(248 days)
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No
The document describes a medical monitor for displaying images and does not mention any AI or ML capabilities, image processing, or performance studies related to algorithmic analysis.
No
The device is a medical monitor used to display images from endoscopic camera systems and other medical imaging systems for real-time use during medical procedures. It does not actively treat or diagnose a condition.
No
Explanation: The device is a monitor intended to display images from endoscopic camera systems and other medical imaging systems. It does not perform any analysis, interpretation, or diagnosis of the images itself.
No
The device is described as a "color LCD monitor" and details its physical characteristics like resolution and panel technology, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a monitor intended to display color video displays of images from endoscopic camera systems and other compatible medical imaging systems. It is a display device for real-time use during procedures.
- No Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on materials taken from the body. Its function is solely to display images generated by other medical devices.
Therefore, the CuratOR EX3242-FD falls under the category of a medical device used for displaying images, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
endoscopic/laparoscopic camera systems and other compatible medical imaging systems
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Doctors and Assistants, hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No bench, animal or clinical testing was performed on the CuratOR EX3242-FD.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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 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).
1
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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 and |
| Safety | |
| 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 LCD |
| Monitor 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 to | |
| provide color video displays of | ||
| images from | ||
| endoscopic/laparoscopic 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. | 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. | ||
| 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) | 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 DC | |
| OUT | 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, Flip |
| display |
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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.