(9 days)
Not Found
No
The description focuses on standard image processing techniques (convolution, histogram-based operations) and mentions "patented algorithms" implemented with "standard electronic components," without any mention of AI, ML, or related concepts like training data or performance metrics typically associated with AI/ML devices.
No.
The device is a video processor used to enhance images for diagnosis and aid in treatment, but it does not directly treat a disease or condition itself.
No
The device processes video signals to enhance clarity, contrast, and detail for viewing, aiding in treatment and diagnosis in conjunction with other viewing devices like fluoroscopes and endoscopes. It does not independently provide a diagnosis.
No
The device description explicitly states the VP4000 is a "video processing system" with a physical chassis constructed of aluminum, specific dimensions, and weight. It also mentions using "standard electronic components" and being connected "between a video source and a display," indicating it is a hardware device that performs video processing.
Based on the provided text, the ZMED VP4000 Video Processor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for use in applications where a viewing device (fluoroscope, endoscope, laparoscope, etc.) and monitor are incorporated to aid in diagnosis and treatment. This involves processing live video signals from within or on the body, not analyzing samples taken from the body (which is the core of IVD).
- Device Description: The description focuses on enhancing video signals in real-time to improve visibility during procedures. It doesn't mention any analysis of biological samples or substances.
- Input Imaging Modality: The input is "video signals," which are visual representations, not biological samples.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. The ZMED VP4000's function is to improve the visual quality of live video feeds during medical procedures, which falls outside the scope of IVD.
N/A
Intended Use / Indications for Use
The ZMED VP4000 Video Processor is intended for use in any application where a viewing device (fluoroscope, endoscope, laparoscope, etc.) and monitor are incorporated to aid in diagnosis and treatment of a disease such as an arthroscopy or cholecystectomy.
Product codes
LLZ
Device Description
The ZMED VP4000 is a simple-to install, easy to use video processing system which provides powerful real-time enhancement of input video signals. The enhanced output video provides increased clarity, contrast, and detail, aiding in the ability to see through smoke, in poor lighting conditions, and other suboptimal conditions. The VP4000 is connected between a video source and a display. The system uses standard electronic components to implement patented algorithms which are designed to improve the ability of the human eye to perceive fine details in the image which might otherwise be obscured by smoke, haze, poor lighting, etc. This is accomplished via a combination of locally-adaptive contrast enhancement using a very large-kernel convolution operation (identical to that used in the CE3000), and histogram-based operations. Like the CE3000, a key feature of the VP4000 is its ability to perform these complex operations in real time, adding virtually imperceptible system latency from input of raw video to output of enhanced video. The effectiveness of the algorithms combined with this real-time capability makes the VP4000 ideally suited for use in applications which live video is required to perform a given function. The VP4000 chassis is constructed of lightweight aluminum, measures 15.7" wide by 12.0" deep by 1.7" high, and weighs 4.95 pounds. The device is compatible with DVI-D and HD-SDI video signals in a variety of standard resolutions, up to 1080p. Internally, the VP4000 is constructed using UL- and IEC-approved components, circuit boards, and harnessing. The VP4000 has been successfully tested to meet IEC60601-1 Second Edition safety standards, and FCC Part 15 Subpart B.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
video signals
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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K130929
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APR 1 2 2013
APPENDIX 1 510(k) SUMMARY
| APPLICANT: | ZMED, Inc.
9820 Summers Ridge Road
San Diego, CA 92121
858.831.7000 |
|-------------------|------------------------------------------------------------------------------|
| CONTACT: | Randall S. Millar
858.831.7059 |
| DATE OF SUMMARY: | 20 MARCH 2013 |
| DEVICE NAME: | ZMED VP4000 Video Processor |
| PREDICATE DEVICE: | DigiVision CE3000
FDA 510(k) file #: K962260
Year approved: 1996 |
DEVICE DESCRIPTION
The ZMED VP4000 is a simple-to install, easy to use video processing system which provides powerful real-time enhancement of input video signals. The enhanced output video provides increased clarity, contrast, and detail, aiding in the ability to see through smoke, in poor lighting conditions, and other suboptimal conditions.
The VP4000 is connected between a video source and a display. An example of a typical installation is shown below:
Image /page/0/Figure/7 description: The image shows a diagram of a ZMED VP4000 connected to a video source and a video display. The video source is labeled as "VIDEO SOURCE (camera, etc.)" and the video display is labeled as "VIDEO DISPLAY". Arrows indicate the direction of the video signal from the video source to the ZMED VP4000 and from the ZMED VP4000 to the video display.
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The system uses standard electronic components to implement patented algorithms which are designed to improve the ability of the human eye to perceive fine details in the image which might otherwise be obscured by smoke, haze, poor lighting, etc. This is accomplished via a combination of locallyadaptive contrast enhancement using a very large-kernel convolution operation (identical to that used in the CE3000), and histogram-based operations. Like the CE3000, a key feature of the VP4000 is its ability to perform these complex operations in real time, adding virtually imperceptible system latency from input of raw video to output of enhanced video. The effectiveness of the algorithms combined with this real-time capability makes the VP4000 ideally suited for use in applications which live video is required to perform a given function.
The VP4000 chassis is constructed of lightweight aluminum, measures 15.7" wide by 12.0" deep by 1.7" high, and weighs 4.95 pounds. The device is compatible with DVI-D and HD-SDI video signals in a variety of standard resolutions, up to 1080p. Internally, the VP4000 is constructed using UL- and IEC-approved components, circuit boards, and harnessing. The VP4000 has been successfully tested to meet IEC60601-1 Second Edition safety standards, and FCC Part 15 Subpart B. These tests were performed by:
TÜV SÜD America Inc., 10040 Mesa Rim Road. San Diego, CA 92121 Tel: (858) 678-1400
No adaptations to or deviations from these Standards were employed during testing.
STATEMENT OF INTENDED USE
" The ZMED VP4000 Video Processor is intended for use in any application where a viewing device (fluoroscope, endoscope, laparoscope, etc.) and monitor are incorporated to aid in diagnosis and treatment of a disease such as an arthroscopy or cholecystectomy."
This statement is virtually identical to that of the predicate device (CE3000). Both the subject and predicate devices have the same function and purpose and the differences in intended use do not create new safety or effectiveness issues.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The VP4000 is an evolutionary development of the CE3000. Whereas the CE3000 is compatible with outdated analog video signals, the VP4000 has been designed to work with modern high-definition digital video formats. Additionally, advancements in electronic component capability since the CE3000 was designed have allowed for a higher degree of integration (fewer components required) when implementing the enhancement algorithms.
Both systems operate on standard AC power (100-240VAC). Both systems utilize an internal medical-grade power supply to convert the input AC power to low-voltage DC supplies for use by the electronics. Refer to the table below for a
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summary comparison of changes between the unmodified (CE3000) and proposed (VP4000) devices.
| Features | VP4000 | CE3000 (unmodified) | |
|---|---|---|---|
| Similarities | |||
| Intended Use | The ZMED VP4000 Video | ||
| Processor is intended for use | |||
| in any application where a | |||
| viewing device | |||
| (fluoroscope, endoscope, | |||
| laparoscope, etc.) and | |||
| monitor are incorporated to | |||
| aid in diagnosis and | |||
| treatment of a disease such | |||
| as an arthroscopy or | |||
| cholecystectomy. | The CE3000 Contrast | ||
| Enhancer like the | |||
| FluoroVision, may be used in | |||
| any application where a | |||
| viewing device (fluoroscope, | |||
| endoscope, laparoscope, etc.) | |||
| and monitor is incorporated to | |||
| aid in diagnosis and treatment | |||
| of a disease such as an | |||
| arthroscopy or | |||
| cholecystectomy. | |||
| Device | Non-patient contact | Non-patient contact | |
| Category | Pre-market notification | ||
| 510(k) | Approved via 510(k) | ||
| submission | |||
| Technology | Real-time video | ||
| enhancement | Real-time video enhancement | ||
| Differences | |||
| User Interface | Simplified, selectable | ||
| presets | Individual controls for | ||
| parametric settings | |||
| Supported | |||
| video formats | Digital, high-definition | Analog, standard-definition |
(
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Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 12, 2013
ZMed, Inc. % Mr. Randall Millar VP of Engineering 9820 Summers Ridge Road SAN DIEGO CA 92121
Re: K130929
Trade/Device Name: ZMED VP4000 Video Processor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 27, 2013 Received: April 3, 2013
Dear Mr. Millar:
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.
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 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.
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Page 2 - Mr. Millar
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/delault.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/Industrv/default.htm.
Sincerely yours,
Smh.7)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K130929 510(k) Number (if known):
ZMED VP4000 Video Processor Device Name:
Indications for Use:
The ZMED VP4000 Video Processor is intended for use in any application where a viewing device (fluoroscope, endoscope, laparoscope, etc.) and monitor are incorporated to aid in diagnosis and treatment of a disease such as an arthroscopy or cholecystectomy.
Prescription Use X ____________________________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Smh.7)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) # K130929
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