(32 days)
The Welch Allyn 300 Watt Xenon Light Source is indicated for medical lighting applications requiring a remotely located, high intensity illumination. The device is not indicated for neonate transillumination.
The purpose of the Welch Allyn 300 Watt Xenon Light Source is to provide lighting for medical applications requiring high intensity illumination. The intended use is to provide illumination for medical products such as existing and approved headlights and various existing and approved rigid or flexible endoscopes.
The provided text describes a 510(k) summary for the Welch Allyn Xenon 300 Light Source. This device is a light source for medical applications, not a diagnostic AI device, therefore, many of the requested categories are not applicable.
Here's the information that can be extracted or reasonably inferred from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Standards: | |
| UL 2601 | The system is designed to meet this standard. |
| CSA 601-1 | The system is designed to meet this standard. |
| IEC 601-1 | The system is designed to meet this standard. |
| Electrical Safety (to patient and user) | Device is designed to provide electrical safety. |
| Mechanical Safety (to user) | All contact surfaces shall be rounded, textured, or deburred where possible and if necessary. |
| IEC601-1-2 | The system will be certified to this standard. |
| Conformance with European Council Directive 93/42/EEC CE Mark (medical devices) | The system will conform with provisions of this directive. |
| ACGIH TLV's (Ultraviolet, Light, and Near Infrared Sections) equations (1994-1995) | Will be used as a basis of comparison for the Welch Allyn 300 Watt Light Source and the predicate device in their intended application. (Implies the device will perform comparably or within acceptable limits based on these standards, though specific performance values are not given) |
| Effectiveness/Intended Use: | |
| Provide high intensity illumination for medical applications | The device is effective for its intended use of providing illumination for medical products such as existing and approved headlights and various existing and approved rigid or flexible endoscopes. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This is a hardware device (light source), not a software/AI device that would involve a "test set" in the context of data. The "testing" referred to is likely in the form of engineering and electrical safety compliance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As above, this is a hardware light source, not an AI device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a light source, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. The "ground truth" for this device relates to its ability to meet specified engineering, electrical, and optical performance standards, as well as safety regulations. These are typically established through laboratory testing, calibration, and compliance checks against industry standards (e.g., IEC, UL, CSA, ACGIH TLV's).
8. The sample size for the training set:
- Not Applicable. This device does not use a "training set" in the context of machine learning.
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.