This instrument has been designed to be used with an OLYMPUS video system center, light source, documentation equipment, display monitor, strobe light source specified by OLYMPUS, and ancillary equipment for endoscopic diagnosis within the nasal lumens and airway anatomy.

Device Description

The subject device, the VISERA Rhino-Larvngovideoscope Olympus ENF type V is identical to the predicate device cleared in #K021073. This premarket notification is submitted to expand the intended use to add compatibility with strobe light sources specified by Olympus and change the applications from the nasal and nasopharyngeal lumens and airway and airway anatomy. Olympus specifies the Light Source Model 9100 B and 9100 C (#K921184) manufactured by Kay Elemetrics corp., for endoscopic diagnosis using the strobe light source.

AI/ML Overview

The provided document describes a 510(k) submission for the "VISERA Rhino-Laryngovideoscope Olympus ENF Type V". This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and detailed device performance data against those criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information cannot be extracted from the given text.

The document states:
"When compared to the predicate device, the ENF-V does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect safety and effectiveness. Therefore clinical data is not necessary for evaluation of safety and efficacy."

This indicates that the submission relies on the established safety and effectiveness of the predicate device and does not present new performance data from a specific study designed to meet new acceptance criteria. The device's compliance is primarily demonstrated through meeting voluntary safety standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-18) and ISO 10993-1 for materials, rather than a clinical performance study with the metrics you've requested.

Summary

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JUL 2 4 2003

SMDA 510(k) SUMMARY

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 Optical Co., Ltd. 34-3 Hirai Hinode-machi, Nishitama-gun, Tokyo, 190-0182 Japan (Registration Number: 3003637092)

2. Submission Correspondence

Olympus Optical Co., Ltd. 2951 Ishikawa-cho Hachioji-shi, Tokyo 192-8507, JAPAN TEL: +81-426-42-5129 FAX: +81-426-42-9979 (Registration Number: 8010047)

3. Official Correspondent

Tina Steffanie-Oak, Senior R.A. Analyst Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-3157 TEL: 631-844-5477 FAX: 631-844-5416 (Registration Number: 2429304)

B. DEVICE IDENTIFICATION

1. Common/Usual Name

RHINO-LARYNGOVIDEOSCOPE, its accessories and ancillary equipment

2. Device Name

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V, its accessories and ancillary equipment

3. Classification Name

CFR Number	Classification Name	Class	Product Code
874.4760	Nasopharyngoscope (flexible) andaccessories	II	EOB

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C. IDENTIFICATION OF LEGALLY MARKETED DEVICES WHICH WE CLAIM SUBSTANTIAL EQUIVALENCE

Model	510(k)#	Manufacturer	Class	ProductCode
VISERA Rhino-LaryngovideoscopeOlympus ENF type V	#K021073	Olympus Optical Co., Ltd.	II	EOB
EVIS EXERA BronchovideoscopeOlympus BF type 3C160	#K023984	Olympus Optical Co., Ltd.	II	EOQ

D. DEVICE DESCRIPTION

1. Summarv

2. Design

The VISERA Rhino-Larvngovideoscope Olympus ENF type V has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirement of IEC60601-1. IEC60601-1-1, IEC60601-1-2 and IEC60601-2-18.

3. Materials

All the patient contacting materials used in this endoscope and ancillary equipment are identical to those used in the devices cleared in the past 510(k) submissions. All materials have been confirmed with ISO 10993-1.

4. Intended Use of the device

5. Summary including conclusion drawn form Non-clinical Tests

When compared to the predicate device, the ENF-V does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect safety and effectiveness. Therefore clinical data is not necessary for evaluation of safety and efficacy.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them.

JUL 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Olympus Optical Co., Ltd. c/o Tina Steffanie-Oak, Senior R.A. Analyst Olympus America Inc. Two Corporate Center Dr. Melville, NY 11747

Re: K031648

Trade/Device Name: Visera Rhino-Laryngovideoscope Olympus ENF Type V Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: May 23, 2003 Received: May 28, 2003

Dear Ms. Steffanie-Oak:

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 - Tina Steffanie-Oak, Senior R.A. Analyst

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 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A halpi 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

Enclosure

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510(k) Number (if known): Not assigned yet_K 0 3 1 k 4 8 Device Name:

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109) ·

Over-The-Counter Use_

(Optional Format 1-2-96)

Keun A. Boles

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

510(k) Number K031658

Regulation Number and Section

§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.

(a)
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.(b)
Classification. Class II.