(48 days)
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.
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.
Acceptance Criteria & Device Performance: OLYMPUS OTV-S300 (Visera Elite II Video System Center)
Summary of Device Modification: The OLYMPUS OTV-S300 (Visera Elite II Video System Center) is an update to a previously cleared device (K201200) with the primary modification being the addition of infrared (IR) functionality.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance (as demonstrated by the study) |
|---|---|---|
| Electrical Safety | Compliance with ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012, and IEC 60601-2-18:2009 standards. | Electrical safety testing was conducted in accordance with the specified standards. Result: Implied compliance, as the submission states this testing was performed to support the device's safety and effectiveness. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014 standards. | EMC testing was conducted in accordance with the specified standards. Result: Implied compliance, as the submission states this testing was performed to support the device's safety and effectiveness. |
| Software Verification & Validation | Compliance with 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). This implies the software functions correctly, securely, and as intended for integrating the IR functionality. | Software verification and validation testing for the subject device was conducted as recommended by the specified FDA guidance documents. Result: Implied compliance, as the submission states this testing was performed to ensure the software's proper function and cybersecurity. |
| Performance Testing (Bench - General) | The device incorporates the IR functionality and performs as intended, meeting design specifications. This includes, but is not limited to, the specific image quality parameters below. | 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. Result: Implied compliance, as the submission concludes these tests demonstrate the device is safe and effective. |
| Performance Testing (Bench - Image Quality) | ||
| - Brightness | The image brightness with IR functionality meets design specifications. | Evaluated during bench testing. Result: Implied satisfactory performance meeting specifications. |
| - Image Intensity Uniformity | The uniformity of image intensity with IR functionality meets design specifications. | Evaluated during bench testing. Result: Implied satisfactory performance meeting specifications. |
| - Color Performance | The color performance of images (presumably in WLI and NBI modes, and potentially how IR integration affects it or allows for specific IR visualization) meets design specifications. | Evaluated during bench testing. Result: Implied satisfactory performance meeting specifications. |
| - Signal-to-Noise Ratio | The signal-to-noise ratio in images generated (with IR functionality) meets design specifications, ensuring image clarity. | Evaluated during bench testing. Result: Implied satisfactory performance meeting specifications. |
2. Sample Size for Test Set and Data Provenance:
The document describes bench testing and design verification and validation activities. It does not specify a sample size for a "test set" in terms of patient data or clinical images. The data provenance is related to in-house engineering and testing, not patient demographics or clinical data from specific countries. The studies conducted are design verification and validation tests, primarily technical in nature, rather than clinical studies using patient data.
3. Number of Experts and Qualifications for Ground Truth of Test Set:
Not applicable. This submission relies on engineering and technical performance testing, not clinical evaluation requiring expert consensus on ground truth for a test set of images/data derived from patients.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. The submission focuses on technical performance and safety/effectiveness equivalence to a predicate device, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. The device is a "Video System Center" (hardware and integrated software) that provides imaging capabilities for endoscopes, not a standalone AI algorithm. Its performance is evaluated as an integrated system component.
7. Type of Ground Truth Used:
The "ground truth" for the performance criteria appears to be established through engineering design specifications and recognized international and national standards (e.g., ANSI/AAMI, IEC). Compliance with these standards and the device's own design specifications forms the basis of the "ground truth" for its technical performance.
8. Sample Size for the Training Set:
Not applicable. This device is a video system center for endoscopic imaging, not an AI model that undergoes "training" in the machine learning sense with a data set.
9. How Ground Truth for Training Set was Established:
Not applicable, as there is no "training set" in the context of this device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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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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: (508) 244-1921 | |
| Email: Anne-Marie.Keefe@olymus.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 (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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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. | 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 (VISERAELITE II VIDEO SYSTEMCENTER) | OLYMPUS MEDICALSYSTEMS 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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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.
| < Predicate device> | ||
|---|---|---|
| OTV-S300 | OTV-S300 | |
| Manufacturer | Olympus Medical Systems Corp | Olympus Medical Systems Corp |
| Indicationsfor use | The Visera Elite II VideoSystem Center (OLYMPUSOTV-S300) is intended to beused with OLYMPUS cameraheads, endoscopes, monitors,EndoTherapy accessories, andother ancillary equipment forendoscopic diagnosis, treatment,and video observation. | 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 | 100-120 V AC50/60 Hz | 100-120 V AC50/60 Hz |
| Rated input | 400 VA | 400 VA |
| Dimension(maximum) | W383×H199×D506 (mm) | W383×H199×D506 (mm) |
| Weight | 19.3kg | 19.3kg |
| AGC (Autogain control) | Provided | Provided |
| 2D | Provided | Provided |
| Table: Comparison Table of the Subject and Predicate Device | |||
|---|---|---|---|
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K202646 Page 4 of 5
| < Predicate device> | ||
|---|---|---|
| OTV-S300 | OTV-S300 | |
| Observation | ||
| 3Dobservation | Provided | Provided |
| IRobservation | Provided | Not provided |
| Front panel(Operation) | Touch panel | Touch panel |
| ExaminationLamp | LED | LED |
| Average lamplife | 10,000 h | 10,000 h |
| Emergencylamp | LED | LED |
| AverageEmergencylamp life | 10,000 h | 10,000 h |
| Narrow bandimaging(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.
§ 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.