K201200 · Olympus Medical Systems Corp. · FET · Jul 22, 2020 · Gastroenterology, Urology
Device Facts
Record ID
K201200
Device Name
Visera Elite II Video System Center
Applicant
Olympus Medical Systems Corp.
Product Code
FET · Gastroenterology, Urology
Decision Date
Jul 22, 2020
Decision
SESE
Submission Type
Special
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
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.
Device Story
Video system center (OTV-S300) processes signals from Olympus endoscopes/camera heads to display images on monitors. Device integrates processor and LED light source (WLI and NBI modes). Operates by driving endoscope CCD to generate 2D/3D video output. Used in clinical settings by physicians/surgeons for visualization during endoscopic diagnosis and treatment. Provides real-time video observation to assist clinical decision-making and surgical guidance. Subject device adds 2D observation capability to existing 3D-capable platform.
Clinical Evidence
Bench testing only. Verification and validation included electrical safety (ANSI/AAMI ES 60601-1, IEC 60601-2-18), EMC (IEC 60601-1-2), and software validation. Bench performance testing confirmed image quality (brightness, intensity, color, signal-to-noise ratio) and video latency meet design specifications for the new 2D observation function.
Technological Characteristics
Video system center with integrated LED light source (10,000h life). Features 2D and 3D observation modes, touch panel interface, and auto gain control. Rated 100-120V AC, 400VA. Dimensions: 383x199x506mm; Weight: 19.3kg. Connectivity via proprietary camera head/endoscope interfaces. Software-controlled image processing.
Indications for Use
Indicated for use with Olympus camera heads, endoscopes, monitors, and ancillary equipment for endoscopic diagnosis, treatment, and video observation in patients undergoing endoscopic surgical procedures.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
OLYMPUS OTV-S300 (VISERA ELITE II VIDEO SYSTEM CENTER) (K193026)
Reference Devices
OLYMPUS OTV-S200 (VISERA ELITE II VIDEO SYSTEM CENTER) (K190449)
Submission Summary (Full Text)
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July 22, 2020
Olympus Medical Systems Corp. % Lisa Boyle Regulatory Affairs Specialist II Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610
Re: K201200
Trade/Device Name: Visera Elite II Video System Center Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET Dated: April 28, 2020 Received: May 4, 2020
Dear Lisa Boyle:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Jason R. Roberts, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K201200
Device Name VISERA ELITE II VIDEO SYSTEM CENTER
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="font-size:20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="font-size:20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
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Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly blurred, suggesting the image may be a close-up or a lower-resolution file. A thin, horizontal yellow line is visible beneath the word, adding a subtle accent to the logo.
Date Prepared: July 21, 2020
# 510(k) Summary
#### 1. GENERAL INFORMATION
| ■ 510(k) Submitter: | OLYMPUS MEDICAL SYSTEMS CORP.<br>2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ■ Contact Person: | Lisa M. Boyle<br>Olympus Corporation of the Americas<br>3500 Corporate Parkway PO Box 610<br>Center Valley, PA 18034-0610, USA<br>Phone: 484-896-3676<br>Fax: 484-896-7128<br>Email: lisa.boyle@olympus.com |
| ■ Manufacturing site: | Shirakawa Olympus Co., Ltd.<br>3-1 Okamiyama, Odakura, Nishigo-mura,<br>Nishishirakawa-gun, Fukushima 961-8061, Japan |
#### 2. DEVICE IDENTIFICATION
| Trade Name | VISERA ELITE II VIDEO SYSTEM CENTER |
|-------------------|------------------------------------------------------------------------------|
| Model | OTV-S300 |
| Common Name | Endoscope and accessories |
| Regulation Number | 21 CFR 876.1500 |
| Regulation Name | Endoscope and accessories |
| Product Code | FET (endoscopic video imaging<br>system/component, gastroenterology-urology) |
| Regulatory Class | II |
| Review Panel | Obstetrics/Gynecology |
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Image /page/4/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, dark blue letters. The word is in all capital letters and is slightly slanted to the right. There is a yellow line underneath the word. The registered trademark symbol is located to the right of the word.
Special 510(k) VISERA ELITE II VIDEO SYSTEM CENTER
#### 3. PREDICATE DEVICE/REFERENCE DEVICE
| Predicate device | | |
|--------------------------------------------------------------|----------------------------------|------------|
| Device name | 510(k) Submitter | 510(k) No. |
| OLYMPUS OTV-S300 (VISERA<br>ELITE II VIDEO SYSTEM<br>CENTER) | OLYMPUS MEDICAL<br>SYSTEMS CORP. | K193026 |
The predicate device has not been subject to a design-related recall.
| Reference device | | |
|--------------------------------------------------------------|----------------------------------|------------|
| Reference Device | | |
| Device name | 510(k) Submitter | 510(k) No. |
| OLYMPUS OTV-S200 (VISERA<br>ELITE II VIDEO SYSTEM<br>CENTER) | OLYMPUS MEDICAL<br>SYSTEMS CORP. | K190449 |
# 4. DEVICE DESCRIPTION VISERA ELITE II VIDEO SYSTEM CENTER
#### ■ Principle of operation and mechanism of action
The subject device is a video system center to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment used with endoscopes. The subject device is an update to the Visera Elite II Video System Center cleared under K193026 to add a 2D observation function.
The subject device has both a processor function and light source function. By switching on the illumination lamp in the subject device, the device provides light through the endoscopes directly for endoscopic observation.
There are two modes: WLI (White light imaging) mode for normal observation and NBI (Narrow-band imaging) mode for enhanced optical image observation.
By driving the CCD equipped in an endoscope, the subject device displays an endoscopic images on a monitor.
#### 5. INDICATIONS FOR USE
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for
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Image /page/5/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are closely spaced. There is a thin yellow line underneath the word, adding a subtle accent to the logo.
endoscopic diagnosis, treatment, and video observation.
## 6. SUBSTANTIAL EQUIVALENCE DISCUSSION
The table below provides a comparison of the intended use and technological characteristics of the subject and predicate device.
| | <Subject device> | <Predicate device > |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | VISERA ELITE II VIDEO<br>SYSTEM CENTER | VISERA ELITE II VIDEO<br>SYSTEM CENTER |
| Manufacturer | Olympus Medical Systems Corp | Olympus Medical Systems Corp |
| Indications<br>for use | This video system center is<br>intended to be used with<br>OLYMPUS camera heads,<br>endoscopes, monitors,<br>EndoTherapy accessories, and<br>other ancillary equipment for<br>endoscopic diagnosis,<br>treatment, and video<br>observation. | This video system center is<br>intended to be used with<br>OLYMPUS camera heads,<br>endoscopes, monitors,<br>EndoTherapy accessories, and<br>other ancillary equipment for<br>endoscopic diagnosis, treatment,<br>and video observation. |
| Rated voltage | 100-120V AC<br>50/60Hz | 100-120V AC<br>50/60Hz |
| Rated input | 400VA | 400VA |
| Dimension<br>(maximum) | W383×H199×D506<br>(mm) | W383×H199×D506<br>(mm) |
| Weight | 19.3kg | 19.3kg |
| AGC (Auto<br>gain control) | Provided | Provided |
| 2D<br>Observation | Provided | Not Provided |
| 3D<br>observation | Provided | Provided |
| Front panel | Touch panel | Touch panel |
Table: Comparison Table of the Subject and Predicate Device
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| | <Subject device> | <Predicate device > |
|-----------------------------------|-----------------------|-----------------------|
| | VISERA ELITE II VIDEO | VISERA ELITE II VIDEO |
| | SYSTEM CENTER | SYSTEM CENTER |
| (Operation) | | |
| Examination Lamp | LED | LED |
| Average lamp life | 10000h | 10000h |
| Emergency lamp | LED | LED |
| Average<br>Emergency<br>lamp life | 10000h | 10000h |
| NBI (Narrow<br>band<br>imaging) | Provided | Provided |
The subject and predicate devices have identical Indications for Use statements and have the same intended use - for visualization during endoscopic surgical procedures. The subject and the predicate device have different technological characteristics. The predicate device has a 3D circuit board to generate 3D images whereas the subject device incorporates a circuit board that is able to generate both 3D and 2D images. The differences between the subject and predicate device do not raise different questions of safety and effectiveness.
#### 7. PERFORMANCE DATA
To support the modification to the subject device to include a 2D observation function, the following design verification and validation activities were performed and summarized:
#### 7.1 Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted in accordance with ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009
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for electrical safety and IEC 60601-1-2:2014 for EMC.
#### 7.2 Software verification and validation testing
Software verification and validation for the subject device was conducted 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" (2005).
#### 7.3 Performance testing - Bench
Bench testing for the subject device incorporating the 2D function was conducted to ensure that the subject device performs as intended and meets the appropriate design specifications, as follows.
- Image Quality ●
- -Brightness
- Image Intensity -
- Color Performance -
- Signal to Noise ratio -
- Video Latency .
#### 8. CONCLUSIONS
The results of the performance testing described above demonstrate that the VISERA ELITE II VIDEO SYSTEM CENTER is as safe and effective as the predicate device and supports a determination of substantial equivalence
