(243 days)
Not Found.
No
The document describes image processing techniques (NBI, RDI, TXI, BAI-MAC) which are optical-digital enhancements and adjustments, not indicative of AI/ML algorithms. There is no mention of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML devices.
Yes
The device is intended for "endoscopic diagnosis, treatment, and video observation," and is used with "EndoTherapy accessories (such as a biopsy forceps)," directly participating in clinical treatment procedures.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used with Olympus ancillary equipment for endoscopic diagnosis, treatment, and video observation." It also mentions "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." These phrases directly indicate its role in diagnosis.
No
The device description clearly indicates that the system includes hardware components such as a video system center that processes signals, outputs images, provides illumination, supplies air, and controls/monitors ancillary equipment, as well as physical endoscopes with optical fibers and CCDs. While it includes software for image processing and enhancement, it is not solely software.
Based on the provided information, the EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL & CF-HQ1100DI, and GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: An IVD device is a medical device intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The described devices are used for endoscopic examination directly within the patient's body. They capture images of internal tissues and structures using light and electronic signals. They do not analyze specimens in vitro (outside the body).
- Intended Use: The intended use clearly states "endoscopic diagnosis, treatment, and video observation" within the digestive tract. This is an in vivo (within the living organism) procedure.
- Device Description: The description details how the devices illuminate and capture images from inside the body, process those signals, and display them on a monitor. This is consistent with an endoscopic system, not an IVD system.
- Adjunctive Tools: While the system includes image processing 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 involves the in vitro examination of tissue specimens, which is where an IVD device might be used in conjunction with the information gathered by the endoscope.
In summary, these devices are tools for direct visualization and intervention within the body, not for the in vitro analysis of biological specimens.
N/A
Intended Use / 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.
COLONOVIDEOSCOPE 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-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).
Product codes (comma separated list FDA assigned to the subject device)
FET, NWB, NTN, FDF, FDS
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 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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Optical (CCD)
Anatomical Site
Lower digestive tract (including the anus, rectum, sigmoid colon, and ileocecal valve), Upper digestive tract (including the esophagus, stomach, and duodenum)
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)
- Reprocessing validation: Reprocessing instruction and reprocessing method validation testing were conducted for CF-HQ1100DL/I and GIF-1100, and documentations were provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling".
- Biocompatibility: Biocompatibility evaluation were conducted for CF-HQ1100DL/I, GIF-1100, CV-1500, and MAJ-901/902 in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests: Cytotoxicity Study Using the Elution Method, Intracutaneous Irritation Study, Guinea Pig Maximization Sensitization Test.
- Software verification and validation: Software verification and validation testing were conducted for CV-1500, CF-HQ1100DL, CF-HQ1100DI, and GIF-1100, 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 CV-1500, CF-HQ1100DL, CF-HQ1100DI, and GIF-1100 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. Laser safety test was conducted for CV-1500 in accordance with the IEC 60825-1:2007 standards for laser product.
- Performance testing - Bench: Bench testing as listed below were conducted for CV-1500, CF-HQ1100DL, CF-HQ1100Dl, and GIF-1100 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
- Resolution
- Depth of Field
- Noise and Dynamic Range
- Image Intensity Uniformity
- Video Latency
- RDI
- TXI and BAI-MAC
- Automatic Brightness Adjustment
- Pre-Freeze
- Geometric Distortion
- Performance testing - Animal: Animal study was performed for CV-1500 to confirm the White Light Imaging (WLI) and Narrow Band Imaging (NBI) performance, and the effectiveness of Red Dichromatic Imaging (RDI) and TeXture and color enhancement Imaging (TXI) .
- Performance testing - Clinical: No clinical study was performed to demonstrate substantial equivalence.
- Risk management: Risk management was performed for CV-1500, CF-HQ1100DL, CF-HQ1100DI, and GIF-1100 in accordance with ISO 14971:2007. The design verification tests, and their acceptance criteria were identified and performed as a result of this risk management.
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.
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
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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)
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Date Prepared: August 25, 2022
510(k) Summary
1. GENERAL INFORMATION
| 510(k) Submitter: | OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Darlene R. Hull
Olympus Corporation of the Americas
800 West Park Drive
Westborough, MA 01581
Phone: 385-7996752
Email: darlene.hull@olympus.com |
| Manufacturing site: | Manufacturer for CF-HQ1100DL,CF-HQ1100DI and GIF-1100C
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 |
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.
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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), |
| NWB (Endoscope, Accessories, Narrow Band Spectrum) |
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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 | ||
| CV-190 | OLYMPUS MEDICAL SYSTEMS | |
| CORP. | K131780 | |
| XENON LIGHT SOURCE OLYMPUS | ||
| CLV-190 | OLYMPUS MEDICAL SYSTEMS | |
| 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 | ||
| GIF-H190 | OLYMPUS MEDICAL SYSTEMS | |
| 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
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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.
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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).
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OMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVO
CV-1500
| | Subject Device
CV-1500 | Primary Predicate Device
CV-190 (K131780) | Secondary Predicate Device
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
system/component,
gastroenterology-urology)
NWB(endoscope, accessories,
narrow band spectrum)
NTN (led light source) | FDF (colonoscope and
accessories, flexible/rigid)
FDS (gastroscope and accessories,
flexible/rigid)
NWB (endoscope, accessories,
narrow band spectrum) | FDF (colonoscope and
accessories, flexible/rigid)
FDS (gastroscope and accessories,
flexible/rigid)
NWB (endoscope, accessories,
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
CENTER | EVIS EXERA III XENON LIGHT
SOURCE |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS
CORP. | OLYMPUS MEDICAL SYSTEMS
CORP. | OLYMPUS MEDICAL SYSTEMS
CORP. |
| Indications for use | 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, | 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. |
| Subject Device | Primary Predicate Device
CV-190 (K131780) | Secondary Predicate Device
CLV-190 (K131780) | |
| CV-1500
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
protection | Fuse type
(Built-in type) | Fuse type
(Built-in type) | |
| Rated input | 150 VA | 600 VA | |
| | Subject Device
CV-1500 | Primary Predicate Device
CV-190 (K131780) | Secondary Predicate Device
CLV-190 (K131780) |
| Dimensions
(W×H×D) | 370x198x488 mm | 370x85x455 mm | 370x150x476 mm |
| Dimensions
(maximum)
(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
(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)
• Manual (current control, 17
steps) |
| Touch panel | Provided
(Brightness 10 steps) | Not provided | Not provided |
| | Subject Device
CV-1500 | Primary Predicate Device
CV-190 (K131780) | Secondary Predicate Device
CLV-190 (K131780) |
| Communication
terminals | • Output socket
• 1000BASE-T
• Foot switch
• Keyboard
• Adaptor
• Recorder
• DF
• Printer
• CV-LINK
• LINK OUT
• UPD/PSCU | • Video connector socket
• 100BASE-TX
• Foot switch
• Key board
• Option 1
• Option 2
• Adapter
• Light source
• Light source 2
• Remote 1
• Remote 2
• Monitor remote 1
• Monitor remote 2
• EUS
• CV-LINK | • Output socket
• CV 1
• CV 2
• LINK - OUT
• UPD |
| Analog signal
output | VBS composite | RGB component VBS composite
and Y/C; simultaneous outputs
possible. | |
| Digital signal
output | SDI:2 | SDI:2, DVI:1 | |
| Observation
mode | WLI, NBI, RDI | WLI, NBI | WLI, NBI |
| User settings | The function settings for up to 20
users can be stored. | The function settings for up to 20
users can be stored. | |
| | Subject Device
CV-1500 | Primary Predicate Device
CV-190 (K131780) | Secondary Predicate Device
CLV-190 (K131780) |
| White Balance
adjustment | 190Series
Automatically adjusted using the
white balance switch at the time
of connection with the scope with
Scope ID. | Automatically adjusted using the
white balance switch at the time
of connection with the scope with
Scope ID. | |
| | 1100Series
Automatically adjusted without
pressing white balance switch | | |
| 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). | Structure enhancement
Type A: (8 steps).
Type B: (8 steps). | Edge enhancement
(8 steps). |
| TXI modes | *User can preset three image
enhancement settings
Mode 1/Mode 2/Mode 3 | *User can preset three image
enhancement settings
Not provided | |
| | Subject Device
CV-1500 | Primary Predicate Device
CV-190 (K131780) | Secondary Predicate Device
CLV-190 (K131780) |
| 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 functions screen (Up to 10) | Assign specific functions to the
following buttons.
• Remote switches (Up to 5)
• Foot switches (Up to 2)
• Keyboard custom key (Up to 4) | |
| Pump
Pressure
switching | Diaphragm type pump
4-level available (OFF, low,
medium, high) | | Diaphragm type pump
4-level available (OFF, low,
medium, high) |
| | Subject Device
CV-1500 | Primary Predicate Device
CV-190 (K131780) | Secondary Predicate Device
CLV-190 (K131780) |
| Water Feeding
Method | Can be supplied from the distal
end of the endoscope in
combination with the OLYMPUS
water container. | Can be supplied from the distal
end of the endoscope in
combination with the OLYMPUS
water container. | Can be supplied from the distal
end of the endoscope in
combination with the OLYMPUS
water container. |
| Compatible
water container | MAJ-901, MAJ-902 | MAJ-901, MAJ-902 | MAJ-901, MAJ-902 |
| Record to
portable
memory | Provided | Provided | Not provided |
| Cooling method
of inside | Fan (Variable rotation) | Fan (Forced-air cooling) | Fan (Variable rotation) |
| Type of
protection
against electric
shock | Class I | Class I | Class I |
| Degree of
protection
against electric
shock of applied
part | Type BF applied part
(Depends on applied part) | Type BF or CF applied part
(Depends on applied part) | TYPE BF or CF applied part
(Depend on applied part) |
| Degree or
protection
against
explosion | The video system center should
be kept away from flammable
gases. | The video system center should
be kept away from flammable
gases. | The light source should be kept
away from flammable gases. |
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11
OLYMPUS
CONFIDENTIAL
510(k) Summary
12
OLYMPUS
13
14
15
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F-HQ1100DL & CF-HQ1100
| | Subject Device
CF-HQ1100DL
CF-HQ1100DI | Predicate Device
CF-HQ190L/I |
|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | This submission | K131780 |
| Regulation number | 876.1500 | 876.1500 |
| Regulatory class | Class II | Class II |
| Product code | FDF (colonoscope and accessories, flexible/rigid)
NWB (endoscope, accessories, narrow band
spectrum) | FDF (colonoscope and accessories, flexible/rigid)
FDS (gastroscope and accessories, flexible/rigid)
NWB (endoscope, accessories, narrow band
spectrum) |
| Classification panel | Gastroenterology and urology | Gastroenterology and urology |
| Common name | COLONOVIDEOSCOPE | COLONOVIDEOSCOPE |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. | OLYMPUS MEDICAL SYSTEMS CORP. |
| Indications for use | This instrument 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/I is
indicated for use within the lower digestive tract
(including the anus, rectum, sigmoid colon, colon,
and ileocecal valve). | This instrument 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 EVIS EXERA III COLONOVIDEOSCOPE
CF-HQ190L/I is indicated for use within the lower
digestive tract (including the anus, rectum, sigmoid
colon, colon, and ileocecal valve). |
| Type | CCD
CYM color filter
Sequential read image signal | CCD
CYM color filter
Sequential read image signal |
| Subject Device
CF-HQ1100DL
CF-HQ1100DI | | Predicate Device
CF-HQ190L/I |
| Direction of
View | 0° | 0° |
| Field of View | Normal focus mode: 170°
Near focus mode: 160° | Normal focus mode: 170°
Near focus mode: 160° |
| Depth of Field | Normal focus mode: 5 - 100 mm
Near focus mode: 2 - 6 mm | Normal focus mode: 5 - 100 mm
Near focus mode: 2 - 6 mm |
| Distal end outer
diameter | 13.2 mm | 13.2mm |
| Maximum distal
end outer
diameter | 14.9 mm | 14.9 mm |
| Distal end
enlarged | Image: distal end enlarged | Image: distal end enlarged |
| Insertion tube
outer diameter | 12.8 mm | 12.8mm |
| | Subject Device
CF-HQ1100DL
CF-HQ1100DI | Predicate Device
CF-HQ190L/I |
| Insertion section
working length | L: 1680 mm
I: 1330 mm | L: 1680 mm
I: 1330 mm |
| Channel inner
diameter | 3.7 mm | 3.7 mm |
| Minimum channel inner
diameter | 3.7 mm | 3.7 mm |
| Minimum visible distance | 4 mm (Normal focus mode) | 4 mm (Normal focus mode) |
| Direction from which EndoTherapy accessories enter and exit the endoscopic image | Image: endoscopic image | Image: endoscopic image |
K222584
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Image /page/19/Picture/0 description: The image shows the word "OLYMPUS" in a vertical orientation. The letters are a dark blue color. To the right of the word is a yellow line that is thicker in the middle and thinner at the top and bottom.
| Subject Device
CF-HQ1100DL
CF-HQ1100DI | | Predicate Device
CF-HQ190L/I | |
|------------------------------------------------|-------------------------------------------------|-------------------------------------------------|-----------------------------|
| Configuration | | Configuration | |
| | | | |
| Airflow rate | 25 cm³/s (CV-1500) | Airflow rate | 25 cm³/s (CLV-190, CV-1500) |
| | Subject Device
CF-HQ1100DL
CF-HQ1100DI | Predicate Device
CF-HQ190L/I | |
| Angulation
range | UP 180°
DOWN 180°
RIGHT 160°
LEFT 160° | UP 180°
DOWN 180°
RIGHT 160°
LEFT 160° | |
| Total length | L: 2005 mm
I: 1655mm | L: 2005 mm
I: 1655mm | |
| 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
cauterization
treatment | Available | Available | |
| Endoscope
position
detecting
function | Available | Available | |
| | Subject Device
CF-HQ1100DL
CF-HQ1100DI | Predicate Device
CF-HQ190L/I | |
| Passive bending function | Available | Available | |
| Flexibility adjustment function | Available | Available | |
| Focus switching function | Available | Available | |
| Auxiliary water feeding function | Available | Available | |
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21
CONFIDENTIAI
510(k) Summary
22
GIE-1100
| | Subject Device
GIF-1100 | Predicate Device
GIF-H190 |
|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | This submission | K131780 |
| Regulation number | 876.1500 | 876.1500 |
| Regulatory class | Class II | Class II |
| Product code | FDS (gastroscope and accessories, flexible/rigid)
NWB (endoscope, accessories, narrow band
spectrum) | FDF (colonoscope and accessories, flexible/rigid)
FDS (gastroscope and accessories, flexible/rigid)
NWB (endoscope, accessories, narrow band
spectrum) |
| Classification panel | Gastroenterology and urology | Gastroenterology and urology |
| Common name | GASTROINTESTINAL VIDEOSCOPE | GASTROINTESTINAL VIDEOSCOPE |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. | OLYMPUS MEDICAL SYSTEMS CORP. |
| Indications for use | 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.
The GASTROINTESTINAL VIDEOSCOPE GIF-1100 is
indicated for use within the upper digestive tract
(including the esophagus, stomach, and
duodenum). | 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.
The EVIS EXERA III GASTROINTESTINAL
VIDEOSCOPE GIF-H190 is indicated for use within
the upper digestive tract (including the esophagus,
stomach, and duodenum). |
| Direction of View | 0° | 0° |
| Field of View | 140° | 140° |
| Depth of Field | 2-100 mm | 2-100 mm |
| | Subject Device
GIF-1100 | Predicate Device
GIF-H190 |
| Distal end enlarged |
1 Air/water nozzle
2 Light guide lens
3 Objective lens
4 Instrument channel outlet
5 Auxiliary water channel |
1 Air/water nozzle
2 Light guide lens
3 Objective lens
4 Instrument channel outlet
5 Auxiliary water channel |
| Distal end outer diameter | 8.9 mm | 9.2 mm |
| Maximum distal end outer diameter | 10.7 mm | 11.2 mm |
| Insertion tube outer diameter | 8.9 mm | 9.2 mm |
| Insertion section working length | 1030 mm | 1030 mm |
| Channel inner diameter | 2.8 mm | 2.8 mm |
| | Subject Device
GIF-1100 | Predicate Device
GIF-H190 |
| 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] | Image: [Direction from which EndoTherapy accessories enter and exit the endoscopic image] |
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OLYMPUS
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Image /page/24/Picture/0 description: The image shows the word "OLYMPUS" in a vertical orientation. The letters are in a dark blue color. To the right of the word is a vertical yellow line.
25
Image /page/25/Picture/0 description: The image shows the word "OLYMPUS" in a vertical orientation. The word is written in a dark blue font. To the right of the word is a yellow line that is thicker in the middle and thinner at the top and bottom.
| Configuration | Configuration | Airflow rate | |
|---|---|---|---|
| Subject Device | |||
| GIF-1100 | Image: Configuration of GIF-1100 | Image: Configuration of GIF-1100 | 25 cm³/s (CV-1500) |
| Predicate Device | |||
| GIF-H190 | Image: Configuration of GIF-H190 | Image: Configuration of GIF-H190 | 25 cm³/s(CLV-190, CV-1500) |
| Subject Device | |||
| GIF-1100 | Predicate Device | ||
| GIF-H190 | |||
| Angulation range | UP 210° | ||
| DOWN 90° | |||
| RIGHT 100° | |||
| LEFT 100° | UP: 210° | ||
| DOWN: 90° | |||
| RIGHT:100° | |||
| LEFT:100° | |||
| Total length | 1350 mm | 1350 mm | |
| 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) | |
| Structure enhancement type | Available | Available | |
| Image size large 1 | B | ||
| High frequency cauterization treatment | Available | Available | |
| Endoscope position detecting function | Not available | Not Available | |
| Passive bending function | Not available | Not Available | |
| Subject Device | |||
| GIF-1100 | Predicate Device | ||
| GIF-H190 | |||
| Flexibility | |||
| adjustment | |||
| function | Not Available | Not Available | |
| Focus switching | |||
| function | Not Available | Not Available | |
| Auxiliary water | |||
| feeding function | Available | Available |
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CONFIDENTIAI
510(k) Summary
28
Image /page/28/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 registered trademark symbol to the right of the letter "S". There is a thin yellow line underneath the word.
7. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
1) Reprocessing validation
Reprocessing instruction and reprocessing method validation testing were conducted for CF-HQ1100DL/I and GIF-1100, and documentations were provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling".
2) Biocompatibility
Biocompatibility evaluation were conducted for CF-HQ1100DL/I, GIF-1100, CV-1500, and MAJ-901/902 in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests:
- । Cytotoxicity Study Using the Elution Method
- Intracutaneous Irritation Study ।
- । Guinea Pig Maximization Sensitization Test
3) Software verification and validation
Software verification and validation testing were conducted for CV-1500, CF-HQ1100DL, CF-HQ1100DI, and GIF-1100, 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".
4) Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted for CV-1500, CF-HQ1100DL, CF-HQ1100DI, and GIF-1100 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. Laser safety test was conducted for CV-1500 in accordance with the IEC 60825-1:2007 standards for laser product.
5) Performance testing - Bench
Bench testing as listed below were conducted for CV-1500, CF-HQ1100DL, CF-HQ1100Dl, and GIF-1100 to ensure that the subject device performs as intended and meet design specifications.
29
- Thermal Safety
- Durability
- Photobiological Safety
- Color Performance
- Direction of View
- Field of View
- Resolution
- Depth of Field
- Noise and Dynamic Range
- Image Intensity Uniformity
- Video Latency
- RDI
- TXI and BAI-MAC
- Automatic Brightness Adjustment
- Pre-Freeze
- Geometric Distortion
6) Performance testing - Animal
Animal study was performed for CV-1500 to confirm the White Light Imaging (WLI) and Narrow Band Imaging (NBI) performance, and the effectiveness of Red Dichromatic Imaging (RDI) and TeXture and color enhancement Imaging (TXI) .
7) Performance testing - Clinical
No clinical study was performed to demonstrate substantial equivalence.
8) Risk management
Risk management was performed for CV-1500, CF-HQ1100DL, CF-HQ1100DI,¥ and GIF-1100 in accordance with ISO 14971:2007. The design verification tests, and their acceptance criteria were identified and performed as a result of this risk management.
8. CONCLUSIONS
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate device, the EVIS X1 system raises no new issue of safety and effectiveness and are substantially equivalent to the predicate device in terms of safety, effectiveness and performance.