(143 days)
K970451, K95398
Not Found
No
The description focuses on digital image processing for video signal conversion based on line rates and standard video formats. There is no mention of AI, ML, training data, or performance metrics typically associated with AI/ML algorithms.
No.
The device converts incompatible video signals of medical images for display or recording, rather than directly treating or diagnosing patients.
No.
The device's intended use is to convert video signals with incompatible line rates for display or recording, not to analyze or interpret medical images for diagnostic purposes. Its purpose is to facilitate the display of images from diagnostic modalities, not to perform diagnostics itself.
No
The device description explicitly states it is "Housed in a 1 3/4" EIA half-rack mount chassis" and "operates from 100V to 240V AC power," indicating it is a physical hardware device.
Based on the provided text, the DownScan LT is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- DownScan LT's Function: The DownScan LT's intended use and description clearly state that it is a digital image processing system used to convert video signals from various medical imaging modalities (X-ray, nuclear medicine, MRI, ultrasound) to standard video formats. It deals with the display and recording of images, not the analysis of biological specimens.
Therefore, the DownScan LT falls under the category of medical imaging equipment or accessories, not IVD devices.
N/A
Intended Use / Indications for Use
The intended use for DownScan LT is conversion of X-ray (stationary, Carm, 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 or disk recorders, or other apparatus requiring a standard frame rate video signal (30 or 25 frames/second). The use of DownScan LT is indicated whenever the source and destination of a video signal are incompatible due to different line rates or other signal attributes, and a standard frame rate video signal is required. DownScan LT is intended for use in patient care areas, but is not intended to have any patient contact.
The use of DownScan LT is indicated whenever the source and destination of a video signal are incompatible due to different line rates or other signal attributes, and a standard frame rate video signal (30 or 25 frames/second) is required. Examples include conversion 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, or disk recorders, or other apparatus requiring a standard frame rate signal.
Product codes
90 LMD
Device Description
DownScan LT is a digital image processing system that can convert from high line rate video standard of 1023-1125/60 or 1249/50 to low line rate video standards of 525/30 or 625/25. Housed in a 1 3/4" EIA half-rack mount chassis, DownScan LT operates from 100V to 240V AC power.
Mentions image processing
DownScan LT is a digital image processing system that can convert from high line rate video standard of 1023-1125/60 or 1249/50 to low line rate video standards of 525/30 or 625/25.
DownScan LT and the predicate devices are real-time video processing systems which are designed to convert monochrome video images from one video format to another.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray (stationary, Carm, angiography, etc.), nuclear medicine, magnetic resonance, and ultrasound images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patient care areas
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
DownScan LT was tested to ensure that it meets the appropriate requirements of RS-170 and RS-343A. The data demonstrates that the DownScan LT meets these requirements, as is the case for the predicate devices.
In addition, DownScan LT was tested in accordance with SMPTE RP-133. The system correctly compensates for aspect ratio changes, and it permits low-contrast imaging resolution at the 1% level.
Key Metrics
Not Found
Predicate Device(s)
K970451, K95398
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image is a black and white drawing of an eagle's head. The eagle has a sharp, curved beak and piercing eyes. The feathers around its head and neck are detailed with fine lines, giving the image a textured appearance. The background is a dark, shaded circle, which contrasts with the eagle's head.
22 1999
Image /page/0/Picture/2 description: The image shows a sequence of handwritten characters. The characters are 'K974882'. The characters are written in black ink on a white background. The characters are all connected, and they are all the same size.
Image /page/0/Picture/3 description: The image shows the word "Merlin" in a bold, sans-serif font. The letters are black and stand out against a white background. The text appears to be part of a larger document or publication.
Merlin Engineering Works 1888 Embarcadero Road, Palo Alto, CA 94303 Tel (415) 850
Summary of Safety and Effectiveness 2.
Submitter:
Merlin Engineering Works, Inc. 1888 Embarcadero Road Palo Alto, California 94303
(650) 856-0900 Telephone: (650) 858-2302 Facsimile: Gerald Engbretson, Contact: Operations Manager and Director of Regulatory Affairs
DownScan LT
Device identification:
Model Number: ME-209 Common Name: Video Scan Converter (or Digital Scan Converter)
Trade Name:
K95398
Image Processing System Classification Name:
UniScan
Device(s) to which substantial equivalence is claimed:
Description of the device:
Intended use of the device:
DownScan 120 Merlin Engineering Works K970451 DownScan LT is a digital image processing system that can convert from high line rate video standard of 1023-1125/60 or 1249/50 to low line rate video standards of 525/30 or 625/25. Housed in a 1 3/4" EIA half-rack mount chassis, DownScan LT operates from 100V to 240V AC power.
Merlin Engineering Works
The intended use for DownScan LT is conversion of X-ray (stationary, Carm, 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 or disk recorders, or other apparatus requiring a standard frame rate video signal (30 or 25 frames/second). The use of DownScan LT is indicated whenever the source and destination of a video signal are incompatible due to different line rates or other signal attributes, and a standard frame rate video signal is required. DownScan LT is intended for use in patient care areas, but is not intended to have any patient contact.
1
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:
DownScan LT and the predicate devices are real-time video processing systems which are designed to convert monochrome video images from one video format to another. The main difference between DownScan LT and one of the predicates (Merlin UniScan) is that DownScan LT converts video from high line rate to low line rate formats, where the predicate converts from low line to high line (upscan mode) as well as high line to low line (downscan mode). The only differences between DownScan LT and the other predicate (Merlin DownScan 120) are a varying clock frequencies and the ability of the predicate to input video at twice the standard frame rate (with the DownScan 120).
DownScan LT and the predicate devices utilize similar technology to perform their functions. These systems all convert the incoming analog video signal to digital form using 8-bit analog-to-digital converters, process the signals in the digital domain, and convert back to analog video using 8-bit digital-to-analog converters for the output.
DownScan LT was tested to ensure that it meets the appropriate requirements of RS-170 and RS-343A. The data demonstrates that the DownScan LT meets these requirements, as is the case for the predicate devices.
In addition, DownScan LT was tested in accordance with SMPTE RP-133. The system correctly compensates for aspect ratio changes, and it permits low-contrast imaging resolution at the 1% level.
DownScan LT is electrically compatible with industry standard monochrome video signals. The image quality is preserved (within the limits of standard video technology).
2
Image /page/2/Picture/16 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection. The text "DEPARTMENT OF HEALTH & HUMAN - USA" is arranged in a circular pattern around the figure.
MAY 2 2 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re:
Gerald C. Engbretson Operations Manager and Director of Reguulatory Affairs Merlin Engineering Works 1888 Embarcadero Road
K974882 Merlin DownScan LT Dated: March 24, 1998 Received: March 25, 1998 Unclassified/Procode: 90 LMD
Dear Mr. Engbretson:
We have reviewed your Section 510(k) 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 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). You may, therefore, narket 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 (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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 submission does not affect any obligation you might have under sections 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 device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact 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/cdrb/dsmaldsmam.html".
Sincerely yours,
Kilian Yiu
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
Enclosure
3
510(k) Number (if known):
Device Name: DownScan LT
Indications For Use:
The use of DownScan LT is indicated whenever the source and destination of a video signal are incompatible due to different line rates or other signal attributes, and a standard frame rate video signal (30 or 25 frames/second) is required. Examples include conversion 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, or disk recorders, or other apparatus requiring a standard frame rate 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 | K974882 |
| Prescription Use (per 21 CFR 801.109) | |
|---|---|
| ----------------------------------------------------- | --------------- |
OR
Over-The-Counter Use Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 1-2-96)