(266 days)
Not Found.
No
The document describes image processing techniques (NBI, RDI, TXI, BAI-MAC) which are optical-digital enhancements, but does not mention AI, ML, or any learning algorithms. The performance studies focus on traditional engineering and image quality metrics, not AI/ML performance metrics.
No
The device is described for "endoscopic diagnosis, treatment, and video observation," and specifically states that its imaging features "are not intended to replace histopathological sampling as a means of diagnosis." While it supports treatment by being used with "EndoTherapy accessories," its primary function described is diagnostic imaging and observation, not directly therapeutic.
Yes
The device explicitly states its intended use for "endoscopic diagnosis" and uses various imaging tools like NBI, RDI, TXI, and BAI-MAC as "adjunctive tools for endoscopic examination" to aid in this process, even though they are not meant to replace histopathological sampling for definitive diagnosis.
No
The device description clearly indicates that the system includes hardware components such as the video system center (CV-1500) which functions as a pump and light source, and the endoscopes (BF-H1100 and BF-1TH1100) which contain optical fibers, lenses, and a CCD. The performance studies also include electrical safety, EMC, thermal safety, and durability testing, which are relevant to hardware components. While there is image processing software involved, the device is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: An IVD is a medical device that is used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. These tests are performed outside of the body (in vitro).
- Device Function: The described devices (EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500 and BRONCHOVIDEOSCOPES OLYMPUS BF-H1100/BF-1TH1100) are used for endoscopic diagnosis, treatment, and video observation inside the body. They process signals from endoscopes inserted into the airways and tracheobronchial tree, provide illumination, supply air, and control ancillary equipment.
- Lack of Sample Testing: The description does not mention any testing of biological samples outside of the body. The devices are used for direct visualization and intervention within the patient's body.
- Adjunctive Tools: While the system includes features like NBI, RDI, TXI, and BAI-MAC, these are described as "adjunctive tools for endoscopic examination" and are explicitly stated as "not intended to replace histopathological sampling as a means of diagnosis." Histopathological sampling is a process that often involves in vitro analysis of tissue samples, but the device itself is not performing that analysis.
Therefore, the primary function and intended use of these devices are for in vivo procedures (inside the body), not in vitro diagnostic testing of samples.
N/A
Intended Use / 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.
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
EOQ, FET, NWB, NTN
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.
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.
Mentions image processing
Yes, the device description states: "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."
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Endoscopic video images.
Anatomical Site
airways and tracheobronchial tree.
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
Not Found.
Description of the training set, sample size, data source, and annotation protocol
Not Found.
Description of the test set, sample size, data source, and annotation protocol
Not Found.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification and validation testing were conducted for the CV-1500, BF-H1100 and BF-1TH1100 devices and documentations were provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
Electrical safety and EMC testing were conducted for the CV-1500, BF-H1100 and BF-1TH1100 devices in accordance with the ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2014 standards for EMC.
Bench testing as listed below were conducted for CV-1500, BF-H1100, and BF-1TH1100 to ensure that the subject device performs as intended and meet design specifications.
- Thermal Safety
- Durability
- -Photobiological Safety
- Color Performance
- Direction of View
- Field of View
- Distortion
- Resolution
- Depth of Field
- Noise and Dynamic Range
- Image Intensity Uniformity
- -Video Latency
- RDI
- TXI and BAI-MAC
- Automatic Brightness Adjustment
- Pre-Freeze
An animal study was performed for CV-1500 to confirm the White Light Imaging (WLI) and Narrow Band Imaging (NBI) performance, TeXture and color enhancement Imaging (TXI) and Brightness Adjustment Imaging with MAintenance of Contrast (BAI-MAC).
No clinical study was performed to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
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.(b)
Classification. Class II.
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) |
|---|
| ------------------------------------------------- |
| ☑ 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
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) | |
|---|---|
| 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.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)
| ☑ 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.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.
2951 Ishikawa-cho
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) |
| FET (Endoscopic Video Imaging System/Component, | |
| Gastroenterology-Urology) | |
| NWB (endoscope, accessories, narrow band spectrum) | |
| NTN (Led Light Source) | |
| ■ Classification Panel: | Ear Nose & Throat (EOQ, EOB) |
| 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) |
| NWB (endoscope, accessories, narrow band spectrum) | |
| ■ Classification Panel: | Ear Nose & Throat (EOQ, EOB) |
| 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) |
| NWB (Endoscope, accessories, narrow band spectrum) | |
| ■ Classification Panel: | Ear Nose & Throat (EOQ, EOB) |
| Gastroenterology/Urology (NWB) |
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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 & | ||
| XENON LIGHT SOURCE OLYMPUS CLV-190 | Olympus Medical | |
| Systems Corp. | K121959, | |
| K131780 |
Predicate device for BF-H1100 .
| Device Name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| PREDICATE | ||
| EVIS EXERA III BRONCHOSCOPE OLYMPUS BF- | ||
| H190 | Olympus Medical | |
| Systems Corp.. | K121959 |
Predicate device for BF-1TH1100
| Device Name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| PREDICATE | ||
| EVIS EXERA III BRONCHOSCOPE OLYMPUS BF- | ||
| 1TH190 | Olympus Medical | |
| 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 | |
| Source (K121959, K131780) | ||
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP | SAME |
| Classification & | ||
| Regulation Number | Class II | |
| 21 CFR §874.4680 | SAME | |
| Product Code | EOQ - Bronchoscope (Flexible or Rigid) | |
| FET -endoscopic video imaging | ||
| system/component, gastroenterology-urology | ||
| NWB - endoscope, accessories, narrow band | ||
| spectrum | ||
| NTN - led light source | EOQ - bronchoscope (flexible or rigid) | |
| EOB Nasopharyngoscope (Flexible or rigid) | ||
| NWB - endoscope, accessories, narrow band | ||
| spectrum | ||
| 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. | This video system center is intended to be used | |
| with OLYMPUS camera heads, endoscopes, | ||
| light sources, monitors, EndoTherapy | ||
| accessories, and other ancillary equipment for | ||
| endoscopic diagnosis, treatment, and video | ||
| observation. | ||
| This light source is intended to be used With | ||
| Olympus endoscopes, video system center, and | ||
| other ancillary equipment for endoscopic | ||
| diagnosis, treatment and video observation. | ||
| Overall System Features | ||
| Rated voltage | 100 - 120V AC ±10 % | Video Center: 100 - 120 V AC ± 10% |
| Light Source: 100 - 120 V AC ± 10% | ||
| Rated frequency | 50/60 Hz ± 1 Hz | Video Center: 50/60 Hz ± 1 Hz |
| Light Source: 50/60 Hz ± 1 Hz | ||
| Over-current | ||
| protection | Fuse type (Built-in type) | Video Center: Fuse type (Built-in type) |
| Light Source: Fuse type (Built-in type) | ||
| Rated input | 600 VA | Video Center: 150 VA |
| Light Source: 600 VA | ||
| Dimensions | ||
| (W×H×D) | 370×198×488 mm | Video Center: 370×85×455 mm |
| Light Source: 370×150×476 mm | ||
| Dimensions | ||
| (maximum) | ||
| (W×H×D) | 398×218×580 mm | Video Center: 382×91×489 mm |
| Light Source: 382×162×551 mm | ||
| SUBJECT DEVICE | PREDICATE | |
| CV-1500 Video System Center | CV-190 Video System Center & CLV-190 Light | |
| Source (K121959, K131780) | ||
| Weight | 19.4 kg | Video Center: 10.7 kg |
| Light Source: 19 kg | ||
| Communication | ||
| terminals | • Output socket | |
| • 1000BASE-T | ||
| • Foot switch | ||
| • Keyboard | ||
| • Adaptor | ||
| • Recorder | ||
| • DF | ||
| • Printer | ||
| • CV-LINK | ||
| • LINK OUT | ||
| • UPD/PSCU | Video Center: | |
| • Video connector socket | ||
| • 100BASE-TX | ||
| • Foot switch | ||
| • Keyboard | ||
| • Option 1 | ||
| • Option 2 | ||
| • Adapter | ||
| • Light source | ||
| • Light source 2 | ||
| • Remote 1 | ||
| • Remote 2 | ||
| • Monitor remote 1 | ||
| • Monitor remote 2 | ||
| • EUS | ||
| • CV-LINK | ||
| Light Source: | ||
| • Output socket | ||
| • CV 1 | ||
| • CV 2 | ||
| • 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 |
| Light Source: WLI, NBI | ||
| Record to portable | ||
| memory | Provided | Video Center: Provided |
| Light Source: Not provided | ||
| Cooling method of | ||
| inside | Fan (Variable rotation) | Video Center: Fan (Forced-air cooling) |
| Light Source: Fan (Variable rotation) | ||
| Type of protection | ||
| against electric | ||
| shock | Class I | Video Center: Class I |
| Light Source: Class I | ||
| Degree of protection | ||
| against electric | ||
| shock of applied part | Type BF applied part | |
| (Depends on applied part) | Video Center: Type BF or CF applied part | |
| (Depends on applied part) | ||
| Light Source: Type BF or CF applied part | ||
| (Depends on applied part) | ||
| Degree or protection | ||
| against explosion | The video system center should be kept away | |
| from flammable gases. | Video Center: The video system center should | |
| be kept away from flammable gases. | ||
| Light Source: The light source should be kept | ||
| away from flammable gases. | ||
| Light Source Features | ||
| Bulb type | LED | Xenon short-arc lamp (ozone-free) 300W |
| Providing maximum | ||
| 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 | |
| Source (K121959, K131780) | ||
| Video Center Features | ||
| Analog signal output | VBS composite | RGB component VBS composite and Y/C; |
| simultaneous outputs possible. | ||
| Digital signal output | SDI:2 | SDI:2, DVI:1 |
| User settings | The function settings for up to 20 users can be | |
| stored. | The function settings for up to 20 users can be | |
| stored. | ||
| White Balance | ||
| adjustment | BF-H190 and BF-1TH190Automatically | |
| adjusted using the white balance switch at the | ||
| time of connection with the scope with Scope ID | ||
| BF-H1100 and BF-1TH1100Automatically | ||
| adjusted without pressing white balance switch | Automatically adjusted using the white balance | |
| switch at the time of connection with the scope | ||
| with Scope ID | ||
| Standard color chart | ||
| output | Color bar image | Color bar image or the 50% white screen can be |
| displayed | ||
| Color tone 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 enhancement | Structure enhancement | |
| Type A: (8 steps) | ||
| Type B: (8 steps) | ||
| *User can preset three image enhancement | ||
| settings | Structure enhancement | |
| Type A: (8 steps) | ||
| Type B: (8 steps) | ||
| Edge enhancement | ||
| (8 steps) | ||
| *User can preset three image enhancement | ||
| settings | ||
| TXI modes | Mode 1/Mode 2/Mode 3 | Not provided |
| Image size selection | The size of the endoscopic image can be | |
| selected from 2 modes. (Except SDTV) | The size of the endoscopic image can be | |
| selected from 2 modes. (Except SDTV) | ||
| Electric zoom | Switch between mode 1, mode 2, and mode 3. | Switch between mode 1, mode 2, and mode 3. |
| PIP/POP | Provided | Provided |
| Aspect ratio | Switch between 16:9 and 4:3. (Except SDTV) | Switch between 16:9 and 4:3. (Except SDTV) |
| Freeze | Still the endoscopic image | Still the endoscopic image |
| Pre-freeze | Available | Available |
| Custom switch | Assign specific functions to the following | |
| buttons. | ||
| • Remote switches (Up to 5) | ||
| • Foot switches (Up to 2) | ||
| • Keyboard custom key (Up to 4) | ||
| • Touch panel custom button of basic functions | ||
| screen (Up to 3) | ||
| • Touch panel custom button of custom | Assign specific functions to the following | |
| buttons. | ||
| • Remote switches (Up to 5) | ||
| • Foot switches (Up to 2) | ||
| • Keyboard custom key (Up to 4) |
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Image /page/12/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are all capitalized and have a slightly rounded appearance. A registered trademark symbol is located to the right of the letter "S".
Bronchoscope BF-H1100
| | SUBJECT DEVICE
BF-H1100 Bronchoscope | PREDICATE
BF-H190 Bronchoscope
(K121959) |
|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP | SAME |
| Classification &
Regulation Number | Class II
21 CFR §874.4680, | SAME |
| Product Code | EOQ: Bronchoscope (Flexible or rigid)
NWB: endoscope, accessories, narrow band spectrum | SAME |
| Indications for Use | 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. | This instrument 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. This instrument is indicated for use within
the airways and tracheobronchial tree. |
| Type | CCD
CYM color filter
Sequential read image signal | CCD
CYM color filter
Sequential read image signal |
| Direction of View | 0° | 0° |
| Field of View | 120° | 120° |
| Depth of Field | 3 - 100 mm | 3 - 100 mm |
| Distal end outer
diameter | ø 4.9 mm | ø 5.5mm |
| Distal end enlarged | Image: Distal end enlarged diagram with labels 1, 2, 3, UP, DOWN, Objective lens, Light guide Lens, Instrument channel outlet | Image: Distal end enlarged diagram with labels 1, 2, 3, UP, DOWN, Objective lens, Light guide Lens, Instrument channel outlet |
| Insertion tube outer
diameter | ø 4.9 mm | ø 5.1 mm |
| Insertion section
working length | 600 mm | 600 mm |
| Channel inner
diameter | ø 2.2 mm | ø 2.0 mm |
| Channel length | 850 mm | 850 mm |
| Total length | 880 mm | 880 mm |
| Minimum visible
distance | 3 mm | 3 mm |
| Direction from which
EndoTherapy
accessories enter and
exit the endoscopic
image | | |
| | | EVIS XI VIDEO SYSTEM CENTER WITH BRONCHOSCOPES |
| | SUBJECT DEVICE | PREDICATE |
| | BF-H1100 Bronchoscope | BF-H190 Bronchoscope
(K121959) |
| | Image: BF-H1100 Bronchoscope | Image: BF-H190 Bronchoscope |
| Configuration | Image: BF-H1100 Bronchoscope | Image: BF-H190 Bronchoscope |
| Configuration | Image: BF-H1100 Bronchoscope | Image: BF-H190 Bronchoscope |
| Angulation range | UP 210°
DOWN 130° | UP 210°
DOWN 130° |
| Pre-freeze function | Available | Available |
| Electronic zoom
function | Available | Available |
| Electronic shutter
function | Available | Available |
| Records of endoscope's
information | Available | Available |
| NBI observation | Available | Available |
| RDI observation | Available (when using CV-1500) | Available (when using CV-1500) |
| High frequency
treatment | Available | Available |
| | | PREDICATE: |
| | SUBJECT DEVICE: | BF-1TH190 Bronchoscope |
| | BF-1TH1100 Bronchoscope | (K121959) |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP | SAME |
| Classification &
Regulation Number | Class II
21 CFR §874.4680, | SAME |
| Product Code | EOQ: Bronchoscope (Flexible or rigid)
NWB: endoscope, accessories, narrow band
spectrum | SAME |
| Indications for Use | 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. | This instrument 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. This instrument is indicated for use within
the airways and tracheobronchial tree. |
| Direction of View | 0° | 0° |
| Field of View | 120° | 120° |
| Depth of Field | 3 - 100 mm | 3 - 100 mm |
| Distal end outer
diameter | ø 5.8 mm | ø 6.2 mm |
| Distal end enlarged | Image: Distal end enlarged BF-1TH1100 | Image: Distal end enlarged BF-1TH190 |
| | 1 Objective lens
2 Light guide lens
3 Instrument channel outlet | 1 Objective lens
2 Light guide lens
3 Instrument channel outlet |
| Insertion tube outer
diameter | ø 6.1 mm | ø 6.0mm |
| Insertion section
working length | 600 mm | 600 mm |
| Channel inner
diameter | ø 3.0 mm | ø 2.8 mm |
| Channel length | 850 mm | 850 mm |
| Total length | 880 mm | 880 mm |
| Minimum visible
distance | 3 mm | 3 mm |
| Direction from which
EndoTherapy
accessories enter and
exit the endoscopic
image | Image: Direction from which EndoTherapy accessories enter and exit the endoscopic image BF-1TH1100 | Image: Direction from which EndoTherapy accessories enter and exit the endoscopic image BF-1TH190 |
| Configuration | | |
| | SUBJECT DEVICE:
BF-1TH1100 Bronchoscope | PREDICATE:
BF-1TH190 Bronchoscope
(K121959) |
| | Image: BF-1TH1100 Bronchoscope | Image: BF-1TH190 Bronchoscope |
| Configuration | Image: Configuration BF-1TH1100 Bronchoscope | Image: Configuration BF-1TH190 Bronchoscope |
| Angulation range | UP 180°
DOWN 130° | UP: 180°
DOWN: 130° |
| Pre-freeze function | Available | Available |
| Electronic zoom function | Available | Available |
| Electronic shutter function | Available | Available |
| Records of endoscope's information | Available | Available |
| NBI observation | Available | Available |
| RDI observation | Available (when using CV-1500) | Available (when using CV-1500) |
| High frequency treatment | Available | Available |
| Laser treatment | Available | Available |
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Image /page/13/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. A registered trademark symbol is located to the right of the word. A thin yellow line is located underneath the word.
14
Image /page/14/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced together, creating a solid block of text. A registered trademark symbol is located to the right of the letter "S". A thin, horizontal, yellow line is located underneath the word.
Bronchoscope BF-1TH1100
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PERFORMANCE DATA
> Software verification and validation
Software verification and validation testing were conducted for the CV-1500, BF-H1100 and BF-1TH1100 devices and documentations were provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
> Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted for the CV-1500, BF-H1100 and BF-1TH1100 devices in accordance with the ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2014 standards for EMC.
> Performance testing - Bench
Bench testing as listed below were conducted for CV-1500, BF-H1100, and BF-1TH1100 to ensure that the subject device performs as intended and meet design specifications.
- Thermal Safety -
- Durability -
- -Photobiological Safety
- Color Performance -
- Direction of View -
- Field of View -
- Distortion -
- Resolution -
- Depth of Field -
- Noise and Dynamic Range -
- Image Intensity Uniformity -
- -Video Latency
- RDI -
- TXI and BAI-MAC -
- Automatic Brightness Adjustment -
- Pre-Freeze -
> Performance testing - Animal
An animal study was performed for CV-1500 to confirm the White Light Imaging (WLI) and Narrow Band Imaging (NBI) performance, TeXture and color enhancement Imaging (TXI) and Brightness Adjustment Imaging with MAintenance of Contrast (BAI-MAC).
> Performance testing - Clinical
No clinical study was performed to demonstrate substantial equivalence.
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Image /page/17/Picture/0 description: The image contains the word OLYMPUS in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. There is a registered trademark symbol to the right of the letter S. The background is white.
> Risk management
Risk management was performed for the CV-1500, BF-H1100 and BF-1TH1100 devices in accordance with ISO 14971:2007. The design verification tests and the acceptance criteria were identified and performed as a result of the risk management.
CONCLUSION
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate device. the CV-1500, BF-H1100 and BF-1TH1100 devices raise no new issues of safety and effectiveness and are substantially equivalent to the predicate devices in terms of safety, effectiveness and performance.