(72 days)
The Telemis-Medical solution is a software package intended for the acquisition, management, distribution and display of medical images within the healthcare system.
The Telemis-Medical Solution is a Medical Image Management software package designed to perform required functions for the import, storage, archive, distribution, review, analysis of digital medical images in DICOM 3.0 and other formats. The Telemis Medical Solution consists of the TM-AutoAcquisition. TM-Worklist. TM-Server. TM-Reception, TM-ReceptionHE, TM-Reception Lite, TM-Home, TM-Link and TM-Publisher.
TM-AutoAcquisition acquires image studies from medical devices, converts them into secure multimedia documents and sends them to the TM-Server. The TM-Worklist is used by the TM-AutoAcquisition to validate patient information. The TM-Server manages documents and security permissions. The TM-Reception allows authenticated users to retrieve, manage, review and process their image documents. The TM-ReceptionHE is an enhanced TM-Reception that provides users with extra image processing features. The TM-Reception Lite allows users to manage and review local image documents. The TM-Home delivers TM-Reception's features for personal use. The TM-Link provides transparent integration between Telemis-Medical and Electronic Patient Record system. The TM-Publisher makes image study summary available on CD-ROM, paper or e-mail.
The provided text is a 510(k) summary for the Telemis-Medical PACS system and the FDA's acceptance letter. It describes the device's function, intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding specific acceptance criteria, study methodologies, or performance data related to the device's accuracy, efficacy, or safety in a quantitative manner.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method.
- MRMC comparative effectiveness study results or effect size.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on establishing "substantial equivalence" based on technological characteristics and intended use compared to a predicate device (Stentor, Inc. iSite Radiology). It states that "Any differences between the Telemis-Medical solution and the equivalent devices have no significant influence on safety or effectiveness," and concludes that the "Level of Concern" is "minor" because "no software component...whose failure or latent design flaw would be expected to result in death or injury to a patient." This is a qualitative assessment of risk rather than a quantitative performance study.
In summary, the provided text does not contain the detailed study information you requested.
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Ko3 2/5 7
SEP 2 4 2003
510(k) SUMMARY
Company Identification:
Telemis S.A. Avenue du Grand Cortil, 34 B-1348 Louvain-la-Neuve Belgium Phone: +32-10-48 00 11 Fax: +32-10-48 00 20
Official Correspondent:
Eric Thibau. European Certification Partners, Inc. 7560 Lindbergh Drive Gaithersburg, MD 20879 FAX: (240) 631-8228 (240) 631-8558 Tel:
Date Summary Prepared:
September 1, 2002
Name of the Device:
| Trade Name: | Telemis-Medical |
|---|---|
| Common name: | PACS |
| Classification name: | Picture Archiving and Communication System |
Predicate Device:
| Name of the device: | iSite Radiology |
|---|---|
| 510(K) Number: | K013630 |
| Company: | Stentor, Inc.385 Oyster Point Blvd., Suite 8BEstablishment Registration #2954704Tel: (650) 866-4100Fax: (650) 866-4197 |
Device Description:
The Telemis-Medical Solution is a Medical Image Management software package designed to perform required functions for the import, storage, archive, distribution, review, analysis of digital medical images in DICOM 3.0 and other formats. The Telemis Medical Solution consists of the TM-AutoAcquisition. TM-Worklist. TM-Server. TM-Reception, TM-ReceptionHE, TM-Reception Lite, TM-Home, TM-Link and TM-Publisher.
TM-AutoAcquisition acquires image studies from medical devices, converts them into secure multimedia documents and sends them to the TM-Server. The TM-Worklist is used by the TM-AutoAcquisition to validate patient information. The TM-Server manages documents and security permissions. The TM-Reception allows
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authenticated users to retrieve, manage, review and process their image documents. The TM-ReceptionHE is an enhanced TM-Reception that provides users with extra image processing features. The TM-Reception Lite allows users to manage and review local image documents. The TM-Home delivers TM-Reception's features for personal use. The TM-Link provides transparent integration between Telemis-Medical and Electronic Patient Record system. The TM-Publisher makes image study summary available on CD-ROM, paper or e-mail.
Intended Use:
The Telemis-Medical solution is a software package intended for the acquisition, management, distribution and display of medical images within the healthcare system. It can be marketed as software only, as well as packaged with standard PC hardware. It was developed with the Java® technology that allows the software to run on every operating system implementing a Java Virtual Machine Environment (f.i. Windows, MacOS, Unix). It communications using the standard TCP/IP network protocol.
Technological comparison to Predicate Device:
The Telemis-Medical solution is substantially equivalent to the Stentor, Inc. iSite Radiology (K013630) system, in that it receives DICOM images, converts them to lossless or lossy (wavelet or jpeq) format, store, transmit and displays them. The intended use and technological characteristics of the Telemis-Medical solution are virtually identical to the Stentor iSite system. Any differences between the Telemis-Medical solution and the equivalent devices have no significant influence on safety or effectiveness.
Conclusion:
It is our conclusion that there is no software component in the Telemis-Medical solution or hardware component that would be used in conjunction with the Telemis-Medical solution that we know of, whose failure or latent design flaw would be expected to result in death or injury to a patient. Thus, the "Level of Concern" of the Telemis Medical Solution product is "minor".
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Image /page/2/Picture/1 description: The image shows a black and white logo. The logo features a stylized bird with three curved lines forming its body and wings. The bird is oriented to the right. Encircling the bird is text that reads 'National Institute for Healthcare Research'.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas J. Bouchard Official Correspondent Telemis-Medical S.A. 7560 Lindberg Drive
GAITHERSBURG MD 20879
Re: K032157
SEP 2 4 2003
Trade/Device Name: Telemis-Medical Solution Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: May 20, 2003 Received: July 14, 2003
Dear Mr. Bouchard:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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 (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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of Page
510(k) Number (if known):
Device Name: Telemis-Medical
Indications For Use:
The Telemis-Medical solution is a software package intended for the acquisition, management, distribution and display of medical images within the healthcare system.
It can be marketed as software only, as well as packaged with standard PC hardware. It was developed with the Java® technology that allows the software to run on every operating system implementing a Java Virtual Machine Environment (f.i. Windows, MacOS, Unix). It communications using the standard TCP/IP network protocol.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
(Optional Format 3-10-98)
David M. Sezmm
(Division Sign-Off) Division of Reproductive. and Radiological Devic 510(k) Number
§ 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).