(266 days)
The device is used to provide light for endoscopic devices. Those devices can be connected directly to the light source or by fiber bundles or single fibers. The device is intended for prescription use only.
The cold light sources of the PS series consist of short arc metal-halide or xenon lamps, driven by electronic ballasts. Optical components such as mirrors, lenses, filters and coatings focus the light to a small diameter of typically 1.5-4mm. Fiber light guides (single or bundles) transmit the light to the application such as endoscopes.
The provided text is a 510(k) summary for a medical device called the "PS series" light source with fiber. This submission focuses on establishing substantial equivalence to predicate devices rather than demonstrating performance through a clinical study with acceptance criteria.
Therefore, the document explicitly states: "No performance data is required for this Class II device nor requested by FDA (ODE)."
This means most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this particular 510(k) submission.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| N/A | N/A |
| (No specific performance criteria or data were required or provided in this 510(k) submission.) | (The submission asserts effectiveness based on components and design similarities to predicate devices, stating the device produces white light similar to sunlight and improves focusing of light into fibers due to an extra short arc lamp, similar to the predicate device.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No test set performance data was provided or required for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No ground truth establishment was performed as no test set data was provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set data was provided for adjudication.
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 a light source, not an AI-powered diagnostic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a light source, not an algorithm. No standalone performance study was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth was established as no performance study was conducted.
8. The sample size for the training set
- Not applicable. No training set was used as this device is a light source, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable. No training set or associated ground truth was used for this device.
Summary of Device Safety and Effectiveness Demonstration:
Instead of performance criteria, the submission focuses on demonstrating safety and effectiveness through:
- Substantial Equivalence: Comparing the PS series to legally marketed predicate devices (Isolux and Cogent/WelchAllyn light sources and cables) in terms of use, design, and function.
- Safety Standards Compliance: The device is designed to and fully meets several international safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, UL2601-1, CAN/CSA-C22.2 No. 601-1-M90, 47 CFR Ch.1 Part 15 (FCC), IEC 60601-2-41).
- Technological Characteristics: Describing the components (short arc metal-halide or xenon lamps, electronic ballasts, optical components) and how they function to focus white light into fiber light guides for endoscopic applications. The short arc lamp is cited as improving effectiveness of focusing, similar to the predicate device.
The conclusion states that the technological differences to the predicate devices do not affect the safety or efficacy of the submitted devices, leading to the determination of substantial equivalence.
§ 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.