Endoscopes (OLYMPUS BF-Q190, OLYMPUS BF-H190, OLYMPUS BF-1TH190 EVIS EXERA BRONCHOVIDEOSCOPE)
This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.
OLYMPUS CV-190 EVIS EXERAIII VIDEO SYSTEM CENTER
This video system center is intended to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
OLYMPUS CLV-190 EVIS EXERATI XENON LIGHT SOURCE
This light source is intended to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

Device Description

The EVIS EXERA III VIDEO SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

The primary components of the subject system, which are part of this submission, are:

Video System Center OLYMPUS CV-190
XENON LIGHT SOURCE OLYMPUS CLV-190
RENON ENOVIDEOSCOPE OLYMPUS BF-Q190, BF-H190, BF-H190, BF-1TH190

The CV-190 contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The OLYMPUS CV-190 allows image display on HDTV (16:9).

The XENON LIGHT SOURCE OLYMPUS CLV-190 is intended for endoscopic diagnosis, treatment and video observation.

In addition, both the CV-190 and CLV-190 can be used with any specified Olymous flexible and rigid including gastroscopes, ultrasound gastroscopes, duodenoscopes, endoscope models, colonoscopes, sigmoidscopes, choledochoscopes, rhino-laryngoscopes, tracheal intubation scopes, transnasal esophago scopes, hysteroscopes, cystoscopes, ureterorenoscopes, laparo-thoracoscopes.

The subject endoscopes are intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment.

AI/ML Overview

The provided document, K121959 for the EVIS EXERA III VIDEO SYSTEM, is a 510(k) premarket notification. This type of submission typically focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical trials with specific acceptance criteria and performance metrics for new or significantly altered functions.

Therefore, based on the provided text, I can extract information regarding non-clinical testing and general acceptance of safety and effectiveness through substantial equivalence, but I cannot provide a table of acceptance criteria and reported device performance related to a specific study proving those criteria, nor can I provide information on sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are not detailed in this type of regulatory submission.

Here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, a detailed table with specific performance metrics against acceptance criteria from a clinical study is not available in this 510(k) summary. The document states that "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment." However, the specific acceptance criteria and the numerical results of these design verification tests are not provided in the summary.

The primary method for demonstrating safety and effectiveness in this 510(k) is through substantial equivalence to predicate devices. The conclusion states: "When compared to the predicate device, the EVIS EXERA III VIDEO SYSTEM does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device."

2. Sample Sizes Used for the Test Set and Data Provenance

This information is not available in the provided document. The submission focuses on non-clinical testing and substantial equivalence, not clinical testing with a "test set" in the context of AI/algorithm performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not available in the provided document. As there is no "test set" described for performance evaluation, there is no mention of experts establishing ground truth.

4. Adjudication Method for the Test Set

This information is not available in the provided document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not available in the provided document. The device described is an endoscopic video imaging system, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable/available as the device is an imaging system, not a standalone algorithm.

7. The Type of Ground Truth Used

Based on the document, the "ground truth" for the device's acceptable performance is primarily established through:

Compliance with recognized standards: Such as IEC 60601-1, ISO 14971, ASTM E1837-96, ANSI/AAMI/ISO 11135-1, ISO 10993-1, ISO 10993-5, ISO 10993-10.
Risk analysis: "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007."
Design verification tests: The design verification tests and their acceptance criteria were identified and performed as a result of the risk analysis assessment.
Reprocessing validation: "Reprocessing validation was carried out in accordance with 'Labeling Reusable Medical Devices Reprocessing Vallaulton was camose of the FDA Reviewer Guidance - April 1996.'"
Software validation: "The software validation activities were performed in accordance with the FDA Guidance 'for the Contained of Premarket Submissions for Software Contained in Medical Devices.' The device software is considered a 'Minor Level of Concern.'"
Substantial Equivalence to Predicate Devices: The overall conclusion of the 510(k) is that the device is substantially equivalent to legally marketed predicate devices, implying its safety and effectiveness are comparable.

8. The Sample Size for the Training Set

This information is not available/applicable. The device is an endoscopic video system, not an AI algorithm that would typically have a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

This information is not available/applicable for the same reason as point 8.

Summary

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K121959

510(k) SUMMARY EVIS EXERA III VIDEO SYSTEM

JAN 1 0 2013

ENDOSCOPIC VIDEO IMAGING SYSTEM

January 8, 2013

1 General Information

OLYMPUS MEDICAL SYSTEMS CORP. 배 Applicant: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047 Laura Storms-Tyler Official Correspondent: 월 Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5688 FAX: 484-896-7128 Email: laura.storms-tyler@olympus.com (Endoscopes) 트 Manufacturer: Aizu Olympus Co , Ltd. 500 Aza-Muranishi, Ooaza-lidera, Monden-cho, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No .: 9610595 (CV-190, CLV-190) SHIRAKAWA OLYMPUS CO., LTD.3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura, Nishirakawa-gun, Fukushima, Japan 961-8061 Establishment Registration No: 3002808148

2 Device Identification

Device Trade Name:	EVIS EXERA III VIDEO SYSTEM
Common Name:	ENDOSCOPIC VIDEO IMAGING SYSTEM
Regulation Number:	874.4680876.1500
Regulation Name:	Bronchoscope (flexible or rigid) and accessoriesEndoscope and Accessories
Regulatory Class:	II

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Ear, Nose and Throat ■ Classification Panel:
EOQ and NWB 를 Product Code:

Predicate Device Information 3

Subject Device(Part of this submission)	Predicate Device	PD's510(k) No.	Manufacturer
OLYMPUS BF-Q190EVIS EXERA IIIBRONCHOVIDEOSCOPE	EVIS EXERA IIBRONCHOVIDEOSCOPEOLYMPUS BF TYPEP180,	K061313	Aizu Olympus Co.,Ltd.
OLYMPUS BF-H190EVIS EXERA IIIBRONCHOVIDEOSCOPE	EVIS EXERA IIBRONCHOVIDEOSCOPEOLYMPUS BF TYPEQ180,
OLYMPUS BF-1TH190EVIS EXERA IIIBRONCHOVIDEOSCOPE	EVIS EXERA IIBRONCHOVIDEOSCOPEOLYMPUS BF TYPE1T180
OLYMPUS CLV-190EVIS EXERA III XENONLIGHT SOURCE	EVIS EXERA Xenon LightOLYMPUSSourceCLV-160A	K051645	SHIRAKAWAOLYMPUS CO., LTD.3-1,
	EVIS EXERA II XENONLIGHT SOURCEOLYMPUS CLV-180	K061313 K062049 K100584
OLYMPUS CV-190EVIS EXERA III VIDEOSYSTEM CENTER	EVIS EXERA VideoSystem CenterOLYMPUS CV-160A	K051645
	EVIS EXERA II VIDEOSYSTEM CENTEROLYMPUS CV-180	K061313 K062049 K100584

Device Description 4

The primary components of the subject system, which are part of this submission, are:

Video System Center OLYMPUS CV-190
XENON LIGHT SOURCE OLYMPUS CLV-190
RENON ENOVIDEOSCOPE OLYMPUS BF-Q190, BF-H190, BF-H190, BF-1TH190

The CV-190 contains the video signal processing technology which enables the endoscope to

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illuminate, enhance, view, record and transmit video data of endoscopic images. The OLYMPUS CV-190 allows image display on HDTV (16:9).

The XENON LIGHT SOURCE OLYMPUS CLV-190 is intended for endoscopic diagnosis, treatment and video observation.

Indications for Use 5

Endoscopes (OLYMPUS BF-Q190, OLYMPUS BF-H190, OLYMPUS BF-1TH190 EVIS EXERAM BRONCHOVIDEOSCOPE)

This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

- OLYMPUS CV-190 EVIS EXERAIII VIDEO SYSTEM CENTER

This video system center is intended to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

- OLYMPUS CLV-190 EVIS EXERAIII XENON LIGHT SOURCE

This light source is intended to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

Comparison of Technological Characteristics હ

The CV-190 incorporates the following features that are different from the compared predicate device: (1) Provides high quality endoscopic image by using the subject device with new endoscopes and light sources, (2) Noise reduction, (3) Color correction, (4) Pre-freeze, (5) Brighter and more contrasted NBI observation, (6) Ethernet interface.

The CLV-190 incorporates the following features compared to the predicate device: (1) User friendly new connector, (2) Built-in type power fuse, (3) High-definition images, (4) IR absorbing filter removed.

The endoscopes contains the following features compared to the predicate device: (1) Light-guide

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and electronic-contact Integrated connector (2) Insertion function (3) Wider angulation range (4) Improved image quality (as a result of a new CCD)

Summary of non-clinical testing . 7

Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.

Reprocessing validation was carried out in accordance with "Labeling Reusable Medical Devices Reprocessing Vallaulton was camose of the FDA Reviewer Guidance - April 1996."

The software validation activities were performed in accordance with the FDA Guidance . for the Contained of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern."

The following standards have been applied to the EVIS EXERA II VIDEO SYSTEM:

· IEC 60601-1
· IEC 60601-1-1
· IEC 60601-2-18
· IEC 60601-1-2
· ISO 14971
· ASTM E1837-96
· ANSI/AAMI/ISO 11135-1
· ISO 10993-1
· ISO 10993-5
· ISO 10993-10

8 Conclusion

When compared to the predicate device, the EVIS EXERA III VIDEO SYSTEM does 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three wing-like shapes extending upwards and to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

January 10, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Laura Storms-Tyler Executive Vice President RA/QA Olympus America, Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610

Re: K121959

Trade Name: Evis Exera III Video System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOQ, NWB Dated: November 30, 2012 Received: December 3, 2012

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Laura Storms-Tyler

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eric A. Mann for

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): K121959 Device Name: EVIS EXERA III 190 SYSTEM

Indications For Use:

Endoscopes (OLYMPUS BF-Q190, OLYMPUS BF-H190, OLYMPUS BF-1TH190 EVIS EXERA BRONCHOVIDEOSCOPE) Ш

This instrument is intended to be used with an Olympus video system center, light source, rinst instration equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and documentation Cquipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

- OLYMPUS CV-190 EVIS EXERAIII VIDEO SYSTEM CENTER

This video system center is intended to be used with Olympus camera heads, endoscopes, light mis video bytion. endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

- OLYMPUS CLV-190 EVIS EXERATI XENON LIGHT SOURCE

This light source is intended to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

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)

(Division Sign-Off)
Division of Neurological and Physical
Medicine Devices
510(k) Number K121959

Page 1 of __ 1

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

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