(91 days)
The Clarus Model 2126 SpinePEN is intended for diagnostic accessing and visualizing tissue during cranial sinus, laryngopharyngeal and bronchial procedures. It is not intended for intraoperative or percutaneous use. The endoscope is reusable and is packaged with five disposable cannulae.
The Clarus Model 2127 Endoscopes will be manufactured using medical grade biocompatible materials. The materials to be used are the same as those used in other Clarus Series 2100 Flexible Endoscopes and other Clarus Series Endoscopes. Further, the sizes and configurations of the endoscope are equivalent as well.
The Model 2127 Endoscope is a flexible tubular device with plastic and stainless steel connectors. The optical element of the endoscope consists of a fiber optic image element with a distal lens and fiber light guide. The endoscope also has separate cannulae. Passive deflection allows the physician to move the endoscope's tip through the curved cannula tube during mounting and also allows the physician to bend the endoscope to the desired shape while the endoscope is attached to the The light and image guides are terminated with standard connectors cannula. designed to interface with light cables and video cameras.
The basic design of the Clarus Model 2127 Endoscope is, and materials used are, equivalent to the Clarus Model 2126, Model 2125, Model 2240, and Model 2120 Endoscopes. The diameter of the Endoscope is 1 mm to 2 mm and the working length varies for the different model dash numbers available. The working length for nasolaryngeal procedures requires a cannula of 10.4. The working length for the cannula which would also pass the larynx and into the bronchi would be of 25.0 to 30.0 cm length.
This 510(k) summary describes a medical device, the Clarus Model 2127 Endoscope, which is a physical device, not an AI/ML powered diagnostic tool. Therefore, the questions related to AI/ML specific criteria like acceptance criteria tables, sample sizes for training/test sets, ground truth establishment, expert adjudication, or MRMC studies, are not applicable.
The document focuses on demonstrating substantial equivalence to predicate devices based on material composition, design, intended use, and physical performance.
Here's a breakdown of the relevant information provided, addressing the categories where applicable:
1. A table of acceptance criteria and the reported device performance:
This type of table is not provided as this is not an AI/ML device. The "testing" section vaguely refers to "acceptable results" for physical testing without specific numerical acceptance criteria or performance metrics for image quality, diagnostic accuracy, or similar.
2. Sample size used for the test set and the data provenance:
Not applicable for an AI/ML device. For physical device testing, the document states "All testing of the product yielded acceptable results" but does not specify sample sizes for individual tests or their provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable for an AI/ML device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for an AI/ML device.
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 as this is a physical endoscope, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable as this is a physical endoscope, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for an AI/ML device. For the physical device, basic engineering and biocompatibility standards serve as benchmarks.
8. The sample size for the training set:
Not applicable as this is a physical endoscope, not an AI/ML algorithm.
9. How the ground truth for the training set was established:
Not applicable as this is a physical endoscope, not an AI/ML algorithm.
Summary of Device-Specific Information from the Text:
- Acceptance Criteria Mentioned (Implicit):
- Biocompatibility testing: "All materials passed biocompatibility testing and are suitable for this application."
- Physical testing: "All testing of the product yielded acceptable results." This included:
- Cleaning validation protocol and study
- Dimensional inspection
- Bond strength testing
- Distal tip temperature
- Optical clarity
- Light transmittance
- Fluid flow
- Study That Proves the Device Meets Acceptance Criteria:
- The document states that "Biocompatibility testing was performed" and "Physical testing of similar and substantially equivalent endoscopes included..." and that "All testing... yielded acceptable results."
- The primary method of demonstrating acceptance is through substantial equivalence to existing predicate devices (Model 2126, 2120, 2125, 2240, 2400 endoscopes, and others like Rapiscope Optical Fiber, Diaguide, and Model SLS endoscope). The argument is that since the materials, design, and intended use are similar to already cleared devices, and their own testing yielded acceptable results, the new device is safe and effective.
- No specific study report details, methodologies, or raw data are provided in this summary. The claim of "acceptable results" is made without granular evidence in this document.
In conclusion, the provided text is a 510(k) summary for a traditional medical device (an endoscope) and therefore does not contain the information requested for AI/ML based devices. The "acceptance criteria" are implied by successful physical and biocompatibility testing and demonstrated substantial equivalence to predicate devices, without detailed reports on these tests.
§ 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.