(71 days)
The Vista Illumination System is intended to provide visible light for illumination of various rigid and flexible endoscopes, laparoscopes, cameras, and headlamps age. "It is intended for use in all types of endoscopic and endoscopic assisted procedures, as well as visualization of the evacuated cardiac chamber.
The Vista Illumination System, is a Xenon Light Source illumination system consisting of a light source unit which houses the lamp and a fiberoptic cable. The system provides visible light for illumination of rigid or flexible endoscopes, laparoscopes, video cameras, headlamps,etc.
The light source has 2 ports which are provided with independent attenuator controls and separate light output intensity level indicators. The front panel contains dual intensity level indicators as well as system fault and lamp fault LED's. The LED's will light if the lamp fails to start or fails during use for any reason. There is a LCD on the front panel that provides an indication of lamp life.
The fiberoptic cable produces a uniform beam profile from a single fiber. There are three different adapters to allow connection to various endoscopic devices currently available. The thread types are for Storz, ACMI and Wolfe. Custom adapters are available. The fiber is available in core diameter of 0.1mm to 1mm with a standard cable length of 10 feet.
Since the provided text describes a 510(k) notification for an illumination system, the "acceptance criteria" and "device performance" are typically related to meeting established electrical safety and electromagnetic compatibility standards, rather than clinical performance metrics found in AI/ML device studies. The document does not provide details of a clinical study as would be expected for AI/ML devices. Therefore, many of the requested fields cannot be filled.
Here's an interpretation based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| IEC 601-1: General Safety Requirements for Medical Electrical Equipment | Complies / Meets Standard |
| IEC 601-1-2: Electrical Magnetic Compatibility | Complies / Meets Standard |
| UL 544: Standards for Safety, Medical and Dental Equipment | Complies / Meets Standard |
2. Sample size used for the test set and the data provenance
Not applicable. This is not a clinical study involving a test set of data. The performance relates to compliance with electrical and safety standards for the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a clinical study involving ground truth established by experts. Compliance with standards is typically assessed through engineering tests and adherence to specified design and manufacturing protocols.
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 device is not an AI/ML device and human reader performance is not relevant to its safety and effectiveness.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
Not applicable. The "ground truth" for this device's performance is adherence to established electrical safety and electromagnetic compatibility standards, demonstrated through testing against those standards.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The provided document indicates that the Vista Illumination System meets its acceptance criteria by complying with several international and national standards for medical electrical equipment. These standards cover general safety requirements (IEC 601-1), electromagnetic compatibility (IEC 601-1-2), and safety specifically for medical and dental equipment (UL 544).
The "study" in this context refers to the engineering and testing processes that demonstrate the device's adherence to these published standards. These typically involve:
- Design and manufacturing controls: Ensuring the device is designed and built according to the specifications outlined in the standards.
- Bench testing: Performing specific electrical, mechanical, and environmental tests as mandated by each standard. This would include tests for electrical current leakage, insulation, temperature rise, mechanical stability, electromagnetic emissions, and immunity to electromagnetic interference.
- Documentation: Providing evidence (test reports, certifications) that the device has undergone and passed the required tests.
The 510(k) submission process relies on demonstrating substantial equivalence to a predicate device (Cogent Light Illuminator 10010 Xenon Light Source and Fiberoptic Cable, K933405) and showing that the new device meets recognized safety and performance standards. The listed standards are the key "acceptance criteria" and compliance with them is the "proof" the device meets these criteria for regulatory clearance.
§ 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.