ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5
Device Facts
| Record ID | K063559 |
|---|---|
| Device Name | ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5 |
| Applicant | Philips Medical Systems |
| Product Code | LNH · Radiology |
| Decision Date | Jan 4, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1000 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Indications for Use
The ACHIEVA , INTERA and PANORAMA 1.0T Release 2.5-series are magnetic resonance diagnostic devices that produce cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis. In addition the Achieva, Intera and Panorama 1.0T devices provide capabilities to perform interventional procedures in the head, body and extremities, which may be facilitated by MR techniques, such as real time imaging. Such procedures must be performed with MR compatible instrumentation as selected and evaluated by the clinical user.
Device Story
System uses magnetic resonance imaging to acquire cross-sectional images and spectra of human body. Release 2.5-series adds: Cardiac MR Functional Analysis (volumetric/wall motion analysis); 4D-THRIVE (dynamic 3D abdominal/breast imaging); Prospective Motion Correction (real-time geometry adjustment); PROPELLER (motion-corrected radial imaging); Prepulse/IR-TFE T1 Imaging (cardiac contrast/tissue analysis); Rapid Focus (post-processing for registration, segmentation, and volumetric measurement); Rapid Locus (MR-guided interventional localization). Operated by trained clinicians/physicians in clinical settings. Output includes images, parametric maps, and quantitative reports used to assist in diagnosis and interventional guidance. Benefits include improved motion artifact reduction, automated cardiac analysis, and precise localization for interventional procedures.
Clinical Evidence
No clinical data provided. Substantial equivalence based on technological characteristics and performance comparisons to predicate devices.
Technological Characteristics
Magnetic resonance diagnostic device; 1.0T field strength; software-based image processing and analysis; connectivity via standard MR workstation interfaces; supports MR-compatible interventional instrumentation. Complies with NEMA standards, FDA MR guidance, and IEC 60601 safety standards.
Indications for Use
Indicated for whole-body diagnostic MR imaging and spectroscopy, and MR-guided interventional procedures in the head, body, and extremities for patients requiring clinical diagnosis or interventional guidance.
Regulatory Classification
Identification
A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).
Special Controls
*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
Submission Summary (Full Text)
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K063559
Appendix IVa
JAN - 4 2007
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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The following information is being submitted in accordance with the requirements of 21 CFR 807.92.
#### General information
| Company Name: | Philips Medical Systems Nederland BV | |
|-------------------|-------------------------------------------------------------------------------------------------------------------------|--|
| Address: | Veenpluis 4-6<br>5684 PC Best, Netherlands, | |
| Registration No.: | 3003768277 | |
| Contact person: | Lynn Harmer<br>Manager, regulatory Submissions<br>Tel: (425) 487-7312<br>Fax: (425) 487-8666<br>Lynn.Harmer@Philips.com | |
| Date Prepared: | |
|------------------------|----------------------------------------------------------------------------------------------------|
| Device (Trade) Name: | ACHIEVA , INTERA and PANORAMA 1.0T. |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Regulatory Number: | 892.1000 |
| Classification: | Class II |
| Product code: | 90L--NH |
| | 90L--NI |
| Performance standards: | NEMA voluntary standards, FDA MR Diagnostic |
| | Device Guidance, UL and IEC 60601 appropriate safety<br>standards and/or draft standards are used. |
#### Predicate Device(s):
The ACHIEVA , INTERA and PANORAMA 1.0T Release 2.5-series are the successor of the predicate devices ACHIEVA, INTERA and PANORAMA 1.0T release 2-series. (FDA references K043147, K041602, K052078 and K013344).
#### Indications for use:
The ACHIEVA , INTERA and PANORAMA 1.0T Release 2.5-series are magnetic resonance diagnostic devices that produce cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
In addition the Achieva, Intera and Panorama 1.0T devices provide capabilities to perform interventional procedures in the head, body and extremities, which may be facilitated by MR techniques, such as real time imaging. Such procedures must be performed with MR compatible instrumentation as selected and evaluated by the clinical user.
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# Device description:
The ACHIEVA , INTERA and PANORAMA 1.0T Release 2.5-series are the successor of the predicate devices ACHIEVA, INTERA and PANORAMA 1.0T release 2-series. The Release 2.5-series introduces the new functionalities:
# · Cardiac MR Functional Analysis
Cardiac MR Functional Analysis provides volumetric analysis of both left and right ventricle, and wall studies (motion, thickness and thickening).
- · Quick Area Length Analysis
- · Automatic slice-to-slice segmentation provides accurate and ultra-fast propagation of an initial user-drawn contour over all heart phases.
- · Papillary muscles may be identified and used as a corrective term for blood volume calculations.
- · User-defined spoke wheel allows results to be shown in terms of anatomically relevant areas.
- · Various numerical and graphical results are provided for optimal data interpretation.
# · 4D-THRIVE
4D-THRIVE is an enhancement of the THRIVE package which combines THRIVE with 4D TRACKS. This is particularly useful for fast, dynamic 3D abdominal and breast studies. The aforementioned packages THRIVE and 4D TRACKS are FDA cleared via former submissions.
#### · Prospective Motion Correction
Prospective Motion Correction (PMC) automatically accounts for subject motion by continually monitoring subject motion during the acquisition and modify the geometry parameters accordingly in real time. It will avoid registration in postprocessing while improving overall registration accuracy.
PMC is a feature of PRESTO Imaging and BOLD Imaging.
- Propeller
Propeller eliminates the effects of patient and physiological motion through the combination of radial imaging and over sampling of data in order to be able to correct for patient and physiological motion. Applying PROPELLER with existing imaging methods (e.g. TSE or TFE) provides motion corrected images in general imaging and diffusion imaging.
#### · CMR Prepulse Imaging.
The Prepulse Imaging package enables cardiac triggered multi-slice dynamic imaging in combination with prepulses for image contrast manipulation. Prepulse Imaging may provide a powerful tool complementary to cardiac function studies. Cardiac MR Prepulse analysis provides analysis of cardiac triggered multi-slice dynamic images in combination with prepulses for image contrast manipulation.
# · CMR IR-TFE T1 Imaging
IR-TFE T1 Imaging can be used for cardiac-triggered T1 analysis of the myocardial tissue with full heart coverage.
Cardiac MR IR-TFE T1 Imaging Assessment enables the quantitative evaluation of inversion recovery over time.
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### • Cardiac MR Reporting
Cardiac MR Reporting provides a user-defined template to report the total cardiac MR case. All results obtained with the extended MR WorkSpace analysis packages are included the report.
- · Rapid Focus
Rapid Focus is a post-processing software package intended for use in viewing and analyzing dynamic magnetic resonance imaging (MRI) studies. Rapid Focus automatically registers serial patient image acquisitions (in 2D or 3D) to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps), and provides quantitative measurements of morphological features of the segmented tissues. Rapid Focus performs other user-defined post-processing functions (image subtractions, multi-planar reformats, maximum intensity projections, image averaging, discarding areas containing motion artifacts).
Rapid Focus also can be used to provide accurate and reproducible measurements of the segmented tissue volumes (volumes of interest - VOI). These measurements include longest diameter, longest in-plane diameters, volume measurement, ratio of breast volume to VOI, distance of VOI to anatomical landmarks, and 3D renderings of the VOI.
The resulting information can be displayed in a variety of formats, including the parametric image maps as color overlays onto the source data. Rapid Focus can be used to display previous studies, including other modalities, such as ultrasound and X-ray images.
Rapid Focus also includes the option to add annotations based on the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) Breast Imaging Atlas.
#### · Rapid Locus
Rapid Locus is a post-processing software package intended for use to support the use of interventional coils and MR stereo-tactic localization devices to perform MR-guided interventional procedures. Using information from MR images regarding the coordinates of a user-specified region of interest, and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion.
#### · Interventional procedures
The Achieva, Intera and Panorama 1.0T systems can be used for imaging during interventional procedures when performed with MR-compatible devices such as in-room display and MR-safe biopsy needles.
- Achieva 3.0T mobile
As for Intera 1.5T and Achieva 1.5T systems it is also possible for Achieva 3.0T systems to built the system into a trailer.
The ACHIEVA, INTERA and PANORAMA 1.0T Release 2.5-series are the successors of the predicate devices ACHIEVA , INTERA and PANORAMA 1.0T Release 2-series. The design of the Release 2.5-series are based on the same software platform and hardware technology as their predicate devices.
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# General Safety and Effectiveness
The ACHIEVA, INTERA and PANORAMA 1.0T Release 2.5-series do not induce any other risks than already indicated for their predicate devices with the same safety and effectiveness.
# Substantial Equivalence
It is the opinion of Philips Medical Systems that the Philips ACHIEVA, INTERA and PANORAMA 1.0T Release 2.5-series are substantially equivalent to their predicate devices Release 2-series.
End
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Philips Medical Systems % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
JAN - 4 2007
Re: K063559
Trade/Device Name: ACHIEVA, INTERA & PANORAMA 1.0T Release 2.5-series Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: December 18, 2006 Received: December 20, 2006
Dear Mr. Job:
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 (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.
Image /page/4/Picture/9 description: The image is a circular logo with the text "1906-2006" at the top. Below that is the text "FDA" in large, bold letters. Underneath "FDA" is the word "Centennial" in a smaller font. At the very bottom of the logo are three stars arranged horizontally. The logo appears to be a commemorative emblem for the centennial anniversary of the FDA.
Protecting and Promoting Public Health
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso or as nove a determination that your device complies with other requirements of the Act thany 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 rooduct 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 of substantial equivalence of your device to a legally promoted 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 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
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 from the Division of Small Manufacturers, 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/cdrl/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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Appendix IVb
Page 1 of 1
KOR3559
510(k) Number (if known):
Device Name :
ACHIEVA, INTERA & PANORAMA 1.0T Release 2.5-series
Indication For Use :
The ACHIEVA , INTERA and PANORAMA 1.0T Release 2.5-series are magnetic resonance diagnostic devices that produce cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
In addition the Achieva, Intera and Panorama 1.0T devices provide capabilities to perform interventional procedures in the head, body and extremities, which may be facilitated by MR techniques, such as real time imaging. Such procedures must be performed with MR compatible instrumentation as selected and evaluated by the clinical user.
Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use _____________
# ( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Gabriel R. Legmann
(Division Sign-Off) Division of Reproductive. Abdom and Radiological Devices 510(k) Number
