(90 days)
Gold Probe Bipolar Electrohemostasis Catheter is indicated for use in transendoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract.
Injection Gold Probe Bipolar Electrohemostasis Catheter is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. The Injection Gold Probe Catheter also has irrigation capability. Any other use is not recommended.
The Gold Probe is a bipolar electrohemostasis catheter with irrigation capabilities. When passed through an endoscope and activated, it will deliver a bipolar current to cauterize tissue. The Gold Probe is available in 7 Fr and 10 Fr with a working length of 300cm (7 and 10 Fr) and 350cm (7 Fr), compatible with a minimum of 2.8 mm and 3.7 mm scope channels, respectively. The catheter shaft provides firmness for perpendicular and tangential use, while the HemoGlide Coating on the catheter promotes minimal friction during endoscope passage.
The Injection Gold Probe is an injection therapy and bipolar electrohemostasis catheter with irrigation capabilities. The Injection Gold Probe is available in a working length of 210 cm with outer diameters of 7F (2.3 mm) and 10F (3.3 mm), compatible with a minimum of 2.8 mm and 3.7 mm scope channels, respectively. The catheter shaft provides firmness for perpendicular and tangential use, while the HemoGlide Coating on the catheter promotes minimal friction during endoscope passage.
This document is a 510(k) premarket notification for a medical device, specifically the Gold Probe Bipolar Electrohemostasis Catheter and the Injection Gold Probe Bipolar Electrohemostasis Catheter.
Based on the provided text, there is no information about a study proving the device meets acceptance criteria related to AI/algorithm performance, human-in-the-loop studies, or detailed ground truth establishment. The document explicitly states:
"The proposed Gold Probe Bipolar Electrohemostasis Catheter and Injection Gold Probe Bipolar Electrohemostasis Cathter technological characteristics remain unchanged from predicate Gold Probe Bipolar Electrohemostasis Catheter (K970278) and Injection Gold Probe Bipolar Electrohemostasis Catheter (K133933) respectively; therefore, no further performance testing was required."
This statement indicates that the submission is based on substantial equivalence to previously cleared predicate devices, claiming that the technological characteristics are unchanged, and thus, no new performance testing was deemed necessary by the manufacturer for this 510(k) submission.
Therefore, I cannot populate the requested table and details because the provided document does not contain information about:
- A table of acceptance criteria and reported device performance (in the context of an AI/algorithm study).
- Sample sizes for a test set or data provenance for such a study.
- Number and qualifications of experts for multi-reader studies or ground truth establishment in this context.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
This 510(k) summary focuses on demonstrating substantial equivalence to existing devices based on technological characteristics and indications for use, rather than presenting a performance study against specific acceptance criteria for a new or AI-enabled device.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).