(20 days)
The intended use of the SDC3 HD Information Management System with Wireless Device Control Capability system is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the SDC3 with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.
The SDC3 HD Information Management System with Wireless Device Control Capability is a network compatible hardware platform that allows the users to control the state, selection, and settings of compatible connected endoscopic and general surgery devices both wired and wirelessly. The SDC3 HD Information Management System with Wireless Device Control Capability consists of the following: a. A SDC3 HD Information Management System console (Class I MDDS) b. A Device Control Package (contains an optional software upgrade and a handheld Infrared (IR) remote control) - Class II c. A Voice Control Package (contains an optional software upgrade and a headset and base station) – Class II d. Connected OR Spoke (Class I MDDS)
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "SDC3 HD Information Management System with Wireless Device Control Capability". This submission argues for substantial equivalence to a predicate device (K160332).
Crucially, this document states that there are no performance studies or clinical trials conducted for this submission (K210584) because the changes are not related to design but to the indications for use, and a risk analysis concluded no new questions of safety and effectiveness were raised.
Therefore, I cannot provide details on the acceptance criteria, study design, sample sizes, expert ground truth establishment, or any other performance-related metrics as these studies were not performed for this 510(k) submission.
The document explicitly states:
"There are no design changes proposed nor necessary to support the change in indications for use. A risk analysis of the indications for use change concluded that the change in indications for use does not raise different questions of safety and effectiveness. Therefore, performance data are not necessary to evaluate the change in indications for use to a tool-type indications for use."
If performance data for the predicate device (K160332) were available, they would be in that submission's documentation. This document (K210584) only refers to a comparison of technological characteristics for substantial equivalence.
§ 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.