Who is the manufacturer of OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190?

Olympus Medical Systems Corp. filed the 510(k) submission for OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190 (K111425).

What is the FDA product code for OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190?

HET. It is classified under 21 CFR 884.1720 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190?

510(k) clearance (submission type: Traditional).

What are the predicate devices for OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190?

HD EndoEYE Laparo-Thoraco Videoscope OLYMPUS LTF Type VH (K080948); EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 (K061313, K062049); EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CV-180 (K061313, K062049, K100584).

Who can help prepare an FDA 510(k) submission like OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

K111425 · Olympus Medical Systems Corp. · HET · Apr 20, 2012 · Obstetrics/Gynecology

Device Facts

Record ID	K111425
Device Name	OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190
Applicant	Olympus Medical Systems Corp.
Product Code	HET · Obstetrics/Gynecology
Decision Date	Apr 20, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.1720
Device Class	Class 2

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.

Device Story

The Olympus Visera Elite system consists of the LTF-S190-10 deflectable videoscope, OTV-S190 video system center, and CLV-S190 xenon light source. The videoscope captures endoscopic images, which are transmitted to the video system center for processing, enhancement, and display on an HDTV monitor. The system is used by physicians in clinical settings for endoscopic diagnosis and surgery. The OTV-S190 processor provides image enhancement features including noise reduction, pre-freeze image capture, and NBI (Narrow Band Imaging) observation. The system supports documentation and video recording. The deflectable scope allows for navigation within thoracic and abdominal cavities. The light source provides illumination via a xenon lamp. The system benefits patients by providing high-definition visualization for minimally invasive procedures.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including mechanical durability, electrical safety, electromagnetic compatibility, thermal safety, Fog Free function performance, image quality/spectrum testing, and phototoxicity analysis. Biocompatibility testing (cytotoxicity, sensitization, intracutaneous reaction) was performed for new patient-contacting materials.

Technological Characteristics

System includes a deflectable videoscope, video processor, and xenon light source. Features include HDTV (16:9) output, NBI observation, and Fog Free function. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, ISO 10993, and ISO 14971. Software is classified as Minor Level of Concern. Sterilization includes steam sterilization. Connectivity via standard video plugs and light guide connectors.

Indications for Use

Indicated for patients undergoing endoscopic diagnosis or surgery within the thoracic and abdominal cavities, including female reproductive organs. Contraindicated for use in or near the heart.

Regulatory Classification

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.

Predicate Devices

HD EndoEYE Laparo-Thoraco Videoscope OLYMPUS LTF Type VH (K080948)
EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 (K061313, K062049)
EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CV-180 (K061313, K062049, K100584)

Related Devices

K112680 — EVIS EXERA III VIDEO SYSTEM · Olympus Medical Systems Corporation · Feb 16, 2012
K121959 — EVIS EXERA III VIDEO SYSTEM · Olympus Medical Systems Corp. · Jan 10, 2013
K051645 — EVIS EXERA 160A SYSTEM · Olympus Medical Systems Corporation · Oct 13, 2005
K100584 — EVIS EXERAII 180 SYSTEM · Olympus Medical Systems Corporation · Jul 2, 2010
K061313 — EVIS EXERA 180 SYSTEM · Olympus Medical Systems Corporation · Aug 31, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ - 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 . ll | 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 | {2}------------------------------------------------ #### Device Description ব 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. ### 5 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. {3}------------------------------------------------ #### 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 : {4}------------------------------------------------ - · 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. {5}------------------------------------------------ # 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 {6}------------------------------------------------ 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 {7}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K111425 Device Name: ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE Indications For 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. 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 {8}------------------------------------------------ # 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 {9}------------------------------------------------ # 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