TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005

K082720 · Olympus Medical Systems Corporation · EOQ · Nov 5, 2008 · Ear, Nose, Throat

Device Facts

• Record ID: K082720
• Device Name: TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005
• Applicant: Olympus Medical Systems Corporation
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Nov 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These instruments have been designed to be used with a Suction Pump and EndoTherapy accessories and other ancillary equipment for airway management, which includes endoscopic treatment, diagnosis, and observation to access airway anatomy, endotracheal/endobronchial intubation and management.

Device Story

The LF-Y0004 and LF-Y0005 are all-in-one, cordless, flexible fiber-videoscopes designed for airway management. Unlike predicate devices requiring external light sources, video processors, and monitors, these units integrate these functions into a single portable device. The device captures visual input from the airway via a distal optical system and displays it on an integrated monitor. Used by clinicians for airway visualization, endotracheal/endobronchial intubation, and diagnostic/therapeutic procedures. The integrated design improves portability and simplifies the setup for airway management in clinical settings. Output allows the physician to navigate the airway and confirm tube placement, facilitating safer intubation and diagnostic observation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics.

Technological Characteristics

Flexible fiber-videoscopes with integrated light source, video processor, and monitor. LF-Y0004: 3.9mm distal end, 4.1mm insertion tube. LF-Y0005: 5.1mm distal end, 5.2mm insertion tube. Both feature 600mm working length, 90-degree field of view, and forward-viewing optics. Cordless, all-in-one form factor.

Indications for Use

Indicated for airway management, including diagnosis, observation, and endoscopic treatment to access airway anatomy, and for endotracheal/endobronchial intubation 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-DP Tracheal Intubation Fiberscope (K981543)
• EVIS EXERA BRONCHOFIBERVIDEO SCOPE OLYMPUS BF TYPE XP160F (K033225)
• Olympus Bronchoscope BF-XT40 (K023984)

Submission Summary (Full Text)

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6082720

# 510(k) SUMMARY

NOV - 5 2008

# TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004 and LF-Y0005

### September 8, 2008

#### 1 General Information

- 트 Applicant: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047 북 Official Correspondent: Stacy Abbatiello Kluesner, RAC
Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: [phone] Fax: [phone] Email:[e-mail] Establishment Registration No: 2429304

- Aizu Olympus Co., Ltd. Manufacturer: 500 Aza-Muranishi, Ooaza-lidera, Monden-cho, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No: 9610595
### Device Identification 2

월

| | Device Trade Name: | TRACHEAL INTUBATION FIBERVIDEOSCOPE<br>LF-Y0004 and LF-Y0005 |
|--|-----------------------|--------------------------------------------------------------|
| | Common Name: | TRACHEAL INTUBATION FIBERVIDEOSCOPE |
| | Regulation Number: | 21 CFR 874.4680 |
| | Regulation Name: | Bronchoscope (flexible or rigid) and accessories |
| | Regulatory Class: | II |
| | Classification Panel: | Ear Nose & Throat |
| | Product Code: | EOQ - Bronchoscope (Flexible Or Rigid) |

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### 3 Predicate Device Information

The following table shows the primary components of the subject devices and the devices to which we claim substantial equivalence (predicate devices).

| Table 14-1. Primary Components & Predicate Devices | | | | | | | |
|----------------------------------------------------|--|--|--|--|--|--|--|
|----------------------------------------------------|--|--|--|--|--|--|--|

| Subject Devices<br>(Part of this submission) | Predicate Devices | PD's<br>510(k) No. |
|-------------------------------------------------|---------------------------------------------------------------------------------------------|--------------------|
| TRACHEAL INTUBATION<br>FIBERVIDEOSCOPE LF-Y0004 | Olympus LF-DP Tracheal Intubation<br>Fiberscope | K981543 |
| TRACHEAL INTUBATION<br>FIBERVIDEOSCOPE LF-Y0005 | EVIS EXERA BRONCHOFIBERVIDEO<br>SCOPE OLYPUS BF TYPE XP160F<br>Olympus Bronchoscope BF-XT40 | K033225<br>K023984 |

#### Device Description ব

The TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004 and LF-Y0005 are all-in-one cordless endoscopes with great portability which include light source, video processor, and video monitor functions.

The new endoscopes are basically identical to each predicate device shown in Table 14-1 in intended use, and similar in specifications, performance and materials.

### ട് Indications for Use

These instruments have been designed to be used with a Suction Pump and EndoTherapy accessories and other ancillary equipment for airway management, which includes diagnosis, and observation endoscopic treatment. to access airway anatomy, endotracheal/endobronchial intubation and management.

### б Comparison of Technological Characteristics

The TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004 and LF-Y0005 are basically identical to the predicate device in intended use, and similar in specifications except for the all-in-one unit, outer diameter, and optical system. Comparison between the subject and predicate devices is shown in Table 14-2.

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Talions : TRACHEAL MTUBATION FIBERVIDEOSCOPE LE-Y0004 and LF-Y000
Trelicate Devices : TRACHEAL NEWS : Present : Prove and LE-Y000
Predicate Devices : TRACHEAL MTUBERVIOR

| Specifications | Subject Device<br>LF-Y0004 | Subject Device<br>LF-Y0005 | Predicate Device<br>LF-DP | Predicate Device<br>BF-XP160F | Predicate Device<br>BF-XT40 |
|----------------------------------------|------------------------------------------------------|------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------|-----------------------------------------------------------------------------------------|
| Field of View | 90° | 90° | 90° | 90° | 120° |
| Depth of Field | 4-50mm | 3-50mm | 3-50mm | 2-50mm | 3-50mm |
| Direction of View | 0° (Forward viewing) | 0° (Forward viewing) | 0° (Forward viewing) | 0° (Forward viewing) | 0°(Forward viewing) |
| Outer Diameter<br>of Distal End | φ3.9mm | φ5.1mm | φ3.1mm | φ2.8mm | φ6.1mm |
| Outer Diameter<br>of Insertion<br>Tube | φ4.1mm | φ5.2mm | φ3.1mm | φ2.8mm | φ6.2mm |
| Angulation<br>UP/DOWN | UP : 120°<br>DOWN : 120° | UP : 180°<br>DOWN : 130° | UP : 120°<br>DOWN : 120° | UP : 180°<br>DOWN : 130° | UP : 180°<br>DOWN : 130° |
| Working Length | 600mm | 600mm | 600mm | 600mm | 550mm |
| Source of<br>examination<br>light | These are built-in<br>functions of the<br>endoscope. | These are built-in<br>functions of the<br>endoscope. | External Light Source<br>Unit | External Light Source<br>Unit | External Light<br>Source Unit |
| Video<br>Processor | | | External Video System<br>Center Unit (when<br>connected via Video<br>Converter Unit) | External Video<br>System Center Unit | External Video<br>System Center Unit<br>(when connected<br>via Video Converter<br>Unit) |
| Monitor | | | External Video Monitor<br>Unit | External Video Monitor<br>Unit | External Video<br>Monitor Unit |

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# 7

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When compared to the predicate device, the TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004 and LF-Y0005 do not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.

:

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Olympus Medical System Corporation c/o Stacy Abbatiello Kluesner Olympus America, Inc 3500 Corporate Parkway P.O. Box 610 Center Valley, PA 18034

NOV - 5 2008

Re: K082720

Trade/Device Name: Tracheal Intubation Fiberscope LF-Y0004 and LF-Y0005 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: II Product Code: EOQ Dated: September 16, 2008 Received: September 23, 2008

Dear Ms. Kluesner:

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 - Stacy Abbatiello Kluesner

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 10(t) marketed predicate device results in a classification for your device and thus, perrorits 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Melvina B. Esguerra, M.D.

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

510(k) Number (if known):

Device Name: TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004, LF-Y0005 Indications For Use:

These instruments have been designed to be used with a Suction Pump and EndoTherapy accessories and other ancillary equipment for airway management, which includes endoscopic treatment, diagnosis, and observation to access airway anatomy, endotracheal/endobronchial intubation and management.

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)

Concur

(Division Sign-Off)

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

510(k) Number *K082720*

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