(77 days)
Designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation current. Coagulation is achieved using electrosurgical energy generated by the electro surgical generator unit and activated by a footswitch. The Stingray Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
These devices are bipolar forceps design for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. The forceps are designed to grasp and manipulate selected tissues. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch. They are constructed of stainless steel, a nylon coating, and a non-stick tip. The devices are provided non-sterile and must be autoclaved prior to use.
Here's an analysis of the provided 510(k) summary regarding the Stingray Electrosurgical Forceps, focusing on acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a predicate device comparison rather than explicit acceptance criteria with specific numerical thresholds for performance. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device. The performance is therefore reported as being "SAME" or equivalent to the predicate device's characteristics.
| Characteristic | Acceptance Criteria (Implicit - Equivalence to Predicate) | Reported Device Performance (Stingray Electrosurgical Forceps) |
|---|---|---|
| Intended Use | Bipolar electrosurgical procedures (same as predicate) | SAME |
| Configuration | Coated handle, bipolar connector, stainless steel, and non-stick plated tip (same as predicate) | SAME |
| Generator | Bipolar electrosurgical (same as predicate) | SAME |
| Connector | 2 pin bipolar, insulated (same as predicate) | SAME |
| Materials | Nylon coated stainless steel (same as predicate) | SAME |
| Sterilization | Autoclave (same as predicate) | SAME |
| Safety | Meets 60601-2-2 (same as predicate) | SAME |
| Standards | Meets ANSI/AAMI HF18-2001 (same as predicate) | SAME |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document refers to "bench and standards testing data" (Section 5. Safety and Effectiveness, comparison to predicate device, and Section 7. Conclusion), but does not provide details on the number of samples or specific test configurations used.
- Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the tests were retrospective or prospective. It only states that "bench and standards testing" was conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is not an AI/ML or diagnostic device that requires expert ground truth establishment for a test set. The evaluation is based on engineering and safety standards and comparison to a predicate device.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication method is described as the evaluation is based on objective bench and standards testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is a medical device (electrosurgical forceps), not an AI/ML diagnostic or image analysis tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent to its design and manufacturing, evaluated through bench testing against established standards and comparisons to a predicate device.
7. The Type of Ground Truth Used
The "ground truth" implicitly used for this device is compliance with established engineering standards (60601-2-2, ANSI/AAMI HF18-2001) and demonstrated equivalence in physical and functional characteristics to a legally marketed predicate device (ProMed Instruments GmbH DORO® Non-Stick Bipolar Forceps K070997). This falls under the category of bench testing and standards compliance.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no "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.