(54 days)
Infinitt G3 PACS is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
INFINITT G3 PACS is a web-based 3D-enabled DICOM viewing station running on Windows 2000/XP. It is adapted for, storing, processing routing and report generating. INFINITT G3 PACS fully supports the DICOM standard and such functions as advanced DICOM viewing, Hanging Protocol, 3D segmentation, various MPRs, fast 3D Volume Rendering, MIP, and Virtual Endoscopy.
INFINITT G3 PACS allows users to take full advantage of the radiographic images from various modalities in order to obtain invaluable mission critical diagnostic data and images. With INFINITT G3 PACS, users can have the same diagnostic environment of their own anywhere anytime because INFINITT G3 PACS is deployed through network and supports hanging protocol radically.
This 510(k) submission for the Infinitt G3 PACS does not contain the information requested regarding acceptance criteria and a study demonstrating the device meets those criteria.
The provided document is a 510(k) Summary of Safety and Effectiveness, which primarily focuses on establishing substantial equivalence to a predicate device. It describes the device's functions and indications for use but does not include:
- A table of acceptance criteria and reported device performance.
- Details of a study conducted to demonstrate performance. This would typically involve specific metrics (sensitivity, specificity, accuracy, etc.) and the results achieved.
- Sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance data, type of ground truth, training set size, or how training ground truth was established. These are all elements of a robust performance study that are absent in this summary.
Key observations explaining the absence of this information:
- Nature of the Device: The Infinitt G3 PACS is described as a "Picture Archiving Communications System" (PACS). Its primary function is to store, display, communicate, and process medical images, not to perform automated diagnostic interpretation or provide quantitative measurements that would necessitate extensive clinical performance metrics like those for an AI diagnostic algorithm.
- Predicate Device Equivalence: The submission focuses on demonstrating "substantial equivalence" to a predicate PACS device (INTEGRADWEB MPR/MIP, K042313). For PACS systems, substantial equivalence often relies on demonstrating similar technological characteristics, functionality, and safety profiles, rather than extensive clinical performance studies comparing diagnostic accuracy.
- Human-in-the-Loop: The document explicitly states: "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed." This highlights that the device is an aid to human interpretation, not a standalone diagnostic tool.
- Specific Limitations on Mammography: The document includes specific limitations for mammography: "Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA." These are usage constraints for a specific diagnostic application, not performance metrics.
In summary, the Infinitt G3 PACS, as described in this 510(k) summary, is a medical imaging display and management system. Its regulatory pathway for approval did not require the kind of detailed performance study and acceptance criteria typically associated with AI-powered diagnostic or screening devices.
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K 052545
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
August 30, 2005
Submitter's Information: 21 CFR 807.92(a)(1) Ms. Bo Hyoung Kim INFINITT CO., LTD 137-072 BIT VILL 4~5F, 1327-33, Seocho-Dong, Seocho-Gu, Seoul, Korea Fax: 82-2-2194-1688
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | Infinitt G3 PACS™ |
|---|---|
| Common Name: | Picture Archiving Communications System |
| Device Classification: | 892.2050 System, Image Processing |
| Product Code: | LLZ |
Predicate Device: 21 CFR 807. 92(a)(3)
| 510(k) Number | K042313 |
|---|---|
| Regulation Number | 892.2050 |
| Device Name | INTEGRADWEB MPR/MIP |
| Applicant | DYNAMIC IMAGING INC. |
| Classification Product Code | LLZ |
Device Classification Name SYSTEM, IMAGE PFROCESSING,
Device Classification Name RADIOLOGICAL
Device Description: 21 CFR 807 92(a)(4)
INFINITT G3 PACS is a web-based 3D-enabled DICOM viewing station running on Windows 2000/XP. It is adapted for, storing, processing routing and report generating. INFINITT G3 PACS fully supports the DICOM standard and such functions as advanced DICOM viewing, Hanging Protocol, 3D segmentation, various MPRs, fast 3D Volume Rendering, MIP, and Virtual Endoscopy.
INFINITT G3 PACS allows users to take full advantage of the radiographic images from various modalities in order to obtain invaluable mission critical diagnostic data and images. With INFINITT G3 PACS, users can have the same diagnostic environment of their own anywhere anytime because INFINITT G3 PACS is deployed through network and supports hanging protocol radically.
Indications for Use: 21 CFR 807 92(a)(5)
Infinitt G3 PACS is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography.
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Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
Technological Characteristics: 21 CFR 807 92(a)(6)
G3 PACS™ is a software product that handles digital medical images.
The device 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.
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification for G3 PACS™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
G3 PACS™ has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "Minor".
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
NOV - 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Infinitt Co., LTD. % Carl Alletto Consultant OTech Inc. 1600 Manchester Way CORINTH TX 76210
Re.. K052545
Trade/Device Name: Infinitt G3 PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 15, 2005 Received: September 15, 2005
Dear Mr. Alletto:
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. Iabeling. and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or 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 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 this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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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(Indications for Use Form)
510(k) Number:
Device Name: Infinitt G3 PACS ™
Indications for Use:
Infinitt G3 PACS is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations. Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K052545
§ 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).