(261 days)
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.
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.
Based on the provided FDA 510(k) clearance letter and documentation for the Olympus VISERA ELITE III Surgical Imaging System, here's a description of the acceptance criteria and the study proving the device meets them:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed "acceptance criteria" and exhaustive study results as might be found in a full clinical trial report or a PMA submission. For a device like this (endoscopic video imaging system), performance is typically evaluated through a combination of internationally recognized standards, bench testing, and comparison to predicate devices, rather than clinical efficacy studies in the way you might see for an AI diagnostic tool. Therefore, some of the requested information (especially regarding statistical metrics like sensitivity/specificity, sample sizes for training/test sets, expert adjudication, or MRMC studies) is not explicitly stated or applicable in the context of this 510(k) summary for an imaging system that primarily focuses on image quality and safety.
The summary emphasizes "substantial equivalence" based on similar intended use and technological characteristics, and that the differences do not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
For an endoscopic video imaging system, acceptance criteria are primarily related to image quality, safety (electrical, EMC, photobiological, laser), and functional performance in accordance with recognized industry standards. The reported "performance" is generally that the device meets these standards and functions as intended, with specific measurements taken during bench testing.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance (Summary) |
|---|---|---|
| Image Quality & Function | Field of View and Direction of View | Tested and functions as intended (Specific values provided in comparison tables for FoV for the camera head). |
| Resolution | Tested and functions as intended (4K compatible, higher pixel count compared to predicate). | |
| Image Noise and Dynamic Range | Tested and functions as intended (HDR Function available for OTV-S700). | |
| Brightness | Tested and functions as intended. | |
| Image Intensity Uniformity | Tested and functions as intended. | |
| Color Performance | Tested and functions as intended. | |
| Latency | Tested and functions as intended. | |
| Iris Area Observation | Tested and functions as intended. | |
| Laser Mode Observation | Tested and functions as intended. | |
| Magnification | Tested and functions as intended. | |
| Distortion | Tested and functions as intended. | |
| Depth of Field | Tested and functions as intended. | |
| Auto Focus Function (CH-S700-XZ-EA) | Tested and functions as intended (New feature: Electrical automatically focus with one-touch auto focus/Continuous auto focus). | |
| Electrical Safety | Compliance with ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012 | Confirmed in compliance. |
| Compliance with IEC 60601-2-18 Ed. 3.0 2009-08 (Endoscopic equipment) | Confirmed in compliance. | |
| Degree of protection against electric shock (CH-S700-XZ-EA) | Type CF (improved from predicate's Type BF). | |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 Ed. 4.1 2020-09 | Confirmed in compliance. |
| Usability | Compliance with IEC 60601-1-6 Ed. 3.2 2020-07 | Confirmed in compliance. |
| Human Factors Validation (for CH-S700-XZ-EA reprocessing) | Performed; risks mitigated effectively. | |
| Reprocessing/Sterilization | Validation for 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA | Validated for Manual Cleaning, Delayed Manual Cleaning (Endozime AW), Sterilization (V-PRO maX, Autoclave), Drying time. |
| Software | Compliance with "Guidance for the Content of Premarket Submissions for Device Software Functions" and "Cybersecurity in Medical Devices" | Verification and validation performed and documented. |
| Risk Management | Established in-house acceptance criteria based on ISO 14971:2019 | Risk analysis conducted; design verification tests identified and performed. |
| Photobiological Safety | Compliance with IEC 62471:2006-07 | Tested and functions as intended. |
| Laser Product Safety | Compliance with IEC 60825-1 Edition 2.0 2007-03 | Tested and functions as intended. |
| Durability | Tested and functions as intended. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: The document does not provide details on specific "sample sizes" in terms of number of patients or images for the performance tests. The testing described (bench testing, electrical safety, EMC, software V&V, reprocessing validation) typically involves testing of the physical devices themselves and their components, rather than a dataset of patient images.
- Data Provenance: The testing was conducted in support of a 510(k) submission from Olympus, with manufacturing in Japan. The testing described is bench testing and laboratory validation, not human clinical data. Therefore, the concept of "country of origin of the data" or "retrospective/prospective" does not apply in the typical sense of clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Ground Truth Experts: Not applicable in this context. The "ground truth" for an imaging system like this is its ability to accurately capture and display images according to objective physical and electrical parameters, as measured through engineering and quality control tests (e.g., resolution targets, color charts, electrical signal analysis). It's not about expert interpretation of medical images.
- Qualifications of Experts: The testing would be performed by qualified engineers, technicians, and quality assurance personnel with expertise in electrical engineering, optics, software testing, and medical device regulations.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no human rating or judgment that requires adjudication for the types of tests described (bench tests, safety, EMC). The results are objective measurements against predefined engineering specifications and regulatory standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for AI-driven diagnostic tools to assess how human reader performance (e.g., diagnostic accuracy) changes with and without AI assistance. This device is a foundational imaging system, not an AI diagnostic tool, so such a study would not be relevant for its clearance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a hardware imaging system, not an algorithm, so the concept of "standalone performance" of an AI algorithm does not apply. Its "performance" is inherently tied to its function as a tool for human use.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device's performance relies on objective engineering specifications, standardized test targets (e.g., resolution charts, color references), and regulatory safety standards. It's not based on expert consensus, pathology, or outcomes data in a clinical sense. For example, to test resolution, a known resolution target is imaged, and the system's ability to resolve details is measured.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a hardware imaging system and does not involve machine learning or AI models that require a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
In summary, the 510(k) process for a device like the VISERA ELITE III Surgical Imaging System primarily relies on demonstrating technical performance, safety, and substantial equivalence to legally marketed predicate devices through rigorous engineering testing (bench testing, electrical safety, EMC, software validation) against established standards, rather than clinical studies or AI model validation studies. The "acceptance criteria" are compliance with these standards and the "proof" is the successful completion of these tests.
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.
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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 | <170VA | 400VA |
| Dimensions (Max.) | W: 390 x H: 198 x D: 500 mm | W: 383 x H: 199 x D: 506 mm |
| Weight | 12.1 kg | 19.3 kg |
| 2D Observation | Same as predicate | Available |
| 3D Observation | With the accessory MAJ-2511 | Available |
| WLI Observation | Same as predicate | Available |
| NBI Observation | Same as predicate | Available |
| HDR Observation | Available | Not Available |
| Iris Area Observation | Same as predicate | Available |
| Laser Mode Observation | Same as predicate | Available |
| Automatic Gain Control | Same as predicate | Available |
| Front Panel (Operation) | Same as predicate | Touch Panel |
| Fog Free Function | Same as predicate | Available |
| Compatible Endoscopes | Same as predicate | Legacy 2D and 3D endoscopes |
Table 3 compares VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 to the predicate device with respect to intended use, technological characteristics, and principle of operation, providing detailed information regarding the basis for the determination of substantial equivalence.
Page 9
TRADITIONAL 510(K) NOTIFICATION
VISERA ELITE III Surgical Imaging System
510(k) Summary
Page 5 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 | <170VA | 400VA |
| Dimensions (Max.) | W: 390 x H: 198 x D: 500 mm | W: 383 x H: 199 x D: 506 mm |
| Weight | 12.1 kg | 19.3 kg |
| 2D Observation | Same as predicate | Available |
| 3D Observation | With the accessory MAJ-2511 | Available |
| WLI Observation | Same as predicate | Available |
| NBI Observation | Same as predicate | Available |
| HDR Observation | Available | Not Available |
| Iris Area Observation | Same as predicate | Available |
| Laser Mode Observation | Same as predicate | Available |
| Automatic Gain Control | Same as predicate | Available |
| Front Panel (Operation) | Same as predicate | Touch Panel |
| Fog Free Function | Same as predicate | Available |
| Compatible Endoscopes | Same as predicate | Legacy 2D and 3D endoscopes |
Table 3. Comparison of the VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 to the predicate device
| Feature/Technological Characteristics | Subject Device | Predicate Device |
|---|---|---|
| Regulatory | ||
| Device Name | VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 | VISERA ELITE II Video System Center w/Light Source |
| Model Number | OLYMPUS CLL-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 |
| 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 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. | 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 | Light Source | Video System Center and Light Source |
| Rated Voltage | AC 100-240V/ 50-60Hz | AC 100V/ 50-60Hz |
| Rated Input | 215VA | 400VA |
| Dimensions (Max.) | W: 390 x H: 162 x D: 502 mm | W: 383 x H: 199 x D: 506 mm |
| Weight | 13.5 kg | 19.3 kg |
| 2D Observation | Same as predicate | Available |
| 3D Observation | Same as predicate | Available |
| WLI Observation | Same as predicate | Available |
| NBI Observation | Same as predicate | Available |
| Iris Area Observation | Same as predicate | Available |
| Laser Mode Observation | Same as predicate | Available |
| Front Panel (Operation) | Not Available | Touch Panel |
| Examination Lamp | Same as predicate | LED |
| Average Lamp Life | Same as predicate | 10,000 hours |
| Emergency Lamp | Same as predicate | LED |
| Average Emergency Lamp Life | Same as predicate | 10,000 hours |
| Compatible Endoscopes | Same as predicate | Legacy 2D and 3D endoscopes |
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Table 3. Comparison of the VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 to the predicate device
| Feature/Technological Characteristics | Subject Device | Predicate Device |
|---|---|---|
| Regulatory | ||
| Device Name | VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 | VISERA ELITE II Video System Center w/Light Source |
| Model Number | OLYMPUS CLL-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 |
| 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 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. | 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 | Light Source | Video System Center and Light Source |
| Rated Voltage | AC 100-240V/ 50-60Hz | AC 100V/ 50-60Hz |
| Rated Input | 215VA | 400VA |
| Dimensions (Max.) | W: 390 x H: 162 x D: 502 mm | W: 383 x H: 199 x D: 506 mm |
| Weight | 13.5 kg | 19.3 kg |
| 2D Observation | Same as predicate | Available |
| 3D Observation | Same as predicate | Available |
| WLI Observation | Same as predicate | Available |
| NBI Observation | Same as predicate | Available |
| Iris Area Observation | Same as predicate | Available |
| Laser Mode Observation | Same as predicate | Available |
| Front Panel (Operation) | Not Available | Touch Panel |
| Examination Lamp | Same as predicate | LED |
| Average Lamp Life | Same as predicate | 10,000 hours |
| Emergency Lamp | Same as predicate | LED |
| Average Emergency Lamp Life | Same as predicate | 10,000 hours |
| Compatible Endoscopes | Same as predicate | Legacy 2D and 3D endoscopes |
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Table 4 compares 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA to the predicate device with respect to intended use, technological characteristics, and principle of operation, providing detailed information regarding the basis for the determination of substantial equivalence.
Table 4. Comparison of the 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA to the predicate device
| Feature/Technological Characteristics | Subject Device | Predicate Device |
|---|---|---|
| Regulatory | ||
| Device (Model) Name | 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA | HD 3CMOS AUTOCLAVABLE CAMERA HEAD |
| Model Number | OLYMPUS CH-S700-XZ-EA | OLYMPUS CH-S200-XZ-EA |
| Legal Manufacturer | Same as the predicate | OLYMPUS MEDICAL SYSTEMS CORP. |
| Regulatory Decision | This submission | K190449 |
| Regulation Number | Same as predicate | 876.1500 |
| Regulation Name | Same as predicate | Endoscope and accessories |
| Product Code | Same as predicate | FET, NWB |
| Regulatory Class | Same as predicate | II |
| Classification Panel | Same as predicate | Gastroenterology/Urology |
| Indications for Use | 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. | The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and observation. |
| Specifications | ||
| Observation Function | Same as predicate | 2D Function |
| 4K Compatible | Available | Not Available |
| Head Dimensions (Max.) | W: 44 x H: 54 x L:133 mm | W: 44 x H: 52 x L: 120 mm |
| Cable | Diameter: 5.1 mm x L: 3 m | Diameter: 6.8 mm x L: 3 m |
| Connector Surface | Card edge Connector with Optical Connection | Card Edge Connector |
| Image Module | 1 CMOS | 3CMOS |
| Pixel Count | 4,152(H) x 3,062(V) = 12,713,424 pixels | 1,944(H) x 1,092(V) = 2,122,848 pixels (Per CMOS) |
| Pixel Size | 1.55μm(H) x 1.55μm(V) | 2.75μm(H) x 2.75μm(V) |
| Focus Control | Electrical manual focus with focus control switches | Electrical manual focus with focus control switches |
| Electrical automatically focus with one-touch auto focus/Continuous auto focus switch | Not Available | |
| Continuous electrical automatically focus | Not Available | |
| Optics Zoom | Not Available | Available |
| Field of View | 20.7° 88° with representative rigid scope | 10.90° (Low magnification) to 22.42° (High magnification) |
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Table 4. Comparison of the 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA to the predicate device
| Feature/Technological Characteristics | Subject Device | Predicate Device |
|---|---|---|
| Regulatory | ||
| Device (Model) Name | 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA | HD 3CMOS AUTOCLAVABLE CAMERA HEAD |
| Model Number | OLYMPUS CH-S700-XZ-EA | OLYMPUS CH-S200-XZ-EA |
| Legal Manufacturer | Same as the predicate | OLYMPUS MEDICAL SYSTEMS CORP. |
| Regulatory Decision | This submission | K190449 |
| Regulation Number | Same as predicate | 876.1500 |
| Regulation Name | Same as predicate | Endoscope and accessories |
| Product Code | Same as predicate | FET, NWB |
| Regulatory Class | Same as predicate | II |
| Classification Panel | Same as predicate | Gastroenterology/Urology |
| Indications for Use | 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. | The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and observation. |
| Specifications | ||
| Observation Function | Same as predicate | 2D Function |
| 4K Compatible | Available | Not Available |
| Head Dimensions (Max.) | W: 44 x H: 54 x L:133 mm | W: 44 x H: 52 x L: 120 mm |
| Cable | Diameter: 5.1 mm x L: 3 m | Diameter: 6.8 mm x L: 3 m |
| Connector Surface | Card edge Connector with Optical Connection | Card Edge Connector |
| Image Module | 1 CMOS | 3CMOS |
| Pixel Count | 4,152(H) x 3,062(V) = 12,713,424 pixels | 1,944(H) x 1,092(V) = 2,122,848 pixels (Per CMOS) |
| Pixel Size | 1.55μm(H) x 1.55μm(V) | 2.75μm(H) x 2.75μm(V) |
| Focus Control | Electrical manual focus with focus control switches | Electrical manual focus with focus control switches |
| Electrical automatically focus with one-touch auto focus/Continuous auto focus switch | Not Available | |
| Continuous electrical automatically focus | Not Available | |
| Optics Zoom | Not Available | Available |
| Field of View | 20.7° 88° with representative rigid scope | 10.90° (Low magnification) to 22.42° (High magnification) |
| NBI Observation | Same as predicate | Available |
| Image Signal Transmission | Optical transmission (Digital) | Electro transmission (Digital) |
| Degree of protection against electric shock | Type CF | Type BF |
| Number of remote switches | Same as predicate | 3 |
| Compatible endoscopes | Same as predicate | Legacy 2D endoscopes |
| Head Weight | 270 g (excluding cable) | 295 g (excluding cable) |
| Reprocessing | End User Sterilized Autoclaving/V-PRO | End User Sterilized Autoclaving/V-PRO/STERRAD |
Compliance to Voluntary Standards
The following voluntary standards have been applied to the subject devices:
- ISO 15223-1
- ISO 7000
- ISO 7010
- ANSI AAMI ST98:2022
- ISO 17664-2 First Ed. 2021-02
- ISO 17665-1 First Ed. 2006-08
- ANSI AAMI IEC 62304:2006/A1: 2016
- IEC 81001-5-1 Ed. 1.0 2021-12
- AAMI TIR57:2016
- ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012
- IEC 60601-1-2 Ed. 4.1 2020-09
- IEC 60601-1-6 Ed. 3.2 2020-07
- IEC 60601-4-2 Ed. 1.0 2016-05
- IEC 60601-2-18 Ed. 3.0 2009-08
- ISO 8600-1:2015
- ISO 8600-3:2019
- IEC 62471:2006-07
- IEC 60825-1 Edition 2.0 2007-03
- ISO 14971:2019
Summary of Performance Testing
The following performance testing was conducted in support of the substantial equivalence determination.
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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. Therefore, sterilization and reprocessing testing and data was not applicable for these devices. The VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 and VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 are reusable and the associated instruction manuals for these devices includes cleaning and disinfection instructions with the following:
- Endozime AW
- 70% Isopropyl Alcohol
- Sodium Hypochlorite
The 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is distributed non-sterile to the end user. Before using the instrument for the first time and after each use, the device must be reprocessed according to the instructions in the companion Reprocessing Manual. The 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is validated as safe and effective for reprocessing as detailed in the Reprocessing Manual with the following:
- Manual Cleaning with Endozime AW
- Delayed Manual Cleaning with Endozime AW
- Sterilization with:
- V-PRO maX
- Autoclave
- Drying time of 80 minutes
The VISERA ELITE III Surgical Imaging System has a low likelihood of time-dependent product degradation. Therefore, shelf life testing and data was not applicable for the VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700, VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700, and 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA.
Software Verification and Validation Testing
Software verification and validation testing of the VISERA ELITE III Surgical Imaging System has been performed and documented in compliance with the FDA guidance "Guidance for the Content of Premarket Submissions for Device Software Functions" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions."
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC performance testing for VISERA ELITE III Surgical Imaging System is confirmed to be in compliance with the relevant requirements as noted below:
- ANSI AAMI ES 60601-1:2005+A1:2012 [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2 Edition 4.1: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 4)
- IEC 60601-2-18: Edition 3.0 2009-08: Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
- IEC 60601-1-6 Edition 3.1: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Bench Testing
Bench testing as listed below was conducted for VISERA ELITE III Surgical Imaging System to ensure that the subject device performs as intended and meets design specifications for the following:
- 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
Risk Analysis
Risk analysis for the VISERA ELITE III Surgical Imaging System was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2019. The design verification tests, and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
In the risk management process, Olympus performed preliminary analysis and evaluation to identify user tasks, user interface components, and use issues of the VISERA ELITE III Surgical Imaging System in accordance with the FDA Guidance, "Applying Human Factors
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and Usability Engineering to Medical Devices" issued on February 2, 2016. Olympus determined that human factors validation testing was not required for the VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 and VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700. For 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA, user tasks associated with reprocessing procedures were identified as critical tasks. Therefore, Olympus performed human factors validation and determined that risks have been mitigated effectively.
Animal and Clinical Testing
Animal and Clinical testing was not applicable and not performed.
Substantial Equivalence
Olympus has determined that the VISERA ELITE III Surgical Imaging System is substantially equivalent to the legally marketed predicate devices, VISERA ELITE II Video System Center OLYMPUS OTV-S300 (K201200) and the VISERA ELITE II HD 3CMOS Autoclavable Camera Head OLYMPUS CH-S200-XZ-EA (K190449) for the following reasons:
- same intended use;
- technological characteristics (design, materials, and operations) are similar or identical to the predicate devices; and
- does not introduce any new or novel treatments or standard of care that differs from predicate devices in commercial use.
VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700
The intended use, principles of operation, fundamental technology of VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 are identical to the predicate device. The differences in specifications include separation of processing and light source functions, rated voltage and input, device dimensions, and weight. New features include HDR Observation and 3D functionality availability via the accessory, MAJ-2511 which have been verified as safe and effective. The difference in indications for use between the VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 and the VISERA ELITE II Video System Center with Light Source is not a change from single use labeling to reusable and is not a change from prescription (Rx) use to over the counter (OTC) use. Further, this change does not describe a new disease, condition, or patient population that the device is intended in diagnosing, treating, preventing, curing, or mitigating. A risk-based assessment of these differences did not identify any new risks or significantly modified existing risks or raise new or different questions with respect to safety and effectiveness.
VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700
The intended use, principles of operation, fundamental technology of VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 are identical to the predicate device. The differences in specifications include rated voltage and input, device dimensions, weight, and absence of a front panel. The difference in indications for use between the VISERA ELITE III LED LIGHT
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SOURCE OLYMPUS CLL-S700 and the VISERA ELITE II Video System Center with Light Source is not a change from single use labeling to reusable, is not a change from prescription (Rx) use to over the counter (OTC) use. Further, this change does not describe a new disease, condition, or patient population that the device is intended in diagnosing, treating, preventing, curing, or mitigating. A risk-based assessment of these differences did not identify any new risks or significantly modified existing risks or raise new or different questions with respect to safety and effectiveness.
4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA
The intended use, principles of operation, fundamental technology of 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA are identical to the predicate device. The differences in specifications include 4K compatibility, device dimensions, image module, increased pixel count, decreased pixel size, additional focus control, digital zoom, increased field of view, image signal transmission, degree of protection against electric shock, and weight. The difference in indications for use between the 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA and the HD 3CMOS AUTOCLAVABLE CAMERA HEAD is not a change from single use labeling to reusable, is not a change from prescription (Rx) use to over the counter (OTC) use. Further, this change does not describe a new disease, condition, or patient population that the device is intended in diagnosing, treating, preventing, curing, or mitigating. A risk-based assessment of these differences did not identify any new risks or significantly modified existing risks or raise new or different questions with respect to safety and effectiveness.
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.
Conclusion
In summary, the VISERA ELITE III Surgical Imaging System (VISERA ELITE III VIDEO SYSTEM, CENTER OLYMPUS OTV-S700, VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700, and 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA) is substantially equivalent to the predicate devices and raises no new questions of safety or effectiveness.
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§ 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.