MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES

K023984 · The Olympus Optical Co. · EOQ · Jan 31, 2003 · Ear, Nose, Throat

Device Facts

• Record ID: K023984
• Device Name: MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES
• Applicant: The Olympus Optical Co.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Jan 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BF-40 Series: These instruments have been designed to be used with an Olympus Light Source, documentation equipment, display monitor, Endo-Therapy Accessories and other ancillary equipment for endoscopic diagnostic and treatment within the airways and tracheobronchial tree. BF-240 Series: This instrument has been designed to be used with an Olympus Video System Center, Light Source, Documentation Equipment, Display monitor, Endo-Therapy Accessories, Electrosurgical Unit, and other ancillary equipment for endoscopic diagnosis and treatment within the airways and tracheobronchial tree. BF-160 Series: These instruments have been designed to be used with an OLYMPUS video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

Device Story

Flexible bronchoscopes (BF-40, 240, 160 series) used for visualization and intervention in airways/tracheobronchial tree; devices connect to Olympus light sources, video system centers, and monitors; used with endo-therapy accessories (e.g., biopsy forceps) and electrosurgical units; operated by physicians in clinical settings; provides direct visualization to guide diagnostic/therapeutic procedures; benefits include minimally invasive access to pulmonary structures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Flexible fiber-optic or video bronchoscopes; intended for use with ancillary endoscopic equipment (light sources, video processors, monitors, electrosurgical units); biopsy port material modified from predicate; Class II device per 21 CFR 874.4680.

Indications for Use

Indicated for endoscopic diagnostic and treatment procedures within the airways and tracheobronchial tree. Intended for use by clinicians in a medical setting.

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

• BF-N20 (K910423)

Submission Summary (Full Text)

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K023984

# JAN 31 2003

Revised 1/27/03

# SMDA 510(k) SUMMARY

## Olympus Bronchoscopes BF-40, 240 and 160 series

## A. Submitter's Name, Address, Phone and Fax Numbers

Name & Address of manufacturer:

Registration No .: Address, Phone and Fax Numbers: Of R&D Endoscope Division

Olympus Optical Co., Ltd. 34-3 Hirai Hinide-Machi, Nishitama-Gun , Tokyo 190-00182, Japan 3003637092 2951 Ishikawa-Cho, Hachioji-shi, Tokyo 192-8507 Japan 81- 426-42-2891 TEL FAX [phone]

#### B. Name of Contact Person

Name: Address, Phone and Fax Numbers: Laura Storms-Tyler Olympus America Inc. Two Corporate Center Drive Melville, New York 11747-3157 TEL: [phone] FAX: [phone]

## C. Trade Name, Common Name, Classification Name and Predicate Devices

| <Olympus Bronchoscopes BF-40 series> | |
|--------------------------------------|-----------------------------------------------------------------------------|
| Trade Name: | Olympus Bronchoscopes BF-40 series |
| Common Name: | Bronchoscope |
| Classification: | 21 CFR 874.4680 Bronchoscopes (flexible or rigid) and accessories, Class II |
| *Predicate Device: | BF-N20(#K910423) |

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- * Predicate Device:
* The difference between the predicate devices and subjects devices is only a change in material of the Biopsy Port. The change in material would not effect safety and effectiveness of the device.

## D. Description of the Device(s)

#### < BF-40 Series>

These instruments have been designed to be used with an Olympus Light Source, documentation equipment, display monitor, Endo-Therapy Accessories and other ancillary equipment for endoscopic diagnostic and treatment within the airways and tracheobronchial tree.

#### <BF-240 Series>

This instrument has been designed to be used with an Olympus Video System Center, Light Source, Documentation Equipment, Display monitor, Endo-Therapy Accessories, Electrosurgical Unit, and other ancillary equipment for endoscopic diagnosis and treatment within the airways and tracheobronchial tree.

#### <BF-160 Series>

These instrument have been designed to be used with an OLYMPUS video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

## E. Intended Use of the Device(s)

#### < BF-40 Series>

These instruments have been designed to be used with an Olympus Light Source, documentation equipment, display monitor, Endo-Therapy Accessories and other ancillary equipment for endoscopic diagnostic and treatment within the airways and tracheobronchial tree.

## <BF-240 Series>

This instrument has been designed to be used with an Olympus Video System Center, Light Source, Documentation Equipment, Display monitor, Endo-Therapy Accessories, Electrosurgical Unit, and other ancillary equipment for endoscopic diagnosis and treatment within the airways and tracheobronchial tree.

#### <BF-160 Series>

These instruments have been designed to be used with an OLYMPUS video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 31 2003

Olympus Optical Co., LTD c/o Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, NY 11747-3157

Re: K023984

Trade/Device Name: Olympus Bronchoscopes BF-40, 240, 160 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscopes (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOO Dated: November 26, 2002 Received: December 2, 2002

Dear Ms. Storms-Tyler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A halyi korenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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#### INDICATIONS FOR USE STATEMENT

510(k) Number(if known): Not assigned yet. KO2 3984 Device Name: Olympus Bronchoscopes BF-40, 240, 160 Indications for Use:

#### < BF-40 Series>

These instruments have been designed to be used with an Olympus Light Source, documentation equipment, display monitor, Endo Therapy Accessories and other ancillary equipment for endoscopic diagnostic and treatment within the airways and tracheobronchial tree.

<BF-240 Series>

This instrument has been designed to be used with an Olympus Video System Center, Light Source, Documentation Equipment, Display monitor, Endo-Therapy Accessories, Electrosurgical Unit, and other ancillary equipment for endoscopic diagnosis and treatment within the airways and tracheobronchial tree.

<BF-160 Series>

These instrument have been designed to be used with an OLYMPUS video system center, light source, documentation equipment, video monitor, endo therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

✓

OR

Over-The-Counter Use_

(Per 21 CFR 801.109)

Kuen Bahr

Division of Ophthalmic Nose and Throat De

510(k) Number

(Optional Format 1-2-96)