(24 days)
The Radiance Ultra series ZeroWire G2 is a paired wireless video communication transmitter and receiver, intended for delivery of video signals from a source such as an endoscopy cameralprocessor, or other video source over a radio-frequency link to a ZeroWire Receiver for display of images during endoscopic and general surgical procedures. The Radiance Ultra series ZeroWire Embedded and ZeroWire G2 wireless video system is a non-sterile reusable device not intended for use in the sterile field
Radiance Ultra series ZeroWire Embedded monitors are designed with an integrated wireless video receiver module (Rx), enabling the reception of a video signal over a radio frequency link instead of a video cable. These monitors are designed for use in non-sterile healthcare environments. The Radiance Ultra series ZeroWire Embedded is a medical grade wireless video streaming device pair. The external transmitter (Tx) unit is designed to be mounted on a primary display, on an endoscopic cart, or any other elevated location in close vicinity to the video source. The Tx unit obtains its video input signal from either the loop through output of the primary display, or directly from the video source. The Tx unit will accept video in either HDMI/DVI or SDI formats up to 1920 x 1080p 60 Hz resolution. The Tx unit is powered by a NDS 12-24V DC-DC power converter while the Rx module shares the same 24V DC input of the display.
The provided text describes a medical device called "Radiance Ultra series ZeroWire Embedded" and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or a detailed breakdown of performance metrics, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
The document is a 510(k) premarket notification letter from the FDA, along with the applicant's 510(k) summary. It primarily focuses on establishing substantial equivalence to a predicate device (K151609 model ZeroWire G2) based on technological characteristics and intended use.
Here's a breakdown of what can be extracted and what is missing:
Information that can be extracted from the provided text:
- Device Name: Radiance Ultra series ZeroWire Embedded (and ZeroWire G2 for the paired transmitter/receiver system).
- Intended Use: Delivery of video signals from a source (e.g., endoscopy camera/processor) over a radio-frequency link to a ZeroWire Receiver for display of images during endoscopic and general surgical procedures. It is a non-sterile reusable device not intended for use in the sterile field.
- Predicate Device: K151609 model ZeroWire G2.
- Performance Claim (General): The device "meet and exceed IEC 60601-1, ANSI/AAMI ES60601-1, IEC 60601-1-2 and FCC part 15." It also states, "The displays have successfully passed design validation to further demonstrate their safety and effectiveness."
- Conclusion: The device demonstrates performance, safety, and effectiveness that are equivalent to the predicate device.
Information that is missing from the provided text regarding acceptance criteria and studies:
- A table of acceptance criteria and the reported device performance: While general standards (IEC, FCC) are mentioned, specific measurable acceptance criteria (e.g., latency, signal integrity, resolution maintenance under specific conditions) and the corresponding device performance against these criteria are not provided.
- Sample size used for the test set and the data provenance: No information on any specific test set, its size, or the origin of data is present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a test set requiring expert ground truth.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, the effect size: Not applicable, as this device is a video transmission system, not an AI diagnostic tool that would typically involve human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, for the same reason as above.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable, as this is hardware for video transmission, not an AI algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a video display and transmission system. It focuses on compliance with general safety and electromagnetic compatibility standards and functional equivalence to a predicate device, rather than detailed performance metrics from a specific clinical or technical study against predefined acceptance criteria for a diagnostic or AI-driven device.
§ 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.