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K Number
K974484
Device Name
ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE
Manufacturer
XIMED/PROSURE/INJECTX
Date Cleared
1998-02-10

(76 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The electrosurgical probes and devices are to be used with commercially availbale R.F. Generators, endoscopes, and suction/irrigation sytems. These devices can be used for laparoscopic, hysteroscopic, endoscopic and open surgical procedures designed for soft tissue removal using coagulation/ablation/vaporization mode of R.F. energy.

Device Description

Isolated Electrosurgical Probe/Device-Salinetrode

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for an electrosurgical device (Salinetrode™) from February 1998. It primarily addresses the regulatory status (substantial equivalence) of the device to previously marketed predicate devices.

This type of document (a 510(k) clearance letter) does not contain the detailed technical study information you are asking for.

Specifically, a 510(k) clearance letter:

  • Does not include acceptance criteria for device performance. It confirms that the device is "substantially equivalent" to a predicate device, meaning it has the same intended use and technological characteristics, or different characteristics that do not raise new questions of safety and effectiveness.
  • Does not include specific study data, sample sizes, expert qualifications, or ground truth methodologies. These details would be found in the 510(k) submission itself, which is typically a much more extensive document that includes performance data, bench testing, and potentially clinical studies, depending on the device and its risk profile.
  • Does not discuss multi-reader multi-case (MRMC) studies or standalone algorithm performance, as this device is a physical electrosurgical probe, not an AI/software device.

Therefore, I cannot provide the requested information based on the input text. The document only confirms the device's regulatory clearance based on substantial equivalence, not its specific performance metrics or the studies backing them up.

§ 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.