EPS

K974504 · E For M Imaging Systems Div., Marquette Electronic · LLZ · Feb 27, 1998 · Radiology

Device Facts

• Record ID: K974504
• Device Name: EPS
• Applicant: E For M Imaging Systems Div., Marquette Electronic
• Product Code: LLZ · Radiology
• Decision Date: Feb 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The EPS system is a digital recording system designed for use as an electronic photospot device on OEM manufactured Radiographic & Fluoroscopic ("R/F") systems. The system is modular in configuration allowing single and dual room configurations for acquisition and/or review, providing assistance to Radiologic Technologists in routine diagnostic examinations and special procedures in R/F. The EPS system may be used to acquire, display, record, archive, and disseminate digital R/F image data.

Device Story

EPS is a 10-bit PC-based digital recording system for R/F imaging; functions as an electronic photospot device on OEM R/F systems. Inputs: X-ray image data from R/F systems. Processing: Simultaneous acquisition, review, post-processing, and archival of raw data. Outputs: Digital images displayed on monitors; archived to MOD media; disseminated via LAN. Used in clinical settings (single/dual room configurations) by Radiologic Technologists. Facilitates diagnostic examinations and special procedures; supports clinical review, reporting, and billing. Benefits: Enables digital capture, storage, and efficient management of R/F images.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

10-bit, 1024 digital acquisition/display system; PC-based architecture (Pentium processors); Windows NT OS; DICOM 3.0 compliant; modular configuration; MOD archival media; connectivity via LAN. Complies with UL 2601.1, UL 1950, and 21 CFR 1020.10/1040.10.

Indications for Use

Indicated for use by Radiologic Technologists to assist in routine diagnostic examinations and special procedures in Radiographic and Fluoroscopic (R/F) imaging.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• EPS-20 (K922240)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

The following summary is submitted pursuant to 21 CFR 807.92:

FES 27 1998

| [1] Submitter: | Marquette Medical Systems |
|-----------------------------|--------------------------------------------------------------------------------------|
| | E for M Imaging Systems Division |
| | 625 Alaska Avenue |
| | Torrance, CA 90503 USA |
| Date Prepared: | November 26, 1997 |
| [2] Trade/Proprietary Name: | EPS |
| Common/Usual Name: | R/F Digital Image Acquisition and Review System |
| Classification: | Class II per 21 CFR 892.1620 |
| Classification Name: | (Accessory to) Cine or Spot Fluorographic X-Ray Camera |
| Panel: | Radiology |
| Performance Standards: | 21 CFR 1020.10, Performance Standards for Ionizing Radiation Emitting |
| | Products; |
| | 21 CFR 1040.10, Performance Standards for Light-Emitting Products; |
| | DICOM 3.0 Standard for Digital Exchange Media (Voluntary); |
| | UL 2601.1, Standard for Safety, Medical Electrical Equipment, Part 1: General |
| | Requirements for Safety [Underwriters Laboratories] (Voluntary); |
| | UL 1950, Safety of Information Technology Equipment, Including Electrical Business |
| | Equipment [Underwriters Laboratories] (Voluntary); |
| | SMPTE (Society of Motion Picture and Television Engineers) Test Patterns (Voluntary) |
| Reason for 510(k): | New product equivalency. |
| [3] Predicate Device: | EPS-20, K922240, manufactured by Toshiba America Medical Systems, Inc. |

EPS-20, K922240, manufactured by Toshiba America Medical Systems, Inc. [3] Predicate Device:

#### [4] Description:

The Electronic PhotoSpot (EPS) is a 10 bit PC based multitasking acquisition/display system configured for use in R/F applications. This system is designed for use by a qualified Radiologic Technologist.

More specifically, the EPS system is a digital recording system designed for use as an electronic photospot device on OEM manufactured R/F systems. This system consists of independent and simultaneous acquisition of data, review, post processing of raw data and archive transfer functions. The system is modular in configuration allowing single and dual room configurations for acquisition and/or review. The system has 10 bit, 1024 digital acquisition, display and storage capability and uses a Windows based operator interface on the Operator Console/Review Station. It includes the following major components (minimally):

- Pentium computers a.
- b. Image monitor(s)
- Camera X-Ray Interface C.
- MOD media for archival d.
- Software program developed by Marquette Medical Systems to run in conjunction with Microsoft Windows NT e.

The EPS provides image acquisition, display, archival, and exchange media compliant with the DICOM 3.0 standard. Furthermore, the EPS allows connection to the medical facility's existing LAN network for data dissemination to support reviews, reports, and patient billing.

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The following questions have been addressed:

| • Is the device life supporting or life sustaining? | No |
|------------------------------------------------------------------------|-------|
| • Is the device implanted (short term or long term)? | No |
| • Does the device design use software? | Yes |
| • Level of concern for software (if applicable)? | Minor |
| • Is the device sterile? | No |
| • Is the device for single use? | No |
| • Is the device for home use or prescription use? | No |
| • Does the device contain drugs or biological products as a component? | No |
| • Is the device a diagnostic kit? | No |

### [5] Intended Use:

The EPS system is a digital recording system designed for use as an electronic photospot device on OEM manufactured Radiographic & Fluoroscopic ("R/") systems. The system is modular in configuration allowing single and dual room configurations for acquisition and/or review, providing assistance to Radiologic Technologists in routine diagnostic examinations and special procedures in R/F. The EPS system may be used to acquire, display, record, archive, and disseminate digital R/F image data.

## [6] Comparison to Predicate Devices:

The Toshiba EPS-20 is a legally marketed predicate device with the same intended use as Marquette Medical Systems' EPS System. The Toshiba EPS-20 was successfully cleared through the FDA 's premarket notification process under file number K922240. A comparison of device specifications and principles of operation indicates no new questions of safety or efficacy, or substantial risk are raised.

#### Official Correspondent: Stu Bush

Signature: Ster Back 11/26/97

Telephone: Fax

[phone] [phone]

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of a human figure with three faces in profile, stacked on top of each other. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 1998

Stu Bush Director, Regulatory Affairs & Quality Assurance Official Correspondent Marquette Medical Systems 625 Alaska Avenue Torrance, CA 90503-5124

Dear Mr. Bush:

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 Coometic 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 and prohibitions against misbranding and adulteration.

Re:

K974504

Review System

Regulatory class: II

Dated: November 26, 1997

Received: December 1, 1997

EPS (R/F Digital Image Acquisition and

21 CFR 892.1650/Procode: 90 JAA/90 LLZ

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 Feleval 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 persons, the Food and Drug Administration (FDA) will verify systems. 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 531 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 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 question 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/cdr/dsmaln.html".

Sincerely yours,

Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Thros and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

### B. INTENDED USE

The EPS system is a digital recording system designed for use as an electronic photospot device on OEM manufactured Radiographic & Fluoroscopic ("R/F") systems. The system is modular in configuration allowing single and dual room configurations for acquisition and/or review, providing assistance to Radiologic Technologists in routine diagnostic examinations and special procedures in R/F.

# (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 K974504

V Prescription Use_ (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)