(79 days)
No
The summary describes a video system center for endoscopic imaging with standard image processing modes (WLI and NBI). There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
No
The device is described as a video system center for endoscopic diagnosis, treatment, and video observation, providing light and displaying images. While it supports diagnosis and treatment by offering visualization, it does not directly perform a therapeutic action; instead, it is an accessory used with other equipment that may be therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "endoscopic diagnosis".
No
The device description explicitly states it has both a processor function and a light source function, indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "endoscopic diagnosis, treatment, and video observation." This involves visualizing internal body structures, which is a diagnostic process performed in vivo (within the living body), not in vitro (outside the living body, typically on biological samples).
- Device Description: The description details how the device provides light and displays endoscopic images from a CCD in an endoscope. This is consistent with a system used for direct visualization of internal anatomy.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific analytes, or performing tests on specimens outside the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to facilitate the visualization of internal anatomy during an endoscopic procedure.
N/A
Intended Use / 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.
Product codes
FET
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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) | |
|---|---|
| ☑ 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. Boyle
Olympus Corporation of the Americas
3500 Corporate Parkway PO Box 610
Center Valley, PA 18034-0610, USA
Phone: 484-896-3676
Fax: 484-896-7128
Email: 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 imaging |
| 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 | ||
| ELITE II VIDEO SYSTEM | ||
| CENTER) | OLYMPUS MEDICAL | |
| 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 | ||
| ELITE II VIDEO SYSTEM | ||
| CENTER) | OLYMPUS MEDICAL | |
| 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.
| VISERA ELITE II VIDEO | ||
| SYSTEM CENTER | VISERA ELITE II VIDEO | |
| SYSTEM CENTER | ||
| Manufacturer | Olympus Medical Systems Corp | Olympus Medical Systems Corp |
| 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. | 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. | ||
| Rated voltage | 100-120V AC | |
| 50/60Hz | 100-120V AC | |
| 50/60Hz | ||
| Rated input | 400VA | 400VA |
| Dimension | ||
| (maximum) | W383×H199×D506 | |
| (mm) | W383×H199×D506 | |
| (mm) | ||
| Weight | 19.3kg | 19.3kg |
| AGC (Auto | ||
| gain control) | Provided | Provided |
| 2D | ||
| Observation | Provided | Not Provided |
| 3D | ||
| observation | Provided | Provided |
| Front panel | Touch panel | Touch panel |
Table: Comparison Table of the Subject and Predicate Device
6
| 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 | ||
| Emergency | ||
| lamp life | 10000h | 10000h |
| NBI (Narrow | ||
| band | ||
| 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
7
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