EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100

K222584 · Olympus Medical Systems Corporation · FET · Apr 26, 2023 · Gastroenterology, Urology

Device Facts

Record IDK222584
Device NameEVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100
ApplicantOlympus Medical Systems Corporation
Product CodeFET · Gastroenterology, Urology
Decision DateApr 26, 2023
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 876.1500
Device ClassClass 2

Intended Use

The EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500 is intended to be used with Olympus ancillary equipment for endoscopic diagnosis, treatment, and video observation. This product is designed to process electronic signals transmitted from Olympus video endoscopes, output images to monitors, provide illumination to the endoscope, supply air through the endoscope while inside the body and control/monitor ancillary equipment. NBI (Narrow Band Imaging), RDI (Red Dichromatic Imaging), TXI (TeXture and color enhancement Imaging), and BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast) are adjunctive tools for endoscopic examination which can be used to supplement Olympus white light imaging. NBI, RDI, TXI and BAI-MAC are not intended to replace histopathological sampling as a means of diagnosis. The CV-1500 Video System Center is compatible with scopes within the EVIS 190 and 1100 families.

Device Story

EVIS X1 Video System Center (CV-1500) processes electronic signals from Olympus video endoscopes (CF-HQ1100DL/I, GIF-1100) for display on monitors; provides LED illumination; supplies air; controls ancillary equipment. System features optical-digital observation modes: NBI (Narrow Band Imaging), RDI (Red Dichromatic Imaging), TXI (TeXture and color enhancement Imaging), and BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast). Endoscopes feature CCD sensors to convert reflected light into electrical signals. Used in clinical settings by physicians for endoscopic surgery and diagnosis. Output images assist clinicians in visualizing anatomy and identifying lesions; adjunctive tools supplement white light imaging to enhance visibility of tissue structures and bleeding points. Does not replace histopathological sampling. Benefits include improved visualization of mucosal patterns and vascularity, aiding diagnostic and therapeutic procedures.

Clinical Evidence

No clinical study was performed. Evidence includes bench testing (thermal safety, durability, photobiological safety, color performance, resolution, latency, etc.), animal study (confirming WLI, NBI, RDI, and TXI performance), and software/cybersecurity validation.

Technological Characteristics

System uses LED light source; CCD-based endoscopes; digital signal processing. Connectivity includes 1000BASE-T, SDI, and various peripheral ports. Biocompatibility per ISO 10993-1. Electrical safety per ANSI/AAMI ES 60601-1 and IEC 60601-2-18. EMC per IEC 60601-1-2. Laser safety per IEC 60825-1.

Indications for Use

Indicated for endoscopic diagnosis, treatment, and video observation in the lower digestive tract (CF-HQ1100DL/I: anus, rectum, sigmoid colon, colon, ileocecal valve) and upper digestive tract (GIF-1100: esophagus, stomach, duodenum).

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. April 26, 2023 Olympus Medical Systems Corporation % Darlene Hull Regulatory Program Manager Olympus Corporation of the Americas 800 West Park Drive Westborough, MA 01581 Re: K222584 Trade/Device Name: Evis X1 Video System Center Olympus CV-1500, Colonovideoscope Olympus CF-HQ1100DL/I, Gastrointestinal Videoscope Olympus GIF-1100 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FET, NWB, NTN, FDF, FDS Dated: March 23, 2023 Received: March 23, 2023 Dear Darlene Hull: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, #### Shanil P. Haugen -S Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K222584 #### Device Name CV-1500, CF-HQ1100DL, CF-HQ1100DI, GIF-1100 #### Indications for Use (Describe) #### EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500 The EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500 is intended to be used with Olympus ancillary equipment for endoscopic diagnosis, treatment, and video observation. This product is designed to process electronic signals transmitted from Olympus video endoscopes, output images to monitors, provide illumination to the endoscope, supply air through the endoscope while inside the body and control/monitor ancillary equipment. NBI (Narrow Band Imaging), RDI (Red Dichromatic Imaging), TXI (TeXture and color enhancement Imaging), and BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast) are adjunctive tools for endoscopic examination which can be used to supplement Olympus white light imaging. NBI, RDI, TXI and BAI-MAC are not intended to replace histopathological sampling as a means of diagnosis. The CV-1500 Video System Center is compatible with scopes within the EVIS 190 and 1100 families. #### COLONOSCOPE OLYMPUS CF-HQ1100DL & CF-HQ1100DI The COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I is intended to be used with an Olympus video system center, endoscope position detecting unit, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopic surgery. The COLONOVIDEOSCOPE CF-HQ1100DL &CF-HO1100DI (product codes may be combined into a shorter code: CF-HO1100DL/I) is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, and ileocecal valve). #### GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 is intended to be used with an Olympus video system center, Light source, document, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The GASTROINTESTINAL VIDEOSCOPE GIF-1100 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are spaced closely together, and the word is centered in the image. There is a registered trademark symbol to the right of the word. The background is white. Date Prepared: August 25, 2022 #### 510(k) Summary #### 1. GENERAL INFORMATION | 510(k) Submitter: | OLYMPUS MEDICAL SYSTEMS CORP.<br>2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Darlene R. Hull<br>Olympus Corporation of the Americas<br>800 West Park Drive<br>Westborough, MA 01581<br>Phone: 385-7996752<br>Email: darlene.hull@olympus.com | | Manufacturing site: | Manufacturer for CF-HQ1100DL,CF-HQ1100DI and GIF-1100C<br>Aizu Olympus Co., Ltd.,<br>3-1-1 Niiderakita, Aizuwakamatsu-shi, Fukushima 965-8520,<br>Japan | | | Manufacturer for CV-1500<br>Shirakawa Olympus Co., Ltd.<br>3-1 Okamiyama, Odakura, Nishigo-mura, Nishishirakawa-gun<br>Fukushima 961-8061, Japan | Image /page/3/Picture/6 description: The image shows the text "510(k) Summary". The text is written in a simple, sans-serif font. The text is centered on the image and is the only element present. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced and appear to be a sans-serif font. There is a registered trademark symbol to the right of the letter "S". The background is white. #### 2. DEVICE IDENTIFICATION #### 2-1. CV-1500 Device Name: #### EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500 [New components] - FOOT HOLDER MAJ-2431 - Power code 3.0m MAJ-2270 - Water container MAJ-901 - · Portable memory 2 MAJ-2427 - 12G SDI cable MAJ-2428 - White cap set MAJ-941 - Pump remote cable MAJ-920 #### [New accessories] - WATER CONTAINER MAJ-902 - 12G-SDI cable 1.5M MAJ-2426 - 12G-SDI cable 2.9M MAJ-2428 - 12G-SDI cable 8.5M MAJ-2429 - 3G-SDI cable 1.5M MAJ-2430 - Y/C Cable MH-985 - · Footswitch Conversion Cable MAJ-2437 #### Model Name: OLYMPUS CV-1500 ENDOSCOPIC VIDEO IMAGING SYSTEM Common Name: Classification Number: 876.1500 Classification Name: Endoscope and accessories Regulatory Class: = Product Code FET (Endoscopic Video Imaging System/Component, (Product Code Name): Gastroenterology-Urology), NWB (Endoscope, Accessories, Narrow Band Spectrum), NTN (Led Light Source) Device Panel: Gastroenterology/Urology #### 2-2. CF-HQ1100DL and CF-HQ1100Dl | Device Name: | COLONOSCOPE OLYMPUS CF-HQ1100DL & CF-HQ1100DI | |------------------------|----------------------------------------------------------------------------------------------------------| | Model Name: | OLYMPUS CF-HQ1100DL & CF-HQ1100DI | | Common Name: | COLONOSCOPE | | Classification Number: | 876.1500 | | Classification Name: | Endoscope and accessories | | Regulatory Class: | II | | Product Code | FDF (Colonoscope And Accessories, Flexible/Rigid),<br>NWB (Endoscope, Accessories, Narrow Band Spectrum) | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are closely spaced together. A registered trademark symbol is located to the right of the letter "S". EVIS X1 Device Panel: Gastroenterology/Urology #### 2-3. GIF-1100 | Device Name: | GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 | |------------------------|----------------------------------------------------| | Model Name: | OLYMPUS GIF-1100 | | Common Name: | GASTROINTESTINAL VIDEOSCOPE | | Classification Number: | 876.1500 | | Classification Name: | Endoscope and accessories | | Regulatory Class: | II | | Product Code | FDS (Gastroscope and accessories, flexible/rigid), | | (Product Code Name): | NWB (Endoscope, Accessories, Narrow Band Spectrum) | | Device Panel: | Gastroenterology/Urology | #### 3. PREDICATE DEVICE #### Predicate device for CV-1500 | Device name | 510(k) Submitter | 510(k) No. | |---------------------------------------|----------------------------------|------------| | VIDEO SYSTEM CENTER OLYMPUS<br>CV-190 | OLYMPUS MEDICAL SYSTEMS<br>CORP. | K131780 | | XENON LIGHT SOURCE OLYMPUS<br>CLV-190 | OLYMPUS MEDICAL SYSTEMS<br>CORP. | K131780 | #### Predicate device for CF-HQ1100DL & CF-HQ1100DI | Device name | 510(k) Submitter | 510(k) No. | |------------------------------|-------------------------------|------------| | COLONOVIDEOSCOPE CF-HQ190L/I | OLYMPUS MEDICAL SYSTEMS CORP. | K131780 | #### Predicate device for GIF-1100 | Device name | 510(k) Submitter | 510(k) No. | |-----------------------------------------|----------------------------------|------------| | GASTROINTESTINAL VIDEOSCOPE<br>GIF-H190 | OLYMPUS MEDICAL SYSTEMS<br>CORP. | K131780 | #### 4. DEVICE DESCRIPTION #### General Device Description This video system center is intended to be used with Olympus ancillary equipment for endoscopic diagnosis, treatment, and video observation. This product is designed to process electronic signals transmitted from Olympus video endoscopes, output images {6}------------------------------------------------ to monitors, provide illumination to the endoscope, supply air through the endoscope while inside the body and control/monitor ancillary equipment. NBI (Narrow Band Imaging), RDI (Red Dichromatic Imaging), TXI (TeXture and color enhancement Imaging), and BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast) are adjunctive tools for endoscopic examination which can be used to supplement Olympus white light imaging. NBI, RDI, TXI and BAI-MAC are not intended to replace histopathological sampling as a means of diagnosis. #### RDI (Red Dichromatic Imaging) observation: RDI is optical-digital observation using red dichromatic narrow band light and green illumination light to enhance visibility of bleeding points in the endoscopic image due to the difference in light absorption. #### TXI (TeXture and color enhancement Imaging): TXI emphasizes tonal changes, patterns, and image outlines. It also corrects the brightness of dark areas. #### BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast): BAI-MAC maintains the brightness of the bright part of the endoscopic image and corrects the brightness of the dark part of the endoscopic image. #### EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500 This video system center is indicated to process electronic signals transmitted from Olympus video endoscopes, output images to monitors, and be used with Olympus ancillary equipment for endoscopic diagnosis, treatment, and video observation. This product also functions as a pump to supply air through the endoscope, a light source to the endoscope, and a controller/monitor of ancillary equipment. #### COLONOSCOPE OLYMPUS CF-HQ1100DL &CF-HQ1100DIGASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 The endoscope receives the illumination light from light guide connector connected to the video system center (CV-1500: part of this submission). The illumination light is transferred to the distal end through the optical fiber bundle inside of the endoscope and illuminates the inside of the patient body through the illumination lens at the distal end. The endoscope receives the reflected light from the inner lumen of a patient by objective lens at the distal end. The built-in CCD at the distal end converts the light to the electrical signal, and the signal is sent to the video system center via the electrical cable and the video connector of the endoscope. The endoscope transfers {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are closely spaced together. A registered trademark symbol is located to the right of the word. the image signal and displays the observation image on the screen. The endoscope consists of three parts: the control section, the insertion section, and the connector section. The basic principle including user interface and operation for the procedure of the endoscope is identical to that of the predicate device. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, dark blue letters. The letters are closely spaced together, creating a solid block of text. A registered trademark symbol is located to the upper right of the word. #### 5. INDICATIONS FOR USE #### EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500 The EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500 is intended to be used with Olympus ancillary equipment for endoscopic diagnosis, treatment, and video observation. This product is designed to process electronic signals transmitted from Olympus video endoscopes, output images to monitors, provide illumination to the endoscope, supply air through the endoscope while inside the body and control/monitor ancillary equipment. NBI (Narrow Band Imaging), RDI (Red Dichromatic Imaging), TXI (TeXture and color enhancement Imaging), and BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast) are adjunctive tools for endoscopic examination which can be used to supplement Olympus white light imaging. NBI, RDI, TXI and BAI-MAC are not intended to replace histopathological sampling as a means of diagnosis. The CV-1500 Video System Center is compatible with scopes within the EVIS 190 and 1100 families. #### COLONOSCOPE OLYMPUS CF-HQ1100DL & CF-HQ1100DI The COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I is intended to be used with an Olympus video system center, endoscope position detecting unit, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The COLONOVIDEOSCOPE CF-HQ1100DL &CF-HQ1100DI (product codes may be combined into a shorter code: CF-HQ1100DL/I) is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). #### GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 is intended 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. The GASTROINTESTINAL VIDEOSCOPE GIF-1100 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). {9}------------------------------------------------ # OMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVO CV-1500 | | Subject Device<br>CV-1500 | Primary Predicate Device<br>CV-190 (K131780) | Secondary Predicate Device<br>CLV-190 (K131780) | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number | This submission | K131780 | K131780 | | Regulation number | 876.1500 | 876.1500 | 876.1500 | | Regulatory class | Class II | Class II | Class II | | Product code | FET (endoscopic video imaging<br>system/component,<br>gastroenterology-urology)<br>NWB(endoscope, accessories,<br>narrow band spectrum)<br>NTN (led light source) | FDF (colonoscope and<br>accessories, flexible/rigid)<br>FDS (gastroscope and accessories,<br>flexible/rigid)<br>NWB (endoscope, accessories,<br>narrow band spectrum) | FDF (colonoscope and<br>accessories, flexible/rigid)<br>FDS (gastroscope and accessories,<br>flexible/rigid)<br>NWB (endoscope, accessories,<br>narrow band spectrum) | | Classification panel | Gastroenterology and urology | Gastroenterology and urology | Gastroenterology and urology | | Common name | EVIS X1 VIDEO SYSTEM CENTER | EVIS EXERA III VIDEO SYSTEM<br>CENTER | EVIS EXERA III XENON LIGHT<br>SOURCE | | Manufacturer | OLYMPUS MEDICAL SYSTEMS<br>CORP. | OLYMPUS MEDICAL SYSTEMS<br>CORP. | OLYMPUS MEDICAL SYSTEMS<br>CORP. | | Indications for use | This video system center is<br>intended to be used with<br>Olympus ancillary equipment for<br>endoscopic diagnosis, treatment,<br>and video observation. This<br>product is designed to process<br>electronic signals transmitted<br>from Olympus video endoscopes, | This video system center is<br>intended to be used with<br>OLYMPUS camera heads,<br>endoscopes, light sources,<br>monitors, EndoTherapy<br>accessories, and other ancillary<br>equipment for endoscopic<br>diagnosis, treatment, and video<br>observation. | This light source is intended to be<br>used With Olympus endoscopes,<br>video system center, and other<br>ancillary equipment for<br>endoscopic diagnosis, treatment<br>and video observation. | | Subject Device | Primary Predicate Device<br>CV-190 (K131780) | Secondary Predicate Device<br>CLV-190 (K131780) | | | CV-1500<br>output images to monitors, provide illumination to the endoscope, supply air through the endoscope while inside the body and control/monitor ancillary equipment. NBI (Narrow Band Imaging), RDI (Red Dichromatic Imaging), TXI (TeXture and color enhancement Imaging), and BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast) are adjunctive tools for endoscopic examination which can be used to supplement Olympus white light imaging. NBI, RDI, TXI and BAI-MAC are not intended to replace histopathological sampling as a means of diagnosis. Compatible scope family: EVIS 190 series, 1100 series. | observation. | | | | Rated voltage | 100-120 V AC ± 10% | 100-120 V AC ± 10% | | | Rated frequency | 50/60 Hz ± 1 Hz | 50/60 Hz ± 1 Hz | | | Over-current<br>protection | Fuse type<br>(Built-in type) | Fuse type<br>(Built-in type) | | | Rated input | 150 VA | 600 VA | | | | Subject Device<br>CV-1500 | Primary Predicate Device<br>CV-190 (K131780) | Secondary Predicate Device<br>CLV-190 (K131780) | | Dimensions<br>(W×H×D) | 370x198x488 mm | 370x85x455 mm | 370x150x476 mm | | Dimensions<br>(maximum)<br>(W×H×D) | 398x218x580 mm | 382x91x489 mm | 382x162x551 mm | | Weight | 19.4 kg | 10.7 kg | 19 kg | | Bulb type | LED | | Xenon short-arc lamp<br>(ozone-free)300W | | Providing<br>maximum light<br>intensity | Less than 3.93 W | | 3.21 W | | Observation<br>mode | WLI, NBI, RDI | | WLI, NBI | | Emergency Lamp | Not provided | | Halogen Lamp 12V35W | | Brightness<br>adjustment | Automatic (current control,<br>17 steps) | | Automatic (current control,<br>17 steps)<br>• Manual (current control, 17<br>steps) | | Touch panel | Provided<br>(Brightness 10 steps) | Not provided | Not provided | | | Subject Device<br>CV-1500 | Primary Predicate Device<br>CV-190 (K131780) | Secondary Predicate Device<br>CLV-190 (K131780) | | Communication<br>terminals | • Output socket<br>• 1000BASE-T<br>• Foot switch<br>• Keyboard<br>• Adaptor<br>• Recorder<br>• DF<br>• Printer<br>• CV-LINK<br>• LINK OUT<br>• UPD/PSCU | • Video connector socket<br>• 100BASE-TX<br>• Foot switch<br>• Key board<br>• Option 1<br>• Option 2<br>• Adapter<br>• Light source<br>• Light source 2<br>• Remote 1<br>• Remote 2<br>• Monitor remote 1<br>• Monitor remote 2<br>• EUS<br>• CV-LINK | • Output socket<br>• CV 1<br>• CV 2<br>• LINK - OUT<br>• UPD | | Analog signal<br>output | VBS composite | RGB component VBS composite<br>and Y/C; simultaneous outputs<br>possible. | | | Digital signal<br>output | SDI:2 | SDI:2, DVI:1 | | | Observation<br>mode | WLI, NBI, RDI | WLI, NBI | WLI, NBI | | User settings | The function settings for up to 20<br>users can be stored. | The function settings for up to 20<br>users can be stored. | | | | Subject Device<br>CV-1500 | Primary Predicate Device<br>CV-190 (K131780) | Secondary Predicate Device<br>CLV-190 (K131780) | | White Balance<br>adjustment | 190Series<br>Automatically adjusted using the<br>white balance switch at the time<br>of connection with the scope with<br>Scope ID. | Automatically adjusted using the<br>white balance switch at the time<br>of connection with the scope with<br>Scope ID. | | | | 1100Series<br>Automatically adjusted without<br>pressing white balance switch | | | | Standard color<br>chart output | Color bar image | Color bar image or the 50% white<br>screen can be displayed | | | Color tone<br>adjustment | Red adjustment ±8 steps Blue adjustment ±8 steps Chroma adjustment ±8 steps | Red adjustment ±8 steps Blue adjustment ±8 steps Chroma adjustment ±8 steps | | | Contrast | Normal / High / Low | Normal / High / Low | | | Iris | AUTO/PEAK/AVE | AUTO/PEAK/AVE | | | Image<br>enhancement | Structure enhancement<br>Type A: (8 steps).<br>Type B: (8 steps). | Structure enhancement<br>Type A: (8 steps).<br>Type B: (8 steps). | Edge enhancement<br>(8 steps). | | TXI modes | *User can preset three image<br>enhancement settings<br>Mode 1/Mode 2/Mode 3 | *User can preset three image<br>enhancement settings<br>Not provided | | | | Subject Device<br>CV-1500 | Primary Predicate Device<br>CV-190 (K131780) | Secondary Predicate Device<br>CLV-190 (K131780) | | Image size<br>selection | The size of the endoscopic image<br>can be selected from 2 modes.<br>(Except SDTV) | The size of the endoscopic image<br>can be selected from 2 modes.<br>(Except SDTV) | | | Electric zoom | Switch between mode 1, mode 2,<br>and mode 3. | Switch between mode 1, mode 2,<br>and mode 3.…
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