This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.

This instrument must not to be used for observation or treatment of the heart and must not contact the heart or any area near the heart. In addition, this instrument must not come into contact with any device or therapeutic accessory that contacts the heart or any area near the heart.

This video system center has been designed 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.

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

Device Description

ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-10 is a flexible video endoscope used for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs which is basically identical to predicate device LTF-VH, for the same application area.

The subject device LTF-S190-10 is utilized with the OLYMPUS OTV-S190 VISERA ELITE VIDEO SYSTEM CENTER and OLYMPUS CLV-S190 VISERA ELITE XENON LIGHT SOURCE. The subject endoscope LTF-S190-10 connects to the VISERA ELITE XENON LIGHT SOURCE OLYMPUS CLV-S190 through the light guide connector and the video plugs into video system processors, OTV-S190.

The compatible VISERA ELITE VIDEO SYSTEM CENTER OLYMPUS OTV-S190 and VISERA ELITE XENON LIGHT SOURCE OLYMPUS CLV-S190 are intended for endoscopic diagnosis, treatment and video observation.

The OTV-S190 contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The OLYMPUS OTV-S190 allows image displav on HDTV (16:9).

In addition, both the OTV-S190 and CLV-S190 can be used with any specified Olymous flexible and rigid endoscope models, including rhino-laryngoscopes, tracheal intubation scopes, transnasal esophago scopes, hysteroscopes, cystoscopes, ureterorenoscopes, laparo-thoracoscopes.

AI/ML Overview

This document, K111425, describes the Olympus LTF-S190-10 ENDOEYE FLEX Deflectable Videoscope, OTV-S190 VISERA ELITE Video System Center, and CLV-S190 VISERA ELITE Xenon Light Source. These are medical devices used for endoscopy and endoscopic surgery. The submission focuses on demonstrating substantial equivalence to predicate devices rather than a standalone clinical study on novel performance claims.

Here's a breakdown of the requested information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to predicate devices, meaning the new device performs at least as well as the already approved predicate devices. The acceptance criteria for this type of submission are generally that the device meets safety and effectiveness requirements and is "substantially equivalent" in design, materials, and technological characteristics to a legally marketed predicate device.

The reported device performance, in this context, is that the subject devices are largely identical to their predicates, with some enhancements.

Acceptance Criteria (Demonstrates Substantial Equivalence)	Reported Device Performance (Summary of Differences/Improvements)
Intended Use: Identical to predicate device.	LTF-S190-10: Identical intended use.
Specifications: Similar to predicate device.	LTF-S190-10: Wider field of view, additional reprocessing method (steam sterilization), incorporation of Fog Free Function.
Safety and Effectiveness: No significant changes that affect safety or effectiveness.	OTV-S190: Improved high-quality endoscopic image (noise reduction, pre-freeze image capture, brighter/more contrasted NBI observation), incorporation of Fog Free Function.
Material: Identical to predicate device.	CLV-S190: Built-in power fuse, provides high-definition images when connected to OTV-S190 and LTF-S190-10, allows for brighter NBI image, no air feeding pump.
Design: Identical to predicate device.	No significant design changes affecting safety/effectiveness beyond those listed above.
Biocompatibility: Meets applicable standards.	Passed Cytotoxicity, Sensitization, Intracutaneous Reaction tests.
Software Validation: Meets FDA guidance.	Software validation performed; considered "Minor Level of Concern."
Bench Testing: Satisfies safety and performance.	Mechanical durability, electrical safety, EMC, thermal safety, Fog Free Function effectiveness/performance, image quality/spectrum testing, phototoxicity analysis tests completed.

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

The document does not describe a clinical "test set" in the traditional sense of patient data. The evaluation relies on bench testing and biocompatibility testing to demonstrate the safety and performance of the device's components and overall system.

Bench Test Samples: The specific sample sizes for mechanical durability, electrical safety, EMC, thermal safety, image quality, and phototoxicity analysis are not explicitly stated in this summary. These typically involve a number of units of the device or its components sufficient to demonstrate statistical confidence or compliance with specific testing standards.
Biocompatibility Samples: Samples of the new patient-contacting material were used for cytotoxicity, sensitization, and intracutaneous reaction tests. The exact number of samples or subjects (e.g., animals for sensitization/intracutaneous tests) is not specified in this summary.
Data Provenance: The bench tests and biocompatibility tests were conducted by the manufacturer, primarily in Japan given the company headquarters. The data is prospective in the sense that these tests were specifically performed for this 510(k) submission. There is no indication of external or retrospectively collected data.

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

This submission does not describe a clinical study with a "test set" that requires ground truth established by human experts for diagnostic accuracy or similar performance metrics. Instead, the evaluation is based on engineering and biocompatibility standards. Therefore, information on the number and qualifications of experts for ground truth establishment is not applicable to this type of submission.

4. Adjudication Method for the Test Set

Since there is no "test set" requiring human expert interpretation or consensus, an adjudication method is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described in this 510(k) summary. The submission focuses on substantial equivalence through bench testing, not on improved human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device is a hardware and software system for medical imaging and observation, not an AI algorithm intended for standalone diagnostic interpretation. Therefore, a "standalone algorithm performance" study is not applicable. The performance refers to the improved image quality and functional aspects of the videoscope and video system.

7. Type of Ground Truth Used

As mentioned, there isn't a "ground truth" derived from expert consensus, pathology, or outcomes data in the context of diagnostic accuracy. The "ground truth" for this submission is based on:

Engineering Standards: Compliance with established international and national standards (e.g., IEC 60601 series, ISO 14971, ASTM E1837-96, ANSI/AAMI/ISO 11135-1, ISO 10993 series) for electrical safety, EMC, mechanical durability, thermal safety, and image quality parameters.
Biocompatibility Test Results: Objective measurements from standardized cytotoxicity, sensitization, and intracutaneous reaction tests.
Functional Performance Specifications: Objective measurements demonstrating the performance of features like the "Fog Free Function" and image quality improvements.

8. Sample Size for the Training Set

This submission does not involve a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training set" concept is not applicable here.

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

As there is no training set for an AI algorithm, the method of establishing its ground truth is not applicable.

Summary

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K111425

510(k) SUMMARY

APR 2 0 2012

OLYMPUS LTF-S190-10 OLYMPUS OTV-S190 OLYMPUS CLV-S190 ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE VISERA ELITE VIDEO SYSTEM CENTER VISERA ELITE XENON LIGHT SOURCE

April 09, 2012

General Information 1

. Applicant:
OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047
. Official Correspondent:
Stacy Abbatiello Kluesner, M.S., RAC Requlatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5405 FAX: 484-896-7128

Email: stacy.kluesner@olympus.com

를 Manufacturer:

(LTF-S190-10) Aizu Olympus Co., Ltd. 500 Aza-Muranishi, Ooaza-lidera, Monden-cho, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No .: 9610595

(OTV-S190, CLV-S190) SHIRAKAWA OLYMPUS CO., LTD. 3-1. Aza-Ookamiyama, Ooaza-Odakura. Nishigo-mura,

Nishirakawa-qun, Fukushima, Japan 961-8061 Establishment Registration No: 3002808148

2 Device Identification

Device Trade Name:
OLYMPUS LTF-S190-10 OLYMPUS OTV-S190 OLYMPUS CLV-S190
. Common Name:
ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE VISERA ELITE VIDEO SYSTEM CENTER VISERA ELITE XENON LIGHT SOURCE

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I Regulation Number:
21 CFR 884.1720 21 CFR 876.1500 21 CFR 874.4680
트 Regulation Name:

Gynecologic laparoscope and accessories Endoscope and Accessories Bronchoscope (flexible or rigid) and accessories

■ Regulatory Class:

l Classification Panel:
General and plastic surgery, Obstetrics/Gynecology Ear Nose & Throat
Product Code: HET, GCJ, FGB, EOQ, EOB and NWB
.

3 Predicate Device Information
Subject Device(Part of this submission)	Predicate Device	PD's510(k) No.	Manufacturer
OLYMPUS LTF-S190-10LAPRO-THORACOVIDEOSCOPE	HD EndoEYELaparo-ThoracoVideoscope OLYMPUSLTF Type VH	K080948	Aizu Olympus Co.,Ltd.500 Aza-Muranishi,Ooaza-lidera,Monden-cho,Aizuwakamatsu-shi,Fukushima, Japan965-8520EstablishmentRegistration No.:9610595
OLYMPUS CLV-S190VISERA ELITE XENONLIGHT SOURCE	EVIS EXERA II XENONLIGHT SOURCEOLYMPUS CLV-180	K061313 K062049	SHIRAKAWAOLYMPUS CO., LTD.3-1,
OLYMPUS OTV-S190VISERA ELITE VIDEOSYSTEM CENTER	EVIS EXERA II XENONLIGHT SOURCEOLYMPUS CV-180	K061313 K062049 K100584	Aza-Ookamiyama,Ooaza-Odakura,Nishigo-mura,Nishishirakawa-gun,Fukushima, Japan961-8061EstablishmentRegistrationNo: 3002808148

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Device Description ব

The compatible VISERA ELITE VIDEO SYSTEM CENTER OLYMPUS OTV-S190 and VISERA ELITE XENON LIGHT SOURCE OLYMPUS CLV-S190 are intended for endoscopic diagnosis, treatment and video observation.

5 Indications for Use

- OLYMPUS LTF-S190-10 ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

- OLYMPUS OTV-S190 VISERA ELITE VIDEO SYSTEM CENTER

- OLYMPUS CLV-S190 VISERA ELITE XENON LIGHT SOURCE

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

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Comparison of Technological Characteristics 6

The OLYMPUS LTF-S190-10, OLYMPUS OTV-S190, OLYMPUS CLV-S190 are basically identical to the predicate device in intended use, and similar in specifications.

The subject LTF-S190-10 is nearly identical to the predicate LTF-VH device. It has identical spefications to the predicate device except for; (1) a wider field of view, (2) an additional reprocessing method (steam sterilization) and (3) incorpotion of a Fog Free Function.

Compared to the predicate device, the OTV-S190 incorporates the following features: (1) Provide an improved high quality endoscopic image and (2) incoropration of a Fog Free Function.

The improved endoscopic imaging during procedures is achieved by the following modifications; A) noise reduction, B) pre-freeze image capture and C) a brighter and more contrasted NBI observation.

The subject CLV-S190 has almost the same in design and function to its predicate CLV-180, and except as following features:

(1) Built-in type power fuse is incorporated

(2) Provides high-definition images when connected to the OTV-S190 and the LTF-S190-10 and

(3) Allow for a brighter NBI image

(4) The subject device does not have an air feeding pump.

7 Summary of non-clinical testing

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 analvsis assessment.

As a new patient contacting material was used, the following biocompatibility tests were performed on the subject endoscope in accordance with "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, Blue Book Memo, G95-13"

. Cytotoxicity test
Sensiization test �
Intracutaneous Reaction test .

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

The following bench tests were conducted to demonstrate the substaintal equivalence and safety and effectiveness of the subiect devices:

Mechanical durability testing .
Electrical safety testing .
Electromagnetic compatibility testing �
Thermal safety testing ●
Effectiveness / performance testing of Fog Free Function .
Image quality improvement / spectrum testing for multiple CCD �
Phototoxicity analysis testing .

The following standards have been applied to the subject VISERA ELITE SYSTEM :

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· IEC 60601-1
· IEC 60601-1-1
· IEC 60601-2-18
· IEC 60601-1-2
ISO 14971
ASTM E1837-96 (Reapproved 2007)
ANSI/AAMI/ISO 11135-1
· ISO 10993-1
· ISO 10993-5
ISO 10993-7
· ISO 10993-10
Light and Near-Infrared Radiation: TLV Physical Agents
· Ultraviolet Radiation: TLV Physical Agents

8 Conclusion

When compared to the predicate device, the OLYMPUS LTF-S190-10, OLYMPUS OTV-S190 and OLYMPUS CLV-S190 do not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device and therefore is Substantially Equivalent to the identified predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle.

Public Health Service

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

OLYMPUS MEDICAL SYSTEM CORP. % Ms. Sheri Musgnung Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034

APR 2 0 2012

Re: K111425

Trade/Device Name: ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE, VISERA ELITE VIDEO SYSTEM CENTER and VISERA ELITE XENON LIGHT SOURCE

Regulation Number: 21 CFR§ 884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: HET, GCJ, FGB, EOQ, EOB and NWB Dated: April 9, 2012 Received: April 17, 2012

Dear Ms. Musgnung:

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 I loase oc advised that I Dr Formstion that your device complies with other requirements of the Act that I Dri has Intact a and regulations administered by other Federal agencies. You must of any I cuchar statutes and regurements, including, but not limited to: registration and listing Comply with an the 110 110 1 2 1 2 1 2 1 2 1 2 3 1 3 0 1 3 1 2 1 2 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1

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Page 2-

device-related adverse events) (21 CFR 803); 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.

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,

Benjamin K. Tschopp

Benjamin R. Fisher. Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K111425

Device Name: ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE Indications For Use:

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 Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K111425

Page 3 of _ 1

222222
333333

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Indications for Use

510(k) Number (if known): Device Name: VISERA ELITE VIDEO SYSTEM CENTER Indications For Use:

This video system center has been designed to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, endo-therapy accessories 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)

uctive. Gastro-Re

Page 3 of 2

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Indications for Use

510(k) Number (if known): Device Name: VISERA ELITE XENON LIGHT SOURCE Indications For Use:

This light source has been designed 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)

Page 3 of 3

lome 772

ductive, Gastro-Renal, a

Regulation Number and Section

§ 884.1720 Gynecologic laparoscope and accessories.

(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.