Search Results

The Mitsubishi Battery Powered Endoscopic Light Source is intended for use as a light source for diagnostic endoscopes.

The Mitsubishi Battery Powered Endoscopic Light Source is a lightweight, portable, battery powered light source intended for use with diagnostic endoscopes. The light source is powered by one three-volt lithium battery contained within a leakproof case and controlled by a manual on/off switch. Illumination is provided by a 1.7-watt The unit may be connected by friction-fit to most manufacturers' halogen bulb. endoscopes via adaptors (supplied separately) that attach to the endoscope light cable post.

This 510(k) submission (K960081) for the Mitsubishi Battery Powered Endoscopic Light Source does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document describes a medical device, its intended use, and its comparison to a predicate device for the purpose of demonstrating substantial equivalence. It is a 510(k) summary, which focuses on regulatory clearance based on equivalence rather than detailed performance study results against specific criteria.

Therefore, I cannot provide the following information based on the given text:

1. A table of acceptance criteria and the reported device performance: This document does not list specific performance criteria (e.g., light output in lumens, battery life in hours, specific spectral characteristics) that the device must meet, nor does it provide detailed study results demonstrating performance against such criteria.
2. Sample size used for the test set and the data provenance: There is no mention of a formal "test set" or any data collection for evaluating performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant as no test set or ground truth establishment is described.
4. Adjudication method: Not applicable as no test set or ground truth establishment is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: MRMC studies are typically for diagnostic imaging devices involving human interpretation, which is not relevant for a light source. No such study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This device is a physical light source, not an algorithm. This question is not applicable.
7. The type of ground truth used: Not applicable as no test set or ground truth establishment is described.
8. The sample size for the training set: Not applicable as this is a physical device, not a machine learning algorithm.
9. How the ground truth for the training set was established: Not applicable as this is a physical device, not a machine learning algorithm.

Key takeaway from the document:
The submission demonstrates substantial equivalence to "Xomed-Treace E-Luminator II Battery Powered Disposable Endoscope Light Source" (K932771). The key arguments for equivalence are:

• Same design considerations and operating principles.
• Differences (sterilizable, replaceable battery) do not raise new questions regarding safety or effectiveness.
• Both deliver incandescent light to illuminate the target.

Ask a specific question about this device