(261 days)
Not Found
No.
The document explicitly states "Mentions AI, DNN, or ML: Not Found" for this device. The device description focuses on processing electronic signals from video endoscopes and outputting image signals, which are standard functions of video systems and do not inherently involve AI models.
No
The device is used for diagnosis, observation, and treatment, but it is not a therapeutic device itself. It processes signals, provides light, and captures images to facilitate treatment, but does not directly provide therapy.
Yes
The device is intended for "endoscopic diagnosis" as stated in the 'Intended Use / Indications for Use' section, which is a diagnostic purpose.
No
The device is not a software-only medical device because it includes multiple hardware components such as a Video System Center, an LED Light Source, and a Camera Head, which are all physical devices that process signals, provide light, and capture images. While there is a "3D Upgrade Pack" described as a "function activation portable memory key accessory that unlocks the 3D software function," this is an accessory to a hardware system and not the primary medical device itself. The extensive performance studies also include testing for electrical safety, EMC, and bench testing of physical characteristics like field of view, resolution, and durability, which are all indicative of a hardware device.
No.
This device is an imaging system designed for endoscopic diagnosis, treatment, and observation; it directly visualizes internal organs rather than performing in vitro analysis of biological samples.
N/A
Intended Use / Indications for Use
The VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 is intended to process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, light sources, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
The VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 is intended to provide light to an endoscope/video endoscope in order to process electronic signals transmitted from them and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, video system centers, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
The 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is intended to be used with endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
Product codes (comma separated list FDA assigned to the subject device)
FET, NWB
Device Description
The VISERA ELITE III Surgical Imaging System is intended to be used with ancillary equipment for endoscopic diagnosis, treatment, and observation and supports the function of high definition (HD) videoscopes and is Camera Head (CH) compatible.
The following devices of the VISERA ELITE III Surgical Imaging System are the subject of this premarket notification submission:
-
VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 (Model: OLYMPUS OTV-S700) - A video system center that processes electronic signals transmitted from a video endoscope or a camera head and outputs the image signal to a monitor.
- VISERA ELITE III 3D Upgrade Pack (Model: MAJ-2511) - A function activation portable memory key accessory that unlocks the 3D software function when connected with OTV-S700 to enable the observation of 3D mode.
-
VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 (Model: OLYMPUS CLL-S700) - A LED light source provides examination light to a video endoscope and a camera head.
-
4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA (Model: OLYMPUS CH-S700-XZ-EA) - A 4K Inline camera head is intended to be used with Olympus endoscopes, the video system center, and other ancillary equipment for the visualization of internal organs (endoscopic diagnosis), treatment and observation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The following performance testing was conducted in support of the substantial equivalence determination: Reprocessing, Sterilization, and Shelf Life Validation; Software Verification and Validation Testing; Electrical Safety and Electromagnetic Compatibility (EMC); Bench Testing (Field of View and Direction of View, Resolution, Image Noise and Dynamic Range, Brightness, Image Intensity Uniformity, Color Performance, Latency, Iris Area, Laser Mode, Magnification, Distortion, Depth of Field, Photobiological Safety, Laser Product Safety, Auto Focus Function, High Dynamic Range (HDR) Function, Durability).
Key Results:
- Reprocessing, Sterilization, and Shelf Life Validation: The VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 and VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 are not intended to be sterilized or reprocessed. The 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is validated as safe and effective for reprocessing with specific methods. Shelf life testing was not applicable due to low likelihood of time-dependent product degradation.
- Software Verification and Validation Testing: Performed and documented in compliance with FDA guidance.
- Electrical Safety and Electromagnetic Compatibility (EMC): Confirmed to be in compliance with relevant requirements (ANSI AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-1-6).
- Bench Testing: Conducted to ensure the subject device performs as intended and meets design specifications for listed parameters.
- Risk Analysis: Conducted in accordance with ISO 14971:2019. Human factors validation was not required for the VISERA ELITE III VIDEO SYSTEM CENTER and LED LIGHT SOURCE. For the 4K CAMERA HEAD, human factors validation was performed for reprocessing procedures and risks have been effectively mitigated.
- Animal and Clinical testing: Not applicable and not performed.
The VISERA ELITE III Surgical Imaging System has been verified and validated to be equivalent in electrical performance for use with video endoscopes/camera head to output image signals to a monitor for endoscopic diagnosis, treatment, and observation when compared to the predicates. As the electrical safety and electromagnetic compatibility test results demonstrate equivalent performance, Olympus has determined there are no new concerns or modified existing risks regarding safety and effectiveness of the subject device.
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.
FDA 510(k) Clearance Letter and Documentation
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.07.05
Silver Spring, MD 20993
www.fda.gov
April 2, 2025
Olympus Corporations of the Americas
Elizabeth Greene
Program Manager
800 West Park Drive
Westborough, Massachusetts 01581
Re: K242067
Trade/Device Name: Visera Elite III Video System Center Olympus Otv-s700; Visera Elite III Led Light Source Olympus Cll-s700; 4k Camera Head Olympus Ch-s700-xz-ea
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: Class II
Product Code: FET, NWB
Dated: March 4, 2025
Received: March 4, 2025
Dear Elizabeth Greene:
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.
Page 2
K242067 - Elizabeth Greene Page 2
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" (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).
Page 3
K242067 - Elizabeth Greene Page 3
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).
Sincerely,
TANISHA L. HITHE -S
Digitally signed by TANISHA L. HITHE -S
Date: 2025.04.02 22:57:33 -04'00'
Tanisha Hithe
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K242067
Device Name: VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA
Indications for Use (Describe):
The VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 is intended to process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, light sources, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
The VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 is intended to provide light to an endoscope/video endoscope in order to process electronic signals transmitted from them and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, video system centers, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
The 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is intended to be used with endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
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."
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
510(k) Number (if known): K242067
Device Name: VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA
Indications for Use (Describe):
The VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 is intended to process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, light sources, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
The VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 is intended to provide light to an endoscope/video endoscope in order to process electronic signals transmitted from them and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, video system centers, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
The 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is intended to be used with endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
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."
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
TRADITIONAL 510(K) NOTIFICATION
VISERA ELITE III Surgical Imaging System
510(k) Summary
Page 1 of 11
510(k) Summary
For
VISERA ELITE III Surgical Imaging System
General Information
Applicant: OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan
192-8507
Phone: (+81) 42-642-2111
Fax: (+81) 42-642-2307
Establishment Registration Number: 8010047
Manufacturer: Shirakawa Olympus Co., Ltd.
3-1 Okamiyama, Odakura, Nishigo-mura,
Nishishirakawa-gun, Fukushima 961-8061,
Japan
510(k) Submitter: Olympus Corporation of the Americas
800 West Park Drive
Westborough, MA 01581
Establishment Registration Number: 2429304
Contact Person: Elizabeth Greene
Program Manager
Mobile: (772) 254-3793
Email: elizabeth.greene@olympus.com
Date Prepared: July 12, 2024
Device Description
Device Name: VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700
Model Name: OLYMPUS OTV-S700
Generic/Common Name: Endoscopic Video Imaging System
Regulation Number: 876.1500
Regulatory Class: Class II
Classification Name: Endoscope and accessories
Product Codes: FET, NWB
Review Panel: Gastroenterology/Urology
Page 6
TRADITIONAL 510(K) NOTIFICATION
VISERA ELITE III Surgical Imaging System
510(k) Summary
Page 2 of 11
Device Name: VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700
Model Name: OLYMPUS CLL-S700
Generic/Common Name: Endoscopic Video Imaging System
Regulation Number: 876.1500
Regulatory Class: Class II
Classification Name: Endoscope and accessories
Product Codes: FET, NWB
Review Panel: Gastroenterology/Urology
Device Name: 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA
Model Name: OLYMPUS CH-S700-XZ-EA
Generic/Common Name: Endoscopic Video Imaging System
Regulation Number: 876.1500
Regulatory Class: Class II
Classification Name: Endoscope and accessories
Product Codes: FET, NWB
Review Panel: Gastroenterology/Urology
Predicate Device
| Device Name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| OLYMPUS OTV-S300 Video System Center w/ Light Source | Olympus Medical Systems Corp. | K201200 |
| OLYMPUS CH-S200-XZ-EA HD 3CMOS AUTOCLAVABLE CAMERA HEAD | Olympus Medical Systems Corp. | K190449 |
Indications for Use
Table 1 details the Indications for Use for the devices in the VISERA ELITE III Surgical Imaging System.
Table 1. Indications for Use for VISERA ELITE III Surgical Imaging System
| Device | Indications for Use |
|---|---|
| VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 | The VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 is intended to process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, light sources, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation. |
| VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 | The VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 is intended to provide light to an endoscope/video endoscope in order to process electronic signals transmitted from them and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, video system centers, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation. |
Page 7
TRADITIONAL 510(K) NOTIFICATION
VISERA ELITE III Surgical Imaging System
510(k) Summary
Page 3 of 11
| Device | Indications for Use |
|---|---|
| 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA | The 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is intended to be used with endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. |
Device Description
The VISERA ELITE III Surgical Imaging System is intended to be used with ancillary equipment for endoscopic diagnosis, treatment, and observation and supports the function of high definition (HD) videoscopes and is Camera Head (CH) compatible.
The following devices of the VISERA ELITE III Surgical Imaging System are the subject of this premarket notification submission:
-
VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 (Model: OLYMPUS OTV-S700) - A video system center that processes electronic signals transmitted from a video endoscope or a camera head and outputs the image signal to a monitor.
- VISERA ELITE III 3D Upgrade Pack (Model: MAJ-2511) - A function activation portable memory key accessory that unlocks the 3D software function when connected with OTV-S700 to enable the observation of 3D mode.
-
VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 (Model: OLYMPUS CLL-S700) - A LED light source provides examination light to a video endoscope and a camera head.
-
4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA (Model: OLYMPUS CH-S700-XZ-EA) - A 4K Inline camera head is intended to be used with Olympus endoscopes, the video system center, and other ancillary equipment for the visualization of internal organs (endoscopic diagnosis), treatment and observation.
Comparison of Technological Characteristics
Table 2 compares VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 to the predicate device with respect to intended use, and technological characteristics, providing detailed information regarding the basis for the determination of substantial equivalence.
Table 2. Comparison of the VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 to the predicate device
| Feature/Technological Characteristics | Subject Device | Predicate Device |
|---|---|---|
| Regulatory | ||
| Device Name | VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 | VISERA ELITE II Video System Center w/Light Source |
| Model Number | OLYMPUS OTV-S700 | OLYMPUS OTV-S300 |
| Legal Manufacturer | Same as the predicate | OLYMPUS MEDICAL SYSTEMS CORP. |
| Regulatory Decision | This submission | K201200 |
| Regulation Number | Same as predicate | 876.1500 |
Page 8
TRADITIONAL 510(K) NOTIFICATION
VISERA ELITE III Surgical Imaging System
510(k) Summary
Page 4 of 11
| Feature/Technological Characteristics | Subject Device | Predicate Device |
|---|---|---|
| Regulation Name | Same as predicate | Endoscope and accessories |
| Product Code | Same as predicate | FET, NWB |
| Regulatory Class | Same as predicate | II |
| Classification Panel | Gastroenterology/Urology | Obstetrics/Gynecology |
| Indications for Use | The VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 is intended to process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, light sources, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation. | This video system center is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation. |
| Specifications | ||
| Main Function | Video System Center | Video System Center and Light Source |
| Rated Voltage | AC 100-240V/ 50-60Hz | AC 100V/ 50-60Hz |
| Rated Input |