(127 days)
The DATACOM™ DC-PACS is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards.
The DATACOM™ PACS system is based on DICOM standard application. The main function of DC-PACS is about medical image management within a PACS environment. It's including Image archival, retrieval and distribution of medical images.
This document is a 510(k) summary for the DATACOM™ DC-PACS system. It does not provide detailed information about acceptance criteria or specific study results to prove a device meets those criteria. The provided text is primarily focused on establishing substantial equivalence to a predicate device and outlining the intended use and technological characteristics of the DC-PACS.
Here's an analysis of the information not present in the provided text, based on your request:
Information Not Present in the Provided Text:
- A table of acceptance criteria and the reported device performance: This information is completely absent. The document focuses on regulatory approval based on equivalence rather than performance metrics against specific criteria.
- Sample sizes used for the test set and the data provenance: There is no mention of a test set, its sample size, or the provenance of any data used for testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As no test set is described, there's no information on experts or ground truth establishment.
- Adjudication method for the test set: No test set is described, so no adjudication method is mentioned.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: An MRMC study is not mentioned. The device is a PACS system for image management and display, not an AI-assisted diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This is not applicable as the device is a PACS system designed for human interpretation of images.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is described.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
What the Documents DO Indicate about the Device and its Evaluation:
- Intended Use: The DATACOM™ DC-PACS is intended for the manipulation, management, and display of medical images across different modalities. It distributes images to workstations, storage, and printing devices using DICOM or similar standards.
- Users: Trained medical professionals, including physicians, nurses, technicians, and computer system professionals.
- Technological Characteristics: It's a software server application, does not contact patients, and does not control life-sustaining devices. A physician interprets the displayed images and information.
- Evaluation Method: The primary evaluation for regulatory clearance was a claim of "Substantial Equivalence (SE)" to a predicate device, Smart PACS (K022710). The submission included results of software validation, risk analysis, and hazard classification (minor).
- Approval Basis: FDA found the device substantially equivalent to legally marketed predicate devices, allowing it to proceed to market under general controls provisions of the Act.
- Device Type: This is a Picture Archiving and Communications System (PACS), classified as a Class II device under regulation 21 CFR 892.2050.
In summary, the provided text does not contain the specific performance acceptance criteria and study data you requested because the regulatory submission was based on substantial equivalence to an existing PACS system rather than a de novo performance study against defined metrics.
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งค์ที่ย์ที่ตัวตัวตาม เกม FDA CDRH DMC ADMINISTRATIVE INFORMATION OCT 28 2008 2.1 510(k) Summary of Safety and Effectiveness (Per 21 CFR 807.92) Received General Information Establishment 트 Manufacturer: DATACOM Technology Corp. Address: 6F, No.69-3, Sec.2, Chung Cheng E. Rd., Tam Shui, Taipei, 25170, Taiwan, ROC 지 . Owner Number: 10026153 Contact Person: Dr. Jen, Ke-Min E-mail: ceirs.jen@msa.hint.net (official correspondent) 886-3-5208829 (Tel); 886-3-5209783 (Fax) No.58, Fu Chiun Street, Hsin Chu City, 30067, Taiwan, ROC Address: . Date Prepared: October 24, 2008 Device Information DATACOM™ DC-PACS Proprietary Name: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL tion Name: Class II ● Regulation Number: 892.2050 Product Code: . LLZ Safety and Effectiveness Information Predicate Device:
Claim of Substantial Equivalence (SE) is made to Taiwan Electronics Data Processing Corporation Smart PACS (K022710)
- Device Description:
The DATACOM™ PACS system is based on DICOM standard application. The main function of DC-PACS is about medical image management within a PACS environment. It's including Image archival, retrieval and distribution of medical images.
MAR. 4 2009
| Proprietary Name: | DATA |
|---|---|
| Classification Name: | SYSTEM |
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E-MAIL:Kennethlogstacom con
0 Intended Use:
The DATACOM™ DC-PACS is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards. Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.
Technological Characteristics
The DATACOM™ DC-PACS is a software server application and does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.
Substantial Equivalence (SE)
A claim of substantial equivalence is made to Smart PACS (K022710). Both of them have the same working principle and technologies. The differences are due to the feature design aspects, not relating to the safety or effectiveness aspects. Besides, the submission contains the results of software validation that the risks analysis and the potential hazards have been classified Minor. Thus they are substantially equivalent.
Keiziten
Dr. Jen, Ke-Min official correspondent for DATACOM Technology Corp.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
MAR 4 2009
DATACOM Technology Corp. % Dr. Jen, Ke-Min Official Correspondent ROC Chinese-European Industrial Research Society No. 58, Fu Chiun Street Hsin Chu City , 30067, ROC TAIWAN
Re: K083182
Trade/Device Name: DATACOM™ DC-PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 15, 2009 Received: January 21, 2009
Dear Dr. Jen, Ke-Min:
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 such 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.
Image /page/2/Picture/13 description: The image shows a partial view of a seal or emblem, featuring a stylized graphic element resembling waves or abstract shapes. To the left of this graphic, a portion of text is visible, reading "DEPARTMENT OF HEALTH &". The text is arranged vertically, following the curve of the emblem, suggesting it is part of a circular design. The overall impression is that of an official or organizational symbol related to health.
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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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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 this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.
Sincerely yours,
Janine M. Morris
anine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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F NO.69-3,SEC.2,CHUNG CHE TAM SHUI, TAIPEI, TAIWAN TEL:886-2-28094611 E-MAIL:Kenneth@datacom.com.tw
2.2 FDA Indication for Use Form :
Indications for Use
510(k) Number: K083182
Device Name: DATACOM Technology Corp.
DATACOM™ DC-PACS
Indications for Use :
- The DATACOM™ DC-PACS is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards.
Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(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,
and Radiological Devices
510(k) Number. K08318
Pe
§ 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).