(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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 24, 2019
Cynosure, Inc Michael King Regulatory Affairs Specialist II 5 Carlisle Road Westford, Massachusetts 01886
Re: K190678
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: March 15, 2019 Received: March 18, 2019
Dear Michael King:
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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 mediation-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) K190678
Device Name TempSure System
Indications for Use (Describe)
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
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------------- |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
|__| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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, LLC |
| Address | 5 Carlisle Road, Westford MA, 01886 |
| Phone Number | 781-993-2454 |
| Fax Number | 978-256-6556 |
| Establishment Registration Number | 1222993 |
| Contact Person | Michael King |
| Preparation Date | March 15, 2019 |
| 807.92(a)(2) Name of Device | |
| Trade or Proprietary Name | TempSure System |
| Common or Usual Name | Surgical RF Generator |
| Classification Name | Electrosurgical, Cutting & Coagulation & Accessories;Massager, Vacuum, Radio Frequency Induced Heat |
| Classification Panel | General & Plastic Surgery |
| Regulation | 21 CFR 878.4440 |
| Regulatory Class | II |
| Product Code(s) | GEI, PBX |
| 807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed | |
| Predicate Devices | Cynosure TempSure (K182365)Cynosure TempSure (K171262) |
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| K190678 |
|---|
| 807.92(a)(4) Device Description |
| The Cynosure TempSure™ System is a radiofrequency generatorwith a variety of applications both aesthetic and surgical 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.An additional 60mm Smart Handpiece is now included for thepurpose of tissue heating for selected medical conditions. The 60mmhandpiece can also be used with a new massage head for thetemporary reduction in the appearance of cellulite. The handpiece hasthe same maximum output power of 300W in the Smart HandpieceMode. In addition, a new larger disposable neutral pad is provided forthese body treatments. There have been no additional changes to theprevious existing handpieces (10, 15, 18, 20, 25, or 30mm) orSurgical modes (COAG, Cut, Blend, Bipolar, Fulgurate) of thesystem. The TempSure system is still used with the same existingelectrosurgical 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) |
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| 807.92(a)(5) Intended Use of the Device | |
|---|---|
| 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: 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: snoring. 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 |
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807.92(b)(1) Non-clinical tests submitted
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.
Tissue Heating with 60mm Handpiece
Bench testing was conducted to show that the new 60mm handpiece 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. Refer to Section 18 - Performance Testing, Bench for additional information.
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". 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
807.92(b)(3) Conclusions drawn from clinical and non-clinical tests submitted
The non-clinical tests demonstrate that the TempSure generator with the 60mm handpiece 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 10minute treatment time when used as intended under clinical conditions at various treatment areas and settings. In addition, the Electrosurgical 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 60mm handpiece meets design specifications as well as performance requirements.
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| Characteristic | Cynosure TempSure System(K190678) | Cynosure TempSure System(K182365) | Cynosure TempSure (K171262) |
|---|---|---|---|
| Indications forUse | The 10mm, 15mm, and 20mmhandpieces are indicated for non-ablative treatment of mild to moderatefacial wrinkles and rhytids. | The 10mm, 15mm, and 20mmhandpieces are indicated for non-ablativetreatment of mild to moderate facialwrinkles and rhytids | The 10mm, 15mm, and 20mm handpiecesare indicated for non-ablative treatment ofmild to moderate facial wrinkles andrhytids |
| The 18mm, 25mm, 30mm, and 60mmhandpieces provide heating for thepurpose of elevating tissuetemperature for selected medicalconditions such as temporary relief ofpain, muscle spasms, and increase inlocal circulation. | The 25mm, and 30mm handpiecesprovide heating for the purpose ofelevating tissue temperature for selectedmedical conditions such as temporaryrelief of pain, muscle spasms, andincrease in local circulation. | The 18mm, 25mm, and 30mm handpiecesprovide heating for the purpose ofelevating tissue temperature for selectedmedical conditions such as temporaryrelief of pain, muscle spasms, andincrease in local circulation. | |
| The massage device is intended toprovide a temporary reduction in theappearance of cellulite | The massage device is intended toprovide a temporary reduction in theappearance of cellulite | The massage device is intended to providea temporary reduction in the appearanceof cellulite | |
| The following surgical modes areapplicable to the generator: | The following surgical modes areapplicable to the generator: | Coagulation/Hemostasis: Using thesurgical handpieces and accessories,general surgical procedures including | |
| Coagulation/Hemostasis: Generalsurgical procedures including urologic,thoracic, plastic, reconstructive, andgynecological procedures where | Coagulation/Hemostasis: Generalsurgical procedures including urologic,thoracic, plastic, reconstructive, andgynecological procedures whereelectrosurgical coagulation of tissue isperformed | urologic, thoracic, plastic, reconstructive,and gynecological procedures where | |
| electrosurgical coagulation of tissue isperformed | Cutting: snoring. submucosal palatalshrinkage, traditional uvulopalatoplasty(RAUP), myringotomy with effective | electrosurgical coagulation of tissue isperformed | |
| Cutting: snoring. submucosal palatalshrinkage, traditionaluvulopalatoplasty (RAUP), | hemorrhage control. epistaxis treatment,turbinate shrinkage. skin incisions,biopsy, cysts, abscesses. tumors. | ||
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| Characteristic | Cynosure TempSure System(K190678) | Cynosure TempSure System(K182365) | Cynosure TempSure (K171262) |
|---|---|---|---|
| Rx/OTC | Prescription | Prescription | Prescription |
| Energy Type | Radiofrequency | Radiofrequency | Radiofrequency |
| Modality | Monopolar, Bipolar | Monopolar, Bipolar | Monopolar |
| TemperatureSensing | Temperature-Sensitive Handpiece | Temperature-Sensitive Handpiece | Temperature-Sensitive Handpiece |
| TemperatureResponse Time | <1 second | <1 second | <1 second |
| Handpiece Size | 10mm, 15mm, 18mm, 20mm, 25 mm,30 mm, 60mm | 10mm, 15mm, 20mm, 25 mm, 30 mm | 10mm, 15mm, 18mm, 20mm, 25 mm, 30mm |
| TreatmentActivation | Fingerswitch, Footswitch | Fingerswitch, Footswitch | Fingerswitch, Footswitch |
| AestheticOptimalTemperature | 39-45°C | 39-45°C | 39-45°C |
| PatientContactingMaterial | Gold-Plated Aluminum, PVDF,Polyetherimide, Loctite, Delrin,Polycarbonate sabic lexan, Hydrogel | Gold-Plated Brass, Polyetherimide,Loctite, Delrin | Gold-Plated Brass, Polyetherimide,Loctite, Delrin |
| Massage Head | Yes | Yes | Yes |
| OutputWaveform | 4.0 MHz Sin-wave CW, FullyRectified, Partially Rectified, and 1.7MHz for Bipolar | 4.0 MHz Sin-wave CW, Fully Rectified,Partially Rectified, and 1.7 MHz forBipolar | 4.0 MHz Sin-wave CW |
| Modes | Surgical (Coag, Cut, Blend, Fulgurate,Bipolar)Smart Handpiece Mode | Surgical (Coag, Cut, Blend, Fulgurate,Bipolar)Smart Handpiece Mode | Surgical (Coag only)Portrait Mode (Smart Handpiece) |
| Max PowerOutput | 300W (Surgical)120W (Wrinkles)300W (Tissue Heating) | 300W (Surgical)120W (Wrinkles)300W (Tissue Heating) | 50W (Surgical - Coag only)120W (Wrinkles)300W (Tissue Heating) |
| Dimensions | 22.5" x 18" x 12" | 22.5" x 18" x 12" | 18" x 18" x 12" |
| Weight | 30 lbs | 30 lbs | 30 lbs |
§ 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.