K Number

Device Name

OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190

Manufacturer

OLYMPUS MEDICAL SYSTEMS CORP.

Date Cleared

2012-04-20

(333 days)

Product Code

HET EOB EOQ FGB GCJ NWB

Regulation Number

884.1720

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K080948, K061313, K062049, K100584

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard video signal processing for image enhancement and display, but there is no mention of AI, ML, or any related technologies like deep learning or neural networks. The focus is on hardware and basic image processing for visualization.

Therapeutic

Yes
The device is described as being used for "endoscopic diagnosis, treatment and video observation," indicating that it is involved in therapeutic procedures.

Diagnostic

Yes

The "Intended Use / Indications for Use" section and the "Device Description" repeatedly state that the instrument, video system center, and light source are designed for "endoscopic diagnosis." This directly indicates its diagnostic purpose.

SaMD (Software as a Medical Device)

The device description clearly outlines hardware components like a flexible video endoscope, video system center, and light source. While software is mentioned for image processing, the device is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use clearly states the instrument is for "endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs." This involves direct visualization and potentially surgical intervention within the body.
Device Description: The device is described as a "flexible video endoscope" used for "endoscopy and endoscopic surgery." It works by illuminating, viewing, recording, and transmitting video data of endoscopic images.
Lack of In Vitro Activity: An IVD device is intended for use in the examination of specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such examination of specimens outside the body. It is used for direct visualization inside the body.

The device is an endoscopic system used for in vivo (within the living body) procedures, not in vitro (in glass/outside the body) diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

OLYMPUS LTF-S190-10 ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
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.

OLYMPUS OTV-S190 VISERA ELITE VIDEO SYSTEM CENTER
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.
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.

Product codes (comma separated list FDA assigned to the subject device)

HET, GCJ, FGB, EOQ, EOB and NWB

Device Description

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

thoracic and abdominal cavities including female reproductive organs

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K080948, K061313, K062049, K100584

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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

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's
510(k) No.	Manufacturer
OLYMPUS LTF-S190-10
LAPRO-THORACO
VIDEOSCOPE	HD EndoEYE
Laparo-Thoraco
Videoscope OLYMPUS
LTF Type VH	K080948	Aizu Olympus Co.,
Ltd.
500 Aza-Muranishi,
Ooaza-lidera,
Monden-cho,
Aizuwakamatsu-shi,
Fukushima, Japan
965-8520
Establishment
Registration No.:
9610595
OLYMPUS CLV-S190
VISERA ELITE XENON
LIGHT SOURCE	EVIS EXERA II XENON
LIGHT SOURCE
OLYMPUS CLV-180	K061313
K062049	SHIRAKAWA
OLYMPUS CO., LTD.
3-1,
OLYMPUS OTV-S190
VISERA ELITE VIDEO
SYSTEM CENTER	EVIS EXERA II XENON
LIGHT SOURCE
OLYMPUS CV-180	K061313
K062049
K100584	Aza-Ookamiyama,
Ooaza-Odakura,
Nishigo-mura,
Nishishirakawa-gun,
Fukushima, Japan
961-8061
Establishment
Registration
No: 3002808148

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

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.

- 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.

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

. Cytotoxicity test
Sensiization test �
Intracutaneous Reaction test .

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 :

· 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.

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

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

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

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

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