(87 days)
The EG&G Xenon 300mx is intended to be used with fiber optic cables for endoscopes, surgical headlamps and other lighted tools that contain fiber optic bundles. Illumination from this device is to be used for observation of body cavities, hollow organs and other surgical sites. Specific areas of application include arthroscopy, laproscopy, gynecology, borncoscopy, urology and vascular endoscopy. The device is also intended for use as a light source for surgical headlights used in various surgical procedures.
The Xenon 300mx Illuminator is intended for use as a high intensity light to be used with Fiberoptic cables. Applications include endoscopes, surgical headlamps, and other lighted tools that contained Fiberoptic bundles. Illumination from this device is intended to be used for observation of body cavities, hollow organs, and other surgical sites. Specific areas of application include arthroscopy, laproscopy, gynecology, broncoscopy, urology, and vascular endoscopy. The device is also intended for use as a light source for surgical headlights used in various open surgical procedures.
EG&G Optoelectronics has engineered the Xenon 300mx to provide a high intensity white light source for fiber optic cables. The system consists of a single cabinet containing a power supply, a Xenon Lamp with focusing optics, a variable light attenuator, a selector for four standard fiber optic cable sizes, and a forced air cooling system.
This document is a 510(k) summary for a Xenon Light Source (Xenon 300mx). The core of this document is a claim of substantial equivalence to predicate devices, rather than a detailed study proving performance against defined acceptance criteria.
As such, no comprehensive study proving the device meets acceptance criteria is present in the provided text. The document explicitly states: "No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)."
However, based on the information provided, we can infer some details and present what is available:
1. Table of Acceptance Criteria (Inferred) and Reported Device Performance
Since no explicit "acceptance criteria" are provided as a formal table, we can infer them from the "Effectiveness" statement and the claim of substantial equivalence. The primary acceptance criterion appears to be achieving a certain light output sufficient for intended use, and being comparable to predicate devices.
| Acceptance Criterion (Inferred from "Effectiveness" and Equivalence Claim) | Reported Device Performance (from "Effectiveness") |
|---|---|
| Light Output (Intensity): Sufficient for all known endoscopic illumination tasks. | Up to 800 lumens of white light at the output of a seven-foot-long, 5.0 mm diameter fiber bundle. This level is stated as "sufficient for all presently known endoscopic illumination tasks." |
| Temperature Control: Maintain temperature of the fiber bundle termination. | Internal forced air cooled turret design provides "greater control over the light delivered... [and] also serves to maintain temperature control of the bundle termination." |
| Functional Equivalence: Similar intended use, design, and function to predicate devices (Karl Storz Xenon 300, BFW MID 3000, Applied Fiberoptics Brite Lite III). | The device "is substantially equivalent to several medical illuminator systems presently on the market, while incorporating certain design improvements." All cited equivalent systems use 300W xenon lamps and have similar sub-systems. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not applicable. No formal "test set" or clinical study data is presented for direct evaluation of the device's performance against detailed acceptance criteria. The submission relies on demonstrating substantial equivalence to predicate devices.
- Data Provenance: Not applicable. The "performance data" mentioned (for the lamp and power supply, and a database search for adverse effects of marketed devices) is not described in detail regarding its origin or nature (retrospective/prospective, country of origin).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. There's no "test set" and thus no ground truth established by experts for that purpose. The determination of "sufficiency" for light output (800 lumens for endoscopic tasks) is a generalized statement, not attributed to a specific expert consensus on a test set.
4. Adjudication Method for the Test Set
- Not applicable. No test set where adjudication would be necessary is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This document does not describe an MRMC study. It pertains to a light source, not an AI or diagnostic device that typically undergoes such studies for human-in-the-loop performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
- Not applicable in the typical sense for medical device performance (e.g., pathology, outcomes data). The "ground truth" for this submission revolves around the functional characteristics (light output, temperature control) of the device being comparable to those of legally marketed predicate devices and adequate for its intended use. The "effectiveness" statement implicitly defines this ground truth.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI device that would require a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See #8)
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.