(58 days)
No
The description focuses solely on the monitor's function of displaying images and explicitly states "Not Found" for mentions of AI, DNN, or ML, and training/test sets.
No
The device is a monitor intended to display images from medical imaging systems; it does not directly treat or diagnose a medical condition.
No
The device is a monitor intended to display images from endoscopic camera systems and other medical imaging systems. It does not perform any analysis or interpretation of the images to render a diagnosis.
No
The device description explicitly states it is a "4K UHD LCD Monitor" and describes its physical components (LCD panel, backlight, liquid crystal, color filters), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a monitor for displaying images from endoscopic camera systems and other compatible medical imaging systems. This is a display device for visual information, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The description focuses on how the monitor displays images using LCD technology. It doesn't mention any analysis or testing of biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information based on laboratory tests
The device is a medical monitor used for displaying images generated by other medical devices (endoscopic cameras, etc.). This falls under the category of medical imaging display devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The 4K UHD LCD Monitor is intended to provide 4K 2D color video displays of images from endoscopic camera systems and other compatible medical imaging systems. The 4K UHD LCD Monitor is a wide-screen, high-definition, medical grade monitor for real-time use during endoscopic procedures and is suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments.
Product codes
GCJ
Device Description
The 4K UHD LCD Monitor (Model Name: OEV321UH, Generic/Common Name: LCD Monitor) displays color video images that are output from medical imaging systems on the LCD (liquid crystal display) panel. Liquid crystal and color filters are laid on the front of the flat light source (backlight) of the LCD panel. The LCD panel displays images by controlling the aperture of the liquid crystal according to input signals.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic camera systems and other compatible medical imaging systems.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments. Intended users include Doctors and Assistants.
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
The following performance testing was conducted in support of the substantial equivalence determination:
- Electrical Safety and Electromagnetic Compatibility (EMC) confirmed to be in compliance with ANSI AAMI ES 60601-1:2005+A1:2012 and IEC60601-1-2:2014.
- Software Verification and Validation Testing performed and documented in compliance with FDA guidances "Guidance for the Content of Premarket Submissions for Software contained in medical devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
- Risk analysis conducted in accordance with ISO 14971, including human factors validation testing in accordance with FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices."
- Animal and Clinical testing was not applicable and not performed.
Key results: The 4K UHD LCD Monitor OEV321UH has been verified and validated to be equivalent in electrical performance for displaying images from endoscopic camera systems and other compatible medical imaging systems, when compared to the predicate. Electrical safety and electromagnetic compatibility test results demonstrate equivalent performance.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
March 9, 2022
Olympus Medical Systems Corp. % Elizabeth Greene Program Manager Olympus Corporation of the Americas 3500 Corporate Parkway Center Valley, Pennsylvania 18034-0610
Re: K220069
Trade/Device Name: 4K UHD LCD Monitor, Model Number: OEV321UH Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: December 28, 2021 Received: January 10, 2022
Dear Elizabeth Greene:
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/cdrl/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.
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 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.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K220069
Device Name 4K UHD LCD Monitor, Model Number: OEV321UH
Indications for Use (Describe)
The 4K UHD LCD Monitor is intended to provide 4K 2D color video displays of images from endoscopic camera systems and other compatible medical imaging systems. The 4K UHD LCD Monitor is a wide-screen, highdefinition, medical grade monitor for real-time use during endoscopic procedures and is suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments.
| 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 font is sans-serif and the letters are closely spaced together. There is a registered trademark symbol to the right of the letter "S".
510(k) Summary
For
4K UHD LCD MONITOR, Model Number: OEV321UH
| General Information | |
|---|---|
| Applicant: | OLYMPUS MEDICAL SYSTEMS CORP. |
| 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan | |
| 192-8507 | |
| Phone: (+81) 42-642-2694 | |
| Fax: (+81) 42-642-2307 | |
| Establishment Registration Number: 8010047 | |
| Manufacturer: | Shirakawa Olympus Co., Ltd. |
| 3-1 Okamiyama, Odakura, Nishigo-mura, | |
| Nishishirakawa-gun, Fukushima 961-8061, | |
| Japan | |
| Phone: (+81) 248-27-2239 | |
| Fax: (+81) 248-27-2429 | |
| Establishment Registration Number: 3002808148 | |
| Sony Global Manufacturing & Operations | |
| Corporation | |
| Kosai Site | |
| 554 Sakaijuku, Kosai-shi, Sizuoka 431-0496, | |
| Japan | |
| Phone: +(1) 201-358-4945 | |
| Establishment Registration Number: 3004421482 | |
| 510(k) Submitter: | Olympus Corporation of the Americas |
| 3500 Corporate Parkway | |
| Center Valley, PA 18034-0610 | |
| Establishment Registration Number: | 2429304 |
| Contact Person: | Elizabeth Greene |
| Program Manager | |
| Fax: 484-896-7128 | |
| Mobile: (561) 774-1483 | |
| Email: elizabeth.greene@olymus.com | |
| Date Prepared: | December 28, 2021 |
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Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are closely spaced together. A registered trademark symbol is located to the right of the word.
Device Description
| Device Name: | 4K UHD LCD Monitor |
|---|---|
| Model Name: | OEV321UH |
| Generic/Common Name: | LCD Monitor |
| Regulation Number: | 876.1500 |
| Regulatory Class: | Class II |
| Classification Name: | Endoscope and accessories |
| Product Codes: | GCJ |
| Review Panel: | General and Plastic Surgery |
Predicate Device
| Device Name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| Sony LMD-X310S LCD Monitor | Sony Electronics Incorporated | K150377 |
Indications for Use
The 4K UHD LCD Monitor is intended to provide 4K 2D color video displays of images from endoscopic/laparoscopic camera systems and other compatible medical imaging systems. The 4K UHD LCD Monitor is a wide-screen, high-definition, medical grade monitor for real-time use during endoscopic procedures and is suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments.
Principle of Operation
This monitor displays color video images that are output from medical imaging systems on the LCD (liquid crystal display) panel.
Liquid crystal and color filters are laid on the front of the flat light source (backlight) of the LCD panel. The LCD panel displays images by controlling the aperture of the liquid crystal according to input signals.
Comparison of Technological Characteristics
Table 5-1 compares 4K UHD LCD Monitor OEV321UH to the predicate device with respect to intended use, technological characteristics, and principle of operation, providing detailed information regarding the basis for the determination of substantial equivalence.
Table 5-1: Comparison of the technological characteristics of 4K UHD LCD Monitor to predicate device Eeature/Technological Subigat Daviga Dradionto Davico
| Feature/Technological
| Characteristics | Subject Device | Predicate Device |
|---|---|---|
| Regulatory | ||
| Device Name | Olympus 4K UHD LCD Monitor | |
| OEV321UH | Sony LCD Monitor | |
| LMD-X310S | ||
| Feature/Technological | ||
| Characteristics | Subject Device | Predicate Device |
| Regulatory Decision | This submission | K150377 |
| Product Code | Same as predicate | GCJ |
| Regulatory Class | Same as predicate | II |
| Regulation Number | Same as predicate | 876.1500 |
| Regulation Name | Same as predicate | Endoscope and accessories |
| Classification Panel | Same as predicate | General and Plastic Surgery |
| Indications for Use | The 4K UHD LCD Monitor is | |
| intended to provide 4K 2D color | ||
| video displays of images from | ||
| endoscopic/laparoscopic camera | ||
| systems and other compatible | ||
| medical imaging systems. The 4K | ||
| UHD LCD Monitor is a wide- | ||
| screen, high-definition, medical | ||
| grade monitor for real-time use | ||
| during endoscopic/laparoscopic | ||
| procedures and is suitable for use in | ||
| hospital operating rooms, surgical | ||
| centers, clinics, doctors' offices and | ||
| similar medical environments. | The LCD Monitor is intended to | |
| provide 4K 2D color video displays | ||
| of images from | ||
| endoscopic/laparoscopic camera | ||
| systems and other compatible | ||
| medical imaging systems. | ||
| The LCD Monitor is a wide-screen, | ||
| high-definition, medical grade | ||
| monitor for real-time use during | ||
| minimally invasive surgical | ||
| procedures and is suitable for use in | ||
| hospital operating rooms, surgical | ||
| centers, clinics, doctors' offices, | ||
| and similar medical environments. | ||
| Mode of Action | Same as predicate | This monitor displays color video |
| images that are output from medical | ||
| imaging systems on the LCD (liquid | ||
| crystal display) panel. | ||
| Liquid crystal and color filters are | ||
| laid on the front of the flat light | ||
| source (backlight) of the LCD panel. | ||
| The LCD panel displays images by | ||
| controlling the aperture of the liquid | ||
| crystal according to input signals. | ||
| Intended Environment | Same as predicate | Hospital operating rooms, surgical |
| centers, clinics, doctors' offices and | ||
| similar medical environments | ||
| Intended Users | Same as predicate | Doctors and Assistants |
| System Parameters and Specifications | ||
| Power | Same as predicate | AC 100-240V/ 50-60Hz |
| Dimensions (excluding | ||
| max. protrusions) | $753.9 \times 476.3 \times 79.2{\rm mm}$ | $753.8 \times 456.4 \times 69.3{\rm mm}$ |
| Display Dimension | Same as predicate | 2D |
| Input Signals | 12G-SDI1, 12G-SDI2, 3G-SDI, | |
| DisplayPort, HDMI, DVI-D, DC | ||
| IN | DVI-D, HDMI, 3G/HD/SD-SDI | |
| Output Signals | 12G-SDI1, 12G-SDI2, 3G-SDI, | |
| CloneOUT, +5V DC OUT, +12V | ||
| DC OUT | DVI-D, 3G/HD/SD-SDI | |
| Display Device | Same as predicate | LCD panel (IPS) |
| Backlight Device | Same as predicate | LED |
| Feature/Technological | ||
| Characteristics | Subject Device | Predicate Device |
| Viewing Angle | Same as predicate | Right>89[deg] (CR>10) |
| Left>89[deg] (CR>10) | ||
| Up>89[deg] (CR>10) | ||
| Down>89[deg] (CR>10) | ||
| Active Screen Size | 697(H)×392(V) mm | 697.958(H)×368.064(V) mm |
| Resolution | 3840 × 2160 pixels | 4096 × 2160 pixels |
| Luminance | ≥280[cd/m²] | ≥550[cd/m²] |
| Primary Colors | Same as predicate | RGB |
| Gamma Curve | 1.8, 2.0, 2.2, 2.4, 2.6, DICOM, Endoscope, HLG | 1.8, 2.0, 2.2, 2.4, 2.6, DICOM, Endoscope, Highlight |
| Color Space | Same as predicate | Auto, BT.709, BT.2020, Native |
| Refresh Rate | Same as predicate | 50/60Hz |
| Frame Rate | Same as predicate | 50/60 fps |
| Display Format | Same as predicate | Normal |
| Multi display | ||
| Flip display |
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Image /page/5/Picture/0 description: The image shows the text "K220069" in a bold, serif font. The text is black and the background is white. The letters and numbers are evenly spaced and aligned horizontally.
Image /page/5/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. A registered trademark symbol is located to the right of the word.
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Image /page/6/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, dark blue letters. The font is sans-serif and the letters are closely spaced together. A registered trademark symbol is located to the right of the word.
Traditional 510(k) Notification 4K UHD LCD Monitor, Model Number: OEV321UH
Compliance to Voluntary Standards
The following voluntary standards have been applied to the subject devices respectively:
- ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012
- IEC 60601-1-2: 2014
- ISO 14971:2007/2019 ●
Summary of Performance Testing
The following performance testing was conducted in support of the substantial equivalence determination.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC performance testing for the 4K UHD LCD Monitor OEV321UH is confirmed to be in compliance with the relevant requirements as noted below.
- ANSI AAMI ES 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 4)
Software Verification and Validation Testing
Software testing has been performed and documented in compliance with the FDA guidance "Guidance for the Content of Premarket Submissions for Software contained in medical devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
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Image /page/7/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. Below the word is a yellow line. The registered trademark symbol is located to the right of the word.
Risk Analysis
Risk analysis for the subject device was conducted in accordance with established in-house acceptance criteria based on ISO 14971. The design verification tests, and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
In the risk management process, the human factors validation testing was also performed in accordance with the FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices". In terms of human factors, an assessment of applicable adverse events along with a review of the overall risk analysis was conducted. These assessments confirmed that there was no unacceptable user-related residual risk for the 4K UHD LCD Monitor OEV321UH.
Animal and Clinical Testing
Animal and Clinical testing was not applicable and not performed.
Substantial Equivalence
Olympus has determined that the 4K UHD LCD Monitor OEV321UH is substantially equivalent to the legally marketed predicate device, Sony LCD Monitor LMD-X310S (K150377) for the following reasons:
- . same intended use;
- technological characteristics (design, materials, and operations) are similar or identical to the predicate devices; and
- does not introduce any new or novel treatments or standard of care that differs from ● predicate devices in commercial use.
The intended use, principles of operation, fundamental technology of the 4K UHD LCD Monitor OEV321UH are identical to the predicate device. The differences in system parameters, and specifications include device dimensions, input and output signals, active screen size, resolution, luminance, and gamma curve. The 4K UHD LCD Monitor OEV321UH is a general use medical monitor and is not intended to be used in limited procedures. The difference in indications for use between the 4K UHD LCD Monitor OEV321UH and Sony LCD Monitor LMD-X310S is not a change from single use labeling to reusable, is not a change from prescription (Rx) use to over the counter (OTC) use. Further, this change does not describe a new disease, condition, or patient population that the device is intended in diagnosing, treating, preventing, curing, or mitigating. A risk-based assessment of these differences did not identify any new risks or significantly modified existing risks, or raise new or different questions with respect to safety and effectiveness.
The 4K UHD LCD Monitor OEV321UH has been verified and validated to be equivalent in electrical performance for displaying images from endoscopic camera systems and other compatible medical imaging systems, when compared to the predicate. As the electrical safety and electromagnetic compatibility test results demonstrate equivalent performance, Olympus believe there are no new concerns or modified existing risks regarding safety and effectiveness of the subject device.
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Image /page/8/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. A registered trademark symbol is located to the right of the word. The font is sans-serif and the letters are closely spaced together.
Conclusion
In summary, the Olympus 4K UHD LCD Monitor OEV321UH is substantially equivalent to the predicate device and raise no new questions of safety or effectiveness.