(123 days)
The SLT bipolar sheath is indicated for use with currently marketed cutter systems used in Orthopedic Surgery. The SLT bipolar sheath is intended to provide coagulation of tissue at the distal end of the cutter tip. This sheath is designed with a standard interface to allow use with most electrosurgical generators.
The SLT HemoSleeve Bipolar Sheath is indicated for use in general surgery procedures to provide coagulation at the distal end of a tissue debrider tip.
The SLT bipolar sheath is intended to provide coagulation of tissue at the distal end of the cutter tip. This sheath is designed with a standard interface to allow use with most electrosurgical generators.
The provided text is a 510(k) summary for the SLT HemoSleeve Bipolar Sheath, which is a medical device. It does not contain information about acceptance criteria, device performance metrics, detailed study designs, sample sizes for test or training sets, ground truth establishment, expert qualifications, or comparative effectiveness studies.
The document primarily focuses on:
- Indications for Use
- A general description of the device
- A statement of substantial equivalence to predicate devices based on intended use and technological features, supported by "performance data from device validation" (though the data itself is not presented).
- A formal FDA letter confirming substantial equivalence and market clearance.
Therefore, I cannot provide the requested information from the given text.
The document explicitly states:
"Description statements were not relied on to show substantial equivalence to legally marketed devices; instead, performance data from device validation is used."
This indicates that performance data and validation were conducted, but the details of those studies are not included in this summary. This type of summary typically omits the detailed study results and focuses on the regulatory conclusion.
§ 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.