(89 days)
Not Found
No
The description focuses on digital image processing for displaying multiple images and scan conversion, with no mention of AI, ML, or related concepts like training or testing data sets for algorithmic learning.
No.
The device is described as an "image processing system" that converts and displays multiple medical images. It does not exert any direct therapeutic action on a patient.
No
The device is described as an "image processing system" and "video processing systems designed to convert monochrome video images from one format to another." Its function is to combine and display multiple images from various imaging modalities (X-ray, nuclear medicine, magnetic resonance, ultrasound), or convert video signals, for display or storage. It does not perform analysis or interpretation of medical data to aid in diagnosis.
No
The device description explicitly states it is a "digital image processing system" and mentions "provisions for video scan conversion," implying hardware components are involved in processing and converting video signals. The performance studies also focus on meeting video standards (RS-170, RS-343A, SMPTE RP-133), which are typically related to hardware performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a system for displaying and combining medical images from various modalities (X-ray, nuclear medicine, MRI, ultrasound) and converting video signals. This is related to medical imaging and display, not the analysis of biological samples (blood, urine, tissue, etc.) to diagnose or monitor a disease or condition.
- Device Description: The description reinforces that it's a digital image processing system for displaying multiple pictures on a monitor and performing video scan conversion.
- No mention of biological samples or diagnostic testing: The entire description focuses on image manipulation and display, with no reference to analyzing biological materials or providing diagnostic information based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The intended use for MultiPics is conversion and combining of X-ray (stationary, C-arm, angiography, etc.), nuclear medicine, magnetic resonance, and ultrasound images either directly from their source, or from an intermediate storage device (like a video tape or video disk), for use on display monitors, optical, tape, disk, or other apparatus requiring a video signal. MultiPics is not intended to have any patient contact.
The use of MultiPics is indicated whenever multiple images (2, 3, or 4) are required to be shown together in a single image/display, and a highline rate (e.g., 1049 lines @ 30 frames/sec or 1249 lines @ 25 fps) video signal is required. Examples include conversion/combining of X-ray (stationary, C-arm, angiography, etc.), nuclear medicine, magnetic resonance, and/or ultrasound images either directly from their source, or from an intermediate storage device (like a video tape or video disk), for use on display monitors, optical, tape, disk, or other apparatus requiring a high-line rate video signal.
Product codes (comma separated list FDA assigned to the subject device)
90 LMD
Device Description
MultiPics (Multiple Picture Scan Converter) is a digital image processing system that can display 2, 3, or 4 pictures on a single video monitor. Additionally, MultiPics has provisions for video scan conversion.
MultiPics provides up to three modes of operation:
DuoPics operation (Model ME-977-2)
In the DuoPics mode, MultiPics accepts two input signals, each at various scan rates, and it outputs high-line video. At the output, each image is one-quarter of its original size with the two images located one beside the other (horizontally spaced), centered vertically, thus fitting into the video frame with no cropping. Each "quarter" picture contains the same information as would be found in a full size, standard rate picture.
TriPics operation (Model ME-977-3)
In the TriPics mode, MultiPics accepts three input signals, each at various scan rates, and it outputs high-line video. At the output, each image is one-quarter of its original size with two of them located one beside the other (horizontally spaced) in the bottom half of the picture, and the other located above the two, thus fitting into the video frame with no cropping. Each "quarter" picture contains the same information as would be found in a full size, standard rate picture.
QuadPics operation (Model ME-977-4)
In the QuadPics mode, MultiPics accepts four input signals, each at various scan rates, and it outputs high-line video. At the output, each image is one-quarter of its original size with two of them located one beside the other (horizontally spaced) in the bottom half of the picture, and the other two located one beside the other (horizontally spaced) in the top half of the picture, thus fitting into the video frame with no cropping. Each "quarter" picture contains the same information as would be found in a full size, standard rate picture.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray (stationary, C-arm, angiography, etc.), nuclear medicine, magnetic resonance, and ultrasound images
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
MultiPics was tested to ensure that it meets the appropriate requirements of RS-170 and RS-343A. The data demonstrates that MultiPics meets these standards, as appropriate to the specific signal, as is the case for the predicate devices.
In addition, MultiPics was tested in accordance with SMPTE RP-133. The system correctly compensates for aspect ratio changes in accordance with the requirements of the particular scan conversion selected. In addition, the system permits low-contrast imaging resolution at the 1% level.
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
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
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Image /page/0/Picture/0 description: The image shows a black and white drawing of an eagle's head in profile. The eagle has a sharp, curved beak and piercing eyes. The eagle's feathers are detailed with fine lines, and the background is a solid black circle. The text "Keen of Eye, Swift of Wing" is at the bottom of the image.
ﻤﺴﻴﺴﻴﺔ
Image /page/0/Picture/1 description: The image shows the word "Merlin" in a bold, sans-serif font. The letters are black and appear to be slightly distressed, giving them a textured look. The word is the main focus of the image, taking up a significant portion of the frame.
Merlin Engineering Works 1888 Embarcadero Road. Palo Alto, CA 94303 Tel (415) 856-0900 Fax (415) 8
Summary of Safety and Effectiveness 2.
| Submitter: | Merlin Engineering Works, Inc.
1888 Embarcadero Road
Palo Alto, California 94303
JUN 25 1997 | | | |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------------|
| | Telephone:
Facsimile: | (415) 856-0900
(415) 858-2302 | | |
| | Contact: | Gerald Engbretson,
Operations Manager / Director, Regulatory Affairs | | |
| Device identification: | Trade Name: | | MultiPics | |
| | Model Number(s): | | ME-977 | |
| | Common Name: | | Multiple Picture Digital Scan Converter. | |
| | Classification
Name: | | (A component of) stationary x-ray system, per 21
CFR 892.1680 (or equivalent) | |
| Device(s) to which
substantial equivalence
is claimed: | K953398 | UniScan
(a.k.a. Model ME-959) | Merlin Engineering
Works, Inc. | |
| | K920550 | IDP-5100 Interventional
Display Processor | Perkins Manufacturing
Co. | |
| | K904447 | SME-3500 Cine Video System | | Sony Medical
Electronics |
| Description of the
device: | MultiPics (Multiple Picture Scan Converter) is a digital image processing
system that can display 2, 3, or 4 pictures on a single video monitor.
Additionally, MultiPics has provisions for video scan conversion. | | | |
| | MultiPics provides up to three modes of operation: | | | |
| | DuoPics operation (Model ME-977-2) | | | |
| | In the DuoPics mode, MultiPics accepts two input signals, each at
various scan rates, and it outputs high-line video. At the output, each
image is one-quarter of its original size with the two images located
one beside the other (horizontally spaced), centered vertically, thus
fitting into the video frame with no cropping. Each "quarter" picture
contains the same information as would be found in a full size,
standard rate picture. | | | |
| | TriPics operation (Model ME-977-3) | | | |
| | In the TriPics mode, MultiPics accepts three input signals, each at
various scan rates, and it outputs high-line video. At the output, each
image is one-quarter of its original size with two of them located one
beside the other (horizontally spaced) in the bottom half of the
picture, and the other located above the two, thus fitting into the
video frame with no cropping. Each "quarter" picture contains the
same information as would be found in a full size, standard rate
picture. | | | |
1
Intended use of the device:
Summary of how the technological characteristics compare to predicate device(s):
Summary of (nonclinical) performance tests and how their results support a determination of substantial equivalence:
Conclusions drawn from the performance tests:
QuadPics operation (Model ME-977-4)
- In the QuadPics mode, MultiPics accepts four input signals, each at various scan rates, and it outputs high-line video. At the output, each image is one-quarter of its original size with two of them located one beside the other (horizontally spaced) in the bottom half of the picture, and the other two located one beside the other (horizontally spaced) in the top half of the picture, thus fitting into the video frame with no cropping. Each "quarter" picture contains the same information as would be found in a full size, standard rate picture.
When used in conjunction with a Video Scan Converter capable of converting from high-line to low-line, such as Merlin's UniScan (submission K953398), the resulting MultiPics image can be recorded on standard VHS, S-VHS, and other readily available recorder formats, and can be viewed with standard video monitors.
The intended use for MultiPics is conversion and combining of X-ray (stationary, C-arm, angiography, etc.), nuclear medicine, magnetic resonance, and ultrasound images either directly from their source, or from an intermediate storage device (like a video tape or video disk), for use on display monitors, optical, tape, disk, or other apparatus requiring a video signal. MultiPics is not intended to have any patient contact.
The use of MultiPics is indicated whenever multiple images (2, 3, or 4) are required to be shown together in a single image/display, and a highline rate (e.g., 1049 lines @ 30 frames/sec or 1249 lines @ 25 fps) video signal is required.
MultiPics and the predicate devices are real-time video processing systems designed to convert monochrome video images from one format to another (e.g., low line-rate to high line-rate, or visa versa) and/or to convert from full size images to quarter size images. MultiPics and at least two of the predicate devices (Merlin UniScan) utilize similar technology to perform the scan conversion. These systems both convert the incoming analog video signal to digital form using 8-bit analog-todigital converters, process the signals in the digital domain, and convert back to analog video using 8-bit digital-to-analog converters for the output. MultiPics and (applicable portions of) the other predicate devices (Perkins IDP-5100 and Sony SME-3500) both reduce one or more full size images to smaller images, and combine them in one full size picture using digital processing.
MultiPics was tested to ensure that it meets the appropriate requirements of RS-170 and RS-343A. The data demonstrates that MultiPics meets these standards, as appropriate to the specific signal, as is the case for the predicate devices.
In addition, MultiPics was tested in accordance with SMPTE RP-133. The system correctly compensates for aspect ratio changes in accordance with the requirements of the particular scan conversion selected. In addition, the system permits low-contrast imaging resolution at the 1% level.
MultiPics is electrically compatible with industry standard monochrome video signals. The image quality is preserved (within the limits of standard video technology and the line rates selected).
2
QuadPics operation (Model ME-977-4)
In the QuadPics mode, MultiPics accepts four input signals, each at various scan rates, and it outputs high-line video. At the output, each image is one-quarter of its original size with two of them located one beside the other (horizontally spaced) in the bottom half of the picture, and the other two located one beside the other (horizontally spaced) in the top half of the picture, thus fitting into the video frame with no cropping. Each "quarter" picture contains the same information as would be found in a full size, standard rate picture.
When used in conjunction with a Video Scan Converter capable of converting from high-line to low-line, such as Merlin's UniScan (submission K953398), the resulting MultiPics image can be recorded on standard VHS, S-VHS, and other readily available recorder formats, and can be viewed with standard video monitors.
The intended use for MultiPics is conversion and combining of X-ray (stationary, C-arm, angiography, etc.), nuclear medicine, magnetic resonance, and ultrasound images either directly from their source, or from an intermediate storage device (like a video tape or video disk), for use on display monitors, optical, tape, disk, or other apparatus requiring a video signal. MultiPics is not intended to have any patient contact.
The use of MultiPics is indicated whenever multiple images (2, 3, or 4) are required to be shown together in a single image/display, and a highline rate (e.g., 1049 lines @ 30 frames/sec or 1249 lines @ 25 fps) video signal is required.
MultiPics and the predicate devices are real-time video processing systems designed to convert monochrome video images from one format to another (e.g., low line-rate to high line-rate, or visa versa) and/or to convert from full size images to quarter size images. MultiPics and at least two of the predicate devices (Merlin UniScan) utilize similar technology to perform the scan conversion. These systems both convert the incoming analog video signal to digital form using 8-bit analog-todigital converters, process the signals in the digital domain, and convert back to analog video using 8-bit digital-to-analog converters for the output. MultiPics and (applicable portions of) the other predicate devices (Perkins IDP-5100 and Sony SME-3500) both reduce one or more full size images to smaller images, and combine them in one full size picture using digital processing.
MultiPics was tested to ensure that it meets the appropriate requirements of RS-170 and RS-343A. The data demonstrates that MultiPics meets these standards, as appropriate to the specific signal, as is the case for the predicate devices.
In addition, MultiPics was tested in accordance with SMPTE RP-133. The system correctly compensates for aspect ratio changes in accordance with the requirements of the particular scan conversion selected. In addition, the system permits low-contrast imaging resolution at the 1% level.
MultiPics is electrically compatible with industry standard monochrome video signals. The image quality is preserved (within the limits of standard video technology and the line rates selected).
Intended use of the device:
Summary of how the technological characteristics compare to predicate device(s):
Summary of (nonclinical) performance tests and how their results support a determination of substantial equivalence:
Conclusions drawn from the performance tests:
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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo consists of a stylized graphic of three overlapping human profiles facing to the right. The profiles are arranged vertically, with the top profile slightly larger than the others. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the graphic.
food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Gerald C. Engbretson Operations Manager and Director of Regulatory Affairs Merlin Engineering Works ... ... .... 1888 Embarcadero Road Palo Alto, CA 94303 JUN 2 5 1007
Re: K971154 Merlin MultiPics Dated: March 27, 1997 Received: March 28, 1997 .... Regulatory class: II 21 CFR 892.1680/Procode: 90 LMD
Dear Mr. Engbretson:
We have reviewed your Section 510%) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enaction the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmers Acl (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbrancing and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 51 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations,
This letter will allow you to begin marketing your 510(k) premarket noufication. The FDA finding of substantial equivalence of your device to a legally marketed predication for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please of the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrl/dsmamain.html".
Sincerely yours,
William Fox
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear. Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
510(k) Number (if known):
Device Name: MultiPics
Indications For Use:
The use of MultiPics is indicated whenever multiple images (2, 3, or 4) are required to be shown together in a single image/display, and a high-line rate (e.g., 1049 lines @ 30 frames/sec or 1249 lines @ 25 fps) video signal is required. Examples include conversion/combining of X-ray (stationary, C-arm, angiography, etc.), nuclear medicine, magnetic resonance, and/or ultrasound images either directly from their source, or from an intermediate storage device (like a video tape or video disk), for use on display monitors, optical, tape, disk, or other apparatus requiring a high-line rate video signal.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices,
510(k) Number K971154
Prescription Use
X
(per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)