(174 days)
Telescope for endoscopic observation, diagnosis and treatment during nasal endoscopy and sinuscopy.
The "ULTRA" Telescopes are rigid endoscopes. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image. The "ULTRA" Telescopes are delivered non-sterile. They are reusable and fully autoclavable. Before first and each subsequent use the device must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use. The "ULTRA" Telescopes are available with four different directions of view (0°, 30°, 45°, and 70°) to allow use for various applications in accordance with the intended use as submitted with this 510(k). To address surgeon's preferences, the 30°, 45°, and 70° models are available as an inverse version as well (the light guide cable adapter is at the bottom, instead of at the top of the telescope).
This document (K153009) describes the 510(k) premarket notification for the "ULTRA" Telescopes, which are rigid endoscopes. It outlines the performance data and testing conducted to demonstrate safety and effectiveness, and substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Important Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study proving de novo efficacy or significant improvement. Therefore, many of the specific details typically found in a clinical trial report (like MRMC study results, detailed ground truth establishment for a training set, or effect sizes for AI assistance) are not applicable or not present in this type of submission for a medical device cleared via the 510(k) pathway. The performance data presented here are primarily engineering and biocompatibility tests, not clinical performance data in the sense of an algorithm.
1. A table of acceptance criteria and the reported device performance
The document does not provide a direct table of acceptance criteria with corresponding performance metrics in a format like "Target Value | Achieved Value". Instead, it lists the types of tests conducted and states that the device "functions as intended and meets design specifications" and that "The performance data support the safety of the device and demonstrate that the subject devices comply with the intended use as specified."
Here's a breakdown of the performance tests areas, which implicitly define the acceptance criteria:
| Acceptance Criteria (Implied by Test Type) | Reported Device Performance |
|---|---|
| Biocompatibility: Device materials are not toxic or harmful when in contact with the body. | Conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO-10993. |
| Tests included: Biological Safety toxicology (ISO 10993-1), Cytotoxicity (ISO 10993-5), Chemical Analysis (ISO 10993-12). | |
| Electrical Safety: Device does not pose electrical hazards. | Tested according to AAMI/ANSI ES 60601-1:2005 and C1:2009 and A2:2010. |
| Electromagnetic Compatibility (EMC): Device does not interfere with or is not interfered by other electrical devices. | "Not applicable. The devices are not electrically powered and are just used with light from a light source." (This is a statement of non-applicability rather than a test result.) |
| Thermal Safety: Device does not reach unsafe temperatures during use. | Tested according to IEC 60601-2-18:2009. |
| Optical Performance: Image quality, field of view (FOV), direction of view (DOV), illumination. | Bench testing conducted. "The Field of View (FOV) of the subject devices has been decreased by 2° [compared to predicate]." (This is a design characteristic, not a performance metric per se, but implies the FOV was evaluated and falls within an acceptable range). |
| "A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image", "The image relay system of rod lenses transmits the endoscopic image" (describes design, not specific performance metrics). | |
| Mechanical Performance: Durability, structural integrity, dimensions. | Bench testing conducted. "Identical insertion portion width and optical system diameter", "Maximum working length of subject device is slightly longer" (comparative statements, implying these were evaluated and found acceptable). |
| Shipping Tests: Device withstands transportation conditions. | Conducted. |
| Service Life Expectancy: Device maintains performance over its expected lifespan. | Conducted. |
| Illumination System Performance: Adequate light delivery. | Bench testing conducted. |
| Design Validation/Usability: Device is safe and effective for intended use by users. | Conducted. |
| Reprocessing (Sterilization) Compatibility: Device can be safely and effectively reprocessed for reuse. | Device is "reusable and fully autoclavable. Before first and each subsequent use the device must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use." (This implies testing was done to validate the reprocessing methods). No specific test results given in the summary, but this is a critical aspect for reusable devices. |
| Risk Analysis: Identification and mitigation of potential risks. | Carried out in accordance with ISO-14971:2007. |
Summary of Reported Performance: The document generally states that the device "functions as intended and meets design specifications" and that the "performance data support the safety of the device and demonstrate that the subject devices comply with the intended use as specified." It concludes that the device is "substantially equivalent to the predicate devices with respect to the general design approach, function, and the intended use," and "raise no new concerns of safety or effectiveness."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in terms of "patient data" or "image data" as this is not a study assessing an algorithm's performance on patient-derived data. The "test set" here refers to the actual manufactured devices used for the bench and material testing. The specific number of devices tested for each performance test (e.g., how many telescopes were subjected to shipping tests or service life tests) is not provided in this summary.
- Data Provenance: Not applicable in the context of patient data. The tests were performed internally by Olympus Winter & Ibe GmbH (Germany) as the manufacturer, and potentially by third-party labs for specific certifications (e.g., biocompatibility). The summary implies the testing was prospective (i.e., conducted specifically for this 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)
- Number of Experts & Qualifications: Not applicable in the sense of medical experts establishing ground truth for diagnostic accuracy (e.g., reading images). The "ground truth" for this device relates to engineering specifications, safety standards, and functional performance. Experts involved would be engineers, usability specialists, and quality control personnel within the manufacturing company and potentially external certification bodies, but their number and specific qualifications are not detailed. Usability studies would involve medical professionals (surgeons/ENT specialists) but the extent of their involvement and their role in defining "ground truth" (beyond user feedback regarding intuitive design, handling, etc.) is not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This concept pertains to resolving discrepancies in expert interpretations (e.g., conflicting diagnoses from radiologists). For this device, "adjudication" would refer to the internal quality control processes and the interpretation of test results against predefined engineering specifications and regulatory standards.
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
- MRMC Study: No. An MRMC study is typically performed for AI-powered diagnostic devices to assess diagnostic accuracy or the impact of AI assistance on human readers. The "ULTRA" Telescope is a physical, optical endoscope, not an AI-powered device. Therefore, this type of study was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This question again relates to AI algorithms. The "ULTRA" Telescope is an instrument that a human uses. Its "performance" is inherently linked to its physical characteristics and how it functions when operated by a human.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The ground truth for this device's performance are engineering specifications, established international standards (e.g., ISO, IEC, AAMI/ANSI), and regulatory requirements. For example, the ground truth for biocompatibility is "no cytotoxicity" when tested per ISO 10993-5, or for electrical safety, it's compliance with IEC 60601-1. For optical and mechanical properties, the ground truth is adherence to the design specifications (e.g., specified field of view, clarity, light transmission, durability under specific loads).
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this device.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.