(144 days)
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
The Cynosure TempSure™ System is a radiofrequency generator with a variety of applications both aesthetic and electrosurgical 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™ system is intended for non-ablative treatment of mild to moderate facial wrinkles and rhytids, heating for the purpose of elevating tissue temperature for selected medical conditions, and hemostasis/coagulation for general surgery applications. The generator is used with a temperature sensitive handpiece for aesthetic procedures that provides real-time temperature feedback. This temperature 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:
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
Here's a breakdown of the acceptance criteria and study information based on the provided text, focused on the TempSure device:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Temperature Monitoring Accuracy | Equivalent to Fluke Infrared Thermometer (+/- 1.5°C margin for external temperature measurement tools). Ability to maintain desired temperature throughout treatment. | Average difference in temperature between the FLIR camera and the Portrait handpiece was +/- 1.5°C, demonstrating equivalence to the Fluke Infrared Thermometer. The device maintained the desired temperature throughout the treatment with no adverse events. |
| Thermal Effects on Tissue (TAZ) | Thermally Affected Zone (TAZ) should be similar to the predicate device (ForceTriad). | When comparing the TAZ of the TempSure to the ForceTriad on ex-vivo tissue, two of the three power bars showed overlapping results for each point, indicating similar TAZs. This was deemed substantially equivalent despite differences in maximum output power. |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2. | The device demonstrated compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | The device demonstrated compliance with IEC 60601-1-2. |
| Safety and Effectiveness | General safety and effectiveness equivalent to legally marketed predicate devices. | Nonclinical tests demonstrated the TempSure electrosurgical generator is safe and effective and performs as well as or better than the legally marketed predicate devices. The device meets design specifications and performance requirements. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Temperature Monitoring Test: "three different power settings in various treatment areas on two subjects." The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective).
- Thermal Effects on Tissue Test: "performed using both devices in triplicate on three tissue samples (liver, kidney, and muscle), and three power settings." These were ex-vivo tissue samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set. The validation relies on objective measurements against a reference device (FLIR Thermal Camera) or comparative measurements between devices on physical tissue samples.
4. Adjudication Method for the Test Set
No adjudication method is described, as the evaluation methods relied on direct measurements or comparisons rather than expert interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The studies described are technical performance tests and ex-vivo tissue comparisons, not studies involving human readers.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This device, "TempSure," is an electrosurgical generator and not an AI or algorithm-driven diagnostic device. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply. The device's performance is tested directly.
7. The Type of Ground Truth Used
- Temperature Monitoring Test: The ground truth was established by direct physical measurement using a FLIR Thermal Camera, which served as the reference standard for temperature.
- Thermal Effects on Tissue Test: The ground truth for the thermally affected zone (TAZ) was established by measurements using Image-J on ex-vivo tissue samples, comparing the output of the TempSure to the predicate device (ForceTriad).
8. The Sample Size for the Training Set
The document does not describe any machine learning or AI components for which a "training set" would be applicable. The TempSure is a radiofrequency generator, and its validation relies on traditional engineering and medical device performance testing, not AI model training.
9. How the Ground Truth for the Training Set Was Established
As no training set is described or implied, this point is not applicable.
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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 (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 (DICE) 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,
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 RegistrationNumber | 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(K132665)ValleyLab ForceTriad (K051644)Cynosure dba Ellman PelleFirm (K132949) |
| 807.92(a)(4) Device Description | |
| The Cynosure TempSure™ System is a radiofrequency generator with avariety of applications both aesthetic and electrosurgical procedures.The intended action is achieved through application of radiofrequencyenergy to the patient which results in minimization of heat dissipationand cellular alteration. Output of energy is controlled via the guideduser interface (GUI) and the foot and/or hand-switch. The TempSure™system is intended for non-ablative treatment of mild to moderate facialwrinkles and rhytids, heating for the purpose of elevating tissuetemperature for selected medical conditions, andhemostasis/coagulation for general surgery applications. The generatoris used with a temperature sensitive handpiece for aesthetic proceduresthat 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: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: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 celluliteCoagulation/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™(K171262) | Ellman Surgitron 4.0Dual RF S5 (Pelleve S5)(K132665) | Valley Labs ForceTriad (K051644) | Ellman PelleFirm(K132949) |
|---|---|---|---|---|
| Indications for Use | The 10mm, 15mm, and20mm Portrait™handpieces are indicatedfor non-ablative treatmentof mild to moderate facialwrinkles and rhytidsThe 18mm, 25mm, and30mm Portrait™handpieces provideheating for the purpose ofelevating tissuetemperature for selectedmedical conditions such astemporary relief of pain,muscle spasms, andincrease in localcirculation.The Portrait™ massagedevice is intended toprovide a temporaryreduction in theappearance of celluliteCoagulation/Hemostasis:Using the surgicalhandpieces andaccessories, generalsurgical proceduresincluding urologic,thoracic, plastic. | Cutting: Snoring,submucosal palatalshrinkage, traditionaluvulopalatoplasty (RAUP),myringotomy with effecthemorrhage control,epistaxis treatment,turbinate shrinkage, skinincisions biopsy, cysts,abscesses, tumors,cosmetic repairs,development of skin flaps,skin tags, andblepharoplastyBlended Cutting andCoagulation: Snoring,submucosal palatalshrinkage, traditionaluvulopalatoplasty (RAUP),myringotomy witheffective hemorrhagecontrol, epistaxistreatment, turbinateshrinkage, skin tags,papilloma keloids,keratosis, verrucae, basalcell carcinoma, nevi,fistulas, epithelidma,cosmetic repairs, cysts,abscesses, anddevelopment of skin tags. | General (includingurologic, thoracic,plastic andreconstructive,arthroscopic),laparoscopic, andgynecologicalprocedures whereelectrosurgical cuttingand coagulation oftissue, and sealing(fusion) of vessels andtissue bundles isperformed, includingsuch procedures asbowel resections,hysterectomies (bothvaginal and abdominal),laparoscopic,cholecystectomies,laparoscopically assistedvaginal hysterectomies,gall bladder procedures,Nissen fundoplication,adhesiolysis,oophorecftomy, etc.Vessels (arteries, veins,lymph) 7mm and smallerin diameter, and bundlesas large as will fit in thejaws of the devices canbe sealed with Ligasure | Tissue Heating: ThePelleFirm RF device isintended to provide heatingfor the purpose of elevatingtissue temperature forselected medical conditionssuch as temporary relief ofpain, muscle spasms, andincrease in local circulation.The PelleFirm massagedevice is intended to providea temporary reduction in theappearance of cellulite. |
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| Section 5 |
|---|
510(k) Summary
| Characteristic | Cynosure TempSure™(K171262) | Ellman Surgitron 4.0Dual RF S5 (Pelleve S5)(K132665) | Valley Labs ForceTriad (K051644) | Ellman PelleFirm(K132949) |
|---|---|---|---|---|
| reconstructive, andgynecological procedureswhere electrosurgicalcoagulation of tissue isperformed | Hemostasis: Control ofbleeding, epilation,telangiectasia.Fulguration: Basal cellcarcinoma, papilloma,cyst destruction, tumors,verrucae, hemostasis.Bipolar: Pinpoint precisecoagulation, pinpointhemostasis in any field(wet or dry), snoring,submucosal palatalshrinkage, traditionaluvulopalatoplasty (RAUP),myringotomy witheffective hemorrhagingcontrol, epistaxis treatmentand turbinate shrinkage.Wrinkles: Non-ablativetreatment of mild tomoderate facial wrinklesand rhytids. | vessel sealing (tissuefusion) output. | ||
| Rx/OTC | Prescription | Prescription | Prescription | Prescription |
| Energy Type | Radiofrequency | Radiofrequency | Radiofrequency | Radiofrequency |
| Modality | Monopolar | Monopolar, Bipolar | Monopolar, Bipolar | Monopolar, Bipolar |
| Characteristic | Cynosure TempSure™(K171262) | Ellman Surgitron 4.0Dual RF S5 (Pelleve S5)(K132665) | Valley Labs ForceTriad (K051644) | Ellman PelleFirm(K132949) |
| TemperatureSensing | Temperature-SensitiveHandpiece | External temperature monitor | N/A | External temperature monitor |
| TemperatureResponse Time | <1 second | N/A | N/A | N/A |
| Handpiece Size | 10mm, 15mm, 18mm,20mm, 25 mm, 30 mm | 7.5mm, 10mm, 15mm, 20mm | N/A | 25, 30 mm |
| TreatmentActivation | Fingerswitch, Footswitch | Fingerswitch, Footswitch | Fingerswitch, Footswitch | Footswitch |
| Aesthetic OptimalTemperature | 39-45°C | 40-45°C | N/A | 40 -45°C |
| Patient ContactingMaterial | Gold-Plated Brass,Polytheramide, Loctite,Delrin | Gold-Plated Brass | Not applicable – Generatoronly | Delrin |
| Massage Head | Yes | N/A | N/A | Massage Heads, handpieces; |
| Output Waveform | 4.0 MHz Sin-wave CW,Fully, Rectified, PartiallyRectified | 4.0 MHz Sin-wave CW,Fully, Rectified, PartiallyRectified, and 1.7 MHz forFulgurating Spark-Gap | 472 KHz Sin-Wave CW,Fully Rectified, PartiallyRectified, | 4.0 MHz Sin-wave CW, Fully,Rectified, Partially Rectified,and 1.7 MHz for FulguratingSpark-Gap (Used withSurgitron) |
| MaximumFrequency | 4 MHz | 4 MHz (Cut and Coag) | Hemo: 800 HzCoag: 940 Hz | 4 MHz |
| Characteristic | Cynosure TempSure™(K171262) | Ellman Surgitron 4.0Dual RF S5 (Pelleve S5)(K132665) | Valley Labs ForceTriad (K051644) | Ellman PelleFirm(K132949) |
| Modes | Coag, Portrait | Cut, Blend, Coag,Fulgurate, Bipolar | Cut, Valleylab, Coag,Bipolar, Autobipolar,Ligasure | Cut, Blend, Coag,Fulgurate, Bipolar |
| Max PowerOutput | 50W (Coag)120W (wrinkle)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"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
§ 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.