(124 days)
No
The summary describes a standard video processing system for endoscopes with a microprocessor and embedded software for image processing and user interface control. There is no mention of AI, ML, or related concepts like deep learning, neural networks, or algorithms that learn from data. The image processing described appears to be traditional digital signal processing.
No.
The device is solely for observation and diagnostic purposes (receiving and processing images, observing intralaryngeal phenomena to examine vocal apparatus functioning and voice disorders). It does not provide any treatment or therapy.
Yes
Explanation: The device is intended to observe intralaryngeal phenomena of phonation to examine the correct functioning of the vocal apparatus and voice disorders, which are diagnostic purposes.
No
The device description explicitly states that the OLYMPUS OTV-S500 consists of electrical circuit boards, electrical units (cooling fan, unit power supply, and control panel), harnesses, and optical components. It is a physical hardware device with embedded software, not a software-only device.
Based on the provided information, the OLYMPUS OTV-S500 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes the device as receiving and processing electronic signals from endoscopes/camera heads to output images to a monitor for endoscopic observation and surgery. It also mentions observing intralaryngeal phenomena for examining vocal apparatus function and voice disorders. These uses involve direct observation of the body's internal structures, not the examination of specimens derived from the human body (like blood, urine, tissue samples, etc.) outside of the body.
- Device Description: The description details the hardware and software components involved in processing video signals and controlling the system. It does not mention any components or functions related to analyzing biological samples.
- Input Imaging Modality: The input is endoscopic video signals, which are generated from within the body, not from in vitro samples.
- Anatomical Site: The anatomical sites mentioned (intralaryngeal, glottis, rhino-laryngology) are within the human body.
- Performance Studies: The performance studies focus on image quality, electrical safety, software validation, and human factors related to the endoscopic imaging process. There are no studies related to the analysis of biological samples.
IVD devices are specifically designed to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The OLYMPUS OTV-S500's function is to facilitate visual examination of internal body structures, which falls under the category of medical imaging and visualization devices, not IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
EOB, EOQ, NWB, EQL
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic video
Anatomical Site
vocal apparatus (glottis), laryngeal, intralaryngeal
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
Non-clinical performance data support the safety and performance of the Subject device. Testing included:
- Performance Testing Bench: Field of View, Resolution, Image Noise and Dynamic Range, 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 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.
All testing passed/met the acceptance criteria, demonstrated compliance with the cited standards and FDA Guidance, and supported equivalent safety and performance to the Predicate device. No clinical data were collected.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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"
1
(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.
2
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
3
Indications for Use
Submission Number (if known)
Device Name
VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
Indications for Use (Describe)
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.
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 MEDICAL | |
| SYSTEMS CORP. | K241371 | |
| OLYMPUS OTV-S190 (Video System Center) | ||
| with CLV-S190 (Light source for WLI/NBI | ||
| observation) | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K111425 | |
| OLYMPUS OTV-S190 (Video System Center) | ||
| with CLL-S1 (WA97010A) (Light source for | ||
| Stroboscope) | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K111425 (Video | |
| System Center) | ||
| (Light Source is | ||
| 510[k] exempt) |
6
OLYMPUS
4. 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.
5. INDICATIONS FOR USE
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.
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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 Systems
with PVK-J10 Camera Head (PENTAX
Medical EPK-3000 Video Imaging
System) (Predicate Device) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 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 rhino-
laryngeal 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. | PENTAX Medical EPK-3000 Video
Processor is intended to be used with the
PENTAX Medical camera heads with
PENTAX sinuscopes (8890, 8891, 8892,
8893), PENTAX Medical VNL8-J1O,
VNL1-J10, and VNL15-J1O endoscopes,
PENTAX Medical Laryngeal Strobe, video
monitors and other ancillary equipment for
ENT endoscopic observation and ENT
diagnosis, treatment and video observation
with or without stroboscopy.
The PENTAX Medical EPK-3000 Video
Processor includes PENTAX i-Scan™, a
digital, post-processing imaging
enhancement technology. i-Scan is
intended to be used as an optional adjunct
following traditional white light endoscopy
and is not intended to replace
histopathological sampling. |
| Front panel (Operation) | Available | Available |
| Analog HDTV signal
output | Not available | Not available |
| Analog SDTV signal
output | 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 ±5
steps for Magenta/ Red/ Orange/
Yellow color | Available |
| Contrast | Image contrast enhancement can be
set (ON, OFF) | Available |
| | OLYMPUS OTV-S500
(Subject Device) | PENTAX Medical Imaging Systems
with PVK-J10 Camera Head (PENTAX
Medical EPK-3000 Video Imaging
System) (Predicate Device) |
| Image enhancement setting | Structural enhancement
Edge enhancement | Available |
| Switching the
enhancement 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 for
ENT 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.