(386 days)
The Millennium Devices Inc. Midiview Series of MicroEndoscopes are intended for use in providing access to and visualization of body cavities, organs and canals to perform various diagnostic and therapeutic surgical procedures. The Sialoview series of microendoscopes are for use by qualified surgeons for the diagnosis and treatment of salivary gland diseases. The Sialoview scopes are used to visualize the surgical site in salivary gland diagnosis and therapeutic procedures.
The Millennium Devices Inc. MDI-View MicroFibre Endoscope Series and Accessories are fiber optic based flexible and semi rigid endoscopes intended to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs and canals. They also provide working channels to allow insertion of tools and accessories such as drills and stone baskets to facilitate therapeutic procedures. All scopes incorporate an irrigation channel that may provide irrigant flow to the distal end for flushing the operative site. All of the endoscopes are semi rigid, except the SinoView scopes which are flexible. All incorporate a 0.35 mm diameter, 6000 pixel fiber bundle. The SinoView scope is flexible. Surrounding this bundle are fibre cables that are used as light guides. Standard glass lens oculars are provided. Stainless steel sheaths are used for the endoscopes. Fach scope may be attached to standard Fibre Optic light sources and cameras such as the Olympus CLV-160 light source and the Karl Storz Xenon 300 light source. They may also be connected to CCD video adapters that in turn may be used to project the image on standard medical grade TV monitors. All models also include working channels that may be used to introduce accessories such as biopsy needles, stone baskets, drills or other standard type tools. These tools allow the endoscopes to be used in therapy as well as diagnosis of disease.
The provided text describes the Millennium Devices MDI-View Series of Endoscopes and Accessories, which are fiber optic-based flexible and semi-rigid endoscopes. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria and detailed study results for the MDI-View series itself. Therefore, the information requested cannot be fully extracted based on the provided text.
Here's what can be inferred and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists Voluntary Standards that the device "will be tested to pass." These standards implicitly define acceptance criteria for various aspects of the device. However, the specific quantitative pass/fail criteria within these standards and the reported performance of the MDI-View devices against them are not provided.
| Acceptance Criteria (Voluntary Standard) | Reported Device Performance |
|---|---|
| UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety | Not provided in the document. |
| EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety | Not provided in the document. |
| EN 60601-1-18 Collateral Standard | Not provided in the document. |
| EN 60601-1-2:2001 Electromagnetic Compatibility | Not provided in the document. |
| FCC Part 18 EMC Requirements | Not provided in the document. |
| Material Biocompatibility (Tripartite Modified Matrix or actual testing) | "All of the materials of construction are biocompatible as per the Tripartite Modified Matrix or by actual testing." (No specific test results or metrics provided). |
| Sterilization (SAL-6 sterility by ETO gas) | "All Micro endoscopes have been or will be validated for an SAL-6 sterility by ETO gas. Validation statements are contained in Exhibit J." (Exhibit J is not provided, so specific results are missing). |
| Surface Temperature | "Output of Engineering Tests" (No specific results provided) |
| Optical Resolution | "Output of Engineering Tests" (No specific results provided) |
| Electrical Dielectric Strength | "Output of Engineering Tests" (No specific results provided) |
| EMC testing | "Output of Engineering Tests" (No specific results provided) |
| Sterility Testing | "Output of Engineering Tests" (No specific results provided) |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Non-Clinical Tests for Determination of Substantial Equivalence" and "Output of Engineering Tests" and "FMEA Analysis." However, it does not provide information on the sample sizes used for these tests, nor the data provenance (e.g., country of origin, retrospective/prospective). It focuses on general testing to standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable/provided. The document describes a medical device with objective performance characteristics (e.g., optical resolution, electrical safety). There is no indication of a test set requiring expert interpretation or establishment of ground truth in the context of clinical images or diagnoses. The testing described is primarily engineering and performance-based.
4. Adjudication Method for the Test Set:
This information is not applicable/provided. As above, the testing described does not involve expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done or described in this document. The submission is for substantial equivalence based on engineering and performance testing against voluntary standards and comparison to predicate devices, not clinical efficacy or reader performance.
6. If a Standalone Performance Study was done:
Yes, a form of standalone performance assessment was conducted through "Non-Clinical Tests for Determination of Substantial Equivalence," "Output of Engineering Tests," and "Voluntary Consensus Standard Investigations." These tests assess the device's technical specifications and adherence to safety standards. However, specific quantitative results from these tests are not provided in this summary.
7. The type of ground truth used:
The "ground truth" for the non-clinical tests would be the specifications and requirements defined by the voluntary standards (e.g., UL, EN, FCC standards, biocompatibility matrix) and the engineering design specifications. For example, for "Optical Resolution Tests," the ground truth would be the expected or target resolution value. For "Material Biocompatibility tests," the ground truth would be compliance with the Tripartite Modified Matrix or successful actual testing results.
8. The Sample Size for the Training Set:
This information is not applicable/provided. The device does not appear to involve machine learning or AI that would require a "training set." The performance
is based on physical design and manufacturing.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable/provided for the same reasons as #8.
§ 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.