(116 days)
The Sony LMD-2451MT LCD Monitor is intended to provide 3D and 2D color video displays of images from surgical endoscopic/laparoscopic camera systems and other compatible medical imaging systems. The LMD-2451MT is a widescreen, 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.
The Sony LMD-2451MT LCD Monitor is intended primarily for use in a medical environment for displaying images captured during minimally invasive surgical procedures. The monitor features a 24-inch widescreen LCD display panel and employs full WUXGA high-definition (HD) performance. The LMD-2451MT also features Sony's ChromaTru® technology for accurate and consistent color matching across multiple monitors. The monitor is 2D/3D switchable and, therefore, is compatible with both 2D and 3D camera systems to show color and texture variations in full HD in both 2D and 3D modes. In addition to digital signals, the LMD-2451MT accepts analog signals and converts them to digital signals. The 3D mode of the Sony LMD-2451MT LCD Monitor enables more realistic depth perception and spatial orientation than is available in the 2D mode. A micro-polarizer 3D filter is built into the monitor and lightweight circular polarizer 3D glasses are supplied as accessories. The Sony LMD-2451MT LCD Monitor is designed with the flexibility to support a variety of formats with two built-in option slots to select, expand, and change input/output signals.
The provided text is a 510(k) summary for a medical device, the Sony LMD-2451MT LCD Monitor. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria beyond compliance with recognized standards for electromagnetic compatibility and electrical safety.
Therefore, I cannot populate the requested table and answer many of the questions based solely on the provided text. The document is a regulatory submission demonstrating substantial equivalence, not a detailed technical performance study report.
Here's an breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General performance | Not explicitly stated as quantitative acceptance criteria for image quality, resolution, or color accuracy. The document implies compliance with standards is the primary "acceptance." | "demonstrated that the device is in compliance with applicable requirements of recognized standards for electromagnetic compatibility and electrical safety.""The monitor is 2D/3D switchable and, therefore, is compatible with both 2D and 3D camera systems to show color and texture variations in full HD in both 2D and 3D modes.""The 3D mode... enables more realistic depth perception and spatial orientation than is available in the 2D mode." |
| Color Accuracy | Not explicitly stated. | "features Sony's ChromaTru® technology for accurate and consistent color matching across multiple monitors." (This is a feature description, not a performance metric with acceptance criteria.) |
| Resolution | Not explicitly stated. | "employs full WUXGA high-definition (HD) performance." (This is a specification, not a performance metric with acceptance criteria tested against.) |
| Electromagnetic Compatibility | Applicable requirements of recognized standards | In compliance with applicable requirements of recognized standards |
| Electrical Safety | Applicable requirements of recognized standards | In compliance with applicable requirements of recognized standards |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document states "Testing... demonstrated compliance" but does not detail the nature of this testing (e.g., number of units tested, types of image data used). This is a monitor, so "data provenance" in the sense of patient data is not applicable. The "testing" refers to product safety and performance testing.
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. This device is a display monitor. "Ground truth" in the context of diagnostic interpretation by experts is not relevant to its performance testing for regulatory submission. Its performance is measured against technical specifications and safety standards, not against human judgment for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See answer to point 3.
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:
- No. This is a passive display monitor, not an AI-powered diagnostic tool. MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a display monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. For a display monitor, the "ground truth" would be the technical specifications (e.g., color accuracy measured by spectroradiometer, resolution by pixel count verification) and compliance with safety standards, not medical ground truth established by experts or pathology.
8. The sample size for the training set:
- Not applicable. This is a hardware device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. See answer to point 8.
In summary: The provided 510(k) summary focuses on establishing substantial equivalence for a medical monitor by comparing its intended use, technological characteristics, and compliance with general safety and EMC standards to a predicate device. It does not provide the kind of detailed performance study data, acceptance criteria, or ground truth establishment protocols that would be found in submissions for AI/ML-driven diagnostic devices.
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510(k) Summary for Sony LMD-2451MT LCD Monitor (per 21 CFR 807.92)
1. APPLICANT / SPONSOR
Sony Electronics Inc. Sony Medical Systems Division 1 Sony Drive Park Ridge, NJ 07656
Contact Person: Ms. Aleta Moeller Telephone: 201-358-4182
Date Prepared: February 9, 2012
2. DEVICE NAME
Proprietary Name: Sony LMD-2451MT LCD Monitor Common/Usual Name: Monitor Classification Name: Endoscope and Accessories
3. PREDICATE DEVICE
- Polarized 3D Monitor XOEV-3D1, Olympus Medical Systems Corporation, . K102379
4. DEVICE DESCRIPTION
The Sony LMD-2451MT LCD Monitor is intended primarily for use in a medical environment for displaying images captured during minimally invasive surgical procedures. The monitor features a 24-inch widescreen LCD display panel and employs full WUXGA high-definition (HD) performance.
The LMD-2451MT also features Sony's ChromaTru® technology for accurate and consistent color matching across multiple monitors. The monitor is 2D/3D switchable and, therefore, is compatible with both 2D and 3D camera systems to show color and texture variations in full HD in both 2D and 3D modes. In addition to digital signals, the LMD-2451MT accepts analog signals and converts them to digital signals.
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The 3D mode of the Sony LMD-2451MT LCD Monitor enables more realistic depth perception and spatial orientation than is available in the 2D mode. A micro-polarizer 3D filter is built into the monitor and lightweight circular polarizer 3D glasses are supplied as accessories.
The Sony LMD-2451MT LCD Monitor is designed with the flexibility to support a variety of formats with two built-in option slots to select, expand, and change input/output signals.
5. INTENDED USE
The Sony LMD-2451MT LCD Monitor is intended to provide 3D and 2D color video displays of images from surgical endoscopic/laparoscopic camera systems and other compatible medical imaging systems. The LMD-2451MT is a widescreen, highdefinition, 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.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The Sony LMD-2451MT LCD Monitor has the same overall purpose and function as the predicate device cited above. Both of the devices are intended to provide color video displays of images from surgical camera systems, primarily in endoscopic/laparoscopic applications.
7. PERFORMANCE TESTING
Testing of the Sony LMD-2451MT LCD Monitor demonstrated that the device is in compliance with applicable requirements of recognized standards for electromagnetic compatibility and electrical safety.
8. CONCLUSION
Based on the similarities in overall purpose and function, the Sony LMD-2451MT LCD Monitor has demonstrated substantial equivalence to the cited predicate device and any differences do not affect the safety or effectiveness of the device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 2 4 2012
Sony Electronics, Inc. % Medical Device Consultants, Inc. Ms. Cynthia Sinclair 49 Plain Street North Attleboro, Massachusetts 02760
Re: K113203
Trade/Device Name: Sony LMD-2451MT LCD Monitor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: February 09, 2012 Received: February 10, 2012
Dear Ms. Sinclair:
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. 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.
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
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Page 2 - Ms. Cynthia Sinclair
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 70 http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Mulkern
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Sony LMD-2451MT LCD Monitor
KII 3203 Indications for Use:
The Sony LMD-2451MT LCD Monitor is intended to provide 3D and 2D color video displays of images from surgical endoscopic/laparoscopic camera systems and other compatible medical imaging systems. The LMD-2451MT is a widescreen, 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil K.P. Oglem for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113203
§ 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.