(57 days)
Light Projector AUTO LP 5123 provides light for examination, diagnostic and therapeutic applications, in particular, in endoscopy.
The Xenon Light Source is classified as Cardiac Floating (CF) which permits its use for cardiac procedures when used in conjunction with the proper instrumentation for entry into the cardiac system.
Light Projector AUTO LP 5123 uses a xenon arc lamp to provide illumination for an endoscope via a light guide which is connected to the projector's light port. The illumination level is automatically controlled by video.
The provided document is a 510(k) summary for the Auto LP 5123 Xenon Light Projector. It focuses on establishing substantial equivalence to a predicate device and safety through compliance with electrical standards. It does not contain information about acceptance criteria or a study proving device performance against such criteria in the way typically expected for an AI/ML medical device.
Based on the document, I can provide the following, noting where information is explicitly not present for the type of device described:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated as performance criteria but implied by testing) | Reported Device Performance (Implied by compliance) |
|---|---|
| Safety and Effectiveness for intended use (general) | "Designed and tested to guarantee safety and effectiveness" |
| Compliance with IEC601-1 amendment 1 and 2 | Tested and found compliant by independent laboratories |
| Compliance with IEC601-1-1 | Tested and found compliant by independent laboratories |
| Compliance with IEC601-2-18 | Tested and found compliant by independent laboratories |
| Electrical Safety (Type CF applied part) | Classified as Type CF applied part per IEC601-1 |
| Color temperature of 180W xenon arc lamp | About 5600 K |
| Service life of xenon arc lamp | Approximately 500 hours |
2. Sample size used for the test set and the data provenance
- Not Applicable. This device is a xenon light projector, not an AI/ML device that processes data for diagnostic or prognostic purposes. The performance data refers to electrical safety and performance standards, not analysis of a data test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2.
4. Adjudication method for the test set
- Not Applicable. See point 2.
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
- No. This is not an AI/ML device. No MRMC study was conducted. The document explicitly states "No clinical tests performed."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a hardware device; there is no "algorithm only" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For this device, "ground truth" pertains to engineering standards and specifications (e.g., electrical parameters, light output, lifespan) rather than clinical outcomes or diagnostic classifications.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device.
Summary of the Study Proving Device Meets Acceptance Criteria:
The "study" proving the device meets acceptance criteria, as presented in this 510(k) summary, consists of independent laboratory testing against specified international electrical safety and performance standards.
- Standards Tested: IEC601-1 amendment 1 and 2, IEC601-1-1, and IEC601-2-18.
- Conclusion: The testing led to the conclusion that the device is "designed and tested to guarantee the safety and effectiveness when used according to the instruction manual." This implies compliance with the standards, although specific test results are not detailed in this summary.
- Clinical Testing: The document explicitly states, "No clinical tests performed." This is common for predicate-based 510(k) submissions for devices like light sources, where safety and effectiveness are primarily demonstrated through compliance with recognized electrical and performance standards and comparison to a legally marketed predicate device.
- Substantial Equivalence: The main argument for market clearance is "substantial equivalence" to existing 510(k) devices (specifically K952696 from Richard Wolf M.I.C.), asserting that "The new technological characteristics have not diminished safety or effectiveness."
§ 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.