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

Device Description

The subject device is used for endoscopic diagnosis and treatment within the nasal and nasapharyngeal lumens. The optical system is modified from the image guide to CCD and the resolution is improved.

AI/ML Overview

The provided document is a 510(k) summary for the Olympus ENF Type V rhinolaryngovideoscope. It focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be expected for a device incorporating AI or complex computational analysis. Therefore, much of the requested information regarding AI-specific criteria and studies cannot be extracted from this document, as the device is a videoscope and not an AI-driven diagnostic system.

Here's the information that can be extracted and a clear indication of what is not present:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense of performance targets for a scientific study (e.g., sensitivity, specificity thresholds). Instead, it provides a comparative table of specifications between the subject device (ENF-V) and the predicate device (XENF-TP) to demonstrate substantial equivalence. The "acceptance" in this context is that the subject device meets or exceeds the relevant specifications of the predicate device.

Specifications	Acceptance Criteria (Predicate Device XENF-TP)	Reported Device Performance (Subject Device ENF-V)
Field of view	85°	90°
Direction of view	0° (Forward)	0° (Forward)
Depth of field	3-50 mm	5-50 mm
Insertion tube working length	365mm	365mm
Insertion tube outer diameter	$\phi$ 5.0mm	$\phi$ 3.9mm
Bending section angulation range	Up 130°, Down130°	Up 130°, Down130°
Total length	620mm	593mm
Optical system	Image guide	CCD
Resolution (Max, Minimum)	5.62 Lines/mm0.70 Lines/mm	12.6 Lines/mm12.6 Lines/mm

Summary of improved specifications for the subject device (ENF-V):

Wider field of view (90° vs 85°)
Shorter total length (593mm vs 620mm)
Improved optical system (CCD vs Image guide)
Significantly improved resolution (12.6 Lines/mm vs 5.62 Lines/mm Max and 0.70 Lines/mm Min)
Smaller insertion tube outer diameter ($\phi$ 3.9mm vs $\phi$ 5.0mm)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission focuses on device specifications and substantial equivalence, not a clinical study with a defined test set of patients or medical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. As there is no clinical study with a test set of data, there is no mention of experts establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. As there is no clinical study with a test set of data, there is no mention of an adjudication method.

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

This is a videoscope with an improved optical system, not an AI-assisted device. Therefore, an MRMC study related to AI assistance was not applicable and not performed.

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

This is not an AI algorithm. Therefore, a standalone performance evaluation of an algorithm was not applicable and not performed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document. The device itself is an imaging tool; the "ground truth" for its performance is related to its physical and optical specifications, not diagnostic labels derived from expert consensus, pathology, or outcomes data in a clinical study context for a diagnostic algorithm.

8. The sample size for the training set

This information is not provided in the document. This is not an AI-driven device, so there is no concept of a "training set" for an algorithm.

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

This information is not provided in the document. As there is no training set for an algorithm, the establishment of its ground truth is not applicable.

Summary

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MAY 0-1 2002

SMDA 510(k) SUMMARY

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V

A. Submitter's Name, Address, Phone and Fax Numbers

Name & Address of manufacturer:	Olympus Optical Co., Ltd.
	2-3-1 Shinjuku Monolis Nishi-Shinjuku,
	Shinjuku-ku Tokyo, Tokyo 163-0914
	Japan
Registration No.:	8010047
Address, Phone and Fax Numbers:	2951 Ishikawa-Cho,
	Hachioji-shi, Tokyo 192-8507
	Japan
	TEL 81-426-42-2891
	FAX 81-426-46-5613

B. Name of Contact Person

Name:	Laura Storms-Tyler
Address, Phone and Fax Numbers:	Olympus America Inc.Two Corporate Center DriveMelville, New York 11747-3157TEL: (631) 844-5688FAX: (631) 844-5416

C. Device Name, Common Name, Classification Name and Predicate Devices

Trade Name:	VISERA RHINO-LARYNGOVIDEOSCOPEOLYMPUS ENF-TYPE V
Common Name:	Nasopharyngoscope (flexible) and accessories
Classification:	21 CFR 874.4760 Nasopharyngoscope (flexible) andaccessories, Class II
Predicate Device:	XENF-TP (K# 013591)

D. Description of the Device(s)

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Following is the comparison table between the subject ENF-V and the predicate XENF-TP.

Specifications	Subject Device	Predicate Device
	ENF-V	XENF-TP
Field of view	90°	85°
Direction of view	0° (Forward)	0° (Forward)
Depth of field	5-50 mm	3-50 mm
Insertion tube working length	365mm	365mm
Insertion tube outer diameter	$\phi$ 3.9mm	$\phi$ 5.0mm
Bending section angulation range	Up 130°, Down130°	Up 130°, Down130°
Total length	593mm	620mm
Optical system	CCD	Image guide
Resolution (Max, Minimum)	12.6 Lines/mm12.6 Lines/mm	5.62 Lines/mm0.70 Lines/mm

ー

Field of view is wider. -
- Total length is shorter.
- Optical system is CCD which provides observation on a monitor.
Resolution is improved. -

The subject device, ENF-V, has the following similarities to the predicate device which has received 510(k) clearance.

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 body contacting materials 8

In summary, the subject device, ENF-V, described in this substantially equivalent to the predicate device_

E. Intended Use of the Device(s)

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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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest wings and a head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0-1 2002

Olympus America Inc. c/o Laura Storms-Tyler Two Corporate Center Drive Melville, NY 11747

Re: K021073

Trade/Device Name: Olympus ENF Type V Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible) and accessories Regulatory Class: Class II Product Code: EOB Dated: March 29, 2002 Received: March 2, 2002

Dear Ms. Storms-Tyler:

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 - Laura Storms-Tyler

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse of substantial equivalence of your device to a legally prematicate 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 (301) 594-4613. Additionally, for questions on the promotion and advertising of Compinance at (301) 29 - 1 t the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Ralph 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

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Indications for Use Statement

K021073 510(k) Number(if known): ___Not assigned yet. Device Name: YISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V

Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)	Analyst
	(Division Sign-Off)
	Division of Ophthalmic Ear, Nose and Throat Devices
Prescription Use	✓
(Prescription 21 CFR 801.109)	OR
	510(k) Number: K021073
	Over-The-Counter Use

(Optional Format 1-2-96)

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.