(91 days)
No
The description focuses on the physical construction, materials, and optical components of a flexible endoscope. There is no mention of software, algorithms, image analysis, or any terms related to AI/ML.
No
The device is described as "intended for diagnostic accessing and visualizing tissue" and is "not intended for intraoperative or percutaneous use," which indicates a diagnostic rather than a therapeutic purpose.
Yes
The "Intended Use / Indications for Use" states that the device "is intended for diagnostic accessing and visualizing tissue".
No
The device description clearly outlines physical components like a flexible tubular device, plastic and stainless steel connectors, a fiber optic image element, a distal lens, a fiber light guide, and separate cannulae. This indicates a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "diagnostic accessing and visualizing tissue during cranial sinus, laryngopharyngeal and bronchial procedures." This describes a procedure performed in vivo (within the living body) for direct observation and access, not a test performed in vitro (outside the living body) on biological samples to diagnose a condition.
- Device Description: The device is an endoscope, which is a tool used for internal visualization of the body. This aligns with in vivo procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue biopsies) or performing tests on these samples outside the body. The device's function is to provide visual access.
Therefore, the Clarus Model 2127 Endoscope is a medical device used for diagnostic procedures performed directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranial sinus, laryngopharyngeal and bronchial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Biocompatibility testing was performed on the materials used in the construction of these endoscopes. All materials passed biocompatibility testing and are suitable for this application.
Physical testing of similar and substantially equivalent endoscopes included: a cleaning validation protocol and study, dimensional inspection, bond strength testing, distal tip temperature, optical clarity, light transmittance, and fluid flow. All testing of the product yielded acceptable results.
Key Metrics
Not Found
Predicate Device(s)
Model 2126 SpinePEN Endoscope by Clarus Medical, Model 2120 NeuroPEN Endoscope by Clarus Medical, Model 2125 MurphyScope by Clarus Medical, Model 2400 InstrumentScope by Clarus Medical, Model 2240 Otoscope by Clarus Medical, Model Number C-DFO-1.6-40-Radiscope™ Optical Fiber by Cook Critical Care, Model S1002 Diaguide by Mitsubishi, Model SLS Endoscope by Schott
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
11 1000
510(k) Summary
Model 2127 Endoscope
General Information
Classifications Class II
Clarus Model 2127 MurphyPENTM Trade Name
Submitted Clarus Medical Systems, Inc. 1000 Boone Avenue North, #100 Minneapolis, Minnesota 55427
- Contact: John Vanden Hoek Director - Research and Development (612) 525-8400
Substantially Equivalent and Predicate Devices
- Model 2126 SpinePEN Endoscope by Clarus Medical Model 2120 NeuroPEN Endoscope by Clarus Medical Model 2125 MurphyScope by Clarus Medical Model 2400 InstrumentScope by Clarus Medical Model 2240 Otoscope by Clarus Medical Model Number C-DFO-1.6-40-Radiscope™ Optical Fiber by Cook Critical Care Model S1002 Diaguide by Mitsubishi Model SLS Endoscope by Schott
Device Description
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.
1
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.
Intended Use
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.
Testing
Biocompatibility testing was performed on the materials used in the construction of these endoscopes. All materials passed biocompatibility testing and are suitable for this application.
Physical testing of similar and substantially equivalent endoscopes included: a cleaning validation protocol and study, dimensional inspection, bond strength testing, distal tip temperature, optical clarity, light transmittance, and fluid flow. All testing of the product yielded acceptable results.
Summary of Substantial Equivalence
The Clarus Model 2127 Endoscopes are constructed of the same materials as other Series 2100 Flexible Endoscopes and Models 2126, 2125, 2120, 2400 and 2240, as well as other Clarus products. The sizes and configurations available along with the packaging and sterilization methods are equivalent to Model 2126, 2120, and Model 2125. The Model 2127 will fall within the Clarus 2100 Series of endoscopes as filed under K912089 which is cleared for reuse. Models 2126 and 2240 endoscope as filed under K934432 are also cleared for reuse.
The clinical indications for use are similar to those of the Rapiscope Optical Fiber endoscope by Cook Critical Care, the Diaguide endoscope by Mitsubishi and the Model SLS endoscope by Schott.
Therefore, due to the similarity of materials to other Clarus devices, the test results and the equivalent indications for use of other predicate devices, Clarus believes these products do not raise any new safety or effectiveness issues.