XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT

K011869 · The Olympus Optical Co. · EOB · Jul 25, 2001 · Ear, Nose, Throat

Device Facts

• Record ID: K011869
• Device Name: XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
• Applicant: The Olympus Optical Co.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Jul 25, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2

Indications for Use

This instrument has been designed to be used with an Olympus Light Source or an Olympus Miniature Light Source, documentation equipment, display monitor, and other ancillary equipment for endoscpic diagnosis within the upper airway which includes the nasal cavity, nasopharynx, oropharynx, hyporpharynx and larynx.

Device Story

XENF-DP Rhino-Laryngofiberscope is a flexible fiber-optic endoscope used for visualization of the upper airway. It transmits light via a light source (battery-powered or cable-connected) to illuminate the nasal cavity, nasopharynx, oropharynx, hypopharynx, and larynx. The device is operated by a clinician to perform endoscopic diagnosis. The clinician views the internal anatomy directly or via connected display/documentation equipment. The device facilitates visual inspection of the upper airway to assist in clinical diagnosis. It is intended for use in clinical settings.

Clinical Evidence

No clinical data provided. Safety and effectiveness are established based on the device's similarity to legally marketed predicate devices and its use of previously cleared patient-contacting materials.

Technological Characteristics

Flexible fiber-optic endoscope. Compatible with Olympus light sources (battery or cable-powered). Complies with IEC 60601-1 and IEC 60601-2-18 safety standards. Materials are identical to those used in previously cleared Olympus devices.

Indications for Use

Indicated for endoscopic diagnosis of the upper airway, including the nasal cavity, nasopharynx, oropharynx, hypopharynx, and larynx in patients requiring visualization of these structures.

Regulatory Classification

Identification

A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

Predicate Devices

• Pentax Naso-Pharyngo-Laryngosocope FNL-15P2/15RP2 (K921707)
• LF-TP/DP Tracheal Intubation Fiberscopes (K981543)
• LF-DP Gastrointestinal and Sigmoid Fiberscope (K002231)

Submission Summary (Full Text)

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K011869

## 510(k) SUMMARY

# XENF-DP Rhino-Laryngofiberscope, its accessories and ancillary equipment

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section807.92.

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

#### 1. Manufacturer of the subject device

| Name & Address of Manufacturer; | Olympus Optical Co,. Ltd.<br>2-3-1 Shinjuku Monolis Nishi-shinjuku<br>Shinjuku-ku, Tokyo, 163-0914<br>Japan |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Registration No : | 810047 |
| Address, Phone and Fax Number<br>of R&D Department<br>Endoscope Division | 2951 Ishikawa-cho<br>Hachioji-shi, Tokyo 192-8507<br>Japan<br>TEL [phone]<br>FAX [phone] |

#### 2 Name of Contact Person Name :

Address, Phone and Fax

Ms.Laura Storms-Tyler Director, Regulatory Affairs Olympus America Inc. Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157 TEL [phone] FAX [phone]

## B. Device Name, Common Name

| 1. Device Name : | XENF-DP Rhino-Laryngofiberscope, its<br>accessories and ancillary equipment |
|--------------------------|-----------------------------------------------------------------------------|
| 2. Common/Usual Name : | Fiber Scope for Rhino-Laryngofiberscope |
| 3. Classification Name : | 21CFR 876.1500<br>21CFR 868.5530<br>21CFR 874.4760 |

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### C. Predicate Devices :

| Model | Device Description &<br>510(k)#/ Date of Cleared | Manufacturer |
|----------------------------------------------------------|--------------------------------------------------|-------------------------------------|
| Pentax Naso-Pharyngo-<br>Laryngosocope<br>FNL-15P2/15RP2 | #K921707<br>07/01/1992 | Pentax Precision<br>Instrument Corp |
| LF-TP/DP<br>Tracheal Intubation Fiberscopes | #K981543<br>08/06/1998 | Olympus Optical Co., |
| LF-DP<br>Gastrointestinal and Sigmoid<br>Fiberscope | #K002231<br>1/30/2001 | Olympus Optical Co., |

### D. Summary Description of the Device

### 1. Summary

This subject device "XENF-DP Rhino-Laryngofiberscope" is used for observation within nasal and nasopharyngeal lumen. This endoscope enables use of 2 types of light sources, a detachable single use battery light source powered and a light cable light source.

### 2. Design

"XENF-DP Rhino-Laryngofiberscope" has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirements of IEC 60601-1 and IEC60601-2-18.

## 3. Materials

There are no new patient-contacting materials. All of patient contact materials are cleared by previous 510(k) submissions.

## E. Intended Use of the device

This instrument has been designed to be used with an Olympus Light Source or an Olympus Miniature Light Source, documentation equipment, display monitor, and other ancillary equipment for endoscpic diagnosis within the upper airway which includes the nasal cavity, nasopharynx, oropharynx, hyporpharynx and larynx.

## F. Technological Characteristics

This endoscope does not have special technological characteristics, when compared to the predicate device.

## G. Reason for not requiring clinical data

When compared to the predicate devices, "XENF-DP Rhino-Laryngofiberscope" does not incorporate any significant change for safety and efficacy to the predicate device. Observation within nasal and nasopharyngeal lumen has been done widely, and established its safety and effectiveness, therefore clinical data is not necessary for its evaluation of its safety and efficacy.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 5 2001

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

Re: K011869

Trade Name: Olympus XENF-DP Rhino-Laryngofiberscope Regulation Number: 21 CFR 874.4760 Regulatory Class: Class II Product Code: EOB Dated: June 11, 2001 Received: June 14, 2001

Dear Ms. Tyler:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have forious your car ovice is substantially equivalent (for the indications for use above and we nevelopment to devices marketed in interstate commerce prior to May 28, 1976, the suace in the enother) Device Amendments, or to devices that have been reclassified in encentions with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, accordance with the providers subject to the general controls provisions of the Act. The general cherols 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (I remarket I Ipproval), it ina), be our of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may occinery "firm announcements concerning your device in the Federal Register. Please note: publish farther unitounteen notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Laura Storms-Tyler

This letter will allow you to begin marketing your device as described in your 510(k) premarker 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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. Ralph 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

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# Indications for Use Statement

510(k) Number(if known): _____________________________________________________________________________________________________________________________________________________

Device Name: XENF-DP Rhino-Laryngofiberscope, its accessories and ancillary equipment.

#### Indications for Use:

The Olympus XENF-DP Rhino-Laryngofiberscope, its accessories and ancillary equipment have been designed to be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for endoscopic diagnosis within the upper airway which includes the nasal cavity, nasopharynx, hyporpharynx and larynx.

J. Santos

Division Sign-Off Division of Ophthalmic Devic KO1186 510(k) Number _

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ OR

(Prescription 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)