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510(k) Data Aggregation
(203 days)
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is intended to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is indicated for use within the nasal and nasopharyngeal lumen.
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is intended to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is indicated for use within the nasal and nasopharyngeal lumen.
This document describes the premarket notification (510(k)) for the RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP. The device is a flexible nasopharyngoscope indicated for endoscopic diagnosis within the nasal and nasopharyngeal lumen, to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Acceptance Criteria (Compliance to Standards / Bench Performance) | Reported Device Performance |
|---|---|---|
| Regulatory & Safety | ||
| Intent (Predicate Equivalence) | Substantially equivalent to predicate device (ENF-GP2, K181240) | Claimed Substantially Equivalent: The device is claimed to be substantially equivalent based on similarities in indications for use, design, materials, technological characteristics, and operational characteristics. |
| Thermal Safety | Compliance to IEC 60601-2-18:2009-08 | Thermal safety performance test verified compliance. |
| Photobiological Safety | Compliance to IEC 62471:2006-07 | Test confirmed light emitted is low enough not to cause injury to skin and eye. |
| Biocompatibility | Compliance to ISO 10993 series and FDA Guidance | Testing conducted per guidance; deemed acceptable for intended use. |
| Sterilization (EO) | Compliance to ISO 11135:2014 & ISO 10993-7:2008 & FDA Guidance | Validated as safe and effective for reprocessing with EO Gas. |
| Reprocessing Methods | Compliance to FDA guidance: "Reprocessing Medical Devices..." | Validated as safe and effective for manual cleaning, manual disinfection, and with OER-Pro/Mini/Elite. |
| Electrical Safety | Compliance to IEC 60601-1:2005+A1:2012 & IEC 60601-2-18:2009 | Found to be in compliance with relevant requirements. |
| Risk Analysis | Compliance to ISO 14971:2007 | Performed in accordance with ISO 14971:2007; risks considered acceptable and mitigated. |
| Imaging Performance | ||
| Composite Durability | Device retains safety and effectiveness against expected stresses | Durability test against composite stress demonstrates the device retains its safety and effectiveness against the stresses expected in its use-life. |
| Color Performance | Substantially equivalent to predicate devices | Confirmed as substantially equivalent to the predicate devices. |
| Image Intensity Uniformity | Substantially equivalent to predicate devices | Confirmed as substantially equivalent to the predicate devices. |
| Resolution | Similar to predicate device, no new safety/effectiveness issues | Resolution is similar to predicate device and does not raise new issues of safety or effectiveness. |
| Direction of View | Compliance to ISO 8600-1, consistent with design specs | Test verified compliance and confirmed consistency with design specifications, introducing no new safety/effectiveness questions. |
| Field of View | Compliance to ISO 8600-1, consistent with design specs | Test verified compliance and confirmed consistency with design specifications, introducing no new safety/effectiveness questions. (Note: different from PD but area adjustable and difference does not affect safety/effectiveness). |
| Depth of Field | Covers predicate device's depth of field | Increased range covers the predicate's depth of field. Not affected by variations in compatible systems. |
| Compatibility | Compatibility with new processors, light sources, monitors, camera heads does not raise new safety/effectiveness questions | Demonstrated with bench performance testing in Section 18 (not fully detailed here), confirming no new safety or effectiveness questions for OTV-S200/S300, OEV-262H, LMD-X310ST, CH-S200-XZ-EA/EB. |
2. Sample Size Used for the Test Set and Data Provenance:
The document focuses on "Non-Clinical Bench Testing" for the device, which typically involves testing of the physical device components and its performance characteristics in a controlled environment. It does not mention specific 'test sets' in the context of clinical images or patient data. Therefore, information regarding sample size used for a test set (e.g., number of cases/images) and data provenance (country of origin, retrospective/prospective) is not provided as it is not applicable to the type of testing described (bench testing on the physical device).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided and is not applicable, as the evaluation described is non-clinical bench testing of a physical medical device (fiberscope), not an AI or diagnostic software based on image interpretation by experts.
4. Adjudication Method:
This information is not provided and is not applicable for the same reason mentioned in point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
An MRMC comparative effectiveness study was not done. The device is a RHINO-LARYNGOFIBERSCOPE, a physical medical device for visualization, not an AI or software intended to assist human readers in interpretation or diagnosis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
A standalone performance study was not done. This refers to an algorithm's performance without human-in-the-loop, which is relevant for AI/software devices. The device in question is a hardware endoscopic tool.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance criteria in this submission is established through objective measurements and assessments against specified engineering and safety standards. For example:
- Thermal Safety: Adherence to temperature limits set by IEC 60601-2-18.
- Photobiological Safety: Adherence to light emission limits set by IEC 62471.
- Imaging Parameters (Resolution, Field of View, Depth of Field, Color Performance, Image Intensity Uniformity): Measured values are compared against design specifications and predicate device performance to ensure similarity and adequate functionality.
- Biocompatibility: Results of laboratory tests (e.g., cytotoxicity, irritation, sensitization) are compared against established biological evaluation criteria in ISO 10993 standards.
- Sterilization and Reprocessing: Demonstrated efficacy of cleaning/disinfection/sterilization methods through validated protocols according to FDA guidance and ISO 11135.
8. The Sample Size for the Training Set:
This information is not provided and is not applicable for this physical medical device. Training sets are relevant for machine learning algorithms, which this device does not utilize (it "does not contain any software").
9. How the Ground Truth for the Training Set was Established:
This information is not provided and is not applicable for the same reason mentioned in point 8.
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