(92 days)
Single Use Electrosurgical Knife KD-610L/KD-611L/KD-620LR/KD-630L/KD-640L This instrument has been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue within the digestive tract and using high-frequency current.
The following five models of Single Use Electrosurgical Knives are the subject of this 510(k) notification: KD-610L, KD-611L, KD-620LR, KD-630L and KD-640L.
The KD-610L and KD-611L knives have isolation tips on the distal tip to prevent inadvertent deep cauterization. The KD-611L knive also has an electrode at the bottom of the isolation tip, which can also cut tissue.
The KD-620LR knive is a L-shaped knife, which cutstissue by hooking the mucous membrane. This device is rotatable so that both longitudinal and lateral dissection is possible.
The KD-630L knife consists of flexible wire, which is adjustable by the user, preventing inadvertent deep cauterization.
The KD-640L knife has a triangle tip to the distal end of the knife, which hooks mucous membrane to cut. Both longitudinal and lateral dissection is possible without rotating the instrument due to the triangle tip design.
This document is a 510(k) summary for a "Single Use Electrosurgical Knife Series." It describes the device, its intended use, and compares it to a predicate device.
Crucially, this document does not contain information about acceptance criteria or a study demonstrating the device meets those criteria.
510(k) submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics in the same way a PMA (Premarket Approval) submission would.
Therefore, I cannot fulfill your request for the specific points listed (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, training set size and ground truth establishment) because this information is not present in the provided text.
The document states:
- "The Single Use Electrosurgical knives are basically identical to the predicate device in intended use, and similar in specifications except for cutting knife shapes." (Section 6)
- "When compared to the predicate device, the Single Use Electrosurgical Knives do not incorporate any significant changes that could affect the safety or effectiveness of the device." (Section 7)
These statements indicate that the submission relies on the established safety and effectiveness of the predicate device (KD-1L-1, Preamendment Device) to support substantial equivalence for the new devices. No new performance studies with defined acceptance criteria are described.
§ 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).