(248 days)
This product is intended to provide color video displays of images from endoscopic camera systems and other compatible medical imaging systems. This product is a wide-screen, high-definition 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.
CuratOR EX3242-FD is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 3,840 x 2,160 pixels (4K UHD) with a pixel pitch of 0.185 mm.
Based on the provided text, the device in question, CuratOR EX3242-FD, is a color LCD monitor intended for displaying medical images from endoscopic camera systems and other compatible medical imaging systems. It is not an AI-powered diagnostic device, but rather a display monitor.
Therefore, the typical acceptance criteria and study types requested in your prompt (such as accuracy, sensitivity, specificity, expert ground truth, multi-reader multi-case studies, effect size of AI assistance, etc.) are not applicable to this device.
The study described in the document is a comparison of technological characteristics to a predicate device (Olympus 4K UHD LCD Monitor OEV321UH, K220069) to demonstrate substantial equivalence for regulatory clearance.
Here's a breakdown of the information that is available:
1. A table of acceptance criteria and the reported device performance
The provided text does not list specific "acceptance criteria" in the traditional sense for diagnostic performance, as this is a display device. Instead, it compares the technological characteristics of the "Subject Device" (CuratOR EX3242-FD) to a "Predicate Device" (Olympus 4K UHD LCD Monitor OEV321UH). The "performance" in this context refers to meeting or being comparable to the predicate device's specifications.
| Attributes | Subject Device (CuratOR EX3242-FD) | Predicate Device (Olympus 4K UHD LCD Monitor OEV321UH) | Comparison |
|---|---|---|---|
| Regulatory | |||
| Device Name | CuratOR EX3242-FD | Olympus 4K UHD LCD Monitor OEV321UH | Different |
| Regulatory Decision | This submission | K220069 | - |
| Product Code | Same as predicate (GCJ) | GCJ | Same |
| Regulatory Class | Same as predicate (II) | II | Same |
| Regulation Number | Same as predicate (876.1500) | 876.1500 | Same |
| Regulation Name | Same as predicate (Endoscope and accessories) | Endoscope and accessories | Same |
| Classification Panel | Same as predicate (General and Plastic Surgery) | General and Plastic Surgery | Same |
| Indications for Use | Intended to provide color video displays of images from endoscopic/laparoscopic camera systems and other compatible medical imaging systems. Wide-screen, high-definition monitor for real-time use during endoscopic/laparoscopic procedures. Suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments. | Intended to provide 4K 2D color video displays of images from endoscopic/laparoscopic camera systems and other compatible medical imaging systems. Wide-screen, high-definition, medical grade monitor for real-time use during endoscopic/laparoscopic procedures. Suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments. | Substantially Similar |
| Mode of Action | Same as predicate | This monitor displays color video images that are output from medical imaging systems on the LCD panel. LCD panel displays images by controlling the aperture of the liquid crystal according to input signals. | Same |
| Intended Environment | Same as predicate | Hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments | Same |
| Intended Users | Same as predicate | Doctors and Assistants | Same |
| System Parameters and Specifications | |||
| Power | Same as predicate | AC 100-240V/ 50-60Hz | Same |
| Dimensions (excluding max. protrusions) | 760.8 × 463.8 × 91.6 mm | 753.9 × 476.3 × 79.2mm | Different (Minor) |
| Display Dimension | Same as predicate | 2D | Same |
| Input Signals | 12G-SDI, 3G-SDI, DisplayPort, HDMI, DVI-D, DC IN | 12G-SDI1, 12G-SDI2, 3G-SDI, DisplayPort, HDMI, DVI-D, DC IN | Slightly Different |
| Output Signals | 12G-SDI, DVI-D OUT, +5V DC OUT | 12G-SDI1, 12G-SDI2, 3G-SDI, CloneOUT, +5V DC OUT, +12V DC OUT | Slightly Different |
| Display Device | Same as predicate | LCD panel (IPS) | Same |
| Backlight Device | Same as Predicate | LED | Same |
| 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) | Same |
| Active Screen Size | 708(H)×399(V) mm | 697(H)×392(V) mm | Different (Minor) |
| Resolution | Same as predicate | 3840 × 2160 pixels | Same |
| Luminance | 850[cd/m2] typ. | ≥280[cd/m2] | Higher (Subject device is 850, predicate is at least 280) |
| Primary Colors | Same as predicate | RGB | Same |
| Gamma Curve | 1.8, 2.0, 2.2, 2.4, 2.6, DICOM, HLG, PQ | 1.8, 2.0, 2.2, 2.4, 2.6, DICOM, Endoscope, HLG | Slightly Different |
| Color Space | sRGB, BT.2020, Native | Auto, BT.709, BT.2020, Native | Slightly Different |
| Refresh Rate | Same as predicate | 50/60Hz | Same |
| Frame Rate | Same as predicate | 50/60 fps | Same |
| Display Format | Same as predicate | Normal, Multi display, Flip display | Same |
The conclusion states: "It was confirmed that the technological characteristics differences from those of the predicate device do not affect the safety or the effectiveness." This serves as the "acceptance criterion" for this type of submission (substantial equivalence for a display device).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a display device, not a diagnostic algorithm that processes test image sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for diagnostic performance is not relevant for a display monitor's 510(k) submission based on technological equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. The device is a monitor, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
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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.
December 18, 2023
EIZO Corporation Hiroaki Hashimoto Senior Manager 153 Shimokashiwano Hakusan, Ishikawa 924-8566 Japan
Re: K231066
Trade/Device Name: CuratOR EX3242-FD Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: November 28, 2023 Received: November 28, 2023
Dear Hiroaki Hashimoto:
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" (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).
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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 QS 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.
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.
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, Mark Digitally signed by Mark Trumbore -S Trumbore -Date: 2023.12.18 S 12:03:45 -05'00' Mark Trumbore, 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name CuratOR EX3242-FD
Indications for Use (Describe)
This product is intended to provide color video displays of images from endoscopic camera systems and other compatible medical imaging systems. This product is a wide-screen, high-definition 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ 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/2 description: The image shows the logo for EIZO. The logo consists of a stylized, geometric shape on the left and the word "EIZO" in bold, sans-serif font on the right. The geometric shape is composed of squares and triangles, creating a pixelated or mosaic-like appearance. The word "EIZO" is in black, and there is a registered trademark symbol next to the "O".
EIZO Corporation, 153 Shimokashiwano, Hakusan, Ishikawa
U.S. Food and Drug Administration Center for Devices and Radiological Health Document Mail Center - WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
| Name | Hiroaki Hashimoto |
|---|---|
| Department | Regulatory Compliance andSafety |
| Telephone | +81 (76) 274-2468 |
| hiroaki.hashimoto@eizo.com |
510(k) Summary
1. Submitter
EIZO Corporation 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Japan Phone: +81 (76) 274-2468
Contact Person: Hiroaki Hashimoto Date of Prepared: April 13th, 2023
2. Device
●
- CuratOR EX3242-FD ● Name of Device:
- Common or Usual Name: 81.3 cm (32.0 inch) class Color LCD Monitor
- Classification Name: Endoscope and accessories ● (21 CFR 876.1500)
II
- Regulatory Class:
- Product Code: GCJ
3. Predicate Device
- Name of Device: OEV321UH (K220069)
- Common or Usual Name: Olympus 4K UHD LCD Monitor ●
- Classification Name: Endoscope and accessories
- (21 CFR 876.1500) ●
- Regulatory Class: II
- Product Code: GCJ ●
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4. Device Description
CuratOR EX3242-FD is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 3,840 x 2,160 pixels (4K UHD) with a pixel pitch of 0.185 mm.
The CuratOR EX3242-FD is not a cyber device because it does not have the ability to connect to the internet.
5. Comparison of Technological Characteristics with the predicate device
The comparison table below enumerates information derived from the product brochure and measured values of the each device and different technological characteristics are discussed in it:
| Attributes | Subject Device | Predicate Device |
|---|---|---|
| Regulatory | ||
| Device Name | CuratOR EX3242-FD | Olympus 4K UHD LCDMonitor OEV321UH |
| Regulatory Decision | This submission | K220069 |
| 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 | This product is intended toprovide color video displays ofimages fromendoscopic/laparoscopic camerasystems and other compatiblemedical imaging systems. Thisproduct is a wide-screen, high-definition monitor for real-timeuse duringendoscopic/laparoscopicprocedures and is suitable foruse in hospital operating rooms,surgical centers, clinics, doctors'offices and similar medicalenvironments. | The 4K UHD LCD Monitor isintended to provide 4K 2D colorvideo displays of images fromendoscopic/laparoscopic camerasystems and other compatiblemedical imaging systems. The4K UHD LCD Monitor is awide- screen, high-definition,medical grade monitor for real-time use duringendoscopic/laparoscopicprocedures and is suitable foruse in hospital operating rooms,surgical centers, clinics, doctors'offices and similar medicalenvironments. |
| Mode of Action | Same as predicate | This monitor displays colorvideo images that are output |
| from medical imaging systemson the LCD (liquid crystaldisplay) panel.Liquid crystal and color filtersare laid on the front of the flatlight source (backlight) of theLCD panel.The LCD panel displays imagesby controlling the aperture of theliquid crystal according to inputsignals. | ||
| Intended Environment | Same as predicate | Hospital operating rooms,surgical centers, clinics, doctors'offices and similar medicalenvironments |
| Intended Users | Same as predicate | Doctors and Assistants |
| System Parameters and Specifications | ||
| Power | Same as predicate | AC 100-240V/ 50-60Hz |
| Dimensions(excludingmax. protrusions) | 760.8 × 463.8 × 91.6 mm | 753.9 × 476.3 × 79.2mm |
| Display Dimension | Same as predicate | 2D |
| Input Signals | 12G-SDI, 3G-SDI, DisplayPort,HDMI, DVI-D, DC IN | 12G-SDI1, 12G-SDI2, 3G-SDI,DisplayPort, HDMI, DVI-D, DC IN |
| Output Signals | 12G-SDI, DVI-D OUT, +5V DCOUT | 12G-SDI1, 12G-SDI2, 3G-SDI,CloneOUT, +5V DC OUT,+12V DC OUT |
| Display Device | Same as predicate | LCD panel (IPS) |
| Backlight Device | Same as Predicate | LED |
| 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 | 708(H)×399(V) mm | 697(H)×392(V) mm |
| Resolution | Same as predicate | 3840 × 2160 pixels |
| Luminance | 850[cd/m2] typ. | ≥280[cd/m2] |
| Primary Colors | Same as predicate | RGB |
| Gamma Curve | 1.8, 2.0, 2.2, 2.4, 2.6, DICOM,HLG, PQ | 1.8, 2.0, 2.2, 2.4, 2.6, DICOM,Endoscope, HLG |
| Color Space | sRGB, BT.2020, Native | 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, Flipdisplay |
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It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the EX3242-FD.
6. Performance Testing
No bench, animal or clinical testing was performed on the CuratOR EX3242-FD.
7. Conclusion
The CuratOR EX3242-FD was determined to be substantially equivalent to the predicate device due to the following reasons:
- . The stated intended use is substantially the same as that of the predicate device.
- It was confirmed that the technological characteristics differences from those of the predicate device do not affect the safety or the effectiveness.
§ 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.