CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)

K962255 · Clarus Medical Systems, Inc. · EOB · Sep 11, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K962255
• Device Name: CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)
• Applicant: Clarus Medical Systems, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Sep 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2

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.

Device Story

Flexible fiber optic endoscope; utilizes distal lens and fiber light guide for visualization. Physician-operated; used in clinical settings for diagnostic access to cranial sinus, laryngopharyngeal, and bronchial tissues. Device features passive tip deflection for navigation through curved cannulae. Light and image guides interface with standard external light cables and video cameras. Provides direct visualization to assist physician in diagnostic assessment. Reusable device; supplied with disposable cannulae.

Clinical Evidence

Bench testing only. Biocompatibility testing performed on all construction materials with passing results. Physical testing included cleaning validation, dimensional inspection, bond strength, distal tip temperature, optical clarity, light transmittance, and fluid flow. All tests yielded acceptable results.

Technological Characteristics

Flexible tubular endoscope; 1-2 mm diameter. Materials: medical grade biocompatible plastic and stainless steel. Optical system: fiber optic image element, distal lens, fiber light guide. Passive deflection mechanism. Connectivity: standard connectors for external light cables and video cameras. Reusable; sterilization methods equivalent to predicate Clarus 2100 series.

Indications for Use

Indicated for diagnostic visualization of tissue during cranial sinus, laryngopharyngeal, and bronchial procedures. Not for intraoperative or percutaneous use.

Regulatory Classification

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.

Predicate Devices

• Model 2126 SpinePEN Endoscope (Clarus Medical)
• Model 2120 NeuroPEN Endoscope (Clarus Medical)
• Model 2125 MurphyScope (Clarus Medical)
• Model 2400 InstrumentScope (Clarus Medical)
• Model 2240 Otoscope (Clarus Medical)

Reference Devices

• Model Number C-DFO-1.6-40-Radiscope Optical Fiber (Cook Critical Care)
• Model S1002 Diaguide (Mitsubishi)
• Model SLS Endoscope (Schott)

Submission Summary (Full Text)

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K962255
SEP 11 1996

# 510(k) Summary

## Model 2127 Endoscope

### General Information

- **Classifications**: Class II
- **Trade Name**: Clarus Model 2127 MurphyPEN™
- **Submitted**: Clarus Medical Systems, Inc.
1000 Boone Avenue North, #100
Minneapolis, Minnesota 55427
- **Contact**: John Vanden Hoek
Director - Research and Development
[phone]

### Substantially Equivalent and Predicate Devices

1. 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 cannula. The light and image guides are terminated with standard connectors designed to interface with light cables and video cameras.

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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.