(46 days)
The Schoelly Naso-Laryngo-Pharyngoscope is intended to be used by qualified surgeons and physicians to visualize and observe the pharynx and the larynx.
The Schoelly Naso-Laryngo-Pharyngoscope is a flexible and steerable fiberoptic endoscope for diagnostic purposes. Manufactured in two resolutions, 12,000 and 16,000 pixels.
The provided text describes a Special 510(k) submission for a medical device, the Schoelly Naso-Laryngo-Pharyngoscope. This type of submission is for modifications to a legally marketed device that do not significantly alter its safety or effectiveness. The core of the submission, and therefore this response, is a comparison to a predicate device to demonstrate substantial equivalence, rather than a de novo clinical study with strict acceptance criteria and performance metrics typically seen for new devices or algorithms.
Therefore, the "acceptance criteria" here are implicitly linked to demonstrating substantial equivalence to the predicate device, K991560, by showing that any changes do not adversely affect safety or effectiveness. The "study" proving this largely revolves around the provided comparison table and the assertion that validation was performed under design control.
Here's an breakdown of the information requested, based on the provided text:
Acceptance Criteria and Reported Device Performance
Given this is a Special 510(k) for a hardware device, the acceptance criteria are not explicitly stated in terms of diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they are implicitly related to maintaining safety and effectiveness, as demonstrated by the comparison to the predicate device. The "reported device performance" is essentially captured by the specifications of the new device relative to the predicate.
| Acceptance Criteria Category (Implicit from 510(k) process) | Specific Criteria (Derived from comparison to predicate) | Schoelly Naso-Laryngoscope (New Device) Performance (Reported) | Predicate Naso-Laryngoscope (K991560) Performance |
|---|---|---|---|
| Intended Use | Must be the same as the predicate. | Visualize and observe the pharynx and the larynx. | Visualize and observe the pharynx and the larynx. |
| Design | Must be fundamentally the same technology as the predicate. | Flexible and steerable fiberoptic endoscope for diagnostic purposes. | Flexible and steerable fiberoptic endoscope for diagnostic purposes. |
| Tip Tubing Diameter | Changes should not negatively impact safety or effectiveness. (Smaller diameter is generally considered an improvement for patient comfort/access). | 3.2 mm | 3.8 mm |
| Working Length | Maintained for consistent application. | 300 mm | 300 mm |
| Angulation Up/Down | Acceptable range for maneuverability. (Slight reduction is noted, but likely deemed non-significant for its intended use). | Up: 140°, Down: 140° | Up: 150°, Down: 150° |
| Direction of View | Maintained for consistent visualization. | 0° | 0° |
| Field of View | Acceptable range for visualization. (Slight reduction is noted, but likely deemed non-significant). | 70° | 85° |
| Length of Distal Tip Deflection | Acceptable range for maneuverability. (Slight reduction is noted, but likely deemed non-significant). | 20 mm | 25 mm |
| Depth of Field | Acceptable range for clear imaging. (Widened range is an improvement). | 6 - 1000 mm | 3mm - 50mm |
| Total Fibers (pixels) | Acceptable resolution. (Reduction noted, but likely not considered significant enough to impact diagnostic capability for this type of device/intended use). | 7,000 (Later mentions 12,000 and 16,000 pixels manufactured in two resolutions) | 10,000 |
| Fiber Size | Maintained for consistent optical properties. | 83 µm | 83 µm |
| Magnification | Acceptable for visualization. (Significant increase noted, which would typically be an improvement). | 7X | 2.5X |
| Energy Used | Compliance with relevant electrical safety standards. | IEC601-1 and IEC 60601-2-18 2000 compliant. | Not explicitly stated for predicate in comparison table, but compliance expected. |
| Sterilization/Cleaning | Clear instructions and material compatibility for reprocessing. (Changes in specifications for EtO sterilization and cleaning solutions are detailed). | Detailed EtO and cleaning instructions, material compatibility for specific disinfectants. | Detailed EtO sterilization instructions, "mild cleaning substances." |
Study Details:
As this is a Special 510(k) for a physical device rather than an AI/software device, many of the requested categories (sample size for test set, data provenance, number of experts for ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable (N/A) in the context of the provided documentation. The "study" referred to is the design control and validation process undertaken by the manufacturer to ensure the modified device remains safe and effective and substantially equivalent to its predicate.
Here's why and what is relevant:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This document describes a medical device's physical and functional specifications. It is not a clinical study involving a test dataset for diagnostic performance evaluation. The "test set" would implicitly refer to the physical testing and verification/validation activities performed during design control to ensure the device meets its specifications and remains safe and effective (e.g., mechanical tests, optical performance tests, biocompatibility tests), but the sample sizes for these engineering tests are not detailed here.
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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):
- N/A. Ground truth in the context of diagnostic interpretation by experts is not relevant here as there's no diagnostic algorithm being evaluated. The "ground truth" for a physical device effectively refers to its design specifications, regulatory standards, and established performance characteristics of the predicate.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are relevant for resolving discrepancies in expert interpretations of data, which is not the subject of this 510(k).
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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:
- N/A. This is not an AI-assisted device, nor is it a multi-reader, multi-case clinical study.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This is a physical, fiberoptic endoscope, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A (in the diagnostic sense). For a physical device, the "ground truth" for its performance is its adherence to engineered specifications, validated through design verification and validation activities (e.g., measurements of tip diameter, angulation, field of view, depth of field, material compatibility for sterilization). The document states "All changes have been made under design control, and validation was performed and conformance assured," indicating that such engineering-level verification and validation activities were conducted.
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The sample size for the training set:
- N/A. No training set is applicable for this physical device.
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How the ground truth for the training set was established:
- N/A. No training set is applicable for this physical device.
In summary, the provided document is a regulatory submission for a hardware modification, demonstrating substantial equivalence to a predicate device. It does not involve the type of clinical study data or AI performance metrics typically requested for software or AI-enabled medical devices. The "study" is the manufacturer's internal design control and validation process, which presumably confirmed that the altered specifications do not compromise safety or effectiveness compared to the predicate.
§ 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.