OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13

K060243 · Olympus Medical Systems Corporation · EOQ · Jun 23, 2006 · Ear, Nose, Throat

Device Facts

• Record ID: K060243
• Device Name: OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13
• Applicant: Olympus Medical Systems Corporation
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Jun 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2

Intended Use

This instrument has been designed to be used with Olympus bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasound probe to the target area within the respiratory organs.

Device Story

Guide sheath designed for use with Olympus bronchoscopes (2.8 mm instrument channel); facilitates precise, repeated advancement of endo-therapy accessories or ultrasonic probes to targeted respiratory lesions. Device consists of a tube sheath and a radiopaque fluoro tip for distal end visualization under X-ray monitoring. Used by physicians in clinical settings during diagnostic and therapeutic bronchoscopy. Enables stable access to target sites; improves procedural efficiency by allowing accessory exchange without removing the bronchoscope.

Clinical Evidence

Olympus sponsored a prospective clinical evaluation to support the safe and effective use of the device for its intended purpose.

Technological Characteristics

Consists of a tube sheath and a radiopaque fluoro tip for X-ray visualization. Dimensions: 2.7 mm outer diameter, 2.1 mm inner diameter, 900 mm length. Compatible with 2.8 mm minimum instrument channels. Patient-contacting materials are identical to legally marketed Olympus products.

Indications for Use

Indicated for use with Olympus bronchoscopes, endo-therapy accessories, and ultrasound probes to guide these instruments to targeted areas within the respiratory organs for diagnostic and therapeutic procedures.

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

• Cytology Brush: BC-14/15/16C (EVIS 200 System) (K931154)

Submission Summary (Full Text)

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January 23 , 2006

# SMDA 510(k) SUMMARY "Olympus Guide Sheath, XBO1-836-13 "

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR, Part 807, Subpart E, Section 807.92.

## A. GENERAL INFORMATION

| 1. Applicant : | Olympus Medical Systems Corporation<br>2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan<br>Registration number :8010047 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Official Correspondent : | Laura Storm-Tyler<br>Executive Director, Regulatory Affairs and Quality Assurance<br>Olympus America Inc.<br>Two Corporate Center Drive, Melville, NY 11747-9058, USA<br>TEL [phone]<br>FAX [phone]<br>Registration Number :2429304 |
| 3. Manufacturer : | Aomori Olympus Co., Ltd.<br>2-248-1 Okkonoki Kuroishi-shi, Aomori-ken,<br>036-0357, Japan<br>Registration Number : 9614641 |

**B. DEVICE IDENTIFICATION**

| 1. Common/Usual Name : | Bronchoscope accessory |
|--------------------------|-----------------------------------|
| 2. Device Name : | Olympus Guide Sheath, XBO1-836-13 |
| 3. Classification Name : | 874.4680, class II , EOQ |

## C. PREDICATE DEVICES

| Device Name | 510(k) # | Manufacturer | Class | Product<br>Code |
|---------------------------------------------------|----------|-------------------------|-------|-----------------|
| Cytology Brush: BC-14/15/16C<br>(EVIS 200 System) | #K931154 | Olympus<br>Corporation. | II | EOQ |

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### D. SUMMARY DESCRIPTION OF THE DEVICE

#### 1. Summarv

Olympus Medical Systems Corp., intends to introduce the Guide Sheath for use in the respiratory organs. This Guide Sheath,XBO1-836-13 has been designed to be used with Olympus bronchoscopes with 2.8 mm instrument channel, accessories and ultrasonic probe unit for performing diagnostic and therapeutic procedures. The Guide Sheath allows physicians to advance the endo-therapy accessories or guide the ultrasonic probe precisely to the targeted lesions repeatedly.

#### 2. Materials

The patient contacting materials used as components of the Guide Sheath are identical to legally Marketed Olympus products.

### E. SUMMARY

In summary, the Guide Sheath, XBO1-836-13 is basically identical to the predicate device in performance, materials and specifications. The subject device differs from the predicate device relative to the intended use.

### F. INTENDED USE OF THE DEVICE

This instrument has been designed to be used with Olympus bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasound probe to the targeted area within the respiratory organs.

## G. TECHNOLOGICAL CHARACTERISTICS

This Guide Sheath, XBO1-836-13 consists of tube sheath and piece of flouro tip, which shows the distal end position when X-ray was monitored. The following is the specification of the Guide Sheath:

| Specifications | Dimension (m) |
|--------------------------------|---------------|
| Outer Diameter | 2.7 |
| Inner Diameter | 2.1 |
| Sheath Length | 900 |
| Channel Size (Minimum $\phi$ ) | 2.8 |
| Fluoro Tip for X-ray monitor | Provided |

### H. CLINICAL DATA

Olympus sponsored prospective clinical evaluation of the subject device which support the safe and effective use of the subject device for its intended use.

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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 stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2006

Olympus Medical Systems Corporation c/o Ms. Laura Storm-Tyler Two Corporate Center Dr. Melville, NY 11747-9058

Re: K060243

Trade/Device Name: Olympus Guide Sheath. XBO1-836-13 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope and accessories (flexible or rigid) Regulation Class: II Product Code: EOQ Dated: May 30, 2006 Received: May 31, 2006

Dear Ms. Storm-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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#### Page 2 - Ms. Laura Storm-Tyler

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 Iogally marketed predicate device results in a classification for your device and thus, perceits your evice 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 (21 cm 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/industry/support/index.html.

Sincerely yours,

M.B. Eychler-SiMD

Malvina B. Eydelman, 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) :

Device Name: Olympus Guide Sheath, XBO1-836-13

Indications for Use :

This instrument has been designed to be used with Olympus bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasound probe to the target area within the respiratory organs.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

Karen t. Baker

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K060243

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