(13 days)
iPACS CARDIO™is intended for the manipulation, display, and distribution of medical images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. The device assists Cardiology surgeons when doing preoperative planning and post-operative follow-up. Typical users of this system are trained professionals, for example orthopedic surgeons, physicians, and radiologists.
iPACS CARDIO™ is a software product that is added to the iPACS PRISMI™ device (K030751) and displays and manages various digital images and Cine objects in a Picture Archive and Communication System (PACS) environment and is intended to assist cardiology surgeons when doing preoperative planning and post-operative follow-up. iPACS CARDIO™ also includes various tools and can access additional tools within iPACS Prism.
The provided text is a 510(k) summary for the iPACS CARDIO™ device. It establishes substantial equivalence by comparing it to a predicate device (Sectra Angiography Package and Sectra Cardiology Package).
However, the document does not contain any information about acceptance criteria, efficacy studies, device performance metrics, sample sizes for test or training sets, expert qualifications, adjudication methods, or multi-reader multi-case studies.
The text primarily focuses on:
- Identification of the device: iPACS CARDIO™
- Submitter's Information: Real Time Image Inc.
- Trade Name, Common Name, and Classification: Picture Archiving Communications System, 892.2050 Device Classification: System, Image Processing.
- Predicate Device Information: Sectra Angiography Package and Sectra Cardiology Package (K034059).
- Device Description: Software added to iPACS PRISMI™ (K030751) for displaying and managing digital images and Cine objects in a PACS environment, intended to assist cardiology surgeons for pre-operative planning and post-operative follow-up. It includes various tools and can access additional tools within iPACS Prism.
- Indications for Use: Manipulation, display, and distribution of medical images, showing images from different modalities, and interfacing with storage and printing devices using DICOM or similar standards. Assists cardiology surgeons with pre-operative planning and post-operative follow-up. Typical users are trained professionals (e.g., orthopedic surgeons, physicians, radiologists).
- Technological Characteristics: Runs with iPACS Prism on Windows 2000 or XP, does not contact the patient, nor controls life-sustaining devices. A physician interprets images, allowing for human intervention.
- Conclusion: The submission contains adequate information to determine substantial equivalence to the predicate device. Manufacturing adheres to voluntary standards, and a hazard analysis classified potential hazards as "Minor."
- FDA Letter: A letter from the FDA acknowledging receipt and a determination of substantial equivalence.
Therefore, I cannot provide the requested information in the table or the detailed breakdown as the document does not contain data on acceptance criteria, device performance, study details, or ground truth establishment.
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Image /page/0/Picture/1 description: The image contains the words "RealTime" and "Image" stacked on top of each other. The word "RealTime" is in a larger font than the word "Image". There is also a small square image in the upper left corner of the image. The image is blurry and difficult to make out.
OCT 1 9 2004
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: September 3, 2004
Submitter's Information: 21 CFR 807.92(a)(1) Mr. Zvi Eintracht, CEO Real Time Image Inc. 1111 Bayhill Dr, San Bruno, CA94066, suite 290 Tel: 650.616.4671 Fax: 650.616.4680
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) iPACS CARDIO™ Trade Name: Picture Archiving Communications System Common Name: 892.2050 Device Classification: System, Image Processing Name:
Predicate Device: 21 CFR 807. 92(a)(3)
| Device Classification Name | system, image processing, radiological |
|---|---|
| 510(k) Number | K034059 |
| Regulation Number | 892.2050 Class II |
| Device Name | Sectra Angiography Package and SectraCardiology Package |
| Applicant | Sectra-imtec ab |
| Product Code | LLZ |
| Decision Date | 03/09/2004 |
| Decision | Substantially equivalent (SE) |
| Classification Advisory Committee Radiology | |
| Type | Traditional |
Device Description: 21 CFR 807 92(a)(4)
iPACS CARDIO™ is a software product that is added to the iPACS PRISMI™ device (K030751) and displays and manages various digital images and Cine objects in a Picture Archive and Communication System (PACS) environment and is intended to assist cardiology surgeons when doing preoperative planning and post-operative follow-up. iPACS CARDIO™ also includes various tools and can access additional tools within iPACS Prism.
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Image /page/1/Picture/0 description: The image contains the words "RealTime Image" in a sans-serif font. The word "RealTime" is in a larger font size than the word "Image". There is a square graphic in the upper left corner of the image. The graphic is a square with a smaller square to the left of it.
Indications for Use: 21 CFR 807 92(a)(5)
iPACS CARDIO™is intended for the manipulation, display, and distribution of medical images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.
The device assists Cardiology surgeons when doing preoperative planning and post-operative follow-up.
Typical users of this system are trained professionals, for example orthopedic surgeons, physicians, and radiologists.
Technological Characteristics: 21 CFR 807 92(a)(6)
iPACS CARDIO™ runs together with iPACS Prism on Windows 2000 or Windows XP operating systems, (depending upon system configuration). 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 iPACS CARDIO™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
iPACS CARDIO™ 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2004
Real Time Image, Inc. 1% Mr. N. E. Devine Responsible Third Party Official Entela, Inc. 3033 Madison Ave., SE GRAND RAPIDS MI 49548
Re: K042781
Trade/Device Name: iPACS CARDIO™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems
Regulatory Class: II Product Code: 90 LLZ Dated: October 6, 2004 Received: October 6, 2004
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your bother ovece is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the cherosate) to regally mant date of the Medical Device Amendments, or to devices that have been May 20, 1770, the chavannith 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 do not require approval or a provisions of the Act. The general controls provisions of the Act do floor to any go 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 (Premarket a your al), it may be subject to such additional controls. Existing major regulations affecting your Apployally, it the 90 babyer 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 I rease of actives 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 r occares statues ats including, but not limited to registration and listing (21 CFR Part 807); labeling (2) CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 Cric Fart 801); 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) I ms letter will anow you was wegin many of substantial equivalence of your device to a legally premaired predicated on " rivesults 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 If you desire specifice 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 001:57).
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/dsmadsmamain.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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Image /page/4/Picture/0 description: The image shows a logo with a black square in the upper left corner. A smaller black square is located to the left of the text. The text below the squares reads "RealTime Image" with the words stacked on top of each other.
Indications for Use
510(k) Number (if known):
Device Name: iPACS CARDIO™
Indications For Use:
iPACS CARDIO™is intended for the manipulation, displaying, and distribution of medical images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.
The device assists Cardiology surgeons when doing preoperative planning and post-operative follow-up.
Typical users of this system are trained professionals, for example orthopedic surgeons, physicians, and radiologists.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Nancy C. Swagdon
(Division Sign-Off) ()
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042781
§ 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).