FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

For examination, diagnosis, and /or therapy in connection with endoscopic accessories / auxiliary instruments through the working channel of the endoscope. This instruement is used in the medical discipline of ENT (e.g. naso-pharynxngeal cavity - larynx / trachea and bronchial branch by adequately trained and qualified medical personnel.

Device Description

The flexible bronchoscopes and nasopharyngo-laryngoscopes consist of three parts: 1) flexible insertion part with or without a working channel, 2) control part for the deflection of the tip, and 3) an eyepiece for direct view or connection to a video camera.

AI/ML Overview

This device, the Flexible Nasopharyngo-Laryngoscope and Flexible Bronchoscope by Richard Wolf Medical Instruments Corp., is a medical endoscope. The provided 510(k) summary explicitly states that no performance standards are known and no clinical tests were performed. Therefore, the information requested for acceptance criteria and a study proving device performance cannot be fully provided as it pertains to a traditional clinical performance study with acceptance criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety standards.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

Since no specific acceptance criteria for clinical performance are mentioned, nor is a clinical performance study reported, this table cannot be created in the way typically expected for a clinical study with performance metrics.

Instead, the acceptance criteria here are based on compliance with established safety standards and the inherent "safety and effectiveness" derived from substantial equivalence and design/testing.

Acceptance Criteria (Implied)	Reported Device Performance
- Compliance with IEC601-1 (General medical electrical equipment)	Built according to IEC601-1
- Compliance with IEC601-2-18 (Endoscopic equipment)	Built according to IEC601-2-18
- Compliance with IEC601-2-2 (High frequency surgical equipment)	Built according to IEC601-2-2 (for button electrode component)
- Substantial Equivalence to predicate devices (K980401, K951196/K921707, K811053/K951199)	Declared substantially equivalent in design, materials, and intended use to existing cleared devices. "New technological characteristics have not diminished safety or effectiveness."
- Safety and Effectiveness for expected lifetime	"Designed and tested to guarantee the safety and effectiveness during the expected life time of the device when used according to the instruction manual."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. The document explicitly states: "No clinical tests performed." The "testing" mentioned refers to design and manufacturing adherence to standards, not clinical data collection.
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):

Not applicable. No clinical tests or ground truth establishment by experts for a test set are mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical tests requiring adjudication were performed.
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:

Not applicable. This device is an endoscope, not an AI-powered diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The device is not an algorithm, and no standalone performance study was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. No clinical ground truth was established as no clinical studies were performed. The "ground truth" for the submission is the adherence to recognized safety standards and the substantial equivalence to predicate devices already cleared by the FDA.
8. The sample size for the training set:

Not applicable. No algorithm or AI model requiring a training set is involved.
9. How the ground truth for the training set was established:

Not applicable. No algorithm or AI model requiring a training set is involved.

Summary of the Study (as presented in the 510(k) submission):

The "study" presented in this 510(k) is a design and manufacturing compliance assessment and a substantial equivalence comparison, rather than a clinical performance study. The core arguments for safety and effectiveness are:

Adherence to Recognized Standards: The devices were built according to IEC601-1 (medical electrical equipment), IEC601-2-18 (endoscopic equipment), and IEC601-2-2 (for the high-frequency surgical component). This implies that the device design and manufacturing process meet established safety requirements.
Substantial Equivalence: The primary method for demonstrating safety and effectiveness is by showing that the new devices are substantially equivalent to previously cleared predicate devices (K980401 from Richard Wolf, and K951196/K921707 and K811053/K951199 from Pentax). The submission explicitly states the new devices use "the same basic design and device material" as K980401 and that "new technological characteristics have not diminished safety or effectiveness."

In conclusion, for this specific 510(k) submission, the "study" proving the device meets acceptance criteria is the documentation of its design and manufacturing practices in accordance with international safety standards and a detailed comparison demonstrating substantial equivalence to already approved devices. Clinical performance data, as typically understood for diagnostic or therapeutic efficacy, was not required or provided.

Summary

Regulation Number and Section

§ 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.