(246 days)
The Sutter CURIS® RF Generator is intended for:
Orthopedic, arthroscopic, spinal and neurosurgical:
For resection and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurosurgical procedures
For soft tissue resection and coaqulation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist
Cutting:
Snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin tags, Blepharoplasty
Blended Cutting and Coagulation:
Snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal cell carcinoma, Nevi, Fistulas, Epithelioma, cosmetic repairs, cysts, abscesses, development of skin flaps
Hemostasis and nonablative Coagulation:
Control of bleeding, Epilation, Teleangiectasia
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
Contraindications:
This device is not intended for vessel sealing.
The Sutter CURIS® RF Generator is a compact source of high radiofrequency RF energy to be employed for a variety of electrosurqical procedures. This is achieved by the selection of different wave forms and power levels on the front panel of the device. All selections are effected through pushbuttons and knobs. Lamps give the operator feedback on the status.
The power level for each mode is indicated by front-panel digital displays. During self-test or for error messages these digital displays also serve as indicators. Activation of output power is performed through foot switch and/or hand switch. Monopolar and bipolar electrodes are available for use.
The maximum power output of the device in CUT mode is 100 watts (at 400 Ohms load), and 80 watts maximum in COAG mode at 50 Ohms. Operating frequency of the device is maintained at 4.0 MHz.
The device offers both monopolar and bipolar output wave forms. In monopolar mode it offers two CUT wave forms and two COAG wave forms. In bipolar mode it offers three CUT wave forms and three COAG wave forms.
The Sutter CURIS® RF Generator is packaged together with power cord and instruction manual. Optional accessories are a foot switch with cable and appropriate monopolar and bipolar cables.
The Sutter CURIS® RF Generator is an electrosurgical device that operates on high radiofrequency (RF) energy for various electrosurgical procedures. It has both monopolar and bipolar output waveforms and offers different cutting and coagulation modes. The device is not distributed as sterile and is not intended to be sterilized. It is a tabletop device, therefore, has no contact with the patient requiring no biocompatibility assessment.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test) | Pass/Fail Criteria | Reported Device Performance/Results |
|---|---|---|
| Electrical Safety | Compliance to IEC 60601-1: 2005 | Passed: The testing demonstrated that all applicable requirements have been met. |
| Electrical Safety | Compliance to IEC 60601-2-2:2009 | Passed: The testing demonstrated that all applicable requirements have been met. |
| Electromagnetic Compatibility | Compliance to IEC 60601-1-2: 2007 | Passed: The testing demonstrated that all applicable requirements have been met. |
| Risk Management | Compliance to ISO 14971:2007 | Passed |
| Software Performance | Compliance to IEC 62304:2006 | Passed: The functional safety concept of the CURIS® RF Generator has been tested in compliance with IEC 60601-1:2005, IEC 60601-2-2:2009, and IEC 62304:2006, demonstrating compliance. |
| Mechanical Safety | Compliance to IEC 60601-1:2005 | Passed: Protection against mechanical hazards of ME equipment and ME systems has been tested in compliance with IEC 60601-1:2005. The testing demonstrated that all applicable requirements have been met. |
| System Performance Testing | Compliance with FDA Guidance August 15, 2016 | Passed: The review of design requirements was based on control of labeling and packaging, control of weight and external dimensions, visual inspections, functional inspections, and measurements of the generator. The corresponding performance testing demonstrated that all design specifications and performance requirements have been met. |
| Thermal effects on tissue | Adequate coagulation and cutting performance | Passed: In all modes, the CURIS® RF Generator delivered adequate coagulation and cutting performance. Generally, CURIS® RF Generator and the predicate device performed similarly. This was evaluated using commercially available electrosurgical accessories, with the predicate device included for comparison. |
| Usability | Fulfills intended usability and design input | Passed: The results of the thermal effect performance testing, system performance testing, market acceptance tests, and user scenarios tests have been evaluated. It has been assessed that the CURIS® RF Generator fulfills the intended usability and meets the respective design input. |
| Drop Tests | Demonstrates design specifications and performance requirements are met | Passed: Drop tests with the CURIS® RF Generator in its designated packaging have been executed to demonstrate that design specifications and performance requirements are met. |
| Equivalence to predicate device | Internal verification and validation testing confirms that product specifications are met | Passed: Internal verification and validation testing confirms that product specifications are met which are equivalent to the predicate device in design and technological characteristics. The testing results support that the requirements for performance and electrical safety testing were met for the acceptance of the device. The CURIS® RF Generator passed all testing and supports the claims of substantial equivalence to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a "test set" in terms of cases or patient data, as this device (an RF Generator) is evaluated through non-clinical performance testing against established standards and internal R&D processes, rather than through analysis of patient data or clinical trials with a defined test set of medical outcomes.
Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not directly applicable to the type of testing described for this electrosurgical generator.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This is not applicable to the non-clinical performance studies conducted for this device. Ground truth, in the context of device performance, is established through compliance with recognized standards (e.g., IEC, ISO) and internal R&D process validations, not through expert consensus on medical cases.
4. Adjudication Method for the Test Set:
This is not applicable to the non-clinical performance studies for this device. Adjudication methods are typically used in clinical studies involving interpretation of medical data (e.g., imaging, pathology) by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, an MRMC comparative effectiveness study was not done. These types of studies are typically conducted for diagnostic devices where human readers interpret medical information, often with and without AI assistance. This device is an electrosurgical generator, and its performance is evaluated through engineering and safety testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The performance evaluation described is for the device (Sutter CURIS® RF Generator) itself, without direct human-in-the-loop performance assessment in the context of cognitive tasks or interpretation. The performance tests are described as standalone in the sense that they evaluate the device's functional and safety characteristics independent of its operational use on a specific patient.
7. The Type of Ground Truth Used:
The "ground truth" for evaluating the Sutter CURIS® RF Generator's performance is based on:
- Compliance with International Standards: Primarily IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, IEC 62304, and ISO 14971. These standards define the acceptable safety and performance parameters for electrosurgical devices.
- FDA Guidance: "Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery" - Guidance for Industry and Food and Drug Administration Staff, August 15, 2016.
- Internal R&D Process: Design specifications and performance requirements established by the manufacturer and validated through their internal testing processes.
- Comparison to Predicate Device: The predicate device serves as an established benchmark for "adequate coagulation and cutting performance," implying its known and accepted clinical efficacy and safety.
8. The Sample Size for the Training Set:
This is not applicable. The Sutter CURIS® RF Generator is a hardware device for electrosurgery, not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable as there is no training set for this type of medical 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.