(212 days)
The MAHE Pediatric Naso-Pharyngoscope is intended for use only by qualified surgeons. Do not use the instrument for any purpose other than its intended application.
The MAHE Pediatric Naso-Pharyngoscope has been designed to be used with a light source, documentation equipment and video monitor for sinuscopy diagnosis and treatment within the nasal cavity and nasal pharynx.
The MAHE Pediatric Naso-Pharyngoscope is indicated for visual exam during diagnostic and therapeutic procedure within the nasal cavity and nasal pharynx.
The MAHE International Pediatric NASOPHARYNGOSCOPE is indicated for visual examination during a diagnostic and therapeutic procedure within the nasal cavity and nasal pharynx.
The MAHE Pediatric Naso-Pharyngoscope has been designed to be used with a light source, documentation equipment and video monitor for sinuscopy diagnosis and treatment within the nasal cavity and nasal pharynx.
The provided text is a 510(k) summary for the MAHE Pediatric Naso-Pharyngoscope, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than conducting a detailed clinical study with acceptance criteria, ground truth establishment, or specific performance metrics in the way a new diagnostic algorithm might.
Therefore, many of the requested categories are not applicable or not explicitly stated in this type of regulatory submission.
Here's an analysis based on the provided text:
Acceptance Criteria and Study for MAHE Pediatric Naso-Pharyngoscope:
The device's acceptance is based on demonstrating substantial equivalence to a predicate device (KARL STORZ NASOPHARYNGOSCOPE K945381). This means that the new device does not incorporate any significant change in intended use, method of operation, material, or design that could affect safety or effectiveness compared to the predicate. The "study" in this context is the comparison against the predicate device's specifications and the adherence to voluntary safety standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature (Acceptance Criteria implicitly based on predicate or safety standards) | New Device Performance (Reported) | Predicate Device Performance |
|---|---|---|
| Optical System | ||
| Field of view | 95 degree | 80+/-4 degree |
| Depth of view | 3-50mm | 3-50mm |
| Working length | 300-420mm | 320mm |
| Sheath | ||
| Shaft | 2.7mm | 2.7 mm |
| Distal end | 2.8mm | 2.8 mm |
| Material | Identical | Identical |
| Bending Section | ||
| Up | 120 | 160+3,-10 |
| Down | 100 | 130 +5,-10 |
| Sterilization Method(s) | (Not specified, but expected to be compatible) | (Not specified) |
| Weight | not more than 0.8 kg | .5-.7 kg |
Acceptance Criteria Met by the Study:
The "study" presented is a direct comparison of physical and functional characteristics to a legally marketed predicate device. The implicit acceptance criterion is that the new device's specifications are either identical to, or within a range considered safe and effective compared to, the predicate, without introducing new safety or effectiveness concerns. The provided table demonstrates that for most critical dimensions (e.g., shaft, distal end, depth of view, material), the new device is identical or very similar. While some parameters like "Field of view" and "Bending Section" show differences, the FDA's clearance (K030857) implies these differences were deemed not to affect safety or effectiveness negatively for the stated indications. Adherence to Voluntary Safety Standards IEC 601-1 and IEC 601-2-18 is also stated as an acceptance criterion.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This is not a study involving patient data or a test set in the traditional sense of evaluating an algorithm's performance on a dataset. It's a comparison of device specifications.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for a test set is not established in this type of submission. The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.
4. Adjudication method for the test set:
- Not applicable.
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 instrument, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
7. The type of ground truth used:
- The "ground truth" in 510(k) for devices like this is the established safety and effectiveness of the legally marketed predicate device and adherence to relevant voluntary safety standards (IEC 601-1 and IEC 601-2-18).
8. The sample size for the training set:
- Not applicable. This is not a machine learning or algorithm-based device.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.