(128 days)
The 10mm, 15mm, and 20mm handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids.
The 18mm. 25mm. 30mm. and 60mm 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: 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
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.
An additional 60mm Smart Handpiece is now included for the purpose of tissue heating for selected medical conditions. The 60mm handpiece can also be used with a new massage head for the temporary reduction in the appearance of cellulite. The handpiece has the same maximum output power of 300W in the Smart Handpiece Mode. In addition, a new larger disposable neutral pad is provided for these body treatments. There have been no additional changes to the previous existing handpieces (10, 15, 18, 20, 25, or 30mm) 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) 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:
60mm Smart Handpiece (ASY-12745) 60mm Massage Head (ASY-12746) Large Neutral Pad (MEL-01197)
Here's a breakdown of the acceptance criteria and study information for the Cynosure TempSure System (K190678) based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Tissue Heating (60mm Handpiece) | Ability to heat and maintain temperature of the treatment area for 10 minutes in a simulated clinical condition. | Bench testing demonstrated the device effectively heated and maintained temperature for at least the 10-minute treatment time when used as intended under clinical conditions at various treatment areas and settings. |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2 standards. | Testing completed as per these standards, proving safe use of the device. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 standard. | Testing completed as per this standard, demonstrating the device's electromagnetic compatibility. |
| Overall Safety and Effectiveness | Device is safe and effective and performs as well or better than the legally marketed predicate device. | Non-clinical tests conclude that the TempSure generator with the 60mm handpiece is safe and effective, meets design specifications, and performs required functions. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated, as the study described is a bench test rather than a clinical study with human subjects. For "Tissue Heating," it refers to "various treatment areas and settings," but does not quantify these.
- Data Provenance: The studies were non-clinical bench tests. The country of origin of the data is not specified but would typically be the location of the manufacturing or testing facility, which for Cynosure, Inc. is Westford, Massachusetts, USA. The data is prospective in the sense that the tests were specifically conducted to demonstrate compliance for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. The ground truth for bench tests is based on objective measurements against established engineering and safety standards, rather than expert interpretation of a clinical outcome.
- Qualifications of Experts: Not applicable for this type of non-clinical study.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The tests are objective measurements against defined performance and safety standards, not subjective interpretations requiring adjudication.
5. 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
- MRMC Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (RF generator and handpieces) that performs physical treatments, not an AI-driven diagnostic or interpretative tool that would involve human "readers" or AI assistance in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The TempSure System is an electrosurgical cutting and coagulation device. Its performance is evaluated based on its physical operation (e.g., heating capability, electrical safety), not as an algorithm operating independently.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth used for these non-clinical tests is based on:
- Objective measurements and physical parameters: For tissue heating, the "ground truth" is the actual temperature achieved and maintained on a simulated tissue model.
- Compliance with established engineering and safety standards: For electrical safety and EMC, the "ground truth" is adherence to the specifications outlined in IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This submission describes a physical medical device, not a machine learning or AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
§ 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.