(134 days)
Intended Use: Sutter Bipolar Forceps SuperGliss are designed to grasp, manipulate and coagulate selected tissue. They are to be connected to the bipolar output of an electrosurgical generator with an appropriate bipolar cable and must only be used with parameters for bipolar coagulation.
Indications: General surgery, Orthopaedic coagulation, Thoracic coagulation, Neurosurgical coagulation, Gynaecological coagulation (except for use in female sterilisation), Urological coagulation, Ear-, Nose- and Throat coagulation.
Sutter Bipolar Forceps - SuperGliss is an electrosurgical tool in tweezers configuration with differences in tip size and branches styles. It is constructed with medical grade stainless steel (branches), coated with Polyamid PA 11 as electrical insulator and possesses a tip made of silver alloy that is not insulated. The forceps can be connected through an appropriate bipolar cable with the bipolar output of an electrosurgical generator. As an electrosurgical accessory it is designed to grasp, manipulate and coagulate selected tissue. The maximum peak voltage to use the forceps is 500 Vp. The forceps are provided non-sterile, are reusable and must be sterilized prior initial and subsequent use.
The provided text describes a 510(k) summary for the "Sutter Bipolar Forceps - SuperGliss," an electrosurgical tool. This document outlines the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.
Based on the information provided, here's a detailed breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the sense of specific thresholds for performance metrics. Instead, it demonstrates "substantial equivalence" to predicate devices, implying that its performance is comparable and acceptable for its intended use. The performance testing section mentions "determination of coagulation areas for various tip sizes and statistical analysis of the results," but no specific numerical results or targets are provided in this summary.
The "Features" table below highlights the comparative performance and design aspects, showing that the Sutter SuperGliss meets the characteristics of the predicate devices.
| Feature | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (Sutter SuperGliss) |
|---|---|---|
| Intended Use | Grasp, manipulate, coagulate selected tissue; connected to bipolar output of electrosurgical generator with appropriate cable; used only with parameters for bipolar coagulation. | Same as predicate devices |
| Branches Style | Straight, angled, bayonet | Straight, angled, bayonet |
| Dimensions (Length) | 110 - 250 mm (K101080) / 110 - 240 mm (K051429) | 110 - 280 mm |
| Dimensions (Tip size) | 0.25 - 2.0 mm (K101080) / 0.25 - 2.0 mm (K051429) | 0.2 - 2.5 mm |
| Material (Tips) | Silver Alloy | Silver Alloy |
| Material (Coating) | Polyamide (PA) 11 | Polyamide (PA) 11 |
| Material (Connector) | Stainless steel/PEEK | Stainless steel/PEEK |
| Material (Branches) | Stainless steel | Stainless steel |
| Bipolar Function | Yes | Yes |
| Compliance Standard | Meets IEC 60601-2-2 | Meets IEC 60601-2-2 |
| Maximum Peak Voltage | 500 Vp | 500 Vp |
| Sterility | Non-sterile, reusable | Non-sterile, reusable |
| Sterilization Method | Steam-sterilization by user | Steam-sterilization by user |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Non-clinical laboratory performance testing was done on different types of meat with determination of coagulation areas for various tip sizes and statistical analysis of the results."
- Sample Size: Not specified. The phrase "different types of meat" suggests multiple samples were used, but the exact number is not provided.
- Data Provenance: Not specified, but generally, bench testing results conducted by the manufacturer are not typically tied to a specific country of origin in the same way clinical trial data might be. This was a non-clinical laboratory performance test. It's implicitly retrospective as it was conducted by the manufacturer for the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an electrosurgical instrument, and the performance testing involved physical measurements of coagulation areas on meat, not human interpretation requiring expert consensus.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the testing involved physical measurements, not observational assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This device is a surgical instrument, and its performance was assessed through non-clinical laboratory tests.
6. Standalone Performance Study
Yes, a standalone performance study was performed in the form of "Non-clinical laboratory performance testing... on different types of meat with determination of coagulation areas for various tip sizes and statistical analysis of the results. Bench testing according to standards series IEC 60601 has also been performed." This describes the device's performance in isolation from a human operator, focusing on its functional capabilities.
7. Type of Ground Truth Used
For the non-clinical laboratory performance testing, the ground truth was direct physical measurement of "coagulation areas" on "different types of meat." For compliance with IEC 60601, the ground truth rested on fulfilling the requirements of that established standard.
8. Sample Size for the Training Set
Not applicable. This is a medical device (surgical instrument), not an AI/ML algorithm that requires a training set. The performance testing aims to demonstrate the device's functional integrity and equivalence, not to train a model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device submission.
§ 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.