T.I.M.S., VERSION 2.00

K001947 · Total Medical Information Management Systems, Inc. · LLZ · Nov 22, 2000 · Radiology

Device Facts

• Record ID: K001947
• Device Name: T.I.M.S., VERSION 2.00
• Applicant: Total Medical Information Management Systems, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Nov 22, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

T.I.M.S. receives image data, acquired from various sources, including but not limited to CT, MR, US, Nuclear, digital angiography and flourography, secondary capture devices (frame grabbers), scanners (digitizers) or other imaging sources. Images and data can be viewed, stored, transmitted (communicated), processed at the workstation, physician's desktop, or other clinical application and distributed across networks or the world wide web for viewing.

Device Story

T.I.M.S. is a teleradiology software system for acquisition, viewing, archival, and transmission of medical images. Inputs include DICOM-compliant data from imaging modalities (CT, MR, US, Nuclear, angiography, fluorography) or secondary capture devices (frame grabbers, scanners). Software operates on off-the-shelf PC hardware using Windows 95 or higher. Features include image processing, network/web distribution, and 128-bit encryption for secure transmission. Used by physicians and trained medical personnel in clinical settings or remote workstations. Output is displayed on a monitor for physician interpretation. System facilitates clinical decision-making by enabling remote access to diagnostic images; does not contact patient or control life-sustaining equipment.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technical comparison of software functionality, DICOM compliance, and intended use for image management.

Technological Characteristics

Software-based teleradiology system; operates on off-the-shelf PC hardware (Windows 95+). Connectivity via LAN/WAN/Internet. Supports DICOM 3.0 protocol. Includes lossy/lossless image compression. Security features include 128-bit encryption and password-protected access.

Indications for Use

Indicated for medical professionals to view, store, transmit, and process medical images acquired from various sources (CT, MR, US, Nuclear, angiography, fluorography, scanners) for clinical review.

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

• Olicon 02 Workstation and/or PACSVIEW software (K973959)
• Images-On-Call Teleradiology System (K896095)

Submission Summary (Full Text)

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# NOV 2 2 2000

### Total Medical Information Management Systems, Inc. 407 Wekiva Springs Rd. Suite 347 Longwood, Florida 32779 407-788-6353

K001947
page 1 of 3

### 510 (k) Summary

- 1. Identification
Date Prepared:

June 1, 2000

Submitter:

Total Medical Information Management Sys., Inc 407 Wekiva Springs Rd. Suite 347 Longwood, Fl. 32779-6097

Contact:

Don Beavers, President Phone: [phone] Fax: [phone]

2: Device Name

Proprietary Name: T.I.M.S.

Common Name: Teleradiology System

Classification Name:

Picture Archiving and Communication System

3: Regulatory Class

Class: Panel: Product Code: 2 Radiology CFR 892.2050; LLZ

4. Predicate Device

Olicon 02 Workstation and/or PACSVIEW software; K973959 Images-On-Call Teleradiology System; K896095

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- 5. Device Description
K 001947
Page 2 of 3

The T.I.M.S. Teleradiology system is a general purpose software designed for the acquisition/capture/view/archival and transmission of medical images. The software operates on "off the shelf" hardware using a Windows 95 or higher platform. It is designed to capture, acquire, send, receive, archive and display patient images and data, using the DICOM communication standard. T.I.M.S. can be installed on a PC in the hospital, via a web-browser, and on a local LAN or WAN, and includes teleradiology, connectivity and display features. It employs the latest internet security techniques, including 128 bit encryption.

- 6. Indications for Use
T.I.M.S. receives image data, acquired from various sources, including but not limited to CT, MR, US, Nuclear, digital angiography and flourography, secondary capture devices (frame grabbers), scanners or other imaging sources. Images and data can be stored, transmitted (communicated), processed at the workstation, physician's desktop or other clinical application and distributed across networks or the world wide web.

- 7. Substantial Equivalence Comparison
T.I.M.S. is a medical imaging software device that is substantially equivalent to medical image software devices previously cleared and marketed under the names of Olicon 02-Workstation and/or PACSView software (K973959) and Images-On-Call teleragiology system (K896095). The predicate devices have the same intended use for the receipt of images and data from imaging modalities, secondary capture devices, scanners or imaging gateways. This device does not offer any new functions that have not received previous clearance from the Agency.

- 8. Safety and Effectiveness
T.I.M.S. software system is primarily used to capture/view/archive/transmit medical images. It does not require specialized or nonstandard devices of any type. Image acquisition and display is via the industry-standard DICOM 3 protocol, allowing the images to be produced the data originated by the imaging modality, either digital or analog. The software will operate on standard "off the shelt" hardware and system configurations. Similar to predicate devices it can be used with image compression. The lossy/lossless image compression libraries are believed to be substantially equivalent to the libraries used in previously cleared devises.

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Koo 1947
Page 3 of 3

The software is intended to provide the means for medical professionals to I is soll ware generated by medical scanning devices on a personal computer or workstation.

#### 9. Conclusion

Similar to predicate devices, the T.I.M.S. system software does not contact the patient, or control any life sustaining devices. Images and information being reviewed, processed, relayed, and or transmitted are interpreted by a physician or trained medical personnel, providing ample opportunity for competent human intervention. In device failures which might result in partial or failed transmissions, the images and or data may be recovered by re-transmission after correcting the problems. Passwords are required for operation and to protect against unauthorized use of the system.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 22 2000

Don Beavers President Total Medical Information Management Systems, Inc. 407 Wekiva Spring Rd., Suite 347 Longwood, FL 32779-6907

Re:

K001947 T.I.M.S. Version 2.00 Dated: October 2, 2000 Received: October 3, 2000 Regulatory class: II 21 CFR 892.2050/Procode: 90LLZ

Dear Mr. Beavers:

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 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). 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 (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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 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 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 [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" (21CFR 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/cdrh/dsmaldsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D. Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure (s)

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## 510 (k) NUMBER (IF KNOWN): K001947

## DEVICE NAME: T.I.M.S. TELERADIOLOGY SYSTEM

### INDICATIONS FOR USE:

T.I.M.S. receives image data, acquired from various sources, including but not limited to 1.7.M.B. 1000.vos mage digital angiography and flourography, secondary capture devices (frame grabbers), scanners (digitizers) or other imaging sources. Images and data can be viewed, stored, transmitted (communicated), processed at the workstation, physician's vicwou, or other clinical application and distributed across networks or the world wide web for viewing.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Prescription Use<br>(Per 21 CFR 801.109) | <div> <span style="text-decoration: overline;">✓</span> </div> |
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OR

| | Over-The-Counter-Use<br>(Optional Format 1-2-96) |
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David A. Leggion

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices510(k) Number _