(53 days)
Not Found
No
The summary describes a medical monitor that displays images. There is no mention of AI, ML, or any image processing capabilities beyond simple display.
No
The device is a medical monitor designed to display images from endoscopic camera systems, not to actively treat a condition.
No
The device is a medical-grade monitor intended to display medical images from endoscopic camera systems; it does not perform any diagnostic functions itself.
No
The device description explicitly details physical hardware components such as an LCD panel, LED backlight, plastic housing, metal chassis, electronics, sensors, interconnections, and an internal power supply. It is a medical grade monitor, which 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the device is a medical grade monitor intended to display medical images from endoscopic camera systems and other compatible medical image systems. It is a display device, not a device that performs tests on biological samples.
- Intended Use: The intended use is to display images during procedures, not to analyze biological samples.
The device is a medical device, but it falls under a different category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The device is intended to display medical images from endoscopic camera systems and other compatible medical image systems.
The device is a medical grade monitor for real-time use during endoscopic procedures and is suitable for use in hospital operating rooms, surgical centers, doctor's offices, clinics and similar medical environments.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The MDEC-2523 is a medical grade monitor with a 23,8 inch color TFT-LDC screen size and is intended to display medical images from endoscopic or laparoscopic camera systems and other compatible medical image systems.
The MDEC-2523 consists of an LCD panel and LED backlight integrated into a plastic housing body with an internal metal chassis structure, that also integrates the electronics, sensors, and interconnections. The MDEC-2523 encloses user controls that are used to control and configure the device via the embedded on screen display (OSD) software. The device has a glass cover to protect the LCD panel and allow easy cleaning. The MDEC-2523 is powered by means of an internal power supply.
This monitor displays color video images that are output from medical imaging systems on the LCD (liquid crystal display) panel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
endoscopic or laparoscopic camera systems and other compatible medical image systems.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital operating rooms, surgical centers, doctor's offices, clinics and similar medical environments.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance testing was conducted to support the substantial equivalence determination:
-
Electrical safety testing in accordance with ANSI AAMI E560601-1:2005/(R)2012 & A2:2010/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
-
EMC testing in accordance with IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
-
Environmental testing (Climate, shock and vibration, packed, thermal analysis)
-
Software testing
MDEC-2523 is compliant to EMC and safety standards and the environmental and software tests passed.
Additionally, usability/human factors was conducted.
Clinical study -Not Applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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 13, 2024
Barco NV Julie Vandecandelaere Regulatory Affairs Officer President Kennedypark 35 Kortrijk, 8500 Belgium
Re: K243307
Trade/Device Name: LCD Monitor (MDEC-2523) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: October 21, 2024 Received: October 21, 2024
Dear Julie Vandecandelaere:
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 (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/cdrb/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
1
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).
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 Rule"). 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.
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,
Diaitally signed by TANISHA L. TANISHA L. HITHE -S HITHE -S Date: 2024.12.13 21:42:53 -05'00
Tanisha Hithe 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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
LCD Monitor (MDEC-2523)
Indications for Use (Describe)
The device is intended to display medical images from endoscopic camera systems and other compatible medical image systems.
The device is a medical grade monitor for real-time use during endoscopic procedures and is suitable for use in hospital operating rooms, surgical centers, doctor's offices, clinics 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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| A
1 | C | 11
1
11 | 4.
1.00 40
1 80 10
1 |
|--------|---|---------------|-------------------------------|
| | | | |
Prepared on: 2024-10-21
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Barco NV |
|---|---|
| Applicant Address | President Kennedypark 35 Kortrijk 8500 Belgium |
| Applicant Contact Telephone | +32 497 377770 |
| Applicant Contact | Ms. Julie Vandecandelaere |
| Applicant Contact Email | julie.vandecandelaere@barco.com |
21 CFR 807.92(a)(2)
| Device Name | |
|---|---|
| Device Trade Name | LCD Monitor (MDEC-2523) |
| Common Name | Endoscope and accessories |
| Classification Name | Laparoscope, General & Plastic Surgery |
| Regulation Number | 876.1500 |
| Product Code(s) | GCJ |
21 CFR 807.92(a)(3)
Legally Marketed Predicate Devices
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K220069 | 4K UHD LCD Monitor OEV321UH | GCJ |
21 CFR 807.92(a)(4)
Device Description SummaryThe MDEC-2523 is a medical grade monitor with a 23,8 inch color TFT-LDC screen size and is intended to display medical images from endoscopic or laparoscopic camera systems and other compatible medical image systems.
The MDEC-2523 consists of an LCD panel and LED backlight integrated into a plastic housing body with an internal metal chassis structure, that also integrates the electronics, sensors, and interconnections. The MDEC-2523 encloses user controls that are used to control and configure the device via the embedded on screen display (OSD) software. The device has a glass cover to protect the LCD panel and allow easy cleaning. The MDEC-2523 is powered by means of an internal power supply.
This monitor displays color video images that are output from medical imaging systems on the LCD (liquid crystal display) panel.
Intended Use/Indications for Use
The device is intended to display medical images from endoscopic camera systems and other compatible medical image systems.
The device is a medical grade monitor for real-time endoscopic procedures and is suitable for use in hospital operating rooms, surgical centers, doctor's offices, clinics and similar medical environments.
Indications for Use Comparison
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
5
The indications for use are the same.
Technological Comparison
21 CFR 807.92(a)(6)
The principles of operation and the fundamental technology of the MDEC-2523 are identical to the predicate device. The differences in system parameters and specifications include device dimensions, active screen size, timings and resolution, luminance, gamma curve and color space. These differences do not raise new or different questions with respect to safety and effectiveness.
As the electrical safety and electromagnetic compatibility test results demonstrate equivalent performance, we believe there are no new concerns or modified existing risks regarding safety and effectiveness of the subject device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following performance testing was conducted to support the substantial equivalence determination:
-
Electrical safety testing in accordance with ANSI AAMI E560601-1:2005/(R)2012 & A2:2010/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
-
EMC testing in accordance with IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
-
Environmental testing (Climate, shock and vibration, packed, thermal analysis)
-
Software testing
MDEC-2523 is compliant to EMC and safety standards and the environmental and software tests passed.
Additionally, usability/human factors was conducted.
Clinical study -Not Applicable
As a conclusion we can state that the device MDEC-2523 is found to be substantially equivalent to the predicate device 4K UHD LCD Monitor OEV321UH and no new questions of safety or effectiveness are raised.