VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

K052452 · Olympus Medical Systems Corporation · EOB · Sep 21, 2005 · Ear, Nose, Throat

Device Facts

• Record ID: K052452
• Device Name: VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT
• Applicant: Olympus Medical Systems Corporation
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Sep 21, 2005
• 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 video system center, light source, documentation equipment, display monitor, and other therapy accessories, for observation within the nasal and nasopharyngeal lumens.

Device Story

The ENF-VT is a flexible rhino-laryngovideoscope used for visualization of nasal and nasopharyngeal lumens. It functions as an input device for an Olympus video system center, light source, and display monitor. Unlike its predecessor, the XENF-TP, which used a fiberscope, the ENF-VT utilizes a CCD-based imaging system to capture and transmit video signals to a monitor for clinician viewing. The device features a wider field of view, improved resolution, and a smaller instrument channel diameter. It is operated by a physician in a clinical setting to assist in diagnostic or therapeutic procedures. The output allows the clinician to visualize internal anatomy in real-time, facilitating clinical decision-making and procedural guidance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Flexible endoscope with CCD-based imaging system. Features include wider field of view, improved resolution, and smaller instrument channel diameter compared to predicate. Patient-contacting materials are identical to previous Olympus devices. System is designed for use with external video system center, light source, and display monitor. Sterilization/reprocessing methods are consistent with predicate.

Indications for Use

Indicated for observation within the nasal and nasopharyngeal lumens. Prescription use only.

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

• Rhino-Laryngofiberscope Olympus XENF-TP (K013591)

Submission Summary (Full Text)

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K652452

## SEP 2 1 2005

## 510(k) SUMMARY

# VISERA Rhino-Laryngovideoscope Olympus ENF type VT

August 26, 2005

#### General Information 1

| ■ Applicant | Olympus Medical Systems Corp.<br>2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507<br>Establishment Registration No.: 8010047 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ■ Official Correspondent | Laura Storms-Tyler<br>Executive Director,<br>Regulatory Affairs & Quality Assurance<br>Olympus America Inc.<br>Two Corporate Center Drive,<br>Melville, NY 11747-9058, USA<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail]<br>Establishment Registration No.: 2429304 |
| ■ Manufacturer | Aizu Olympus Co., Ltd.<br>500 Aza Muranishi, Oaza-Iidera, Monden-cho, |

500 Aza-Muranishi, Ooaza-lidera, Monden-cho,
Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No.: 9610595

#### Device Identification 2

| Device Name | VISERA Rhino-Laryngovideoscope Olympus ENF type VT |
|------------------------|-------------------------------------------------------|
| Common Name | Nasopharyngoscope |
| Regulation No: | 21 CFR 874.4760 |
| Regulation Name: | Nasopharyngoscope (flexible or rigid) and accessories |
| Regulatory Class: | II |
| Product Code: | EOB |
| Prescription Status: | Prescription device |
| Performance Standards: | None established under Section 514 of FDCA. |

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#### Predicate Device Information 3

| Device Name | Rhino-Laryngofiberscope Olympus XENF-TP |
|----------------|-----------------------------------------|
| 510(k) No: | K013591 |
| Decision Date: | 12/26/2001 |

#### Device Description ব

The VISERA Rhino-Laryngovideoscope Olympus ENF type VT, hereafter referred to as ENF-VT, is and The VISERA Knino-Laryngovicessope Olympos EN. Type V., Hersament within the nasal and nasopharyngeal lumens.

The modifications that were made are:

- Field of view is wider. l
- Instrument channel inner diameter is smaller. -
- Instrument changed to a CCD based system, allowing endoscopic image display on a video monitor.
- Improved resolution -
- Improved resolution
The subject device is not compatible with a miniature light source, whereas the predicate device -ાંડ
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### 5 Intended Use

This instrument has been designed to be used with an Olympus video system center, light souncent This institutient has been designed to be acou therapy accessories, and other and documentation equipment, alsployment within the nasal and nasopharyngeal lumens.

This intended use is identical to the predicate device, the Rhino-Laryngofiberscope Olympus XENF-TP.

#### Conclusion 6

The VISERA Rhino-Laryngovideoscope Olympus ENF type VT has the following similarities to the predicate device:

- The same intended use. ।
- The same operating principle except for the optical system. -
- The same reprocessing method. -
- The same basic endoscope design except for the optical system. -
- The same patient contacting materials as for the Olympus predicate devices. -

In summary, the ENF-VT described in this submission is, in our opinion, substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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SEP 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Olympus Medical Systems Corporation c/o Laura Storms-Tyler Executive Director Olympus America, Inc. Regulatory Affairs and quality Assurance Two Corporate Center Drive PO Box 9058 Melville, NY 11747-9058

Re: K052452

KU52432
Trade/Device Name: VISERA Rhino-Laryngovideoscope Olympus ENF type VT Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: September 1, 2005 Received: September 7, 2005

Dear Ms. Storms-Tyler:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained in the may arranger started in interests a referenced above and nave determined the arrest as a recess marketed in interstate for use stated in the enclosure) to legally manative provide in one of the Enderal Food. Device commerce prior to May 26, 1976, the encordance with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance while toproval applicians of the Act . The and Cosmetic Act (Act) that do not require approvial controls) provisions of the Act. The You may, therefore, market the device, seeject to since general registration, listing of
general controls provisions of the Act include requirements for annual registration, general controls provisions of the Fist list increases of the adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) this child be sites).
may be subject to such additional controls. Existing major regalation FDA may may be subject to such additional connolor Entrological of 898 In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Securer be found in the Code of Poderal Regarning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a but can and other requirements of the Act
that FDA has made a determination that your device complies with on must that FDA has made a decemination administered by other Federal agencies. You must or any Federal Statutes and regulations administers of a fimited to: registration and listing (21 l comply with all the Act Stequirements, morams manufacturing practice requirements as set CFK Part 807); labeling (21 CFR Part 800); god a frapplicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 app 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k)
The start of the same of the same of the same of your device to a legal This letter will allow you to begin marketing your artice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivales on the premarket notification. The FDA inding of substantial equivalians 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
rs the latest of the most of an 11 companses and the regulation entitled If you desire specific advice for your ac 1100 cm ... Also, please note the regulation entitled, and the regulation entitled, would contact the Office of Complance at (301) 627 07 (21CFR Patt 807.97). You may obtain " Misbranding by relerence to premarket notified.com < < t from the Division of Small
other general information on your responsibilities under the Act from the (800) 638-200 other general information on your responsionnes and its toll-fire number [phone] or
Manufacturers, International and Consumer Assistance of thindex html Manufacturers, International and Consumer Assistance at 10 % +
[phone] or at its Internet address http://www.fda.gov/cdrhindustry/support/index.html.

Sincerely yours,

David M. Whipple

Acting 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: VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

Indications For Use:

This instrument has been designed to be used with an Olympus video system center, light This instrument has been designed to be acost man and otherapy accessories, and other source, documentation equipment, display monitor, within the nasal and nasopharyngeal lumens.

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)

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