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.

Device Description

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.

AI/ML Overview

The provided text describes a 510(k) summary for the T.I.M.S. Teleradiology System. This document focuses on establishing substantial equivalence to previously cleared devices rather than presenting specific performance studies or acceptance criteria with detailed results.

Therefore, many of the requested categories for device performance and study details cannot be filled from the given text. The document asserts that the device is substantially equivalent to predicate devices with the same intended use and does not offer any new functions requiring new performance data.

Here's a breakdown based on the provided information:

Acceptance Criteria and Reported Device Performance

Given that the submission is for substantial equivalence and states, "This device does not offer any new functions that have not received previous clearance from the Agency," it implies that the implicit acceptance criteria are met by demonstrating equivalence to the predicate devices, which are already deemed safe and effective. No specific quantitative performance metrics or acceptance criteria are listed in the document for the T.I.M.S. system itself.

Acceptance Criteria (Implicit from Substantial Equivalence)	Reported Device Performance (Implicit from Substantial Equivalence)
Adheres to industry-standard DICOM 3 protocol	Not explicitly stated but implied through adherence to DICOM 3
Operates on standard "off the shelf" hardware and system configurations	Operates on standard "off the shelf" hardware using a Windows 95 or higher platform
Utilizes lossy/lossless image compression libraries substantially equivalent to previously cleared devices	Uses lossy/lossless image compression libraries believed to be substantially equivalent to those in previously cleared devices
Provides means for medical professionals to view images generated by medical scanning devices on a personal computer or workstation	Provides means for medical professionals to view images on a personal computer or workstation
Safety features such as password protection for operation and against unauthorized use	Passwords are required for operation and to protect against unauthorized use
System failures (e.g., partial/failed transmissions) allow for image/data recovery via re-transmission after correction	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

Details of the Study Proving Device Meets Acceptance Criteria

The document does not describe a specific performance study (clinical or analytical) to demonstrate the T.I.M.S. system meets acceptance criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices. This means that if the predicate devices met certain safety and effectiveness standards, and the T.I.M.S. device has the same intended use and technological characteristics (or differences that do not raise new questions of safety and effectiveness), then it is considered to meet those same standards.

Therefore, the following information cannot be extracted from the provided text:

Sample size used for the test set and the data provenance: Not applicable, as no dedicated performance study is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a general teleradiology system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing AI assistance would not be relevant and is not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as it's a general teleradiology system with human intervention inherent in its use.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study is detailed.
The sample size for the training set: Not applicable, as no algorithm training is mentioned for a diagnostic function.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

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: 407-788-6353 Fax: 407-788-2476

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

Predicate Device

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

{1}------------------------------------------------

1. Device Description
  K 001947
  Page 2 of 3

1. 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.
1. 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.
1. 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.

{2}------------------------------------------------

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.

{3}------------------------------------------------

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 (301) 594-4639. 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" (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 (800) 638-2041 or (301) 443-6597 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)

{4}------------------------------------------------

Page 1 of 1

510 (k) NUMBER (IF KNOWN): K001947

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

INDICATIONS FOR USE:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------	--

Prescription Use(Per 21 CFR 801.109)	✓
------------------------------------------	----------------------------------------------------------------

	Over-The-Counter-Use(Optional Format 1-2-96)
--	--------------------------------------------------

David A. Leggion

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

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).