EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT

K033225 · Olympus Optical Co., Ltd. · EOQ · Oct 16, 2003 · Ear, Nose, Throat

Device Facts

• Record ID: K033225
• Device Name: EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
• Applicant: Olympus Optical Co., Ltd.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Oct 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The EVIS Bronchofibervideoscope Olympus BF type XP160F has 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

The BF-XP160F is a flexible bronchoscope designed for visualization and endoscopic surgery within the airways and tracheobronchial tree. It functions as a hybrid device, integrating a CCD sensor directly into the control section to capture video signals, eliminating the need for a separate video converter required by its predecessor (BF-XP40). The device is used in clinical settings by physicians; it connects to an Olympus video system center, light source, and monitor. The physician maneuvers the scope via a control section to navigate the tracheobronchial tree; the CCD transmits real-time images to the monitor. This visual feedback allows the physician to perform diagnostic procedures or guide endo-therapy accessories (e.g., biopsy forceps). The device provides high-resolution visualization, aiding in the diagnosis and treatment of airway conditions, thereby benefiting patients through minimally invasive access to the respiratory tract.

Clinical Evidence

Bench testing only. The device was evaluated for safety and performance through comparison of design, materials, and optical specifications against predicate devices. Compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-18 was confirmed. No clinical data was required for this submission.

Technological Characteristics

Flexible bronchoscope with 2.8mm outer diameter and 600mm working length. Features a 0° forward viewing direction, 90° field of view, and 2mm-50mm depth of field. Includes a 1.2mm instrument channel. Materials are biocompatible per ISO 10993-1. Operates via connection to an Olympus video system center and light source. Meets IEC 60601-1, 60601-1-1, 60601-1-2, and 60601-2-18 standards.

Indications for Use

Indicated for endoscopic diagnosis and surgery within the airways and tracheobronchial tree in patients requiring bronchoscopy.

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

• OES Bronchofiberscope Olympus BF type XP40 (K023984)
• EVIS EXERA Bronchovideoscope Olympus BF type 160 (K023984)
• OES Video Converter Olympus OVC-200 (K931154)

Submission Summary (Full Text)

{0}------------------------------------------------

K033225

# SMDA 510(k) SUMMARY

10-16-03 August 22, 2003 Revised March 19, 2007

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the This Summary of STO(K) Safety and 21CFR, Part 807, Subpart E, Section 807.92.

## A. GENERAL INFORMATION

### 1. Applicant

Olympus Optical Co., Ltd. 34-3 Hirai Hinode-machi, Nishitama-gun, Tokyo, 190-0182 Japan (Registration Number: 3003637092)

### 2. Submission Correspondent

Shiho Otsuki Olympus Optical Co., Ltd. 2951 Ishikawa-cho Hachioji-shi, Tokyo 192-8507, JAPAN TEL: [phone] FAX:[phone] (Registration Number: 8010047)

### 3. Official Correspondent

Tina Steffanie-Oak Senior R.A. Analyst Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-3157 TEL: [phone] FAX: [phone] (Registration Number:2429304)

### B. DEVICE IDENTIFICATION

### 1. Common/Usual Name

Bronchoscope, its accessories and ancillary equipment

### 2. Device Name

Device Name
EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, its accessories and ancillary equipment

### 3. Classification Name

| CFR Number | Classification Name | Class | Product Code |
|------------|-------------------------------------------------------|-------|--------------|
| 874. 4680 | Bronchoscopes (flexible and rigid)<br>and accessories | II | EOQ |

{1}------------------------------------------------

## C. IDENTIFICATION OF LEGALLY MARKETED DEVICES WHICH WE CLAIM SUBSTANTIAL EQUIVALENCE

| Model | 510(k)# | Manufacturer | Class | Product<br>Code |
|-----------------------------------------------------|----------|---------------------------|-------|-----------------|
| OES Bronchofiberscope Olympus BF<br>type XP40 | #K023984 | Olympus Optical Co., Ltd. | II | EOQ |
| EVIS EXERA Bronchovideoscope<br>Olympus BF type 160 | #K023984 | Olympus Optical Co., Ltd. | II | EOQ |
| OES Video Converter Olympus<br>OVC-200 | #K931154 | Olympus Optical Co., Ltd. | II | EOQ |

## D. DEVICE DESCRIPTION

### 1. Summarv

Summary
The subject device, EVIS EXERA Bronchofibervideoscope Olympus BF type XP100F is basically The Subject device, EVIC EXER & Bronchofiberscope Olympus BF type XP40 (BF-XP40) licentical to the predicate device, OEO Bronth hise copy othe control section. The fiber partners them except that the subject dovice to equipped with the control section, and the CCD changes them the insection tube transmite thay of the subject device is equivalent to the combination of the BF-XP40 to video Signals: In printiple, the stayss OVC-200. The CCD equipped with the subject device is and the OLO Video Onvortor Offinial Orympas Oronchovideoscope Olympus BF type 160 (BF-160). By licentical to that of the EVTO EXER & Erenonention tube diameter of the subject device Combining the OOD in the Boops o on comparison with the BF-XP40, the performance of is han ower than that of the essary to attach the video converter.

## 2. Design

Design rne EV10 EXETV Chononoorwith voluntary safety standards. It meets the requirement of IEC60601-1, IEC60601-1-1, IEC60601-1-2 and IEC60601-2-18.

## 3. Materials

Materials
All the patient contacting materials used in this endoscope and ancillary equipment are identical to All the patient oonlaoling material in the past 510(k) submissions. All materials have been confirmed with ISO 10993-1.

## 4. Intended Use of the device

This instrument has been designed to be used with the Olympus video system center, light source, i fills instrument has been dolgnod to be arountherapy accessories (such as a biopsy forceps) and documentation equipment, naos monton, one endoscopic surgery within the airways and tracheobronchial tree.

## 5. Summary including conclusion drawn from Non-clinical Tests

When compared to the predicate device, the BF type XP160F does not incorporate any significant vinen compared to the products do nother, material, or design that could affect safety and cifanges in the finendod ass, mot necessary for evaluation of safety and efficacy.

{2}------------------------------------------------

**Contraindications**

- Hypersensitivity to darisocianer or to any of the excipients
- Severe hepatic impairment
- Severe renal impairment
- Concomitant use of strong CYP3A4 inhibitors
- Pregnancy and breastfeeding
- Children and adolescents under the age of 18 years

6. 6. Omprisons betwen the subject devices
The interled use of the BF-XP (is , is ustartially instrument of the BF-XF40 and BF-100 and BF-100 and BF-100 and Bronning on the C

| CHARACTERISTICS | Subject device | Predicate device (#K023984) | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | BF-XP160F | BF-XP40 | BF-160 |
| Intended Use | Designed to be used with an Olympus<br>video system center, light source,<br>documentation equipment, video<br>monitor, endo-therapy accessories<br>(such as a biopsy forceps) and other<br>ancillary equipment for endoscopy and<br>endoscopic surgery within the airways<br>and tracheobronchial tree. | Designed to be used with an Olympus<br>light source, video<br>documentation equipment, display<br>monitor, endo-therapy accessories<br>and other ancillary equipment for<br>endoscopic diagnosis and treatment<br>within the airways and<br>tracheobronchial tree. | Designed to be used with an Olympus<br>video system center, light source,<br>documentation equipment, video<br>monitor, endo-therapy accessories<br>(such as a biopsy forceps) and other<br>ancillary equipment for endoscopy and<br>endoscopic surgery within the airways<br>and tracheobronchial tree. |
| Optical Characteristics | | | |
| Field of view | 90° | 90° | 120° |
| Depth of Field | 2mm~50mm | 2mm~50mm | 3mm~100mm |
| Direction of view | 0° Forward Viewing | 0° Forward Viewing | 0° Forward Viewing |
| Outer Diameter of Distal End | 2.8mm | 2.8mm | 5.3mm |
| Outer Diameter of Insertion Tube | 2.8mm | 2.8mm | 5.3mm |
| Angulation<br>UP/DOWN | 180° /130° | 180° /130° | 180° /130° |
| Working Length-Insertion Tube | 600mm | 600mm | 600mm |
| Instrument Channel-I.D. | 1.2mm | 1.2mm | 2.0mm |

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 6 2003

Olympus Optical Co., Ltd. c/o Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548

Re: K033225

Trade/Device Name: EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, its accessories and ancillary equipment Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOQ Dated: August 22, 2003 Received: October 6, 2003

Dear Mr. Devine:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

### Page 2 - Ned Devine

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. Rakipi Rosenthal

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

{5}------------------------------------------------

510(k) Number(if known): _____________________________________________________________________________________________________________________________________________________

510(k) Number(if known): _

Device Name: EVIS EXERA BRONCHOEIBERVIDEOSCOPE OLYMPUS BE TYPE

_XP160F, its accessories and ancillary equipment.

Indications for Use:

The EVIS Bronchofibervideoscope Olympus BF type XP160F has 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 | X |
|----------------------|---|
| (Per 21 CFR 801,109) | |

OR

| (Division Sign-Off) | |
|---------------------|--|
|---------------------|--|

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)