(29 days)
The DSP Worldwide Snowden-Pencer Xenon Lightsource is intended for use as an accessory to fiberoptic endoscopes to provide illumination during endoscopic procedures.
The DSP Worldwide Snowden-Pencer Xenon Lightsource is a fiberoptic illuminator for use in endoscopic surgical procedures. The device includes a Power Switch/Circuit Breaker, Light Guide receptacle which accepts the fiber optic cables (designed to accept ACMI cables with Storz, Olympus, and Wolf adapters also available), Lamp Usage Clock which indicates elapsed bulb usage (in hours), Light Intensity Control which allows illumination to be adjusted (clockwise to increase intensity and counterclockwise to decrease intensity), Light Intensity Indicator which provides a graphic representation of the level of light intensity, a Lamp Door on the side of the unit to provide access for replacement of the lamp module, a Cooling Fan to cool the Xenon bulb and the power supply of the unit. Detailed specifications for the Lightsource were provided.
This 510(k) premarket notification for the DSP Worldwide Snowden-Pencer Xenon Lightsource does not contain information about acceptance criteria or a study proving the device meets specific performance acceptance criteria in the way this request is typically understood for AI/ML or diagnostic devices.
The document focuses on demonstrating substantial equivalence to a predicate device (Karl Storz Xenon Light Source) based on design, operational principles, and technological characteristics, rather than reporting on a clinical or performance study with quantified acceptance criteria and device performance results.
Therefore, many of the requested fields cannot be filled. I will explain why for each point.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
| The device to be substantially equivalent to the predicate device in design characteristics, operational principles, and technological characteristics. | The document states, "The DSP Worldwide Snowden-Pencer Xenon Lightsource is substantially equivalent the Karl Storz Xenon Light Source and to other legally marketed xenon light sources in design characteristics, operational principles, and technological characteristics." |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" for performance evaluation in the context of diagnostic accuracy or AI/ML. The assessment is based on a comparison of technical specifications and intended use against a predicate device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. There's no performance evaluation involving expert ground truth in this submission.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This document describes a medical device (a light source for endoscopy), not an AI/ML or diagnostic imaging device that would typically undergo such a study.
6. If a Standalone Performance Study was done
A standalone performance study in the context of diagnostic algorithms or AI performance was not conducted or reported. The 510(k) summary focuses on demonstrating equivalence through design and specifications.
7. The Type of Ground Truth Used
Not applicable. There is no ground truth concept as typically applied to AI/ML or diagnostic studies in this submission.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.