(254 days)
The Surgitron 4.0 Dual RF S5 - IEC is intended to deliver electrosurgical output to perform cutting, coagulation, and hemostasis of soft tissues and to heat tissue in the non-ablative treatment of mild to moderate facial wrinkles and rhytids. The device is used with compatible Ellman International electrodes and handpieces which are used for these various applications in physician offices and surgical centers.
The Surgitron 4.0 Dual RF S5 - IEC indications are the same as those cleared in K082835:
- Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin . . phototypes I-IV
- . 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.
- . Hemostasis: control of bleeding, epilation, telangiectasia.
- 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 Surgitron 4.0 Dual RF S5 - IEC is a radiofrequency energy generator employed for a variety of electrosurgical procedures. The action is achieved by selection of the desired waveform and power level on the front panel. Selections are activated by push buttons and indicated on the digital display giving the operator feedback on device setting status. Device output is controlled via foot and/or hand switch. Monopolar and bipolar electrodes may be used with the device. The generator includes the following accessories:
- IEC Power Cord ●
- Dual Footswitch & Cable .
- IEC Foot controlled Handpiece ●
- . Bipolar Cable
- . Monopolar cables
- Disposable Neutral Plate .
- Multi-Button Finger switch Handpiece .
Acceptance Criteria and Study Details for Surgitron 4.0 Dual RF S5 - IEC
The provided submission, K123366, for the Surgitron 4.0 Dual RF S5 - IEC, focuses on demonstrating substantial equivalence to a predicate device (Surgitron 4.0 Dual RF – IEC) through compliance with recognized electrical safety and performance standards. It does not involve a study of clinical performance or diagnostic accuracy as would be typical for AI-powered devices. Therefore, many of the requested categories are not applicable to this type of device submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Required Standard) | Reported Device Performance |
|---|---|
| IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment) | The Surgitron 4.0 Dual RF S5 - IEC functioned as intended and in conformance with all applicable standards. |
| IEC 60601-2-2 (Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories) | The Surgitron 4.0 Dual RF S5 - IEC functioned as intended and in conformance with all applicable standards. |
2. Sample Size Used for the Test Set and Data Provenance
This device clearance did not involve a "test set" in the context of clinical data or algorithm performance. The testing was physical and electrical conformance testing of the electrosurgical unit itself.
- Sample Size: Not applicable (referring to patient data or images). The "sample" would be the manufactured device(s) subjected to the tests.
- Data Provenance: Not applicable. The testing pertains to the device's adherence to international safety and performance standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in this context typically refers to clinical diagnosis or pathology, which is not relevant for an electrosurgical unit's electrical safety and performance testing. The "ground truth" here is the established requirements of the IEC standards themselves.
4. Adjudication Method for the Test Set
Not applicable. This was conformance testing to standards, not a clinical study requiring expert adjudication of patient cases.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is not relevant for this type of device submission, which focuses on the safety and performance of an electrosurgical generator against established standards, not its comparative effectiveness in a diagnostic or clinical interpretation task involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is an electrosurgical generator, not an AI algorithm. Its performance is always predicated on human operation.
7. The Type of Ground Truth Used
The "ground truth" in this submission is the requirements outlined in the IEC 60601-1 and IEC 60601-2-2 standards. The device's performance was measured against these predefined safety and performance specifications.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this 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.