DOWNSCAN LT

K974882 · Merlin Engineering Works, Inc. · LMD · May 22, 1998 · Radiology

Device Facts

• Record ID: K974882
• Device Name: DOWNSCAN LT
• Applicant: Merlin Engineering Works, Inc.
• Product Code: LMD · Radiology
• Decision Date: May 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1

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.

Device Story

DownScan LT is a digital video scan converter; converts high line rate medical video (1023-1125/60 or 1249/50) to standard low line rate video (525/30 or 625/25). Input sources include X-ray, C-arm, angiography, nuclear medicine, MRI, and ultrasound; outputs to display monitors or recording devices. Operates in patient care areas; used by clinical staff to ensure signal compatibility between imaging sources and recording/display hardware. Device utilizes 8-bit analog-to-digital and digital-to-analog conversion; processes signals in digital domain to preserve image quality. Benefits include enabling use of standard recording/display equipment with high-resolution medical imaging systems.

Clinical Evidence

Bench testing only. Testing verified compliance with RS-170 and RS-343A video standards. SMPTE RP-133 testing confirmed correct aspect ratio compensation and 1% low-contrast imaging resolution. No clinical data provided.

Technological Characteristics

1 3/4" EIA half-rack mount chassis; 100V-240V AC power. 8-bit analog-to-digital and digital-to-analog converters. Real-time digital signal processing. Compatible with industry standard monochrome video signals. Compliant with RS-170, RS-343A, and SMPTE RP-133 standards.

Indications for Use

Indicated for conversion of medical imaging video signals (X-ray, nuclear medicine, MRI, ultrasound) from high line rates (1023-1125/60 or 1249/50) to standard low line rates (525/30 or 625/25) when source and destination equipment are incompatible. Intended for use in patient care areas; no patient contact.

Regulatory Classification

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.

Predicate Devices

• UniScan (K95398)
• DownScan 120 (K970451)

Submission Summary (Full Text)

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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

[phone] Telephone: [phone] 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.

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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).

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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.

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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 <span></span> (per 21 CFR 801.109) | <span></span> |
|-----------------------------------------------------|---------------|
|-----------------------------------------------------|---------------|

OR
Over-The-Counter Use Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 1-2-96)