(90 days)
No
The provided text describes a colonovideoscope and gastrointestinal videoscope designed for endoscopic procedures. The description focuses on mechanical and optical components (e.g., control knobs, bending section, image guide, light guides) and functions (e.g., suction, water/air feeding, focus switching). There is no mention of AI models, machine learning, or deep neural networks being incorporated into the device's functionality. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is primarily for observation and diagnosis of the digestive tract, and while it allows for the passage of therapeutic instruments, it is not described as performing therapy itself.
Yes
The device is described as a videoscope indicated for use in the digestive tract for "observation," "endoscopy and endoscopic surgery," and passing instruments for "endoscopic biopsy," which are all diagnostic activities.
No
The device is a physical endoscope with various hardware components (control section, insertion section, connector section, angulation control knobs, VCM actuator, instrument channels, light guides) designed for physical insertion and observation. It is not solely software.
No
This device is an endoscope for visualization and therapeutic procedures within the digestive tract, which involves direct observation of internal organs, not in-vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
The COLONOVIDEOSCOPE OLYMPUS CF-EZ1500DL & CF-EZ1500DI are intended to be used with a video system center, endoscope position detecting unit, documentation equipment, monitor, endoscopic therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
The COLONOVIDEOSCOPE OLYMPUS CF-EZ1500DL/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-EZ1500 is intended to be used with a video system center, documentation equipment, monitor, endoscopic therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-EZ1500 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
Product codes
FDF, NWB, FDS
Device Description
The COLONOVIDEOSCOPE OLYMPUS CF-EZ1500DL & CF-EZ1500DI is intended to be used with a video system center, Endoscope position detecting unit, documentation equipment, monitor, endoscopic therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
The Olympus COLONOVIDEOSCOPE CF-EZ1500DL/I is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-EZ1500 is intended to be used with a video system center, documentation equipment, monitor, endoscopic therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
Note: The only differences between CF-EZ1500DL and CF-EZ1500DI are the insertion section working length of each scope and the total length of each scope.
The Olympus GASTROINTESTINAL VIDEOSCOPE GIF-EZ1500 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
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.
- Control section
The UP/DOWN angulation control knob and the RIGHT/LEFT angulation control knob on the control section is connected to the tip of the bending section by a series of wires. By operating the UP/DOWN angulation control knob and the RIGHT/LEFT angulation control knob, the bending section at the distal end bends vertically or parallel to guide the distal end for insertion and observation.
The observation mode can be selected by focus switching function, "near focus mode" featuring innovative resolving power for close observation or "normal focus mode" for normal observation. To realize the dual focus mechanism, Voice Coil Motor (VCM) is incorporated as an actuator.
The endoscope contains a cylinder to attach a suction valve for suction and air/water valve. Depressing the suction valve will allow the physician to use the endoscope to suction any fluids which are obscuring a good view of the tissue. Therapeutic instruments can be passed through the instrument channel for performing endoscopic biopsy and other therapies. Depressing the air/water valve will allow the doctor to feed water through the endoscope for lens washing. It also can be operated to feed air for removing any fluids or debris adhering to the objective lens.
- Insertion section
The insertion section has main parts including the image guide, light guides that bring light from the video system center through the endoscope, and instrument channel where therapeutic tools can be pushed in and out (also the suction channel).
- Connector section
The connector section connects the endoscope with the video system center (CV-1500) through the universal cord.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lower digestive tract (including the anus, rectum, sigmoid colon, 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 testing: Reprocessing instruction and reprocessing method validation testing were conducted and documentation 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 testing: Biocompatibility testing were conducted 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 Colony Assay
- Intracutaneous Study in Rabbits
- Guinea Pig Maximization Sensitization Test
Software verification and validation: Software verification and validation testing were conducted, 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 was conducted in accordance with the ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] and IEC 60601-2-18:2009 standards for safety and IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION for EMC.
Performance testing – Bench: Bench testing as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.
- Durability
- Thermal Safety
- Photobiological Safety
- Transportation
- Color Performance
- DOF/FOV
- Distortion
- Resolution
- DOF
- Noise and Dynamic Range
- Image Intensity Uniformity
- Video Latency
- Rates of Air, Water, and Suction
- Magnification
- Automatic brightness adjustment
- Pre-freeze
- Functional Validation
- Stability of EDOF Structure
- Human Factors Evaluation
Performance testing - Animal: Animal study was performed 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 in accordance with ISO 14971:2019. The design verification tests and their acceptance criteria were identified and performed as a result of this risk management.
Key Results: All testing demonstrated that the subject devices met design specifications, performed as intended, and was equivalent to the subject and reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
FDA 510(k) Clearance Letter - Olympus Endoscopes
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 15, 2025
Olympus Medical Systems Corporation
℅ Teffany Hutto
Regulatory Affairs Program Manager
Olympus Corporation of the Americas
800 West Park Drive
Westborough, Massachusetts 01581
Re: K250432
Trade/Device Name: Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: FDF, FDS, NWB
Dated: February 14, 2025
Received: February 14, 2025
Dear Teffany Hutto:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
Page 2
K250432 - Teffany Hutto Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
Page 3
K250432 - Teffany Hutto Page 3
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K250432
Device Name
Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)
Indications for Use (Describe)
The COLONOVIDEOSCOPE OLYMPUS CF-EZ1500DL & CF-EZ1500DI are intended to be used with a video system center, endoscope position detecting unit, documentation equipment, monitor, endoscopic therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
The COLONOVIDEOSCOPE OLYMPUS CF-EZ1500DL/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-EZ1500 is intended to be used with a video system center, documentation equipment, monitor, endoscopic therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-EZ1500 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
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."
Page 5
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
CONFIDENTIAL
K250432
Page 1 of 16
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
Date Prepared: 04/11/2025
510(k) Summary
CONTACT DETAILS
■ 510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan
■ Contact Person: Teffany Hutto
Olympus Corporation of the Americas
3500 Corporate Parkway PO Box 610
Center Valley, PA 18034-0610, USA
Phone: 512-508-6550
Fax: 484-896-7128
Email: teffany.hutto@olympus.com
• Manufacturing site: Aizu Olympus Co., Ltd.
3-1-1 Niiderakita, Aizuwakamatsu-shi, Fukushima 965-8520, Japan
DEVICE NAME
| Device Trade Name | OLYMPUS CF-EZ1500DL |
|---|---|
| Common Name | Colonovideoscope |
| Regulation Number | 876.1500 |
| Classification Name | Endoscope and accessories |
| Regulatory Class | II |
| Product Code | FDF, NWB |
| Device Trade Name | OLYMPUS CF-EZ1500DI |
|---|---|
| Common Name | Colonovideoscope |
| Regulation Number | 876.1500 |
| Classification Name | Endoscope and accessories |
| Regulatory Class | II |
| Product Code | FDF, NWB |
Page 6
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
CONFIDENTIAL
K250432
Page 2 of 16
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
| Device Trade Name | OLYMPUS GIF-EZ1500 |
|---|---|
| Common Name | Gastrointestinal Videoscope |
| Regulation Number | 876.1500 |
| Classification Name | Endoscope and accessories |
| Regulatory Class | II |
| Product Code | FDS, NWB |
LEGALLY MARKETED PREDICATE DEVICE
| Device Name | 510(k) Submitter | 510(k) No. | Product Code |
|---|---|---|---|
| Colonovideoscope Olympus CF-HQ1100L/I | Olympus Medical | K222584 | FDF |
| Gastrointestinal Videoscope OLYMPUS GIF-1100 | Olympus Medical | K222584 | FDS |
DEVICE DESCRIPTION SUMMARY
• General Description of the subject device
The COLONOVIDEOSCOPE OLYMPUS CF-EZ1500DL & CF-EZ1500DI is intended to be used with a video system center, Endoscope position detecting unit, documentation equipment, monitor, endoscopic therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
The Olympus COLONOVIDEOSCOPE CF-EZ1500DL/I is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-EZ1500 is intended to be used with a video system center, documentation equipment, monitor, endoscopic therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
Note: The only differences between CF-EZ1500DL and CF-EZ1500DI are the insertion section working length of each scope and the total length of each scope.
The Olympus GASTROINTESTINAL VIDEOSCOPE GIF-EZ1500 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
Page 7
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
CONFIDENTIAL
K250432
Page 3 of 16
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
• Principle of Operation
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.
1) Control section
The UP/DOWN angulation control knob and the RIGHT/LEFT angulation control knob on the control section is connected to the tip of the bending section by a series of wires. By operating the UP/DOWN angulation control knob and the RIGHT/LEFT angulation control knob, the bending section at the distal end bends vertically or parallel to guide the distal end for insertion and observation.
The observation mode can be selected by focus switching function, "near focus mode" featuring innovative resolving power for close observation or "normal focus mode" for normal observation. To realize the dual focus mechanism, Voice Coil Motor (VCM) is incorporated as an actuator.
The endoscope contains a cylinder to attach a suction valve for suction and air/water valve. Depressing the suction valve will allow the physician to use the endoscope to suction any fluids which are obscuring a good view of the tissue. Therapeutic instruments can be passed through the instrument channel for performing endoscopic biopsy and other therapies. Depressing the air/water valve will allow the doctor to feed water through the endoscope for lens washing. It also can be operated to feed air for removing any fluids or debris adhering to the objective lens.
2) Insertion section
The insertion section has main parts including the image guide, light guides that bring light from the video system center through the endoscope, and instrument channel where therapeutic tools can be pushed in and out (also the suction channel).
3) Connector section
The connector section connects the endoscope with the video system center (CV-1500) through the universal cord.
Page 8
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
CONFIDENTIAL
K250432
Page 4 of 16
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
INTENDED USE/INDICATIONS FOR USE
The COLONOVIDEOSCOPE OLYMPUS CF-EZ1500DL & CF-EZ1500DI are intended to be used with a video system center, endoscope position detecting unit, documentation equipment, monitor, endoscopic therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
The COLONOVIDEOSCOPE OLYMPUS CF-EZ1500DL/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-EZ1500 is intended to be used with a video system center, documentation equipment, monitor, endoscopic therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-EZ1500 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
INDICATIONS FOR USE COMPARISON
CF-EZ1500DL/I have the same intended use and indications for use as compared to the predicate device. The subject device is also equivalent to the predicate device for direction of view, field of view, geometric distortion, diameters of insertion section, diameters of instrument channel, same control section, configuration of control section and connector section, bending section angulation range, total length, functions (excluding electronic shutter function), Scope ID, and RFID. The subject device also utilizes the same manufacturing materials, and the same methods of reprocessing.
GIF-EZ1500 is has the same intended use and indications for use as the predicate devices. The subject device also is equivalent to the predicate devices for direction of view, field of view, geometric distortion, distal end feature, insertion section working length, instrument channel diameters, configuration of control section and connector section, bending section of angulation range, total length, functions (excluding electronic shutter function and focus switching function), Scope ID, and RFID. The subject device also utilizes the same manufacturing materials, and the same methods of reprocessing.
Page 9
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
CONFIDENTIAL
K250432
Page 5 of 16
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
TECHNOLOGICAL COMPARISON
CF-EZ1500DL/I differs from the predicate device for image sensor type and number of pixels, depth of field, and airflow rate. CF-EZ1500DL/I also does not include an electronic shutter function where the predicate does include it.
GIF-EZ1500 differs from the predicate devices for image sensor type, number of pixels, and pixel size, depth of field, outer diameters of distal end, insertion section, insertion tube, and airflow rate. The subject device does not include electronic shutter function where the predicate device does include it. The subject device has a focus switching function, whereas the predicate device does not.
| Subject Device CF-EZ1500DL/I | Predicate Device CF-HQ1100L/I (K222584) | Reference Device CF-HQ190L (K131780) | |
|---|---|---|---|
| 510(k) number | This submission | K222584 | K131780 |
| Regulation number | 876.1500 | 876.1500 | 876.1500 |
| Regulatory class | Class II | Class II | Class II |
| Product code | FDF (colonoscope and accessories, flexible/rigid) NWB (endoscope, accessories, narrow band spectrum) | FDF (colonoscope and accessories, flexible/rigid) NWB (endoscope, accessories, narrow band spectrum) | FDF (colonoscope and accessories, flexible/rigid) NWB (endoscope, accessories, narrow band spectrum) |
| Classification panel | Gastroenterology and urology | Gastroenterology and urology | Gastroenterology and urology |
| Common name | COLONOVIDEOSCOPE | COLONOVIDEOSCOPE | COLONOVIDEOSCOPE |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. | OLYMPUS MEDICAL SYSTEMS CORP. | OLYMPUS MEDICAL SYSTEMS CORP. |
| Indications for use | The COLONOVIDEOSCOPE OLYMPUS CF-EZ1500DL & CF-EZ1500DI is intended to be used with a video system center, Endoscope position detecting unit, documentation equipment, monitor, endoscopic therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. | This instrument is intended to be used with an Olympus video system center, Endoscope position detecting unit, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The Olympus | 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 |
Page 10
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
CONFIDENTIAL
K250432
Page 6 of 16
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
| Subject Device CF-EZ1500DL/I | Predicate Device CF-HQ1100L/I (K222584) | Reference Device CF-HQ190L (K131780) | |
|---|---|---|---|
| The Olympus COLONOVIDEOSCOPE CF-EZ1500DL/I is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). | COLONOVIDEOSCOPE CF-HQ1100DL/I is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). | COLONOVIDEOSCOPE CF-HQ190L/I is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). | |
| Type | - CMOS - RGB color filter - Sequential read image signal | - CCD - CYM color filter - Sequential read image signal | - CCD - CYM color filter - Sequential read image signal |
| Direction of View | 0° | 0° | 0° |
| Field of View | Normal focus mode: 170° Near focus mode: 160° | Normal focus mode: 170° Near focus mode: 160° | Normal focus mode: 170° Near focus mode: 160° |
| Depth of Field | Normal focus mode: WLI, NBI: 3 - 100 mm RDI: 7 - 100 mm Near focus mode: WLI, NBI: 1.5 - 5.5 mm RDI: 2.5 - 5.5 mm | Normal focus mode: WLI, NBI, RDI: 5 - 100 mm Near focus mode: WLI, NBI, RDI: 2 - 6 mm | Normal focus mode: WLI, NBI, RDI: 5 - 100 mm Near focus mode: WLI, NBI, RDI: 2 - 6 mm *RDI is available only connected to CV-1500 |
| Magnification | × 90 (OEV321UH) × 75 (OEV262H) | × 75 (OEV321UH) × 60 (OEV262H) | × 75 (OEV321UH) × 60 (OEV262H) |
| Distal end outer diameter | ø 13.2 mm | ø 13.2 mm | ø 13.2 mm |
| Maximum insertion section outer diameter | ø 14.9 mm | ø 14.9 mm | ø 14.9 mm |
Page 11
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
CONFIDENTIAL
K250432
Page 7 of 16
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
| Subject Device CF-EZ1500DL/I | Predicate Device CF-HQ1100L/I (K222584) | Reference Device CF-HQ190L (K131780) | |
|---|---|---|---|
| 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 | 1 Air/water nozzle 2 Light guide lens 3 Objective lens 4 Instrument channel outlet 5 Auxiliary water channel |
| Insertion tube outer diameter | ø 12.8 mm | ø 12.8 mm | ø 12.8 mm |
| Insertion section working length | L: 1680 mm I: 1330 mm | L: 1680 mm I: 1330 mm | L: 1680 mm I: 1330 mm |
| Range of the flexibility adjustment | The rigidity in the most rigid condition is about twice that in the most flexible condition. | The rigidity in the most rigid condition is about twice that in the most flexible condition. | The rigidity in the most rigid condition is about twice that in the most flexible condition. |
| Channel inner diameter | ø 3.7 mm | ø 3.7 mm | ø 3.7 mm |
| Minimum channel inner diameter | ø 3.7 mm | ø 3.7 mm | ø 3.7 mm |
| Minimum visible distance | 4 mm (Normal focus mode) | 4 mm (Normal focus mode) | 4 mm (Normal focus mode) |
| Direction from which EndoTherapy accessories enter and exit the endoscopic image |
Page 12
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
CONFIDENTIAL
K250432
Page 8 of 16
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
| Subject Device CF-EZ1500DL/I | Predicate Device CF-HQ1100L/I (K222584) | Reference Device CF-HQ190L (K131780) | |
|---|---|---|---|
| Configuration | |||
| Airflow rate *At the setting of the air pressure as "high." | 30 cm³/s | 25 cm³/s | 25 cm³/s |
| Angulation range | UP 180° DOWN 180° RIGHT 160° LEFT 160° | 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 | L: 2005 mm I: 1655mm |
| Pre-freeze function | Available | Available | Available |
| Electronic zoom function | Available | Available | Available |
| Electronic shutter function | Not Available | Available | Available |
Page 13
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
CONFIDENTIAL
K250432
Page 9 of 16
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
| Subject Device CF-EZ1500DL/I | Predicate Device CF-HQ1100L/I (K222584) | Reference Device CF-HQ190L (K131780) | |
|---|---|---|---|
| Records of endoscope's information | Available | Available | Available |
| NBI observation | Available | Available | Available |
| RDI observation | Available | Available | Not Available *RDI is available only connected to CV-1500 |
| High frequency cauterization treatment | Available | Available | Available |
| Endoscope position detecting function | Available | Available | Available |
| Passive bending function | Available | Available | Available |
| Flexibility adjustment function | Available | Available | Available |
| Zoom function | Not Available | Not Available | Not Available |
| Focus switching function | Available | Available | Available |
| Auxiliary water feeding function | Available | Available | Available |
| Transnasal insertion | Not Available | Not Available | Not Available |
Page 14
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
CONFIDENTIAL
K250432
Page 10 of 16
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
| Subject Device GIF-EZ1500 | Predicate Device GIF-1100 (K222584) | Reference Device GIF-1TH190 (K232997) | |
|---|---|---|---|
| 510(k) number | This submission | K222584 | K232997 |
| Regulation number | 876.1500 | 876.1500 | 876.1500 |
| Regulatory class | Class II | Class II | Class II |
| Product code | FDS (gastroscope and accessories, flexible/rigid) NWB (endoscope, accessories, narrow band spectrum) | FDS (gastroscope and accessories, flexible/rigid) NWB (endoscope, accessories, narrow band spectrum) | 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 | GASTROINTESTINAL VIDEOSCOPE | GASTROINTESTINAL VIDEOSCOPE | GASTROINTESTINAL VIDEOSCOPE |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. | OLYMPUS MEDICAL SYSTEMS CORP. | OLYMPUS MEDICAL SYSTEMS CORP. |
| Indications for use | The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-EZ1500 is intended to be used with a video system center, documentation equipment, monitor, endoscopic therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The Olympus GASTROINTESTINAL VIDEOSCOPE GIF-EZ1500 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, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The Olympus 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-1TH190 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). |
Page 15
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
CONFIDENTIAL
K250432
Page 11 of 16
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
| Subject Device GIF-EZ1500 | Predicate Device GIF-1100 (K222584) | Reference Device GIF-1TH190 (K232997) | |
|---|---|---|---|
| Type | - CMOS - RGB color filter - Sequential read image signal | - CCD - CYM color filter - Sequential read image signal | - CCD - CYM color filter - Sequential read image signal |
| Direction of View | 0° | 0° | 0° |
| Field of View | Normal focus mode: 140° Near focus mode: 140° | 140° | 140° |
| Depth of Field | Normal focus mode: WLI, NBI: 3 - 100 mm RDI: 7 - 100 mm Near focus mode: WLI, NBI: 1.5 - 5.5 mm RDI: 2.5 - 5.5 mm | WLI, NBI, RDI: 2 - 100 mm | WLI, NBI: 2 - 100 mm |
| Magnification | × 100 (OEV321UH) × 85 (OEV262H) | × 70(OEV321UH) × 55(OEV262H) | × 65(OEV321UH) × 55(OEV262H) |
| 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 | 1 Air/water nozzle 2 Light guide lens 3 Objective lens 4 Instrument channel outlet 5 Auxiliary water channel |
| Distal end outer diameter | ø 9.9 mm | ø 8.9 mm | ø 10.0mm |
| Maximum insertion section outer diameter | ø 12.5mm | ø 10.7mm | ø 13.0mm |
Page 16
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
CONFIDENTIAL
K250432
Page 12 of 16
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
| Subject Device GIF-EZ1500 | Predicate Device GIF-1100 (K222584) | Reference Device GIF-1TH190 (K232997) | |
|---|---|---|---|
| Insertion tube outer diameter | ø 9.6 mm | ø 8.9 mm | ø 10.9mm |
| Insertion section working length | 1030 mm | 1030 mm | 1030 mm |
| Channel inner diameter | ø 2.8 mm | ø 2.8 mm | ø 3.7 mm |
| Minimum visible distance | 3 mm | 3 mm | 3 mm |
| Direction from which EndoTherapy accessories enter and exit the endoscopic image | |||
| Configuration |
Page 17
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
CONFIDENTIAL
K250432
Page 13 of 16
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
| Subject Device GIF-EZ1500 | Predicate Device GIF-1100 (K222584) | Reference Device GIF-1TH190 (K232997) | |
|---|---|---|---|
| Configuration | |||
| Airflow rate *At the setting of the air pressure as "high." | 30 cm³/s | 25 cm³/s | 25 cm³/s |
| Angulation range | UP 210° DOWN 90° RIGHT 100° LEFT 100° | UP 210° DOWN 90° RIGHT 100° LEFT 100° | UP: 210° DOWN: 90° RIGHT:100° LEFT:100° |
| Total length | 1350 mm | 1350 mm | 1350 mm |
| Pre-freeze function | Available | Available | Available |
| Electronic zoom function | Available | Available | Available |
| Electronic shutter function | Not Available | Available | Available |
| Records of endoscope's information | Available | Available | Available |
| NBI observation | Available | Available | Available |
| RDI observation | Available | Available | Not available |
| High frequency cauterization treatment | Available | Available | Available |
| Endoscope position detecting function | Not available | Not available | Not available |
Page 18
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
CONFIDENTIAL
K250432
Page 14 of 16
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
| Subject Device GIF-EZ1500 | Predicate Device GIF-1100 (K222584) | Reference Device GIF-1TH190 (K232997) | |
|---|---|---|---|
| Passive bending function | Not available | Not available | Not available |
| Flexibility adjustment function | Not available | Not available | Not available |
| Zoom function | Not Available | Not Available | Not Available |
| Focus switching function | Available | Not available | Not available |
| Auxiliary water feeding function | Available | Available | Available |
| Transnasal insertion | Not available | Not available | Not available |
NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY & CONCLUSIONS
Reprocessing validation testing
Reprocessing instruction and reprocessing method validation testing were conducted and documentation 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 testing
Biocompatibility testing were conducted 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 Colony Assay
- Intracutaneous Study in Rabbits
- Guinea Pig Maximization Sensitization Test
Page 19
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
CONFIDENTIAL
K250432
Page 15 of 16
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
Software verification and validation
Software verification and validation testing were conducted, 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 was conducted in accordance with the ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] and IEC 60601-2-18:2009 standards for safety and IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION for EMC.
Performance testing – Bench
Bench testing as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.
- Durability
- Thermal Safety
- Photobiological Safety
- Transportation
- Color Performance
- DOF/FOV
- Distortion
- Resolution
- DOF
- Noise and Dynamic Range
- Image Intensity Uniformity
- Video Latency
- Rates of Air, Water, and Suction
- Magnification
- Automatic brightness adjustment
- Pre-freeze
- Functional Validation
- Stability of EDOF Structure
- Human Factors Evaluation
Page 20
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
CONFIDENTIAL
K250432
Page 16 of 16
Traditional 510(k) Notification
CF-EZ1500DL/I and GIF-EZ1500
Performance testing - Animal
Animal study was performed 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 in accordance with ISO 14971:2019. The design verification tests and their acceptance criteria were identified and performed as a result of this risk management.
All testing demonstrated that the subject devices met design specifications, performed as intended, and was equivalent to the subject and reference devices.