Visera Elite II Video System Center

K202646 · Olympus Medical Systems Corp. · FET · Oct 29, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K202646
• Device Name: Visera Elite II Video System Center
• Applicant: Olympus Medical Systems Corp.
• Product Code: FET · Gastroenterology, Urology
• Decision Date: Oct 29, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Visera Elite II Video System Center (OLYMPUS OTV-S300) 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 endoscopic images for display on monitors; used with camera heads, endoscopes, and ancillary equipment. Provides illumination via integrated LED lamp for White Light Imaging (WLI) and Narrow-Band Imaging (NBI). Updated to include infrared (IR) observation functionality. Operated by clinicians in clinical settings. Device drives CCD in endoscope to capture images; processes signals for real-time visualization. IR functionality enables compatibility with IR light sources for specialized observation. Output assists clinicians in diagnosis and treatment during endoscopic procedures, potentially improving visualization of anatomical structures.

Clinical Evidence

Bench testing only. Performance validation included electrical safety (ANSI/AAMI ES 60601-1, IEC 60601-2-18), electromagnetic compatibility (IEC 60601-1-2), and image quality assessments (brightness, intensity uniformity, color performance, signal-to-noise ratio). Software verification and validation performed per FDA guidance.

Technological Characteristics

Video system center with integrated LED light source (10,000h life). Features WLI, NBI, and IR observation modes. Dimensions: W383xH199xD506 mm; Weight: 19.3kg. Rated 100-120V AC, 50/60Hz, 400VA. Connectivity includes camera head and monitor interfaces. Standards: ANSI/AAMI ES 60601-1, IEC 60601-2-18, IEC 60601-1-2.

Indications for Use

Indicated for use with Olympus camera heads, endoscopes, monitors, and accessories for endoscopic diagnosis, treatment, and video observation in patients undergoing endoscopic 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.

Predicate Devices

• OLYMPUS OTV-S300 (VISERA ELITE II VIDEO SYSTEM CENTER) (K201200)

Reference Devices

• OLYMPUS OTV-S200 (VISERA ELITE II VIDEO SYSTEM CENTER) (K200542)

Submission Summary (Full Text)

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October 29, 2020

Olympus Medical Systems Corp. % Anne-Marie Keefe Program Manager, Regulatory Affairs Olympus Surgical Technologies of America 118 Turnpike Road, Suite 120 Southborough, MA 01772

Re: K202646

> Trade/Device Name: Visera Elite II Video System Center (Olympus OTV-S300) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FET Dated: September 10, 2020 Received: September 11, 2020

Dear Anne-Marie Keefe:

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.

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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 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-regulatoryinformation/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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jason R. Roberts, Ph.D. 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) K202646

Device Name

Visera Elite II Video System Center (Olympus OTV-S300)

Indications for Use (Describe)

The Visera Elite II Video System Center (OLYMPUS OTV-S300) 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) |
|-------------------------------------------------|
|-------------------------------------------------|

X 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, giving the image a soft focus. The registered trademark symbol is visible in the upper right corner of the image, next to the letter "S".

Date Prepared: October 29, 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: | Anne-Marie Keefe |
| | Olympus Surgical Technologies of America |
| | 118 Turnpike Road, Suite 120 |
| | Southborough, MA 01772 |
| | Mobile: [phone] |
| | Email: [e-mail] |
| ■ 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 (Olympus OTV-S300) |
|-------------------|---------------------------------------------------------------------------|
| Model | OTV-S300 |
| Regulation Name | Endoscope and accessories |
| Regulation Number | 21 CFR 876.1500 |
| Product Code | FET (endoscopic video imaging system/component, gastroenterology-urology) |
| Regulatory Class | II |
| Review Panel | Gastroenterology/Urology |

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Image /page/4/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced together, creating a solid block of text. A registered trademark symbol is located to the right of the letter "S". A thin yellow line is located underneath the word.

#### 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. | K201200 |

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. | K200542 |

#### 4. DEVICE DESCRIPTION

#### VISERA ELITE II VIDEO SYSTEM CENTER (OLYMPUS OTV-S300)

#### ■ Principle of operation and mechanism of action

The subject device is a video system center (OTV-S300) 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 K201200 to add an infrared (IR) function. The IR light source (CLV-S200-IR) uses the existing software in the subject device to enable the connection and ensure IR compatibility.

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.

By driving the CCD equipped in the endoscope, the subject device displays an endoscopic image on a monitor.

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Image /page/5/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced and appear to be a sans-serif font. A registered trademark symbol is present to the right of the word. A gradient of yellow is present below the word.

### 5. INDICATIONS FOR USE

This Visera Elite II Video System Center (OLYMPUS OTV-S300) is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.

## 6. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE

The table below provides a comparison of the intended use and technological characteristics of the subject and predicate device.

| | <Subject device> | < Predicate device> |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | OTV-S300 | OTV-S300 |
| Manufacturer | Olympus Medical Systems Corp | Olympus Medical Systems Corp |
| Indications<br>for use | The Visera Elite II Video<br>System Center (OLYMPUS<br>OTV-S300) is intended to be<br>used with OLYMPUS camera<br>heads, endoscopes, monitors,<br>EndoTherapy accessories, and<br>other ancillary equipment for<br>endoscopic diagnosis, treatment,<br>and video 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 | 100-120 V AC<br>50/60 Hz | 100-120 V AC<br>50/60 Hz |
| Rated input | 400 VA | 400 VA |
| Dimension<br>(maximum) | W383×H199×D506 (mm) | W383×H199×D506 (mm) |
| Weight | 19.3kg | 19.3kg |
| AGC (Auto<br>gain control) | Provided | Provided |
| 2D | Provided | Provided |

| Table: Comparison Table of the Subject and Predicate Device | | | |
|-------------------------------------------------------------|--|--|--|
| | | | |

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Image /page/6/Picture/0 description: The image contains the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are closely spaced together. There is a registered trademark symbol to the right of the letter "S".

K202646 Page 4 of 5

| | <Subject device> | < Predicate device> |
|-----------------------------------|------------------|---------------------|
| | OTV-S300 | OTV-S300 |
| Observation | | |
| 3D<br>observation | Provided | Provided |
| IR<br>observation | Provided | Not provided |
| Front panel<br>(Operation) | Touch panel | Touch panel |
| Examination<br>Lamp | LED | LED |
| Average lamp<br>life | 10,000 h | 10,000 h |
| Emergency<br>lamp | LED | LED |
| Average<br>Emergency<br>lamp life | 10,000 h | 10,000 h |
| Narrow band<br>imaging<br>(NBI) | 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 subject device has infrared functionality while the predicate device does not. The differences between the subject and predicate device do not raise different questions of safety and effectiveness.

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#### 7. PERFORMANCE DATA

To support the modification to the subject device to include the IR functionality, 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 the ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2014 standards for EMC.

#### 7.2 Software verification and validation testing

Software verification and validation testing 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" (2005) and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (2014).

#### 7.3 Performance testing - Bench

Bench testing for the subject device incorporating the IR functionality was conducted to ensure that the subject device performs as intended and meets design specifications, as follows:

- Image Ouality .
- Brightness o
- Image Intensity Uniformity o
- Color Performance o
- Signal-to-Noise ratio o

#### 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.