurgical coagulation of tissue is performed

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| X Prescription Use (Part 21 CER 801 Subnart D) | Over-The-Counter Use (21 CFR 801 Subnart C) |

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Section 5

## 510(k) Summary for Cynosure TempSure

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 Road, Westford MA, 01886 |
| Phone Number | 781-993-2454 |
| Fax Number | 978-256-6556 |
| Establishment Registration<br>Number | 1222993 |
| Contact Person | Amy Tannenbaum |
| Preparation Date | May 12, 2017 |
| 807.92(a)(2) Name of Device | |
| Trade or Proprietary Name | TempSure™ Generator |
| Common or Usual Name | Surgical RF Generator |
| Classification Name | Electrosurgical, Cutting / Coagulation / Accessories |
| Classification Panel | General & Plastic Surgery |
| Regulation | 21 CFR 878.440 |
| Regulatory Class | II |
| Product Code(s) | GEI, PBX |
| 807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed | |
| Predicate Devices | Cynosure dba Ellman Surgitron 4.0 Dual RF S5 - Pelleve<br>(K132665)<br>ValleyLab ForceTriad (K051644)<br>Cynosure dba Ellman PelleFirm (K132949) |
| 807.92(a)(4) Device Description | |
| The Cynosure TempSure™ System is a radiofrequency generator with a<br>variety of applications both aesthetic and electrosurgical procedures.<br>The intended action is achieved through application of radiofrequency<br>energy to the patient which results in minimization of heat dissipation<br>and cellular alteration. Output of energy is controlled via the guided<br>user interface (GUI) and the foot and/or hand-switch. The TempSure™<br>system is intended for non-ablative treatment of mild to moderate facial<br>wrinkles and rhytids, heating for the purpose of elevating tissue<br>temperature for selected medical conditions, and<br>hemostasis/coagulation for general surgery applications. The generator<br>is used with a temperature sensitive handpiece for aesthetic procedures<br>that provides real-time temperature feedback. This temperature | |
| Section 5 | 510(k) Summary |
| information is displayed on the user interface that shows the temperature set point and actual tissue temperature along with procedure time, system error, and warning codes. A thermistor protrudes at the end of the temperature-sensitive handpiece at the point of patient contact, which provides a constant information feedback loop as to the tissue temperature throughout a procedure. | |
| The TempSure™ System includes:<br>TempSure™ Surgical RF Generator Portrait™ Temperature Sensing Handpieces IEC Power Cord Footswitch Disposable/Reusable Neutral Pad Surgical Fingerswitch/Foot Controlled Handpieces Monopolar Cables Disposable/Reusable Electrodes | |
| 807.92(a)(5) Intended Use of the Device | |
| The TempSure Generator has the following indications for use:<br>The 10mm, 15mm, and 20mm Portrait™ handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids.<br>The 18mm, 25mm, and 30mm Portrait™ 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.<br>The Portrait™ massage device is intended to provide a temporary reduction in the appearance of cellulite<br>Coagulation/Hemostasis: Using the surgical handpieces and accessories, general surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures where electrosurgical coagulation of tissue is performed | |
| 807.92(b)(1) Non-clinical tests submitted | |
| Section 5 | 510(k) Summary |

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The following non-clinical tests have been included in this 510k submission in determination of substantial equivalence between the test device and the referenced predicates. These tests have been conducted in accordance with the FDA Guidance "Premarket Notification 510k Submissions for electrosurgical Devices for General Surgery' - Section XI. Performance Data. See Section 18 -Performance Testing, Bench. A brief summary is provided below.

### Temperature Monitoring Test

The TempSure with Portrait handpieces was used at three different power settings in various treatment areas on two subjects. The FLIR Thermal Camera was used during the treatment to measure the temperature of the subjects' skin in two minute intervals over the 10 minute total treatment time. The temperature measurements of the Portrait handpieces were compared to those of the FLIR. For each treatment, the average difference in temperature between the FLIR and Portrait handpiece was +/-1.5℃. This +/- 1.5°C margin is equivalent to that of the Fluke Infrared Thermometer, which is used as the external temperature measurement tool for the device's predicates. This test proves that the TempSure with Portrait handpieces has the same temperature measurement capabilities of the Surgitron with GlideSafe or PelleFirm handpieces. In addition, this bench test proved that the TempSure with Portrait handpieces can maintain the desired temperature throughout the treatment and there were no adverse events.

### Thermal Effects on Tissue Test

Testing was performed on ex-vivo tissue samples to compare the thermally affected zone (TAZ) of the TempSure and predicate device ForceTriad. Testing was performed using both devices in triplicate on three tissue samples (liver, kidney, and muscle), and three power settings. The depth and lateral TAZ measurements were recorded using Image-J. For each tissue and power setting combination, the TAZ created by the ForceTriad and TempSure were compared. Two of the three power bars for overlapping for each point, which shows that the TAZs were similar. This test shows that the TempSure is substantially equivalent to the ForceTriad device, despite the variation in maximum output power.

### Electromagnetic Compatibility and Electrical Safety

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". As per the guidance, endoscopic instruments also require compliance with IEC 60601-2-18. The TempSure is not an endoscopic/laparoscopic instrument, and therefore testing to IEC 60601-2-18 is not needed. 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

807.92(b)(2) Clinical tests submitted – N/A - No clinical tests submitted

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#### 807.92(b)(3) Conclusions drawn from clinical and non-clinical tests submitted

The nonclinical tests demonstrate that the TempSure™ electrosurgical generator safe and effective and performs as well as or better than the legally marketed predicate devices. The Temperature Monitoring test demonstrated that the temperature sensing feature worked as intended under clinical conditions at multiple temperature settings and handpiece sizes. The device was able to accurately read the temperature of the skin as similar to the Fluke used with the predicate device. It was also able to maintain the desired temperature throughout a treatment with no adverse events. The Thermal Effects on Tissue test showed that the thermally affected zone created by the TempSure™ device was similar to that created by the predicate device ForceTriad in ex-vivo tissue testing. Despite their difference in maximum output power, the devices created a similar TAZ and therefore the devices can be considered substantially equivalent. 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 can safely deliver RF energy to the patient as intended. The device meets design specifications as well as performance requirements.

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| Characteristic | Cynosure TempSure™<br>(K171262) | Ellman Surgitron 4.0<br>Dual RF S5 (Pelleve S5)<br>(K132665) | Valley Labs Force<br>Triad (K051644) | Ellman PelleFirm<br>(K132949) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The 10mm, 15mm, and<br>20mm Portrait™<br>handpieces are indicated<br>for non-ablative treatment<br>of mild to moderate facial<br>wrinkles and rhytids<br><br>The 18mm, 25mm, and<br>30mm Portrait™<br>handpieces provide<br>heating for the purpose of<br>elevating tissue<br>temperature for selected<br>medical conditions such as<br>temporary relief of pain,<br>muscle spasms, and<br>increase in local<br>circulation.<br><br>The Portrait™ massage<br>device is intended to<br>provide a temporary<br>reduction in the<br>appearance of cellulite<br><br>Coagulation/Hemostasis:<br>Using the surgical<br>handpieces and<br>accessories, general<br>surgical procedures<br>including urologic,<br>thoracic, plastic. | Cutting: Snoring,<br>submucosal palatal<br>shrinkage, traditional<br>uvulopalatoplasty (RAUP),<br>myringotomy with effect<br>hemorrhage control,<br>epistaxis treatment,<br>turbinate shrinkage, skin<br>incisions biopsy, cysts,<br>abscesses, tumors,<br>cosmetic repairs,<br>development of skin flaps,<br>skin tags, and<br>blepharoplasty<br><br>Blended Cutting and<br>Coagulation: Snoring,<br>submucosal palatal<br>shrinkage, traditional<br>uvulopalatoplasty (RAUP),<br>myringotomy with<br>effective hemorrhage<br>control, epistaxis<br>treatment, turbinate<br>shrinkage, skin tags,<br>papilloma keloids,<br>keratosis, verrucae, basal<br>cell carcinoma, nevi,<br>fistulas, epithelidma,<br>cosmetic repairs, cysts,<br>abscesses, and<br>development of skin tags. | General (including<br>urologic, thoracic,<br>plastic and<br>reconstructive,<br>arthroscopic),<br>laparoscopic, and<br>gynecological<br>procedures where<br>electrosurgical cutting<br>and coagulation of<br>tissue, and sealing<br>(fusion) of vessels and<br>tissue bundles is<br>performed, including<br>such procedures as<br>bowel resections,<br>hysterectomies (both<br>vaginal and abdominal),<br>laparoscopic,<br>cholecystectomies,<br>laparoscopically assisted<br>vaginal hysterectomies,<br>gall bladder procedures,<br>Nissen fundoplication,<br>adhesiolysis,<br>oophorecftomy, etc.<br>Vessels (arteries, veins,<br>lymph) 7mm and smaller<br>in diameter, and bundles<br>as large as will fit in the<br>jaws of the devices can<br>be sealed with Ligasure | Tissue Heating: The<br>PelleFirm RF device is<br>intended to provide heating<br>for the purpose of elevating<br>tissue temperature for<br>selected medical conditions<br>such as temporary relief of<br>pain, muscle spasms, and<br>increase in local circulation.<br>The PelleFirm massage<br>device is intended to provide<br>a temporary reduction in the<br>appearance of cellulite. |

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| Section 5 | |
|-----------|--|

### 510(k) Summary

| Characteristic | Cynosure TempSure™<br>(K171262) | Ellman Surgitron 4.0<br>Dual RF S5 (Pelleve S5)<br>(K132665) | Valley Labs Force<br>Triad (K051644) | Ellman PelleFirm<br>(K132949) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| | reconstructive, and<br>gynecological procedures<br>where electrosurgical<br>coagulation of tissue is<br>performed | Hemostasis: Control of<br>bleeding, epilation,<br>telangiectasia.<br>Fulguration: Basal cell<br>carcinoma, papilloma,<br>cyst destruction, tumors,<br>verrucae, hemostasis.<br>Bipolar: Pinpoint precise<br>coagulation, pinpoint<br>hemostasis in any field<br>(wet or dry), snoring,<br>submucosal palatal<br>shrinkage, traditional<br>uvulopalatoplasty (RAUP),<br>myringotomy with<br>effective hemorrhaging<br>control, epistaxis treatment<br>and turbinate shrinkage.<br>Wrinkles: Non-ablative<br>treatment of mild to<br>moderate facial wrinkles<br>and rhytids. | vessel sealing (tissue<br>fusion) output. | |
| Rx/OTC | Prescription | Prescription | Prescription | Prescription |
| Energy Type | Radiofrequency | Radiofrequency | Radiofrequency | Radiofrequency |
| Modality | Monopolar | Monopolar, Bipolar | Monopolar, Bipolar | Monopolar, Bipolar |
| Characteristic | Cynosure TempSure™<br>(K171262) | Ellman Surgitron 4.0<br>Dual RF S5 (Pelleve S5)<br>(K132665) | Valley Labs Force<br>Triad (K051644) | Ellman PelleFirm<br>(K132949) |
| Temperature<br>Sensing | Temperature-Sensitive<br>Handpiece | External temperature monitor | N/A | External temperature monitor |
| Temperature<br>Response Time | <1 second | N/A | N/A | N/A |
| Handpiece Size | 10mm, 15mm, 18mm,<br>20mm, 25 mm, 30 mm | 7.5mm, 10mm, 15mm, 20mm | N/A | 25, 30 mm |
| Treatment<br>Activation | Fingerswitch, Footswitch | Fingerswitch, Footswitch | Fingerswitch, Footswitch | Footswitch |
| Aesthetic Optimal<br>Temperature | 39-45°C | 40-45°C | N/A | 40 -45°C |
| Patient Contacting<br>Material | Gold-Plated Brass,<br>Polytheramide, Loctite,<br>Delrin | Gold-Plated Brass | Not applicable – Generator<br>only | Delrin |
| Massage Head | Yes | N/A | N/A | Massage Heads, handpieces; |
| Output Waveform | 4.0 MHz Sin-wave CW,<br>Fully, Rectified, Partially<br>Rectified | 4.0 MHz Sin-wave CW,<br>Fully, Rectified, Partially<br>Rectified, and 1.7 MHz for<br>Fulgurating Spark-Gap | 472 KHz Sin-Wave CW,<br>Fully Rectified, Partially<br>Rectified, | 4.0 MHz Sin-wave CW, Fully,<br>Rectified, Partially Rectified,<br>and 1.7 MHz for Fulgurating<br>Spark-Gap (Used with<br>Surgitron) |
| Maximum<br>Frequency | 4 MHz | 4 MHz (Cut and Coag) | Hemo: 800 Hz<br>Coag: 940 Hz | 4 MHz |
| Characteristic | Cynosure TempSure™<br>(K171262) | Ellman Surgitron 4.0<br>Dual RF S5 (Pelleve S5)<br>(K132665) | Valley Labs Force<br>Triad (K051644) | Ellman PelleFirm<br>(K132949) |
| Modes | Coag, Portrait | Cut, Blend, Coag,<br>Fulgurate, Bipolar | Cut, Valleylab, Coag,<br>Bipolar, Autobipolar,<br>Ligasure | Cut, Blend, Coag,<br>Fulgurate, Bipolar |
| Max Power<br>Output | 50W (Coag)<br>120W (wrinkle)<br>300W (tissue heating) | 120W | 200W | 120W |
| Dimensions | 18" x 18" x 12" | 9.5" x 7.1" x 16.1" | 18" x 20" x 10" | Handpiece only (approx 6.13"<br>x 1.46" x 0.94") |
| Weight | 30 lbs | 26 lbs | 30 lbs | Handpiece only |

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Section 5

510(k) Summary

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#### Section 5 510(k) Summary