BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES

K963033 · Olympus America, Inc. · EOQ · Sep 9, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K963033
• Device Name: BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES
• Applicant: Olympus America, Inc.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Sep 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BF Type 240 Bronchovideoscopes have been designed to be used with an Olympus EVIS CV-200 video system center, light source, documentation equipment, video monitor, Endo-Therapy accessories, electrocautery devices, electrosurgical unit, and other ancillary equipment for endoscopic diagnosis and treatment within the airways and tracheobronchial tree. All standard set and recommended accessories and equipment submitted in this submission are compatible and should be used with the subject BF 240 Type Bronchovideoscopes.

Device Story

Flexible broncho-videoscope (models BF-240, BF-P240, BF-1T240) used for visualization and therapeutic intervention in airways/tracheobronchial tree; connects to Olympus EVIS CV-200 video system, light source, and monitors. Operates via physician insertion into patient airway; enables use of electrosurgical snares and coagulation electrodes for therapeutic procedures. Provides real-time video output to clinical staff for diagnostic guidance and procedural monitoring. Benefits include enhanced visualization and integrated electrosurgical capability for airway management.

Clinical Evidence

Bench testing only; no clinical data provided. Safety verified through compliance with IEC 601-1 and IEC 601-2-18 standards.

Technological Characteristics

Flexible fiber-optic/video bronchoscope; compatible with EVIS 200 video system. Materials and optical specifications consistent with predicate. Designed for use with electrosurgical units. Safety standards: IEC 601-1, IEC 601-2-18.

Indications for Use

Indicated for endoscopic diagnosis and treatment within the airways and tracheobronchial tree using recommended electrocautery devices.

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)

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K963033

# 510 (k) SUMMARY

## OLYMPUS BF Type 240 BRONCHOVIDEOSCOPES

SEP - 9 1996

| Device Name: | Olympus BF Type 240 Bronchovideoscopes, its associated and ancillary equipment and endoscopic accessories |
| --- | --- |
| Common/Usual Name: | Bronchovideoscope and Accessories |
| Classification Name: | Bronchoscope and Accessories |
| Predicate Devices: | Olympus EVIS 200 System - Bronchoscopy (K931154) |
| Submitted By:
(Contact Person) | Mr. Barry E. Sands
Olympus America Inc.
Endoscope Division
Two Corporate Center Drive
Melville, New York 11747-3157
[phone] |
| Summary Preparation Date: | July 26, 1996 |

## Statement of Intended Use

### BF Type 240 VIDEOBRONCHOSCOPES

The BF Type 240 Bronchovideoscopes have been designed to be used with an Olympus EVIS CV-200 video system center, light source, documentation equipment, video monitor, Endo-Therapy accessories, electrocautery devices, electrosurgical unit, and other ancillary equipment for endoscopic diagnosis and treatment within the airways and tracheobronchial tree.

### ENDOSCOPIC ANCILLARY EQUIPMENT AND ACCESSORIES

All standard set and recommended accessories and equipment submitted in this submission are compatible and should be used with the subject BF 240 Type Bronchovideoscopes. Please refer to Subsection III-A for a copy of the Instruction Manual.

## Statement of Indications for Use

The BF Type 240 Bronchovideoscopes have been specifically designed to be used with the recommended electrocautery devices for endoscopic diagnosis and treatment within the airways and tracheobronchial tree.

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## Device Description

Olympus offers three models: BF-240, BF-P240, and BF-1T240 of Bronchovideoscopes. They are specifically designed to be used in conjunction with the EVIS 200 Video System which was cleared in 510(k) # K931154 and recommended electrocautery devices.

All other characteristics such as optical, product specifications, material, intended use, and indications for use of the BF-240 Bronchovideoscopes remains unchanged except the modifications identified earlier in this section.

Olympus currently markets EVIS BF Type 200Bronchovideoscopes, its associated accessories and ancillary equipment, which were cleared for marketing in 510(k) # K931154. The BF Type 240 Bronchoviseoscopes are substantially equivalent to the BF Type 200 Bronchovideoscopes in design, specifications, materials, intended use, and method of use except the BF-240 allows the user to use the electrocautery devices such as electrosurgical snares and coagulation electrodes during the endoscopic procedure.

## General Safety

The Olympus BF Type 240 Bronchovideoscopes are designed, manufactured and tested according to Voluntary Safety Standards IEC 601-1 and IEC 601-2-18.

When compared with the predicate devices, Olympus BF Type 240 Bronchovideoscopes do not incorporate any significant change in intended use, method of operation, material, or design that could affect the safety or effectiveness.

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