(28 days)
For oral or nasal introduction for the examination of the upper airway from the nasal passage to the vocal cords.
The ENTity NasoView is a modification of the OL-1 Airway Fiberscope. The device has been modified to include a battery-operated LED light source internal to the device control body. An accessory charger is provided for charging the battery outside the scope.
The provided text for the OPTIM's ENTity NasoView LED Nasopharyngoscope does not contain the information requested for a detailed study description with acceptance criteria and device performance.
The document is a 510(k) summary for a Special 510(k) notice, indicating a modification to an existing device (OL-1 Airway Fiberscope). The main modification is the inclusion of a battery-operated LED light source internal to the device control body.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., illumination intensity, battery life, image clarity standards). The document mentions "Verification and validation activities have been completed for the device modifications" and that the modifications "do not raise any new questions of safety or effectiveness." It also states that "Validation and verification testing demonstrates that the ENTity NasoView is as safe and effective as the predicate devices." This implies that the acceptance criteria are related to maintaining the safety and effectiveness profile of the predicate device with the new LED light source.
- Reported Device Performance: No specific performance data (e.g., illumination output, battery duration, resolution, field of view) of the ENTity NasoView is provided. The document only generally states that it meets design control requirements and is as safe and effective as the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not mentioned. No specific test sets are described.
- Data Provenance: Not mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable/Not mentioned. No "ground truth" establishment by experts is described as this is not a diagnostic device relying on expert interpretation of results.
4. Adjudication Method
- Not applicable/Not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not done. This device is a direct visualization tool (nasopharyngoscope), not a diagnostic algorithm that requires human-in-the-loop performance evaluation or comparison against human readers. The change is a light source modification.
6. Standalone Performance Study
- Not explicitly described. While "verification and validation activities" were completed for the device modifications, the document does not detail a specific "standalone" study in the context of an algorithm's performance without human input. The validation would have been on the physical device's functionality (e.g., light output, battery performance, mechanical integrity) but this is not detailed.
7. Type of Ground Truth Used
- Not applicable in the conventional sense of diagnostic algorithms. The "ground truth" for a medical device like a nasopharyngoscope would relate to its physical and optical specifications, safety standards, and functional performance, not diagnostic accuracy against a disease state.
8. Sample Size for the Training Set
- Not applicable/Not mentioned. This is a hardware device modification, not a machine learning algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
- Not applicable/Not mentioned.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence of a modified medical device to its predicates based on design control requirements and general verification/validation activities. It does not contain the detailed performance metrics, study designs, sample sizes, and expert ground truth establishment that would be associated with a new diagnostic algorithm or a study proving specific performance against acceptance criteria.
§ 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.