(170 days)
The KSEA Instrument Set for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities is intended for use by qualified surgeons during endoscopic surgery of superficial veins and fascia of the lower extremities, including vein discission and paratibial fasciotomy.
The KSEA Instrument Set for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities are manually operated, reusable surgical devices consisting of a rigid endoscope, sheath, scissors, forceps, knives, and adapters. The instruments and endoscope are long enough to gain access to the surgical site. The body contact materials have a long history of use in medical devices and do not pose any new issues of safety and effectiveness
The provided document is a 510(k) summary for the "KSEA Instrument Set for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities." This document is a regulatory submission for a medical device (surgical instruments) and not for an AI/ML-driven software device.
Therefore, the requested information about acceptance criteria, study details (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set), which are standard for evaluating AI/ML models, is not applicable to this submission.
The document focuses on:
- Device Description: Manually operated, reusable surgical devices (endoscope, sheath, scissors, forceps, knives, adapters).
- Indication: Use by qualified surgeons during endoscopic surgery of superficial veins and fascia of the lower extremities.
- Substantial Equivalence: Comparison to predicate devices, stating that minor design differences do not raise new safety or effectiveness issues.
There are no acceptance criteria, performance metrics, or study methodologies for an AI/ML algorithm mentioned or implied in this document.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.