The VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500, when used with endoscopes, video endoscopes, camera heads, monitors and other ancillary equipment for endoscopic surgery, is intended to receive and process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor.

Also, the VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500, when used with rhinolaryngeal stroboscopes, is intended to observe the intralaryngeal phenomenon of phonation (speech) for endoscopic observation to examine the correct functioning of the vocal apparatus (glottis) and to examine voice disorders.

Device Description

The OLYMPUS OTV-S500 is a "universal platform" which offers compatibility with various endoscopes for different medical specialties and enables efficient operation to meet the clinical needs of the ENT field; the device has been cleared by FDA for use with OLYMPUS urology/gynecology endoscopes (including CYF-VH, CYF-VHR, URF-V2, URF-V2R, URF-V3. URF-V3R. WA2T400A. WA2T412A. WA2T430A. WA2T43WA. WA2T470A. WA2UR11A, WA2UR12A, WA2UR13A, WA2UR14A, WA2UR21A, WA2UR22A, WA2UR23A, WA2UR31A, WA2UR32A, CYF-5, CYF-5R, URF-P6, URF-P6R, URF-P7, URF-P7R and HYF-XP) under K241371.

The OLYMPUS OTV-S500 consists of electrical circuit boards, electrical units (cooling fan, unit power supply, and control panel), harnesses between circuit boards, and optical components (lens and optical filter). A microprocessor is built into the OLYMPUS OTV-S500 which controls processing of observation images, user interface (front panel switch, indicator LEDs, warning buzzer etc.) and menu. These functions are implemented in the embedded software. Scopes including flexible videoscopes or fiberscopes and rigid videoscopes with camera heads and light source are directly connected to the Subject system. When connected, the endoscope (fiberscopes and rigid videoscope without camera head) acquires and displays images directly to the user or output onto a monitor when using a flexible endoscope or scope and camera head.

The Subject devices submitted for clearance include one (1) major component: the Video System Center (OLYMPUS OTV-S500) with Foor Holder (MAJ-2552), and five (5) optional accessories: an HDMI cable (MAJ-2551); the OTV-S500 Upgrade Pack Strobe (MAJ-2547), which activates the stroboscopy function of the OTV-S500; an Air Microphone (MAJ-2548); a Throat Microphone (MAJ-2549); and the Microphone Extension Cable (MAJ-2550).

The OLYMPUS OTV-S500 is compatible with the following OLYMPUS ENT endoscopes: ENF-VH, ENF-VH2, ENF-V3, ENF-V4, ENF-VT3, ENF-XP, ENF-GP2, WA4KS400, WA4KS430, WA4KS431, WA4KS445, WA4KS446, WA4KS471, WA4KS471, WA96100A and WA96105A.

AI/ML Overview

The provided text is a 510(k) Summary for the OLYMPUS OTV-S500 (VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500).

The 510(k) Summary states that no clinical data were collected to support the performance of the subject device. Therefore, a study proving the device meets acceptance criteria in a clinical setting is not available from this document.

However, the document does describe non-clinical performance data and acceptance criteria based on standard compliance and specified tests.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly mentions performance testing, but does not provide specific acceptance criteria in numerical or qualitative form alongside reported device performance for each criterion. Instead, it states that "all testing passed/met the acceptance criteria."

Acceptance Criteria	Reported Device Performance
Performance Testing Bench	All tests passed/met the acceptance criteria.
Field of View (in compliance with ISO 8600-3:2019)	Results support performance of the Subject device with compatible endoscopes.
Resolution	Results support performance of the Subject device with compatible endoscopes.
Image Noise and Dynamic Range (tested according to ISO 15739:2017)	Results support performance of the Subject device with compatible endoscopes.
Brightness	Results support performance of the Subject device with compatible endoscopes.
Image Intensity Uniformity	Results support performance of the Subject device with compatible endoscopes.
Color Performance (including analysis with the FDA Color Performance Review (CPR) Tool for Endoscopy Devices)	Results support performance of the Subject device with compatible endoscopes.
Latency	Results support performance of the Subject device with compatible endoscopes.
Contrast Enhancement	Results support performance of the Subject device with compatible endoscopes.
Depth of Field	Results support performance of the Subject device with compatible endoscopes.
Optical Magnification and Distortion	Results support performance of the Subject device with compatible endoscopes.
Human Use Factors	Results support performance of the Subject device with compatible endoscopes.
Electrical Safety/EMC Testing (compliance with ANSI AAMI ES60601-1, ANSI AAMI IEC 60601-1-2, IEC 60601-2-18, IEC TR 60601-4-2, IEC 60601-1-6)	All tests passed/met the acceptance criteria, demonstrated compliance with cited standards and FDA Guidance.
Software Validation/Cybersecurity (compliance with IEC 62304, ISO 14971, FDA Guidance Documents for Software, OTS Software, and Cybersecurity)	All tests passed/met the acceptance criteria, demonstrated compliance with cited standards and FDA Guidance.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The document refers to "Performance Testing Bench" with the subject device and compatible endoscopes, but does not specify the number of devices or endoscopes tested. Data provenance (country of origin, retrospective/prospective) is also not mentioned for the non-clinical tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the described tests are non-clinical, bench-top performance, electrical safety, and software validation tests, which do not typically involve human expert establishment of ground truth in the same way clinical or diagnostic studies do. The "truth" for these tests comes from objective measurements against defined standards and specifications.

4. Adjudication Method for the Test Set

This information is not applicable for the non-clinical tests described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No MRMC study was done. The document explicitly states: "No clinical data were collected to support performance of the Subject device." The device itself is a video system center for endoscopes, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable in the context of an "algorithm only" performance. The OLYMPUS OTV-S500 is a hardware device (video system center) with embedded software. The software validation tests mentioned would assess the functionality and safety of the embedded software itself, which is part of the device's standalone operation. However, this is not a standalone "algorithm" in the typical sense of a diagnostic AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the non-clinical tests described, the "ground truth" or reference for performance is established by technical standards and specifications. For instance:

Performance Testing Bench: ISO standards (e.g., ISO 8600-3:2019 for Field of View, ISO 15739:2017 for Image Noise and Dynamic Range), and internal product specifications (e.g., for Brightness, Latency, etc.). The FDA Color Performance Review (CPR) Tool for Endoscopy Devices would provide a standard reference for color analysis.
Electrical Safety/EMC Testing: Compliance with various IEC/ANSI AAMI standards (e.g., ES60601-1, IEC 60601-1-2).
Software Validation/Cybersecurity: Compliance with IEC 62304, ISO 14971, and FDA guidance documents.

8. The Sample Size for the Training Set

This information is not applicable. As no clinical data was collected and the device is a hardware system with embedded software, there's no mention of a "training set" in the context of machine learning.

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

This information is not applicable due to the absence of a training set as described above.

Summary

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March 3, 2025

Olympus Medical Systems Corporation Wendy Perreault Regulatory Affairs SME Consultant Olympus Surgical Technologies of the Americas 800 West Park Drive Westborough, Massachusetts 01581

Re: K243380

Trade/Device Name: Visera S Video System Center Olympus Otv-s500 (olympus Otv-s500) Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB Dated: October 30, 2024 Received: October 30, 2024

Dear Wendy Perrreault:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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For comprehensive regulatory information about medical devices and radiation-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,

Shuchen Peng -S

Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K243380

Device Name

VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

scription Use (Part 21 CFR 801 Subpart D)

The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary: K243380

1. COMPANY INFORMATION

• Applicant

OLYMPUS MEDICAL SYSTEMS CORPORATION 2951 Ishikawa-cho, Hachioji-shi Tokyo 192-8507, Japan FDA Establishment Registration #: 8010047

Official Correspondent .

Wendy Perreault c/o Olympus Surgical Technologies of the Americas 800 West Park Drive Westborough, MA 01581 Cell: 404-542-5854 Email: wendy.perreault@olympus.com

. Manufacturing Site

SHIRAKAWA OLYMPUS CO., LTD. 3-1 Okamiyama, Odakura NISHIGO-MURA NISHISHIRAKAWA-GUN Fukushima, JAPAN 961-8061

Date Prepared: 7 February 2025

2. PRODUCT INFORMATION

Trade Name: VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)

Common Name: Nasopharyngoscope (Flexible or Rigid)

Classification Name: Nasopharyngoscope (Flexible or Rigid) and Accessories

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Classification Number: 874.4760

Product Code Names: Nasopharyngoscope (Flexible or Rigid) and Accessories; Bronchoscope (Flexible or Rigid) and Accessories; Endoscopes and Accessories; Laryngostroboscope

Product Codes: EOB, EOQ, NWB, EQL

Regulatory Class: II

Classification Panel: Ear, Nose & Throat (ENT)

3. PREDICATE DEVICE

The Subject device is equivalent to the Predicate device listed below in Table 1.

Table 1: Predicate device of OLYMPUS OTV-S500

Device name	510(k) Submitter	510(k) No.
PENTAX Medical Imaging Systems with PVK-J10 Camera Head (PENTAX Medical EPK-3000 Video Imaging System)	PENTAX of America, Inc.	K220465

The Predicate device has not been subject to a design-related recall.

The Reference devices to the Subject device are listed in Table 2:

Table 2: Reference devices for OLYMPUS OTV-S500

Device name	510(k) Submitter	510(k) No.
OLYMPUS OTV-S500(Submitted with urology/ gynecology scopes)	OLYMPUS MEDICALSYSTEMS CORP.	K241371
OLYMPUS OTV-S190 (Video System Center)with CLV-S190 (Light source for WLI/NBIobservation)	OLYMPUS MEDICALSYSTEMS CORP.	K111425
OLYMPUS OTV-S190 (Video System Center)with CLL-S1 (WA97010A) (Light source forStroboscope)	OLYMPUS MEDICALSYSTEMS CORP.	K111425 (VideoSystem Center)(Light Source is510[k] exempt)

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OLYMPUS

4. DEVICE DESCRIPTION

5. INDICATIONS FOR USE

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 6.

Compared to the Predicate device, the Subject device offers similar functions including stroboscopy. A detailed comparison of the technological characteristics of the devices is provided in Table 3 below. These differences in technological characteristics do not raise new questions of safety or effectiveness.

	OLYMPUS OTV-S500(Subject Device)	PENTAX Medical Imaging Systemswith PVK-J10 Camera Head (PENTAXMedical EPK-3000 Video ImagingSystem) (Predicate Device)
Indications for Use	The VISERA S VIDEO SYSTEMCENTER OLYMPUS OTV-S500,when used with endoscopes, videoendoscopes, camera heads, monitorsand other ancillary equipment forendoscopic surgery, is intended toreceive and process electronic signalstransmitted from a videoendoscope/camera head and outputimage signal to monitor.Also, the VISERA S VIDEOSYSTEM CENTER OLYMPUSOTV-S500, when used with rhino-laryngeal stroboscopes, is intended toobserve the intralaryngealphenomenon of phonation (speech)for endoscopic observation toexamine the correct functioning ofthe vocal apparatus (glottis) and toexamine voice disorders.	PENTAX Medical EPK-3000 VideoProcessor is intended to be used with thePENTAX Medical camera heads withPENTAX sinuscopes (8890, 8891, 8892,8893), PENTAX Medical VNL8-J1O,VNL1-J10, and VNL15-J1O endoscopes,PENTAX Medical Laryngeal Strobe, videomonitors and other ancillary equipment forENT endoscopic observation and ENTdiagnosis, treatment and video observationwith or without stroboscopy.The PENTAX Medical EPK-3000 VideoProcessor includes PENTAX i-Scan™, adigital, post-processing imagingenhancement technology. i-Scan isintended to be used as an optional adjunctfollowing traditional white light endoscopyand is not intended to replacehistopathological sampling.
Front panel (Operation)	Available	Available
Analog HDTV signaloutput	Not available	Not available
Analog SDTV signaloutput	Not available	RGB, Y/C, composite
Digital signal output	SDI (HD-SDI or 3G-SDI)HDMI (1080P)	DVI
White balance adjustment	Available	Available
Standard color chart output	The “Color bar” can be displayed.	Not available
Color tone adjustment	Color Hue / Saturation adjustment ±5steps for Magenta/ Red/ Orange/Yellow color	Available
Contrast	Image contrast enhancement can beset (ON, OFF)	Available
	OLYMPUS OTV-S500(Subject Device)	PENTAX Medical Imaging Systemswith PVK-J10 Camera Head (PENTAXMedical EPK-3000 Video ImagingSystem) (Predicate Device)
Image enhancement setting	Structural enhancementEdge enhancement	Available
Switching theenhancement modes	Available	Available
Image size selection	Available	Available
Freeze	Available	Available
Pre-freeze	Available	Available
Compatible scopes/Camera	Video endoscopes for· Rhino-Laryngology	PENTAX Medical camera heads with
head	Camera head for· Rhino-Laryngology	PENTAX sinuscopes and endoscopes forENT endoscopic observation and ENT
	Telescope/Fiber scope for· Rhino-Laryngology	diagnosis and treatment
Stroboscopy function	Available	Available
Dimensions (maximum)	308(W) x 157(H) x 461(D) mm	350(W) x 180(H) x 485(D) mm
Weight	10.6kg	13.0kg
Examination Lamp	LED(White LED: 1 and Violet LED: 1)	Xenon 150W
Rated input	150VA	360VA

Table 3: Subject and Predicate Comparison of Technological Characteristics

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7. SUMMARY OF NON-CLINICAL PERFORMANCE DATA

Results of the following testing support the safety and performance of the Subject device and demonstrate its equivalence to the Predicate device and applicable Reference devices; all testing passed/met the acceptance criteria, demonstrated compliance with the cited standards and FDA Guidance shown below, and supported equivalent safety and performance to the Predicate device:

· Performance Testing Bench (including Subject and Reference device testing of Field of View [in compliance with ISO 8600-3:2019); Resolution; Image Noise and Dynamic Range [tested according to ISO 15739:2017]; Brightness; Image Intensity Uniformity; Color Performance [including analysis with the FDA Color Performance Review (CPR) Tool for Endoscopy Devices]; Latency; Contrast Enhancement; Depth of Field; Optical Magnification and Distortion; and Human Use Factors). Test results support performance of the Subject device with compatible endoscopes.
· Electrical Safety/EMC Testing (ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; ANSI AAMI IEC 60601-1-2 [Including AMD 1:2021]; IEC 60601-2-18: Edition 3.0 2009-08; IEC TR

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60601-4-2 Edition 1.0 2016-05; IEC 60601-1-6 Edition 3.2 2020-07 Consolidated Version)

· Software Validation/Cybersecurity (IEC 62304 Edition 1.1 2015-06 Consolidated Version; ISO 14971:2019; FDA Guidance Document Content of Premarket Submissions for Device Software Functions – Guidance for Industry and Food and Drug Administration Staff, issued on June 14, 2023; FDA Guidance Document Off-the-Shelf Software Use in Medical Devices – Guidance for Industry and Food and Drug Administration Staff, issued August 11, 2023; FDA Guidance Document Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, issued on September 27, 2023)

8. SUMMARY OF CLINICAL PERFORMANCE DATA

No clinical data were collected to support performance of the Subject device.

9. CONCLUSION

The results of non-clinical performance testing demonstrate that the Subject device is as safe and effective as the Predicate device to support a substantial equivalence determination.

Regulation Number and Section

§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.

(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.