(57 days)
This instrument has been designed to be used with an Olympus Light Source or an Olympus Miniature Light Source, document, display monitor, Endo-Therapy Accessories and other ancillary equipment for endoscopic diagnosis and treatment within the nasal and nasopharyngeal lumen.
This subject device "XENF-TP Rhino-Laryngofiberscope" is an endoscope used for treatment and observation within the nasal and nasopharyngeal lumen. This endoscpe can be used with two types of light sources, detachable with an reusable battery powered and light cable source. This device is equipped instrument channel, so this device is suitable for treatment within the nasal and nasopharyngeal lumen using recommended ancillary equipment.
This submission (K013591) for the XENF-TP Rhino-Laryngofiberscope is a 510(k) pre-market notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than providing de novo clinical study data to prove safety and effectiveness.
Therefore, the document explicitly states: "Reason for not requiring clinical data: Compared to the predicate devices, "XENF-TP Rhino-Laryngofiberscope" does not incorporate any significant change for safety and efficacy to the predicate device. Treatment and observation within nasal and nasopharyngeal lumen have been done widely, and established its safety and effectiveness, therefore clinical data is not necessary for its evaluation of safety and efficacy."
Based on this, the requested information regarding acceptance criteria, study details, and data provenance (which would typically be found in a performance study) is not present in this 510(k) summary. The device's "performance" is implicitly deemed equivalent to the predicate devices due to its lack of significant changes.
However, I can provide a table summarizing what would be the implied acceptance criteria based on its design and compliance with standards, and categorize the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from 510(k) Rationale) | Reported Device Performance |
|---|---|
| Safety & Effectiveness Equivalent to Predicate Devices: |
- Pentax Naso-Pharyngo-Laryngoscope FNL-15P2/15RP2 (#K921707)
- Laparoscope, Hand Instruments (#K950103)
- LF-TP/DP (#K981543) | "XENF-TP Rhino-Laryngofiberscope" does not incorporate any significant change for safety and efficacy to the predicate device. Treatment and observation within nasal and nasopharyngeal lumen have been done widely, and established its safety and effectiveness. |
| Intended Use: For endoscopic diagnosis and treatment within the nasal and nasopharyngeal lumen. | Device is designed and purports to be suitable for this intended use. |
| Design Compliance: Meets recognized safety standards. | Design complies with IEC 60601 -1, IEC60601-1-1, IEC60601-1-2, IEC60601-2-18. |
| Material Safety: No new patient-contacting materials. | All patient-contacting materials are cleared by previous 510(k) submissions (e.g., LF-TP/DP). |
| Technological Characteristics: No significant difference from predicate devices. | "This endoscope does not have special technological characteristics compared to the predicate device." |
For the remaining points, the information is not available in the provided 510(k) summary because a separate performance study, as would be required for a novel device, was explicitly deemed unnecessary.
Information Not Present (Due to 510(k) Predicate Device Rationale):
2. Sample size used for the test set and the data provenance: Not applicable. No dedicated performance test set was used for this 510(k) submission. The safety and effectiveness are established by substantial equivalence to predicate devices, which are already marketed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new ground truth was established for a test set, as no dedicated clinical performance study was conducted.
4. Adjudication method for the test set: Not applicable. No dedicated test set requiring adjudication was used.
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 a fiberscope, not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a medical instrument, not a standalone algorithm.
7. The type of ground truth used: Not applicable. No new ground truth was established. The basis for safety and effectiveness relies on the widespread and established use of similar devices (predicate devices) for the stated indications.
8. The sample size for the training set: Not applicable. This device is a fiberscope, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established: Not applicable. No training set exists for this device.
§ 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.