BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM

K040940 · Olympus Corporation · EOQ · Apr 19, 2004 · Ear, Nose, Throat

Device Facts

• Record ID: K040940
• Device Name: BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM
• Applicant: Olympus Corporation
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Apr 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

This instrument 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

Flexible bronchovideoscope for visualization of airways and tracheobronchial tree; used with Olympus video system center, light source, and monitor. Features dual optical system for normal and high-magnification observation; enables detailed inspection of bronchial mucosa and capillary blood vessels. Operated by physicians during endoscopic procedures; provides real-time visual feedback to assist in diagnosis and therapeutic interventions. Patient benefits from enhanced visualization of target areas compared to standard bronchoscopes.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing and design comparison.

Technological Characteristics

Flexible bronchoscope; distal end diameter 5.9mm; insertion tube diameter 5.7mm; inner channel diameter 2.0mm. Features dual optical system (normal and high magnification). Patient-contact materials identical to previously cleared devices. Standalone device requiring external video system center, light source, and monitor.

Indications for Use

Indicated for use in endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Intended for use by clinicians in a professional healthcare 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

• EVIS EXERA Bronchovideoscope Olympus BF type 160 (K023984)

Submission Summary (Full Text)

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Kotog4o

# APR 1 9 2004

## 510(k) SUMMARY

## Bronchovideoscope Olympus XBF-D160HM

## 1. General Information

| Date Prepared | February 20, 2004 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Olympus Corporation<br>(Former name: Olympus Optical Co., Ltd.)<br>34-3 Hirai Hinode-machi,<br>Nishitama-gun, Tokyo, 190-0182, Japan<br>Establishment Registration No.: 3003637092 |
| Submission Correspondent | Shiho Otsuki<br>Olympus Corporation<br>(Former name: Olympus Optical Co., Ltd.)<br>2951 Ishikawa-cho Hachioji-shi, Tokyo 192-8507, Japan<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>Establishment Registration No.: 8010047 |
| Official Correspondent | Tina Steffanie-Oak<br>Associate Manager, Regulatory Affairs/Clinical Monitor<br>Olympus America Inc.<br>Two Corporate Center Drive, Melville,<br>NY 11747-3157, USA<br>Phone: [phone]<br>FAX: [phone]<br>Email: Tina [e-mail]<br>Establishment Registration No.: 2429304 |

### 2. Device Identification

| Trade Name: | Bronchovideoscope Olympus XBF-D160HM |
|--------------------|--------------------------------------------------|
| Common Name: | Bronchoscope |
| Regulation Name: | Bronchoscope (flexible or rigid) and accessories |
| Regulation Number: | 21 CFR 874.4680 |
| Class: | |
| Product Code: | 77 EOQ |

## 3. Predicate Device

| Predicate Device Name: | EVIS EXERA Bronchovideoscope Olympus BF type 160 |
|------------------------|--------------------------------------------------|
| Manufacturer: | Olympus Optical Co., Ltd. |
| 510(k) Number: | K023984 |

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#### 4. Device Description

The subject device, Bronchovideoscope Olympus XBF-D160HM, is basically identical to the predicate device, EVIS EXERA Bronchovideoscope Olympus BF type 160, except that the subject device is equipped with an optical system for high magnification observation in addition to an optical system for normal observation.

When compared to the predicate device, this high magnification bronchoscope enables more detailed observation of the target area. For example, a run of the capillary blood vessel in the bronchial mucosa can be observed, which is not observable with the predicate device.

#### 5. Intended Use

This instrument 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.

#### 6. Comparison of Technological Characteristics

The XBF-D160HM is identical to the BF-160 in intended use, and similar in specifications except for the optical system. Comparison between the subject device and predicate device is in Table 4.

| Specifications | Subject Device<br>XBF-D160HM | Predicate Device<br>BF-160 (K023984) |
|----------------------------------|-------------------------------------------------------------|--------------------------------------|
| Distal End Outer Diameter | ☐5.9mm | ☐5.3mm |
| Insertion Tube Outer<br>Diameter | ☐5.7mm | ☐5.3mm |
| Inner Channel Diameter | ☐2.0mm | ☐2.0mm |
| Optical system | High magnification observation<br>and<br>Normal observation | Normal observation |

#### Table 4 Comparison between the subject device and predicate device

#### 7. Materials

All the patient contact materials used in the subject device are identical to those used in the devices cleared in the past 510(k) submissions.

#### 8. Conclusion

When compared to the predicate device, the XBF-D160HM does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety and effectiveness. Therefore, clinical data is not necessary for its evaluation of safety and efficacy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three wing-like shapes above a wavy line.

APR 1 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Olympus Corporation c/o Tina Steffanic-Oak Associate Manager, Regulatory Affaire/Clinical Monitor Two Corporate Center Drive Melville, NY 11747

Re: K040940

Trade/Device Name: Bronchovideoscope Olympus XBF-D160HM Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessorics) Regulatory Class: Class II Product Code: EOQ Dated: February 20, 2004 Received: April 12, 2004

Dear Ms. Steffanie-Oak:

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 Codc 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 mcan 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Tina Steffanie-Oak

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. halpi 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

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## Indications for Use

510(k) Number (if known): Device Name: Bronchovideoscope Olympus XBF-D160HM Indications For Use:

This instrument 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.

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use___ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Karen H. Balin

510(k) Number K040940

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