(176 days)
The Image1 SPIES is a camera control unit (CCU) for use with camera heads or video endoscopes for visualization, image recording and documentation during general endoscopic and microscopic procedures.
The Image1 SPIES (Storz Professional Image Enhancement System) camera control unit is a medical device which consists of an Image1 Connect display module (TC200), and a combination of a minimum of one to a maximum of three camera head input modules that is intended and designed for use during endoscopic procedures. Image1 H3-Link (TC300) and Image1 X-Link (TC301) are available as head input modules. The device's modularity enables customers to customize their Image1 SPIES system to their specific current and future video needs. Descriptions of these three modular devices are provided below.
Image1 Connect (TC200):
The Image1 Connect displav module is connected to the head module(s) via an inter-module link cable. The Image1 Connect accepts video from the head module(s) and offers additional functionality such as image capture, image printing, picture-in-picture representation and generation of a digital video output for monitor viewing purposes.
Image1 H3-Link (TC300):
The Image1 H3-Link head module processes raw video signals from the H3 family of camera heads.
Image1 X-Link (TC301)
The Image1 X-Link head module also processes raw video signal from a certain set of imagers housed in a camera head. Visually, the card edge connector receptacle of the X-Link is wider than the receptacle of the H3-Link.
The provided text describes a 510(k) summary for the KARL STORZ Image1 SPIES, an endoscopic video imaging system. It details the device, its intended use, and substantial equivalence to predicate devices, but does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance criteria through a clinical trial or a statistically designed non-clinical study that would typically generate the requested performance metrics.
The document focuses on demonstrating substantial equivalence to previously cleared devices (Image1 Video Imaging System K070716 and Fujinon EPX-4440HD Video Processor and Light Source K102466) through non-clinical bench testing.
Here's an analysis based on the provided text, addressing each point as much as possible:
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Table of acceptance criteria and the reported device performance:
The document mentions the types of non-clinical tests performed but does not provide specific numerical acceptance criteria or the reported performance values. It states:
Test Category Acceptance Criteria (Not explicitly stated with values) Reported Device Performance (Not explicitly stated with values) Electrical Safety Compliance with IEC 60601-1 and IEC 60601-1-2 standards. "demonstrates the continued electrical safety of the device" Optical Performance "includes white balance, brightness, image enhancement, video output format, zoom, image quality, image capture, latency and interface control" Implied to meet or exceed predicate devices' performance. Software Reliability (Not explicitly stated) "reliability of the software" is tested. Overall Performance As safe, as effective, and performs as well as or better than legally marketed predicate devices. "demonstrates that the device is as safe, as effective and performs as well as or better than the legally marketed devices." Note: The document only lists the categories of tests and a general conclusion of meeting requirements, rather than providing specific quantifiable acceptance criteria (e.g., "latency must be
§ 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.