(27 days)
The KSEA Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Fiberscope, and Broncho-Fiberscope are designed to be used by qualified surgeons and physicians for examination of the nasal sinuses, larynx, pharynx and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The Rhino-Laryngo-Broncho-Fiberscope is indicated for examination of the nasal sinuses, larynx and bronchi and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The Pediatric Broncho-Fiberscope is indicated for examination of the larynx and bronchi in pediatric patients and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The Broncho-Fiberscope is indicated for examination of the larynx and bronchi in adult patients and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The KSEA Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Device Description: Fiberscope, and Broncho-Fiberscope are manually operated surgical devices. The KSEA Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Fiberscope, and Broncho-Fiberscope are flexible fiberoptic telescopes which utilize fiber-optic technology. The body contact portions of the KSEA Intubation Laryngoscope are composed of medical grade polyurethane.
The provided text is a 510(k) summary for the Karl Storz Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Fiberscope, and Broncho-Fiberscope. It aims to establish substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, the document does not contain the detailed information necessary to answer the questions regarding acceptance criteria and a study proving the device meets them. Specifically:
- A table of acceptance criteria and the reported device performance: Not provided. The 510(k) process for this device relies on demonstrating substantial equivalence to predicate devices, not on meeting specific, pre-defined performance acceptance criteria through de novo testing.
- Sample size used for the test set and the data provenance: Not applicable, as a test set for performance evaluation against acceptance criteria is not described. The submission focuses on device description and comparison to predicates.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is a manual fiberoptic scope, not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a manual surgical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
The document states: "The KSEA Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Fiberscope, and Broncho-Fiberscope are substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Fiberscope, and Broncho-Fiberscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices."
This indicates that the "study" proving the device meets "acceptance criteria" (which are implicitly the safety and effectiveness profiles of the predicate devices) is a comparison of features, design, and intended uses to already marketed, legally predicate devices. Performance data from a clinical trial or dedicated performance study against specific acceptance criteria is not typically required or presented in a 510(k) submission when substantial equivalence is established through device similarity and intended use.
§ 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.