OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200)

K962380 · Olympus America, Inc. · EOQ · Aug 9, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K962380
• Device Name: OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200)
• Applicant: Olympus America, Inc.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Aug 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Olympus EVIS BF Type 200 Series video bronchoscopes have been designed for endoscopic diagnosis and treatment within the airways, including the tracheobronchial tree.

Device Story

Video bronchoscopes (BF-200, BF-P200, BF-1T200) used with EVIS 200 video system center; input: optical images of tracheobronchial tree; output: real-time video feed for clinician visualization; used in clinical settings by physicians for airway diagnosis and treatment; modified version of predicate K931154 featuring updated insertion tube outer coating material; all other design, optical, mechanical, and electrical characteristics remain identical to predicate.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Video bronchoscopes; optical imaging system; insertion tube with modified outer coating material; compatible with EVIS 200 video system center; electrical and thermal characteristics identical to predicate.

Indications for Use

Indicated for endoscopic diagnosis and treatment within the airways, including the tracheobronchial tree, in patients requiring bronchoscopic examination.

Regulatory Classification

Identification

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

Predicate Devices

• Olympus EVIS 200 System - Bronchoscopy (K931154)

Submission Summary (Full Text)

{0}

K962380

AUG - 9 1996

# 510 (k) SUMMARY

## OLYMPUS EVIS 200 VIDEO ENDOSCOPY SYSTEM

| Device Name: | Olympus EVIS BF 200 Series Video Bronchoscopes, it’s associated accessories and ancillary equipment |
| --- | --- |
| Common/Usual Name: | Video Bronchoscopes |
| Classification Name: | Bronchoscopes and Accessories |
| Predicate Devices: | Olympus EVIS 200 System - Bronchoscopy (K931154) |
| Submitted By:
(Contact Person) | Mr. Barry Sands
Olympus America Inc.
Endoscope Division
Two Corporate Center Drive
Melville, New York 11747-3157
[phone] |
| Summary Preparation Date: | June 6, 1996 |

## Statement of Intended Use

The Olympus EVIS BF Type 200 Series video bronchoscopes have been designed for endoscopic diagnosis and treatment within the airways, including the tracheobronchial tree.

## Device Description

Olympus intends to offer three modified BF-200, BF-P200, and BF-1T200 models of video bronchoscopes to be used in conjunction with the EVIS 200 video system center. These video bronchoscopes are identical to the legally marketed video bronchoscopes, which were cleared for marketing through 510(k) # K931154, except for the insertion tube’s outer coating material.

All characteristics such as design, construction, optical characteristics, mechanical specifications, electrical and thermal characteristics, intended use, method of use, and application sites remains unchanged.

50