EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100
Device Facts
| Record ID | K222861 |
|---|---|
| Device Name | EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 |
| Applicant | Olympus Medical Systems Corporation |
| Product Code | EOQ · Ear, Nose, Throat |
| Decision Date | Jun 15, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4680 |
| Device Class | Class 2 |
Indications for 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
System comprises CV-1500 Video System Center and compatible BF-H1100/BF-1TH1100 bronchoscopes. System processes electronic signals from endoscope CCDs, outputs images to monitors, provides LED illumination, supplies air, and controls ancillary equipment. Used in clinical settings by physicians for airway endoscopy/surgery. Features include NBI, RDI, TXI, and BAI-MAC for enhanced visualization of tissue/bleeding. System integrates with existing Olympus endoscope families. Output assists clinicians in real-time diagnosis and surgical guidance. Benefits include improved visualization and diagnostic support during bronchoscopic procedures.
Clinical Evidence
No clinical study performed. Evidence consists of bench testing (thermal safety, durability, photobiological safety, image quality metrics, video latency) and an animal study confirming performance of WLI, NBI, TXI, and BAI-MAC imaging modes.
Technological Characteristics
System uses LED light source (vs Xenon in predicate). Endoscopes feature CCD sensors with CYM color filters. Connectivity includes 1000BASE-T, CV-LINK, and various peripheral ports. Software-based image processing for NBI, RDI, TXI, and BAI-MAC. Electrical safety per ANSI/AAMI ES 60601-1 and IEC 60601-2-18; EMC per IEC 60601-1-2. Class I equipment, Type BF applied parts.
Indications for Use
Indicated for endoscopic diagnosis, treatment, and video observation within the airways and tracheobronchial tree using Olympus video endoscopes and ancillary equipment. Adjunctive imaging tools (NBI, RDI, TXI, BAI-MAC) supplement white light imaging but do not replace histopathological sampling.
Regulatory Classification
Identification
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.
Predicate Devices
- VIDEO SYSTEM CENTER OLYMPUS CV-190 & XENON LIGHT SOURCE OLYMPUS CLV-190 (K121959, K131780)
- EVIS EXERA III BRONCHOSCOPE OLYMPUS BF-H190 (K121959)
- EVIS EXERA III BRONCHOSCOPE OLYMPUS BF-1TH190 (K121959)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 15, 2023
Olympus Medical Systems Corporation % Brenda Geary Manager, Regulatory Affairs Olympus Corporation of the Americas 800 West Park Drive Westborough, Massachusetts 01581
Re: K222861
Trade/Device Name: EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ, FET, NWB, NTN Dated: May 16, 2023 Received: May 16, 2023
Dear Brenda Geary:
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/cdrl/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 mediation-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,
Shuchen Peng -S
Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
## Indications for Use
510(k) Number (if known) K222861
Device Name EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500
#### Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
| <div> <span> <span style="font-size: 14px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|---------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 14px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
#### 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}------------------------------------------------
## Indications for Use
510(k) Number (if known) K222861
Device Name BRONCHOVIDEOSCOPE OLYMPUS BF-H1100
Indications for Use (Describe)
The BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 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. This instrument is indicated for use within the airways and tracheobronchial tree.
| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
#### 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.qov
"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."
{4}------------------------------------------------
### Indications for Use
510(k) Number (if known) K222861
Device Name BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100
Indications for Use (Describe)
The BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 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. This instrument is indicated for use within the airways and tracheobronchial tree.
Type of Use (Select one or both, as applicable)
| <div> <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
#### 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.qov
"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."
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are all capitalized and evenly spaced. There is a yellow line underneath the word. The registered trademark symbol is located to the right of the letter "S".
#### Date Prepared: June 15, 2023
# 510(k) Summary
#### SPONSOR INFORMATION
| 510(k) Submitter: | OLYMPUS MEDICAL SYSTEMS CORP.<br>2951 Ishikawa-cho<br>Hachioji-shi, Tokyo, Japan 192-8507 |
|-------------------|-------------------------------------------------------------------------------------------|
|-------------------|-------------------------------------------------------------------------------------------|
Official Correspondent: Brenda Geary Olympus Corporation of the Americas 800 West Park Drive Westborough, MA 01581 Cell: (508) 641-0568 Email: brenda.geary@olympus.com
- Manufacturer for BF-H1100, BF-1TH1100 Manufacturing Site(s): Aizu Olympus Co., Ltd., 3-1-1 Niiderakita, Aizuwakamatsu-shi, Fukushima 965-8520, Japan
Manufacturer for CV-1500 Shirakawa Olympus Co., Ltd. 3-1 Okamiyama, Odakura, Nishigo-mura, Nishishirakawa-gun, Fukushima 961-8061, Japan
| ■ Device Name(s): | EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ■ Model Name(s): | OLYMPUS CV-1500 |
| ■ Common Name: | Endoscopic Video Imaging System |
| ■ Regulation Number: | 874.4680 |
| ■ Regulation Name: | Bronchoscope (flexible or rigid) and accessories |
| ■ Regulatory Class: | II |
| ■ Product Code: | EOQ: Bronchoscope (Flexible or Rigid)<br>FET (Endoscopic Video Imaging System/Component,<br>Gastroenterology-Urology)<br>NWB (endoscope, accessories, narrow band spectrum)<br>NTN (Led Light Source) |
| ■ Classification Panel: | Ear Nose & Throat (EOQ, EOB)<br>Gastroenterology/Urology (FET, NWB, NTN) |
#### DEVICE IDENTIFICATION
{6}------------------------------------------------
| ■ Device Name(s): | BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 |
|-------------------------|---------------------------------------------------------------------------------------------|
| ■ Model Name(s): | OLYMPUS BF-H1100 |
| ■ Common Name: | Bronchoscope |
| ■ Regulation Number: | 874.4680 |
| ■ Regulation Name: | Bronchoscope (flexible or rigid) and accessories |
| ■ Regulatory Class: | II |
| ■ Product Code: | EOQ: Bronchoscope (Flexible or Rigid)<br>NWB (endoscope, accessories, narrow band spectrum) |
| ■ Classification Panel: | Ear Nose & Throat (EOQ, EOB)<br>Gastroenterology/Urology (NWB) |
| ■ Device Name(s): | BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 |
|-------------------------|---------------------------------------------------------------------------------------------|
| ■ Model Name(s): | OLYMPUS BF-1TH1100 |
| ■ Common Name: | Bronchoscope |
| ■ Regulation Number: | 874.4680 |
| ■ Regulation Name: | Bronchoscope (flexible or rigid) and accessories |
| ■ Regulatory Class: | II |
| ■ Product Code: | EOQ: Bronchoscope (Flexible or Rigid)<br>NWB (Endoscope, accessories, narrow band spectrum) |
| ■ Classification Panel: | Ear Nose & Throat (EOQ, EOB)<br>Gastroenterology/Urology (NWB) |
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, dark blue letters. The letters are closely spaced and fill most of the frame. There is a registered trademark symbol to the right of the word. A thin gold line is visible below the word.
#### PREDICATE DEVICES
#### 1 Predicate device for CV-1500
| Device Name | 510(k) Submitter | 510(k) No. |
|----------------------------------------------------------------------------|----------------------------------|---------------------|
| PREDICATE | | |
| VIDEO SYSTEM CENTER OLYMPUS CV-190 &<br>XENON LIGHT SOURCE OLYMPUS CLV-190 | Olympus Medical<br>Systems Corp. | K121959,<br>K131780 |
#### Predicate device for BF-H1100 .
| Device Name | 510(k) Submitter | 510(k) No. |
|-------------------------------------------------|-----------------------------------|------------|
| PREDICATE | | |
| EVIS EXERA III BRONCHOSCOPE OLYMPUS BF-<br>H190 | Olympus Medical<br>Systems Corp.. | K121959 |
#### Predicate device for BF-1TH1100
| Device Name | 510(k) Submitter | 510(k) No. |
|---------------------------------------------------|-----------------------------------|------------|
| PREDICATE | | |
| EVIS EXERA III BRONCHOSCOPE OLYMPUS BF-<br>1TH190 | Olympus Medical<br>Systems Corp.. | K121959 |
#### DEVICE DESCRIPTION
## EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500
The CV-1500 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. 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.
{8}------------------------------------------------
### 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.
## BRONCHOSCOPE OLYMPUS BF-H1100 & BF-1TH1100
The BF-H1100 and BF-1TH1100 endoscopes consist of three parts: the control section, the insertion section, and the connector section. The endoscope receives the illumination light from light guide connector connected to the video system center (CV-1500). 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 charge-coupled device (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 the image signal and displays the observation image on the screen.
### INDICATIONS FOR USE
## EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500
The EVIS XI 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.
## BRONCHOSCOPES - OLYMPUS BF-H1100 & BF-1TH1100
The BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 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. This instrument is indicated for use within the airways and tracheobronchial tree.
The BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 is intended to be used with an Olvmpus video system center, documentation equipment, monitor, EndoTherapy accessories
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are sans-serif and appear to be a custom font. A registered trademark symbol is located to the right of the letter "S".
(such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.
### COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICE
#### EVIS XI VIDEO SYSTEM CENTER CV-1500
| | SUBJECT DEVICE | PREDICATE |
|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | CV-1500 Video System Center | CV-190 Video System Center & CLV-190 Light<br>Source (K121959, K131780) |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP | SAME |
| Classification &<br>Regulation Number | Class II<br>21 CFR §874.4680 | SAME |
| Product Code | EOQ - Bronchoscope (Flexible or Rigid)<br>FET -endoscopic video imaging<br>system/component, gastroenterology-urology<br>NWB - endoscope, accessories, narrow band<br>spectrum<br>NTN - led light source | EOQ - bronchoscope (flexible or rigid)<br>EOB Nasopharyngoscope (Flexible or rigid)<br>NWB - endoscope, accessories, narrow band<br>spectrum |
| Indications for Use | The EVIS X1 VIDEO SYSTEM CENTER<br>OLYMPUS CV-1500 is intended to be used<br>with Olympus ancillary equipment for<br>endoscopic diagnosis, treatment, and video<br>observation. This product is designed to process<br>electronic signals transmitted from Olympus<br>video endoscopes, output images to monitors,<br>provide illumination to the endoscope, supply<br>air through the endoscope while inside the body<br>and control/monitor ancillary equipment. NBI<br>(Narrow Band Imaging), RDI (Red Dichromatic<br>Imaging), TXI (TeXture and color enhancement<br>Imaging), and BAI-MAC (Brightness<br>Adjustment Imaging with Maintenance of<br>Contrast) are adjunctive tools for endoscopic<br>examination which can be used to supplement<br>Olympus white light imaging. NBI, RDI, TXI<br>and BAI-MAC are not intended to replace<br>histopathological sampling as a means of<br>diagnosis. | This video system center is intended to be used<br>with OLYMPUS camera heads, endoscopes,<br>light sources, monitors, EndoTherapy<br>accessories, and other ancillary equipment for<br>endoscopic diagnosis, treatment, and video<br>observation.<br>This light source is intended to be used With<br>Olympus endoscopes, video system center, and<br>other ancillary equipment for endoscopic<br>diagnosis, treatment and video observation. |
| Overall System Features | | |
| Rated voltage | 100 - 120V AC ±10 % | Video Center: 100 - 120 V AC ± 10%<br>Light Source: 100 - 120 V AC ± 10% |
| Rated frequency | 50/60 Hz ± 1 Hz | Video Center: 50/60 Hz ± 1 Hz<br>Light Source: 50/60 Hz ± 1 Hz |
| Over-current<br>protection | Fuse type (Built-in type) | Video Center: Fuse type (Built-in type)<br>Light Source: Fuse type (Built-in type) |
| Rated input | 600 VA | Video Center: 150 VA<br>Light Source: 600 VA |
| Dimensions<br>(W×H×D) | 370×198×488 mm | Video Center: 370×85×455 mm<br>Light Source: 370×150×476 mm |
| Dimensions<br>(maximum)<br>(W×H×D) | 398×218×580 mm | Video Center: 382×91×489 mm<br>Light Source: 382×162×551 mm |
| | SUBJECT DEVICE | PREDICATE |
| | CV-1500 Video System Center | CV-190 Video System Center & CLV-190 Light<br>Source (K121959, K131780) |
| Weight | 19.4 kg | Video Center: 10.7 kg |
| | | Light Source: 19 kg |
| 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 Center:<br>• Video connector socket<br>• 100BASE-TX<br>• Foot switch<br>• Keyboard<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<br>Light Source:<br>• Output socket<br>• CV 1<br>• CV 2<br>• LINK - OUT |
| | | • UPD |
| Touch panel | Provided | Video Center: Not provided |
| | (Brightness 10 steps) | Light Source: Not provided |
| Observation mode | WLI, NBI, RDI | Video Center: WLI, NBI<br>Light Source: WLI, NBI |
| Record to portable<br>memory | Provided | Video Center: Provided<br>Light Source: Not provided |
| Cooling method of<br>inside | Fan (Variable rotation) | Video Center: Fan (Forced-air cooling)<br>Light Source: Fan (Variable rotation) |
| Type of protection<br>against electric<br>shock | Class I | Video Center: Class I<br>Light Source: Class I |
| Degree of protection<br>against electric<br>shock of applied part | Type BF applied part<br>(Depends on applied part) | Video Center: Type BF or CF applied part<br>(Depends on applied part)<br>Light Source: Type BF or CF applied part<br>(Depends on applied part) |
| Degree or protection<br>against explosion | The video system center should be kept away<br>from flammable gases. | Video Center: The video system center should<br>be kept away from flammable gases.<br>Light Source: The light source should be kept<br>away from flammable gases. |
| Light Source Features | | |
| Bulb type | LED | Xenon short-arc lamp (ozone-free) 300W |
| Providing maximum<br>light intensity | Less than 3.93 W | 3.21 W |
| Observation mode | WLI, NBI, RDI | WLI, NBI |
| Emergency Lamp | Not provided | Halogen Lamp 12V35W |
| Brightness adjustment | Automatic (current control, 17 steps) | • Automatic (current control, 17 steps) |
| | SUBJECT DEVICE | PREDICATE |
| | CV-1500 Video System Center | CV-190 Video System Center & CLV-190 Light<br>Source (K121959, K131780) |
| Video Center Features | | |
| Analog signal output | VBS composite | RGB component VBS composite and Y/C;<br>simultaneous outputs possible. |
| Digital signal output | SDI:2 | SDI:2, DVI:1 |
| User settings | The function settings for up to 20 users can be<br>stored. | The function settings for up to 20 users can be<br>stored. |
| White Balance<br>adjustment | BF-H190 and BF-1TH190Automatically<br>adjusted using the white balance switch at the<br>time of connection with the scope with Scope ID<br>BF-H1100 and BF-1TH1100Automatically<br>adjusted without pressing white balance switch | Automatically adjusted using the white balance<br>switch at the time of connection with the scope<br>with Sco…
