V1 SYSTEM

{0}------------------------------------------------ K111756 -/ # MAR 2 0 2012 # 510(k) SUMMARY # V1 SYSTEM #### 1 General Information ■ Applicant: I Official Correspondent: ● Manufacturer: #### Device Identification 2 - Device Trade Name: - 의 Common Name: 트 Regulation Number: ■ Regulation Name: ■ Regulatory Class: Classification Panel: ● Product Code: ■ OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047 Stacy Abbatiello Kluesner, M.S., RAC Regulatory 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 OLYMPUS MEDICAL SYSTEMS CORP. 34-3 Hirai, Hinode-machi, Nishitama-gun, Tokyo, JAPAN 190-0182 Establishment Registration Number: 3003637092 V1 SYSTEM Endoscopic Video Imaging System 21 CFR 876.1500 Endoscope and accessories ll Gastroenterology and urology FDF, FDS {1}------------------------------------------------ K111756 -2 #### 3 Predicate Device Information | Subject Device<br>(Part of this Submission) | Predicate Device | PD's<br>510(k)<br>No. | |----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------| | VIDEO SYSTEM CENTER OLYMPUS | EVIS EXERA II XENON LIGHT<br>SOURCE OLYMPUS CLV-180 | K100584 | | CV-V1 | EVIS EXERA II VIDEO SYSTEM<br>CENTER OLYMPUS CV-180 | K100584 | | GASTROINTESTINAL VIDEOSCOPE<br>OLYMPUS GIF-LV1 (Hereinafter referred | EVIS EXERA II GASTROINTESTINAL<br>VIDEOSCOPE OLYMPUS GIF TYPE<br>Q180 | K100584 | | COLONOVIDEOSCOPE OLYMPUS<br>CF- LV1L (Working Length: 1680mm)<br>and<br>CF-LV1I (Working Length: 1330mm) | EVIS EXERA II<br>COLONOVIDEOSCOPE<br>OLYMPUS CF TYPE Q180AL | K100584 | #### 4 Device Description ## V1 SYSTEM The primary components of the V1 SYSTEM consists of two Olympus colonovideoscopes; CF-LV1L and CF-LV11 (which are identical except for their working) lengths, an Olympus gastrointestinal videoscope; GIF-LV1 and a video system center. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract. The V1 SYSTEM is designed to be used with specified monitors, EndoTherapy accessories and other ancillary equipment. The primary components of the subject system, which are part of this submission, are: VIDEO SYSTEM CENTER OLYMPUS CV-V1 GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-LV1 COLONOVIDEOSCOPE OLYMPUS CF-LV1L COLONOVIDEOSCOPE OLYMPUS CF-LV11 ### CV-V1 CV-V1 can be used with Olympus endoscope models, such as gastorointestinal videoscope GIF-LV1 and colonovideoscope CF-LV1L/I. The subject premarket notification is specific for gastrointestinal videoscopes and colonovideoscopes. ## GIF-LV1, CF-LV1L/I The GIF-LV1, CF-LV1L/I can be used with VIDEO SYSTEM CENTER OLYMPUS CV-V1. The light source and the LG bundle are not used, instead, there are LEDs in the distal end of the scope that runs by electric power from the CV-V1 and light up the distal end. The newly designed one-touch connector is water proof. {2}------------------------------------------------ #### 5 Indications for Use ## VIDEO SYSTEM CENTER OLYMPUS CV-V1 This video system center is intend to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation. The indications include the applicability of endoscopy and endoscopic treatment. ### GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-LV1 This instrument is intended to be used with an Olympus video system center, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery and is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). #### COLONOVIDEOSCOPE OLYMPUS CF-LV1L and CF-LV1L This instrument is intended to be used with an Olympus video system center, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery and is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, and ileocecal valve). #### 6 Comparison of Technological Characteristics · The V1 SYSTEM is basically identical to the predicate device in intended use, and similar in specifications. #### Video System Center: When compared to the predicate device, the subject device has the similar technological features such as the video signal output, automatic gain control/ iris mode function and air feeding pump. There are differences in the input current and compatible endoscopes, however, these differences are considered as minor. #### Endoscope: When compared to the predicate device, the subject device has the similar technological features such as the depth of field, direction of forward view, bending section and inner diameter of instrument channel. There are differences in the field of view, lighting method and outer of distal end/ insertion tube, however, these differences are considered as minor. The following non-clinical test and usability studies were performed. {3}------------------------------------------------ K///756 -4 # 7 Substantially Equivalent Discussion The subject device, V1 SYSTEM, is a modification to LED lightning system. The indications for use, principles of operation and fundamental technology of the V1 SYSTEM are similar to the predicate devices. The maior difference from the predicate devices is lighting method as follow: - The subject device is provided LED in the endoscopes and the Video Processor is able to supply ー power for the LED. - The predicate device (K100584) has the light guide cable in endoscopes and the light source is able to supply light. The newly lighting method has been confirmed that the safety and effectiveness are equivalent i compare with the predicate devices. The CV-V1 and the GIF-LV1 and CF-LV1L/I are similar in method of operation and design as the predicate devices. In addition, similar or identical materials are used and biocompatibility results were provided. #### Summary of Non-Clinical Testing 8 The following non-clinical test and usability studies were performed. Basic safety and performance testing was performed in accordance with IEC 60601-1, 60601-1-1, 60601-1-2. 60601-2-18. In addition, verification and comparison studies were conducted to evaluate the mechanical and functional performance. Specially, test results in the following areas were provided. Biocompatibility Intracutaneous Reactivity Test.doc Cytotoxicity Study.doc Skin Sensitization Test.doc The following standards were used during the design and validation of the subject devices. 1) IEC 60601-1: 1988, A1: 1991, A2: 1995 2) IEC 60601-1-1: 2000, 3) IEC 60601-1-2: 2007 4) IEC 60601-2-18: 1996, A1: 2000 5) ISO 14971: 2007 - 6) ASTM E1837-96: 2007 7) ANSI/AAMI/ISO 11135-1: 2007 8) ISO 10993-1: 2009 9) ISO 10993-5: 2009 10) ISO 10993-10: 2002 11) ISO 10993-11: 2006 The risk analysis was carried out I 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 their risk analysis assessment. {4}------------------------------------------------ K111756 -5 # 9 Conclusion . When compared to the predicate device, the V1 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. 、 : {5}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 OLYMPUS MEDICAL SYSTEMS CORP. % Ms. Stacy Abbatiello Kluesner, M.S., RAC Project Manager Olympus America Inc. 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034 MAR 2 0 2012 Re: K111756 Trade/Device Name: V1 SYSTEM Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: February 24, 2012 Received: February 27, 2012 Dear Ms. Kluesner: 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 {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 R. Fisher, Ph.D. 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}------------------------------------------------ K111756 ## Indications for Use 510(k) Number (if known): Device Name: V1 SYSTEM Indications For Use: ## VIDEO SYSTEM CENTER CV-V1 This video system center is intend to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation. ## GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-LV1 This instrument is intended to be used with an Olympus video system center, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery and is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). ## COLONOVIDEOSCOPE OLYMPUS CF-LV1L and CF-LV11 This instrument is intended to be used with an Olympus video system center, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery and is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). 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) Heidi Leum Page 1 of 1 (Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number L11756