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 Description

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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the VISERA ELITE II VIDEO SYSTEM CENTER. It describes the device, its intended use, and provides a comparison to a predicate device. It also briefly mentions performance data.

However, the document does not contain the detailed information required to answer all parts of your request, especially regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC study results. The document focuses on technological similarities and differences with a predicate device to establish substantial equivalence for regulatory clearance.

Based on the information available, here's what can be extracted:

I. Acceptance Criteria and Reported Device Performance

The document states that bench testing was conducted to ensure the device performs as intended and meets appropriate design specifications. However, the specific acceptance criteria and detailed quantitative performance results for each of the listed image quality parameters are not provided in this regulatory submission summary.

Acceptance Criteria (Explicitly Stated/Implied)	Reported Device Performance
Image Quality:
- Brightness	"Performs as intended and meets appropriate design specifications" (Specific metrics not provided)
- Image Intensity	"Performs as intended and meets appropriate design specifications" (Specific metrics not provided)
- Color Performance	"Performs as intended and meets appropriate design specifications" (Specific metrics not provided)
- Signal to Noise ratio	"Performs as intended and meets appropriate design specifications" (Specific metrics not provided)
Video Latency	"Performs as intended and meets appropriate design specifications" (Specific metrics not provided)
Electrical Safety	Complies with ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2:2014
Software Verification & Validation	Conducted as recommended by FDA guidance.

II. Sample Size and Data Provenance for Test Set

The document mentions "Bench testing" for performance evaluation.

Sample size used for the test set: Not specified. It's likely that "test set" refers to physical setups and controlled environments used for bench testing, rather than a dataset of patient images.
Data provenance: Bench testing suggests controlled laboratory conditions. The document does not specify country of origin for any data or whether it's retrospective or prospective.

III. Number of Experts and Qualifications for Ground Truth

Number of experts: Not specified.
Qualifications of those experts: Not specified.
Method of establishing ground truth: For bench testing, ground truth would typically be established by calibrated measurement devices and reference standards, not human expert consensus on diagnostic images.

IV. Adjudication Method for the Test Set

Not applicable/Not specified as the performance testing described is "Bench testing" of system characteristics (e.g., image quality parameters, electrical safety) rather than diagnostic performance involving human interpretation of clinical cases.

V. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No, the document does not indicate that an MRMC comparative effectiveness study was done. The focus is on technical performance and substantial equivalence to a predicate device, not on improving human reader performance.
Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as no MRMC study was described.

VI. Standalone (Algorithm Only) Performance Study

Was a standalone study done? The performance data mentioned (image quality, video latency) relate to the standalone technical performance of the device's video system, specifically the added 2D observation function. However, this is not an "algorithm-only" performance in the context of an AI/CADe device, but rather the performance of the optical and electronic components of an endoscope video system. The document does not describe any specific algorithm or AI component in the device.

VII. Type of Ground Truth Used

For the bench testing described, the "ground truth" would be objective measurements obtained using calibrated equipment against known physical standards (e.g., for brightness, color accuracy, signal-to-noise ratio, latency). It is not pathology, outcomes data, or expert consensus on clinical findings.

VIII. Sample Size for the Training Set

Not applicable/Not specified. The document does not describe the use of machine learning or AI algorithms that would require a "training set" of data.

IX. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for an AI algorithm is mentioned.

Summary of Device and Study Focus:

This 510(k) submission primarily focuses on demonstrating the substantial equivalence of the "VISERA ELITE II VIDEO SYSTEM CENTER" to a predicate device (K193026). The key change for this submission (K201200) is the addition of a 2D observation function to a device that previously only offered 3D observation. The performance data section describes "Bench testing" of standard technical parameters (electrical safety, EMC, software, and image quality aspects like brightness, intensity, color, SNR, and video latency) to affirm that the device functions as intended and meets design specifications for its intended use as an endoscopic video system. It is a general medical device focused on video processing and illumination, not an AI or diagnostic decision support system.

Summary

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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)

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)

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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.2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
■ Contact Person:	Lisa M. BoyleOlympus Corporation of the Americas3500 Corporate Parkway PO Box 610Center Valley, PA 18034-0610, USAPhone: 484-896-3676Fax: 484-896-7128Email: lisa.boyle@olympus.com
■ Manufacturing site:	Shirakawa Olympus Co., Ltd.3-1 Okamiyama, Odakura, Nishigo-mura,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 imagingsystem/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 (VISERAELITE II VIDEO SYSTEMCENTER)	OLYMPUS MEDICALSYSTEMS 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 (VISERAELITE II VIDEO SYSTEMCENTER)	OLYMPUS MEDICALSYSTEMS CORP.	K190449

4. DEVICE DESCRIPTION VISERA ELITE II VIDEO SYSTEM CENTER

■ Principle of operation and mechanism of action

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.


	VISERA ELITE II VIDEOSYSTEM CENTER	VISERA ELITE II VIDEOSYSTEM CENTER
Manufacturer	Olympus Medical Systems Corp	Olympus Medical Systems Corp
Indicationsfor use	This video system center isintended to be used withOLYMPUS camera heads,endoscopes, monitors,EndoTherapy accessories, andother ancillary equipment forendoscopic diagnosis,treatment, and videoobservation.	This video system center isintended to be used withOLYMPUS camera heads,endoscopes, monitors,EndoTherapy accessories, andother ancillary equipment forendoscopic diagnosis, treatment,and video observation.
Rated voltage	100-120V AC50/60Hz	100-120V AC50/60Hz
Rated input	400VA	400VA
Dimension(maximum)	W383×H199×D506(mm)	W383×H199×D506(mm)
Weight	19.3kg	19.3kg
AGC (Autogain control)	Provided	Provided
2DObservation	Provided	Not Provided
3Dobservation	Provided	Provided
Front panel	Touch panel	Touch panel

Table: Comparison Table of the Subject and Predicate Device

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	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
AverageEmergencylamp life	10000h	10000h
NBI (Narrowbandimaging)	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

Regulation Number and Section

§ 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.