(412 days)
Designed to grasp, manipulate and coagulate selected tissue for single use in general surgical procedures. These forceps can be sold with or without irrigation and are provided sterile. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator and irrigation module. Stingray Ultralite Disposable Irrigation Forceps can 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 Ultralite Disposable Irrigation 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 disposable bipolar forceps design for single use in general surgical procedures. They are connected through a suitable birolar cable with the bipolar output of an electrosurgical generator. The forceps are designed to grasp and manipulate, or irrigate selected tissues. The semi rigid irrigation tube is designed to carry nonpyrogenic fluid through the instrument and outputted to the tip end. 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 alloy tip. The devices are provided sterile ethylene oxide (ETO) and in sterile packs.
The provided text describes a 510(k) summary for the "Stingray Ultralite Disposable Irrigation Bipolar Forceps." This submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving device performance against specific acceptance criteria in the context of an AI/medical imaging device. Therefore, many of the requested elements are not applicable to this type of medical device submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | "The new device is manufactured by the same company in the same way as the new device, it is as safe and effective as the predicate device." "Stingray Ultralite Disposable Irrigation Forceps were designed and manufactured to the same specifications as Stingray Electrosurgical Forceps K083162, which have been subject to bench and standards testing indicating the device is safe and effective." |
| Effectiveness | "The new device is manufactured by the same company in the same way as the new device, it is as safe and effective as the predicate device." "Stingray Ultralite Disposable Irrigation Forceps were designed and manufactured to the same specifications as Stingray Electrosurgical Forceps K083162, which have been subject to bench and standards testing indicating the device is safe and effective." |
| Adherence to Standards | Designed to meet or exceed ANSI/AAMI HF18-2001 and IEC 60601-2-2:2006 voluntary standards. |
| Substantial Equivalence | "few technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not applicable as the submission relies on documentation of a previously cleared predicate device and adherence to established standards, not a specific "test set" of data for performance evaluation in the way an AI/imaging device would. The "study" referenced for the predicate device appears to be bench and standards testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable. The device is a surgical instrument, and its safety and effectiveness are established through engineering design, material selection, manufacturing processes, and compliance with recognized industry standards, not through expert-labeled ground truth like in an AI/imaging study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. The evaluation method described is a comparison to a predicate device and adherence to industry standards, not a review of a data set that would require 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:
This information is not applicable. This submission concerns a physical surgical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this type of device is inherent in its design, manufacturing, and compliance with recognized safety and performance standards for electrosurgical instruments. The safety and effectiveness of the predicate device (K083162) would have been established through bench testing and adherence to relevant industry standards (ANSI/AAMI HF18-2001, IEC 60601-2-2:2006).
8. The sample size for the training set:
This information is not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable. This is not an AI/machine learning 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.