Who is the manufacturer of EVIS EXERAII 180 SYSTEM?

Olympus Medical Systems Corporation filed the 510(k) submission for EVIS EXERAII 180 SYSTEM (K100584).

What is the FDA product code for EVIS EXERAII 180 SYSTEM?

NWB. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for EVIS EXERAII 180 SYSTEM?

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

What are the predicate devices for EVIS EXERAII 180 SYSTEM?

EVIS EXERA Xenon Light Source Olympus CLV-160A (K051645); EVIS EXERA Video System Center Olympus CV-160A (K051645); EVIS EXERA Gastrointestinal Videoscope XGIF-N160Y2 (K051645); EVIS EXERA Gastrointestinal Videoscope XGIF-Q160Y5 (K051645); EVIS EXERA Gastrointestinal Videoscope XGIF-H160Y2 (K051645); EVIS EXERA Colonovideoscope XCF-Q160W6L (K051645); EVIS EXERA Colonovideoscope XCF-H160AY2L (K051645); EVIS EXERA Colonovideoscope XPCF-Q160AY2L (K051645).

Who can help prepare an FDA 510(k) submission like EVIS EXERAII 180 SYSTEM?

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.

EVIS EXERAII 180 SYSTEM

K100584 · Olympus Medical Systems Corporation · NWB · Jul 2, 2010 · Gastroenterology, Urology

Device Facts

Record ID	K100584
Device Name	EVIS EXERAII 180 SYSTEM
Applicant	Olympus Medical Systems Corporation
Product Code	NWB · Gastroenterology, Urology
Decision Date	Jul 2, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180: 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. EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180: 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. EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180, OLYMPUS GIF TYPE XP180N: These instruments have been designed 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 transoral or transnasal endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, and duodenum). EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q180, OLYMPUS GIF TYPE H180: These instruments have been designed 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 within the upper digestive tract (including the esophagus, stomach, and duodenum). EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL, OLYMPUS CF TYPE Q180AI, OLYMPUS CF TYPE H180AL, OLYMPUS CF TYPE H180AI, OLYMPUS PCF TYPE Q180AL (Pediatric), OLYMPUS PCF TYPE Q180AI (Pediatric), OLYMPUS PCF TYPE H180AL (Pediatric), OLYMPUS PCF TYPE H180AI (Pediatric): These instruments have been designed 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 within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

Device Story

EVIS EXERA II 180 System comprises xenon light source (CLV-180), video system center (CV-180), and various flexible videoscopes (gastrointestinal/colonovideoscopes). System captures endoscopic images via CCD sensors in scopes; processes signals in CV-180 for display, recording, and transmission. CLV-180 provides white light or Narrow Band Imaging (NBI) via optical filter to enhance visualization of surface/capillary patterns. Used in clinical settings by physicians for diagnosis and treatment. Scope ID function enables automatic compatibility recognition. Output viewed on monitors to guide clinical decision-making, biopsy, or surgery. Benefits include improved visualization of mucosal structures and vasculature.

Clinical Evidence

No clinical trials conducted for this submission. Substantial equivalence based on bench testing and comparison to predicate devices. Clinical literature cited to support promotional claims regarding Barrett's esophagus, colorectal polyp detection, and histology prediction.

Technological Characteristics

System includes xenon short-arc lamp (300W), CCD-based imaging, and NBI optical filtering. CV-180 provides video processing (AGC, white balance, image enhancement). Connectivity via system/foot switch connectors. Class I electrical safety. Compatible with flexible/rigid endoscopes. Sterilization/reprocessing per standard endoscopic protocols.

Indications for Use

Indicated for endoscopic diagnosis, treatment, and video observation of the upper digestive tract (esophagus, stomach, duodenum) and lower digestive tract (anus, rectum, sigmoid colon, colon, ileocecal valve) in patients requiring endoscopic procedures.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

EVIS EXERA Xenon Light Source Olympus CLV-160A (K051645)
EVIS EXERA Video System Center Olympus CV-160A (K051645)
EVIS EXERA Gastrointestinal Videoscope XGIF-N160Y2 (K051645)
EVIS EXERA Gastrointestinal Videoscope XGIF-Q160Y5 (K051645)
EVIS EXERA Gastrointestinal Videoscope XGIF-H160Y2 (K051645)
EVIS EXERA Colonovideoscope XCF-Q160W6L (K051645)
EVIS EXERA Colonovideoscope XCF-H160AY2L (K051645)
EVIS EXERA Colonovideoscope XPCF-Q160AY2L (K051645)

Related Devices

K061313 — EVIS EXERA 180 SYSTEM · Olympus Medical Systems Corporation · Aug 31, 2006
K051645 — EVIS EXERA 160A SYSTEM · Olympus Medical Systems Corporation · Oct 13, 2005
K072957 — EVIS EXERA II 180 SYSTEM · Olympus Medical Systems Corporation · Mar 18, 2008
K112680 — EVIS EXERA III VIDEO SYSTEM · Olympus Medical Systems Corporation · Feb 16, 2012
K222584 — EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 · Olympus Medical Systems Corporation · Apr 26, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ K100584 JUL-- 2 2010 ## 510(k) SUMMARY # EVIS EXERA II 180 SYSTEM #### February 26, 2010 #### General Information 1 ■ Applicant: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Establishment Registration No.: 8010047 Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance Center Valley, PA 18034-0610, USA Email: stacy.kluesner@olympus.com Olympus America Inc. 3500 Corporate Parkway Phone: 484-896-5405 FAX: 484-896-7128 PO Box 610 Official Correspondent: . 월 Manufacturer: Light source/Video system center: Gastrointestinal videoscope/ Colonovideoscope: Shirakawa Olympus Co., Ltd. 3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura, Nishirakawa-gun, Fukushima, Japan 961-8061 Aizu Olympus Co., Ltd. 500 Aza-Muranishi, Ooaza-lidera, Monden-cho. Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No .: 9610595 Establishment Registration No.: 3002808148 #### 2 Device Identification ■ Device Trade Name: Common Name: 올리 ■ Regulation Number: ■ Regulation Name: 를 Regulatory Class: - l Classification Panel: - Product Code: EVIS EXERA II 180 SYSTEM Endoscopic Video Imaging System 21 CFR 876.1500 Endoscope and accessories II Gastroenterology/Urology NWB, FDF, FDS {1}------------------------------------------------ ### 3 Legally Marketed Device to which Substantial Equivalence is Claimed The following table shows the primary components (part of this submission) of the EVIS EXERA II 180 SYSTEM and each device to which we claim substantial equivalence (predicate device). | Table 16-1 Primary Components & Predicate Devices of the EVIS EXERA II 180 SYSTEM | | | |--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-----------------------| | Subject Device (Part of this Submission) | Predicate Device | PD's 510(k) No. | | EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 (Hereinafter referred to as CLV-180) (K061313, K062049) | EVIS EXERA Xenon Light Source Olympus CLV-160A | K051645 | | EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 (Hereinafter referred to as CV-180) (K061313, K062049) | EVIS EXERA Video System Center Olympus CV-160A | K051645 | | EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180 (Hereinafter referred to as GIF-N180) | EVIS EXERA Gastrointestinal Videoscope XGIF-N160Y2 | K051645 | | EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE XP180N (Hereinafter referred to as GIF-XP180N) | EVIS EXERA Gastrointestinal Videoscope XGIF-N160Y2 | K051645 | | EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q180 (Hereinafter referred to as GIF-Q180) | EVIS EXERA Gastrointestinal Videoscope XGIF-Q160Y5 | K051645 | | EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180 (Hereinafter referred to as GIF-H180) | EVIS EXERA Gastrointestinal Videoscope XGIF-H160Y2 | K051645 | | EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL (Hereinafter referred to as CF-Q180AL) | EVIS EXERA Colonovideoscope XCF-Q160W6L | K051645 | | EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AI (Hereinafter referred to as CF-Q180AI) | EVIS EXERA Colonovideoscope XCF-Q160W6L | K051645 | | EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AL (Hereinafter referred to as CF-H180AL) | EVIS EXERA Colonovideoscope XCF-H160AY2L | K051645 | | EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AI (Hereinafter referred to as CF-H180AI) | EVIS EXERA Colonovideoscope XCF-H160AY2L | K051645 | | EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180AL (Hereinafter referred to as PCF-Q180AL) | EVIS EXERA Colonovideoscope XPCF-Q160AY2L | K051645 | | EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AL (Hereinafter referred to as PCF-H180AL) | EVIS EXERA Colonovideoscope XPCF-Q160AY2L | K051645 | | EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AI (Hereinafter referred to as PCF-H180AI) | EVIS EXERA Colonovideoscope XPCF-Q160AY2L | K051645 | 1 2 . i {2}------------------------------------------------ #### Device Description ব The EVIS EXERA II 180 SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract. The primary components of the subject system, which are part of this submission, are: - EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 - EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 - EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180 - EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE XP180N . - EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q180 . - EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180 트 - EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL I - EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AI . - EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AL - EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AI - . EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180AL (PEDIATRIC) - EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180AI (PEDIATRIC) 1 - EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AL (PEDIATRIC) u - EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AI (PEDIATRIC) The EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 is intended for endoscopic diagnosis, treatment and video observation. The CLV-180 is substantially identical to the predicate device, EVIS EXERA Xenon Light Source CLV-160A cleared under K051645 except that the device size has been slightly changed. The CLV-180 has an optional filter which allows the user to enhance endoscopic white light images by selective processing of green and blue light. This feature, referred to as Narrow Band Imaging (NBI), employs an optical filter to filter the white light spectrum, changing it from a broad band to a narrow band. The user can select eihter the standard obsevation mode by pressing the scope switch on the scope or the filter mode switch on the CLV-180. In comparison to conventional white light observation, NBI observation provides the greater contrast of the surface and fine capillary patterns of the mucous membranes. The EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 is a video processing system intended for use with Olympus endoscopes such as the subject gastrointestinal videoscopes and colonovideoscopes. The CV-180 contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The CV-180 is identical to the predicate device, EVIS EXERA Video System Center CV-160A, cleared under K051645 except that the device size has been slightly changed. {3}------------------------------------------------ videoscopes and colonovideoscopes. TThe CV-180 contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The CV-180 is identical to the predicate device, EVIS EXERA Video System Center CV-160A, cleared under K051645 except that the device size has been slightly changed. The CV-180 incorporates the following features: 1. The CV-180 is compatible with any specified Olympus flexible, both video and fiberoptic, and rigid endoscopes. 2. The CV-180 processes the NBI image, generated by the CLV-180 light source and captured by the endoscope's Charged Coupled Device (CCD), creating an enhanced image of the tissue's vasculature. Both the CLV-180 and CV-180 can be used with any specified Olympus flexible and rigid endoscope models, including gastroscopes, ultrasound gastroscopes, duodenoscopes, colonoscopes, sigmoidscopes, choledochoscopes, rhino-laryngoscopes, tracheal intubation scopes, transnasal esophago scopes, hysteroscopes, cystoscopes, ureterorenoscopes, laparo-thoracoscopes for conventional white light endoscopy. TThe subject premarket notification is specific for gastrointestinal videoscopes and colonovideoscopes. Additionally, when they are combined with the subject endoscopes, both an endoscopic image by white light illumination and that by NBI illumination can be obtained. The user can select either the NBI mode or normal light mode by pressing the scope switch on the scope or the filter mode switch on the CLV-180; the NBI filter in the CLV-180 is inserted on the light axis when the NBI mode is selected. The subject endoscopes are basically identical to each Olympus predicate device shown in Table 16-1 in intended use, and similar in specifications, performance and materials. The CV-180 identifies an NBI-compatible scope when it is connected by using the Scope ID function provided with the scopes .. #### 5 Indications for Use . . #### EVIS EXERA II XENON LIGHT SQURCE OLYMPUS CLV-180 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. ### EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 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. ### EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180, OLYMPUS GIF TYPE XP180N These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy {4}------------------------------------------------ and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, and duodenum). EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL, OLYMPUS CF TYPE Q180AI, OLYMPUS CF TYPE H180AL, OLYMPUS CF TYPE H180AI, OLYMPUS PCF TYPE Q180AL (Pediatric), OLYMPUS PCF TYPE Q180Al (Pediatric), OLYMPUS PCF TYPE H180AL (Pediatric), OLYMPUS PCF TYPE H180AI (Pediatric) These instruments have been designed 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 within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). #### Comparison of Technological Characteristics હ Each primary components of the EVIS EXERA II 180 SYSTEM is basically identical to its predicate device in intended use, and similar in specifications. Comparison between the subject and predicate devices is shown in Table 16-2 to 16-11. The clinical literatures provided in this submission support new sales promotional claims for Barrett's esophagus, colorectal polyp detection and histology prediction. #### Table 16-2 Comparison of Specifications ### Subject Device: EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 ~ Predicate Device: EVIS EXERA Xenon Light Source Olympus CLV-160A (K051645) | Specifications | Subject Device CLV-180 | Predicate Device CLV-160A | |--------------------------------|---------------------------------------|----------------------------------------------| | Power Supply | 100-120V AC ±10%, 50/60 Hz ± 1Hz | 100-240V AC±10%, 50/60 Hz ± 1Hz | | Over-current Protection | Identical to the Predicate Device | Fuse type | | Input Current | Identical to the Predicate Device. | 500VA (at observation) | | Size | 383(W)×162(H)×536(D)mm | 381(W)×162(H)×536(D)mm | | Weight | Identical to the Predicate Device | 15.4kg | | Compatible Endoscopes | Identical to the Predicate Device | Videoscope Fiberscope Rigid scope | | Examination Lamp | Identical to the Predicate Device | Xenon short-arc lamp (ozone-free)300W | | Average Lamp Life | Identical to the Predicate Device | Approximately 500 hours of continuous use | | Emergency Lamp | Identical to the Predicate Device | Halogen lamp 12V 35W | | Average Emergency Lamp Life | Identical to the Predicate Device | Approximately 500 hours | | NBI Filter | Identical to the Predicate Device | Provided | | Brightness Control | Identical to the Predicate Device | Automatic and Manual | | Automatic Exposure | Identical to the Predicate Device | 17 steps | | Photography Function | Identical to the Predicate Device | Not provided. | | Air Feeding | Identical to the Predicate Device | 4 levels available (off, low, mid | 5/12 {5}------------------------------------------------ | | Emergency Lamp | Identical to the Predicate Device | Halogen lamp 12V 35W | |--|-------------------------------------------------------------------|-----------------------------------|--------------------------------------------------------| | | Average Emergency Lamp Life | Identical to the Predicate Device | Approximately 500 hours | | | NBI Filter | Identical to the Predicate Device | Provided | | | Brightness Control | Identical to the Predicate Device | Automatic and Manual | | | Automatic Exposure | Identical to the Predicate Device | 17 steps | | | Photography Function | Identical to the Predicate Device | Not provided. | | | Air Feeding | Identical to the Predicate Device | 4 levels available (off, low, mid, high) | | | Air Feeding Pump | Identical to the Predicate Device | Diaphragm type pump | | | System Connector | Identical to the Predicate Device | Provided | | | Foot Switch Connector | Identical to the Predicate Device | Provided | | | CV Connector | Identical to the Predicate Device | Provided | | | Cooling Air Direction | Identical to the Predicate Device | Rear | | | Type of Protection against Electric Shock | Identical to the Predicate Device | Class I | | | Degree of Protection against Electric Shock of Applied Part | Identical to the Predicate Device | TYPE BF or CF applied part (Depend on applied part) | | | Applicable Standard | Identical to the Predicate Device | UL60601-1 | . and the comments of the comments of the comments of the comments of : : 100 - 100 - ... . · · · : 6/12 : . . . . . . . . . - - - {6}------------------------------------------------ ## Table 16-3 Comparison of Specifications (1/2) Subject Device: EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 Predicate Device: EVIS EXERA Video System Center Olympus CV-160A (K051645) . | Specifications | | Subject Device CV-180 | Predicate Device CV-160A | |----------------------------------------------------------------|---------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Power Supply | | Identical to the Predicate Device | 100-240V AC±10%, 50/60 Hz ± 1Hz | | Over-current Protection | | Identical to the Predicate Device. | Fuse type | | Input Current | | Identical to the Predicate Device. | 150VA | | Size | | 382(W)×91(H)×490 (D) mm | 370(W)×91(H)×462 (D)mm | | Weight | | 10 kg | 10.6 kg | | Compatible Endoscopes | | Identical to the Predicate Device. | · Fiber/rigid scope via camera head · Videoscope | | | Video Signal Output | Identical to the Predicate Device. | RGB:3 Y/C:4 VBS:4 HDTV:1 | | Observation | Auto White Balance | Identical to the Predicate Device. | Automatically adjusted using the white balance switch. At the time of connection with the scope in which Scope ID is provided, compensation is performed automatically. | | | Standard Color Chart Output | Identical to the Predicate Device. | Color bar image | | | Color Tone Adjustment | Identical to the Predicate Device. | R: ±8 steps B: ±8 steps CHROMA: ±8steps | | | Automatic Gain Control (AGC) | Identical to the Predicate Device. | Provided | | | Image Enhancement | Identical to the Predicate Device. | Edge enhancement: [OFF] [Low] [Med] [High] 4 levels available Structure enhancement:[OFF] [Low] [Med] [High] 4 levels available | | | Iris Mode Selection | Identical to the Predicate Device. | AUTO/PEAK EXPOSURE Electrical shutter | | | Optical Zoom | Identical to the Predicate Device. | ×1/×1.2 /×1.5: 3-Mode | | | NBI Observation | Identical to the Predicate Device. | NBI function | | | Picture in Picture | Identical to the Predicate Device. | The image of an external device connected to this instrument is displayed on the main monitor together with the endoscopic image. | | Communication with Scope | | Identical to the Predicate Device. | Provided | | Foot Switch Connector | | Identical to the Predicate Device. | Provided | | Specifications | Subject Device CV-180 | Predicate Device CV-160A | | | Record to Memory Card | Identical to the Predicate Device. | Provided | | | Type of Protection against Electric Shock | Identical to the Predicate Device. | Class I | | | Degree of Protection against Electric Shock of Applied Part | Identical to the Predicate Device. | TYPE BF or CF applied part (Depend on applied part) | | | Applicable Standard | Identical to the Predicate Device. | UL60601-1 | | . 1000 . . . . - {7}------------------------------------------------ ### Table 16-3 Comparison of Specifications (Continued, 2/2) Subject Device: EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 Predicate Device: EVIS EXERA Video System Center Olympus CV-160A (K051645) # Table 16-4 Comparison of Specifications Subject Device: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-N180 # Predicate Device: EVIS EXERA Gastrointestinal Videoscope XGIF-N160Y2 (K051645) | Specifications | Subject Device GIF-N180 | Predicate Device XGIF-N160Y2 | |-----------------------------------------|-----------------------------------|---------------------------------| | Field of View | Identical to the Predicate Device | 120° | | Depth of Field | Identical to the Predicate Device | 3-100mm | | Direction of Forward View | Identical to the Predicate Device | 0° | | Type of CCD | Identical to the Predicate Device | Color | | Outer Diameter of Distal End | Identical to the Predicate Device | 4.9mm | | Outer Diameter of Insertion Tube | Identical to the Predicate Device | 4.9mm | | Bending Section Angulation | Identical to the Predicate Device | UP: 210° DOWN: 120° | | Working Length | Identical to the Predicate Device | 1100mm | | Inner Diameter of Instrument Channel | Identical to the Predicate Device | 2.0mm | . · . {8}------------------------------------------------ # Table 16-5 Comparison of Specifications Subject Device: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-XP180N | Specifications | Subject Device GIF-XP180N | Predicate Device XGIF-N160Y2 | |-----------------------------------------|----------------------------------------------------|---------------------------------| | Field of View | Identical to the Predicate Device | 120° | | Depth of Field | Identical to the Predicate Device | 3-100mm | | Direction of Forward View | Identical to the Predicate Device | 0° | | Type of CCD | Identical to the Predicate Device | Color | | Outer Diameter of Distal End | 5.5mm | 4.9mm | | Outer Diameter of Insertion Tube | 5.5mm | 4.9mm | | Bending Section Angulation | UP: 210° DOWN: 90° RIGHT: 100° LFFT: 100° | UP: 210° DOWN: 120° | | Working Length | Identical to the Predicate Device | 1100mm | | Inner Diameter of Instrument Channel | Identical to the Predicate Device | 2.0mm | #### Predicate Device: EVIS EXERA Gastrointestinal Videoscope XGIF-N160Y2 (K051645) #### Table 16-6 Comparison of Specifications ### Subject Device: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-Q180 Predicate Device: EVIS EXERA Gastrointestinal Videoscope XGIF-Q160Y5 (K051645) | Specifications | Subject Device GIF-Q180 | Predicate Device XGIF-Q160Y5 | |-----------------------------------------|-----------------------------------|----------------------------------------------------| | Field of View | Identical to the Predicate Device | 140° | | Depth of Field | Identical to the Predicate Device | 3-100mm | | Direction of Forward View | Identical to the Predicate Device | 0° | | Type of CCD | Identical to the Predicate Device | Color | | Outer Diameter of Distal End | Identical to the Predicate Device | 8.8mm | | Outer Diameter of Insertion | Identical to the Predicate Device | 8.8mm | | Bending Section Angulation | Identical to the Predicate Device | UP: 210° DOWN: 90° RIGHT: 100° LEFT: 100° | | Working Length | Identical to the Predicate Device | 1030mm | | Inner Diameter of Instrument Channel | Identical to the Predicate Device | 2.8mm | . . {9}------------------------------------------------ #### Table 16-7 Comparison of Specifications Subject Device: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-H180 Predicate Device: EVIS EXERA Gastrointestinalvideoscope XGIF-H160Y2 (K051645) | Specifications | Subject Device | Predicate Device | |-----------------------------------------|-----------------------------------|----------------------------------------------------| | | GIF-H180 | XGIF-H160Y2 | | Field of View | Identical to the Predicate Device | 140° | | Depth of Field | Identical to the Predicate Device | 2-100mm | | Type of CCD | Identical to the Predicate Device | Color | | Outer Diameter of Distal End | Identical to the Predicate Device | 9.8mm | | Outer Diameter of Insertion Tube | Identical to the Predicate Device | 9.8mm | | Bending Section Angulation | Identical to the Predicate Device | UP: 210° DOWN: 90° RIGHT: 100° LEFT: 100° | | Working Length | Identical to the Predicate Device | 1030mm | | Inner Diameter of Instrument Channel | Identical to the Predicate Device | 2.8mm | ### Table 16-8 Comparison of Specifications Subject Device: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE CF-Q180AL, CF-Q180Al #### Predicate Device: EVIS EXERA Colonovideoscope XCF-Q160W6L (K051645) | Specifications | Subject Device CF-Q180AL, CF-Q180AI | Predicate Device XCF-Q160W6L | |-----------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------| | Field of View | Identical to the Predicate Device | 170° | | Depth of Field | Identical to the Predicate Device | 3-100mm | | Direction of Forward View | Identical to the Predicate Device | 0° | | Type of CCD | Identical to the Predicate Device | Color | | Outer Diameter of Distal End | Identical to the Predicate Device | 13.2mm | | Outer Diameter of Insertion Tube | Identical to the Predicate Device | 12.8mm | | Bending Section Angulation | Identical to the Predicate Device | UP: 180° DOWN: 180° RIGHT: 160° LEFT: 160° | | Working Length | CF-Q180AL: Identical to the Predicate Device CF-Q180AI: 1330mm | 1680mm | | Inner Diameter of Instrument Channel | Identical to the Predicate Device | 3.7mm | | Flexibility of Insertion Tube | Identical to the Predicate Device | Adjustable by the user. | . : {10}------------------------------------------------ ### Table 16-9 Comparison of Specifications Subject Device: EVIS EXERA II COLONOVIDEOSCOPE CF-H180AL, CF-H180AI Predicate Device: EVIS EXERA Colonovideoscope XCF-H160AY2L (K051645) | Specifications | Subject Device CF-H180AL, CF-H180AI | Predicate Device XCF-H160AY2L | |-----------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------| | Field of View | Identical to the Predicate Device | 170° | | Depth of Field | Identical to the Predicate Device | 2 -100mm | | Direction of Forward View | Identical to the Predicate Device | 0° | | Type of CCD | Identical to the Predicate Device | Color | | Outer Diameter of Distal End | Identical to the Predicate Device | 13.9mm | | Outer Diameter of Insertion Tube | Identical to the Predicate Device | 12.8mm | | Bending Section Angulation | Identical to the Predicate Device | UP: 180° DOWN: 180° RIGHT: 160° LEFT: 160° | | Working Length | CF-H180AL: Identical to the Predicate Device CF-H180AI: 1330mm | 1680mm | | Inner Diameter of Instrument Channel | Identical to the Predicate Device | 3.7mm | | Flexibility of Insertion Tube | Identical to the Predicate Device | Adjustable by the user. | ### Table 16-10 Comparison of Specifications Subject Device: EVIS EXERA II COLONOVIDEOSCOPE PCF-Q180AL, PCF-Q180AI Predicate Device: EVIS EXERA Colonovideoscope XPCF-Q160AY2L (K051645) . .. : 【 . | Specifications | Subject Device | Predicate Device | |-----------------------------------------|--------------------------------------------------|-----------------------------------------------------| | | PCF-Q180AL, PCF-Q180AI | XPCF-Q160Y2L | | Field of View | Identical to the Predicate Device | 140° | | Depth of Field | Identical to the Predicate Device | 3-100mm | | Direction of Forward View | Identical to the Predicate Device | 0° | | Type of CCD | Identical to the Predicate Device | Color | | Outer Diameter of Distal End | Identical to the Predicate Device | 11.3mm | | Outer Diameter of Insertion Tube | Identical to the Predicate Device | 11.5mm | | Bending Section Angulation | Identical to the Predicate Device | UP: 180° DOWN: 180° RIGHT: 160° LEFT: 160° | | Working Length | PCF-Q180AL: Identical to the Predicate Device | 1680mm | | | PCF-Q180AI: 1330mm | | | Inner Diameter of Instrument Channel | Identical to the Predicate Device | 3.2mm | | Flexibility of Insertion Tube | Identical to the Predicate Device | Adjustable by the user. | {11}------------------------------------------------ ### Table 16-11 Comparison of Specifications Subject Device: EVIS EXERA II COLONOVIDEOSCOPE PCF-H180AL, PCF-H180AI Predicate Device: EVIS EXERA Colonovideoscope XPCF-Q160AY2L (K051645) | Specifications | Subject Device | | Predicate Device | |-----------------------------------------|------------------------------------------------------------------------|-----------------------------------------------------|------------------| | | PCF-H180AL, PCF-H180AI | | XPCF-Q160Y2L | | Field of View | Identical to the Predicate Device | 140° | | | Depth of Field | 2-100mm | 3-100mm | | | Direction of Forward View | Identical to the Predicate Device | 0° | | | Type of CCD | Identical to the Predicate Device | Color | | | Outer Diameter of Distal End | 11.7mm | 11.3mm | | | Outer Diameter of Insertion Tube | 11.8mm | 11.5mm | | | Bending Section Angulation | Identical to the Predicate Device | UP: 180° DOWN: 180° RIGHT: 160° LEFT: 160° | | | Working Length | PCF-H180AL: Identical to the Predicate Device PCF-H180AI: 1330mm | 1680mm | | | Inner Diameter of Instrument Channel | Identical to the Predicate Device | 3.2mm | | | Flexibility of Insertion Tube | Identical to the Predicate Device | Adjustable by the user. | | ## 7 Conclusion ン When compared to the predicate device, the EVIS EXERA II 180 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. {12}------------------------------------------------ Image /page/12/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 Olympus Medical Systems Corporation % Ms. Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway PO Box 610 CENTER VALLEY PA 18034-0610 JUL.-2 2010 Re: K100584 Trade/Device Name: EVIS EXERA II 180 System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codes: NWB, FDS, FDF Dated: June 18, 2010 Received: June 22, 2010 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 of medical device-related {13}------------------------------------------------ Page 2 - 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. http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {14}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: EVIS EXERA II 180 SYSTEM Indications for Use: # EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 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. # EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 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) (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number. Page 1 of {15}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: EVIS EXERA II 180 SYSTEM Indications for Use: # EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180, OLYMPUS GIF TYPE XP180N These instruments have been designed 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 transoral or transnasal endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, and duodenum). # EVIS EXERA II. GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q180, OLYMPUS GIF TYPE H180 These instruments have been designed 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 within the upper digestive tract (including the esophagus, stomach, and duodenum). 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) Dhal Lunn (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number. Page 2 of _ 3 {16}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: EVIS EXERA II 180 SYSTEM Indications for Use: EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL, OLYMPUS CF TYPE Q180AI, OLYMPUS CF TYPE H180AL, QLYMPUS CF TYPE H180AI, OLYMPUS PCF TYPE Q180AL (Pediatric), OLYMPUS PCF TYPE Q180AL (Pediatric), OLYMPUS PCF TYPE H180AL (Pediatric), OLYMPUS PCF TYPE H180Al (Pediatric), These instruments have been designed 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 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) Signature Page 3 of _ 3 Division Sign-Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number