This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, therapy accessories, and other ancillary equipment for observation, diagnosis, and treatment within the nasal and nasopharyngeal lumens.

Device Description

The VISERA Rhino-Laryngovideoscope Olympus ENF type VT, hereafter referred to as ENF-VT, is a flexible endoscope intended for observation, diagnosis, and treatment within the nasal and nasopharyngeal lumens. The modifications from the predicate device are: Field of view is wider, Instrument channel inner diameter is smaller, Instrument changed to a CCD based system, allowing endoscopic image display on a video monitor, Improved resolution. The subject device is not compatible with a miniature light source, whereas the predicate device is.

AI/ML Overview

The provided 510(k) summary for the VISERA Rhino-Laryngovideoscope Olympus ENF type VT (K052452) does not contain specific acceptance criteria or details of a study that objectively proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

This 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device (Rhino-Laryngofiberscope Olympus XENF-TP, K013591). The assessment of substantial equivalence relies on demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate.

The "modifications" listed (wider field of view, smaller instrument channel, CCD-based system, improved resolution) are qualitative descriptions of changes, not quantifiable performance metrics with associated acceptance criteria. The claim of "improved resolution" is stated but without a specific benchmark or a study proving that improvement.

Therefore, I cannot populate most of the requested fields because the information is not present in the provided text.

Here's a breakdown of what can be inferred or is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
(Not explicitly defined in the document)	- Wider field of view - Smaller instrument channel inner diameter - Changed to a CCD based system - Improved resolution

Note: The "reported device performance" here refers to the qualitative description of the device's characteristics or changes from the predicate, not performance against specific acceptance metrics.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. This type of information is typically associated with clinical performance studies or specific technical validation tests involving patient data or objective measurements. The 510(k) emphasizes substantial equivalence based on design and intended use, not new clinical performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. This information would be relevant if a clinical study involving human assessment and ground truth establishment was conducted.

4. Adjudication method for the test set

Not applicable/Not provided. Similar to the above, adjudication methods are used in cases where multiple experts assess an outcome and consensus is needed for ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is a medical endoscope, not an AI-powered diagnostic tool. MRMC studies are not relevant to its type of submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/No. This device is a visual instrument for human operators, not an standalone algorithm.

7. The type of ground truth used

Not applicable. No specific "ground truth" (e.g., pathology, outcomes data) was used in a performance study for this 510(k) submission, as it relies on substantial equivalence.

8. The sample size for the training set

Not applicable/Not provided. The concept of a "training set" applies to machine learning models, which are not involved in this device's submission.

9. How the ground truth for the training set was established

Not applicable/Not provided. (See point 8).

In summary, this 510(k) focuses on demonstrating that the new endoscope, despite its technological updates (CCD, wider field of view, improved resolution), is substantially equivalent to a previously cleared device. The submission does not detail specific performance acceptance criteria or report on studies that would objectively quantify and prove performance against such criteria. For devices like this, the FDA typically reviews engineering specifications, bench testing results (which are not detailed here), and comparison to the predicate to ensure that the changes do not negatively impact safety or effectiveness.

Summary

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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.2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507Establishment Registration No.: 8010047
■ Official Correspondent	Laura Storms-TylerExecutive Director,Regulatory Affairs & Quality AssuranceOlympus America Inc.Two Corporate Center Drive,Melville, NY 11747-9058, USAPhone: 631-844-5688FAX: 631-844-5554Email: Laura.storms-tyler@olympus.comEstablishment Registration No.: 2429304
■ Manufacturer	Aizu Olympus Co., Ltd.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
،

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing movement or connection.

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 (800) 638-2041 or
Manufacturers, International and Consumer Assistance of thindex html Manufacturers, International and Consumer Assistance at 10 % +
(301) 443-6597 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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Kama Baha

510(k) Numb

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.