OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT

K981543 · The Olympus Optical Co. · EOQ · Jun 8, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K981543
• Device Name: OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT
• Applicant: The Olympus Optical Co.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Jun 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2

Intended Use

The Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes are specifically designed for airway management which includes endoscopic observation to assess airway anatomy, endotracheal/endobronchial intubation, and management.

Device Story

Portable bronchofiberscope for airway management; used for endoscopic observation of airway anatomy and endotracheal/endobronchial intubation. Device consists of flexible fiberscope, accessories, and ancillary equipment (e.g., suction pump, light source). Operator (physician) inserts scope into patient airway; visualizes anatomy via fiber-optic bundle; facilitates intubation. Provides direct visualization to assist clinical decision-making during airway procedures. Benefits include improved visualization for difficult intubations and airway assessment.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 safety standards demonstrated. No clinical data provided.

Technological Characteristics

Flexible fiber-optic endoscope; includes suction channel and light guide. Variations in distal end outer diameter, insertion tube outer diameter, channel inner diameter, and angulation range compared to predicate. Complies with IEC 60601-1 safety standards. Non-electronic, fiber-optic imaging system.

Indications for Use

Indicated for airway management, including endoscopic observation of airway anatomy and endotracheal/endobronchial intubation and management in patients requiring such 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

• Olympus LF-1 Intubation Scope (K850978)
• Olympus BF-240 Bronchovideoscope (K963033)
• Olympus BF-200 Bronchovideoscope (K931154)
• Olympus BF-P200 Bronchovideoscope (K931154)
• Olympus Winter & Ibe A5255A Rigid Endoscope (K923982)
• Olympus A3093 Light Guide Cable, 3.5 mm plug type (K944072)

Submission Summary (Full Text)

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K981543

## SMDA 510(k) Summary Olympus Tracheal Intubation Fiberscope LF-TP and LF-DP

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

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

Olympus Optical Co., Ltd. 22-2 Nishi-Shinjuku Shinjuku-ku, Tokyo 163-8610 Japan

# B. Contact Person's Name, Address, Phone and Fax Numbers

Laura Storms-Tyler Olympus America Inc. Endoscope Division Two Corporate Center Drive Melville, NY 11747-3157 Telephone: [phone] Fax: [phone]

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ﺴﺴ

# C. Trade Name, Common Name and Classification Name

| Trade Name: | Olympus LF-TP and LF-DP Tracheal Intubation<br>Fiberscope, accessories and ancillary equipment |
|-----------------|------------------------------------------------------------------------------------------------|
| Common Name: | Portable Bronchofiberscope, accessories and ancillary |
| equipment | |
| Classification: | Bronchoscope and accessories |
| | Class II, 21 CFR 874.4680 |

#### D. Legally Marketed Devices which we Claim Substantial Equivalence

| Olympus LF-1 Intubation Scope | K850978 |
|---------------------------------------------------|---------|
| Olympus BF-240 Bronchovideoscope | K963033 |
| Olympus BF-200 Bronchovideoscope | K931154 |
| Olympus BF-P200 Bronchovideoscope | K931154 |
| Olympus Winter & Ibe A5255A Rigid Endoscope | K923982 |
| Olympus A3093 Light Guide Cable, 3.5 mm plug type | K944072 |

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#### E. Description of the Device

The Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes and it's accessories are specifically designed to be used with a Suction Pump and other ancillary equipment for airway management.

#### F. Intended Use of the Device

The Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes are specifically designed for airway management which includes endoscopic observation to assess airway anatomy, endotracheal/endobronchial intubation, and management.

The difference between the LF-TP and LF-DP fiberscopes are as follows:

- Distal end outer diameter
- Insertion tube outer diameter
- Channel inner diameter
- Angulation range

### G. Summary of the Technological Characteristics of the Device compared to the Predicate Device(s)

Except for the combined use with the Miniature Light Source and some modifications for the improvement of performance, other characteristics of the Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes are identical to the predicate Olympus LF-1 Intubation Scope.

## H. Summary including a Brief Discussion of Non-Clinical Tests and How their Results support Determination of SE

Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes are designed, manufactured, and tested in compliance with the requirements of the voluntary safety standard, IEC 60601-1.

#### I. Summary including Conclusions drawn from Non-Clinical Tests

When compared to the predicate devices, Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes do not incorporate any significant change in intended use, method of operation, material, and design that could affect device safety or effectiveness.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 8 1998

Laura Storms-Taylor Director, Regulatory Affairs Olympus Optical Co., Ltd. 22-2 Nishi-Shinjuku, 1-Chome Shinjuku-ku, Tokyo 163-8610 Japan

Re:

K981543

Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, accessories and ancillary equipment Dated: April 28, 1998 Received: April 30, 1998 Regulatory class: II 21 CFR 874.4680/Procode: 77 EOQ

Dear Ms. Storms-Taylor:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice reguirements, as set forth in the Quality System Regulation (OS) 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 publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 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/dsmaldsmamain.html".

Sincerely yours,

William Yin

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological 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

Device Name:

Olympus LF-TP and LF-DP Tracheal Intubation Fiberscope, accessories and ancillary equipment.

12431543

Indications for Use:

Olympus LF-TP and LF-DP Tracheal Intubation Fiberscope, accessories and ancillary equipment are intended for airway management which includes endoscopic observation to assess airway anatomy, endotracheal/endobronchial intubation, and management.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21CFR 801.109)

OR

Over-the Counter Use (Optional Format 1-2-96)

Ovid le. Stymm
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(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devi 510(k) Number

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