(90 days)
The Endoscopic Light Source XL180/L3 is intended to be used with fiber optic endoscopes to provide illumination of body cavities, hollow organs and canals during endoscopic procedures.
The Endoscopic Light Source XL180/L3 uses a 180 W xenon lamp to provide illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature of the xenon lamp is approximately 6000 °K and the lamp life is approximately 500 hours.
The provided text describes a 510(k) premarket notification for an Endoscopic Light Source XL180/L3. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or specific performance metrics through clinical trials. Therefore, the information requested about acceptance criteria for device performance, sample sizes, expert ground truth adjudication, MRMC studies, and standalone algorithm performance is not applicable to this document.
The document focuses on the device's compliance with established industry standards as evidence of safety and effectiveness, rather than specific performance metrics against a clinical ground truth.
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with International Standard IEC 60601-1 (General requirements for safety of medical electrical equipment) | The Endoscopic Light Source XL180/L3 complies with IEC 60601-1. |
| Compliance with International Standard IEC 60601-1-2 (Electromagnetic compatibility - Requirements and tests) | The Endoscopic Light Source XL180/L3 complies with IEC 60601-1-2. |
| Conformity to Medical Device Directive 93/42/EEC (European directive for medical devices) | The Endoscopic Light Source XL180/L3 conforms to Medical Device Directive 93/42/EEC. |
| Meeting requirements of Underwriters Laboratories Standard UL2601-1 (Similar to IEC 60601-1, specific to North America) | The device will meet the requirements of UL2601-1. |
2. Sample size used for the test set and the data provenance: Not applicable. The "study" described is compliance testing against safety and electromagnetic compatibility standards, not a clinical performance study using a "test set" in the context of AI/diagnostic device evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic device performance (e.g., disease presence) is not relevant for this type of submission focused on safety and technical standards compliance.
4. Adjudication method 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 a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used: For the purposes of this submission, the "ground truth" is defined by the compliance requirements of the specified international and regional standards (IEC 60601-1, IEC 60601-1-2, MDD 93/42/EEC, UL2601-1). This is a technical and regulatory ground truth rather than a clinical one.
8. The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of light source device and its regulatory submission focus.
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.