(275 days)
The EndoLED is to be used in conjunction with endoscopic devices to provide illumination and visualization of optical images.
The EndoLED is a lightweight portable lamp for the use with endoscopes. The device is battery-operated and uses LEDs to illuminate the area of interest. For the users convenience, the EndoLED come in different designs, the straight and the angled one. The accessories comprise adapters for the use of the EndoLED with different types of endoscopes.
The provided document is a 510(k) summary for the Olympus EndoLED. It primarily discusses the device's substantial equivalence to a predicate device and non-clinical testing performed.
The document does NOT contain information about a study that proves the device meets specific acceptance criteria related to its performance in a clinical or standalone setting.
Instead, it focuses on:
- Substantial Equivalence: The primary assertion is that the EndoLED is substantially equivalent to the predicate device (PLS Portable Light Source by OPTIM Inc., K091829) in terms of general design, function, and indications for use.
- Non-Clinical Testing: Risk analysis, reprocessing validation, and software validation were carried out according to established standards (ISO-14971, FDA guidance for reprocessing, and FDA guidance for software in medical devices).
- Compliance with Standards: The device applied standards such as ISO 14971, IEC 62366, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18.
Therefore, many of the requested sections about a performance study, sample sizes, experts, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be filled from the provided text because such a study is not described.
Here's a response based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Technological Characteristics (Comparison to predicate) | - Portable detachable light source for endoscopes. |
- Available in straight and angled versions.
- Utilizes a rechargeable NiMH battery.
- Offers 40 minutes of use at maximum power.
- Features a low battery indicator.
- Houses an integrated cooling element. | These are comparative characteristics, not explicit acceptance criteria with quantitative targets and outcomes. The "acceptance" is based on being substantially equivalent to the predicate, which also offers 40 minutes of use. |
| Risk Analysis | Carried out in accordance with established in-house acceptance criteria based on ISO-14971:2007. | No specific risk acceptance criteria or outcomes are detailed. Implies risks are acceptable per ISO 14971. |
| Reprocessing Validation | Carried out in accordance with "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance - April 1996." | No specific reprocessing acceptance criteria or outcomes are detailed. Implies reprocessing is validated per FDA guidance. |
| Software Validation | Performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software is "Minor Level of Concern." | No specific software validation acceptance criteria or outcomes are detailed. Implies software is validated per FDA guidance and deemed low risk. |
| Electrical Safety & EMC | Applied standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18. | Implies the device meets the safety and electromagnetic compatibility requirements of these standards. |
| Usability | Applied standards: IEC 62366 (Medical devices - Application of usability engineering to medical devices). | Implies the device meets usability requirements of this standard. |
2. Sample size used for the test set and the data provenance:
- Not applicable. The document describes non-clinical testing and a comparison to a predicate device, not a performance study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No test set or ground truth establishment by experts for performance evaluation is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication process is described.
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 device is an LED light source, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a hardware device (light source); it does not have an "algorithm only" performance. The software is noted as a "Minor Level of Concern," indicating its function is likely related to device control rather than interpretation or diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No clinical performance study requiring a specific type of ground truth is described. The "ground truth" for the non-clinical tests would be the specifications and requirements of the applied standards (e.g., ISO 14971, IEC 60601 series).
8. The sample size for the training set:
- Not applicable. No machine learning or AI training set is mentioned or relevant for this device.
9. How the ground truth for the training set was established:
- Not applicable. No machine learning or AI training set is mentioned or relevant for this 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.