(38 days)
Not Found
No
The summary lists new functionalities which are image processing techniques and procedural capabilities, but none explicitly mention or imply the use of AI or ML. There is no mention of AI, DNN, or ML in the provided text, nor are there descriptions of training or test sets typically associated with AI/ML development.
No
The intended use states that the device produces images and/or spectra that may assist in diagnosis, not treatment. While it can facilitate interventional procedures, these procedures are performed with separate instruments and the device itself is for imaging and guidance, not therapy.
Yes
The document explicitly states that the devices "are magnetic resonance diagnostic devices".
No
The device description explicitly states it is a "magnetic resonance diagnostic device" and describes hardware components and functionalities related to MRI systems, not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the ACHIEVA, INTERA, and PANORAMA 1.0T Release 2.5-series are magnetic resonance diagnostic devices that produce images of the internal structure of the whole body. This is an in vivo (within the living body) imaging technique, not an in vitro (outside the living body) test.
- Intended Use: The intended use is to produce images that, when interpreted by a trained physician, may assist in diagnosis. This is consistent with the function of an imaging device, not an IVD.
The device is a medical imaging system used for diagnostic purposes, but it does not perform tests on samples taken from the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
90L--NH, 90L--NI, LNH
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 provides volumetric analysis of both left and right ventricle, and wall studies (motion, thickness and thickening). This includes Quick Area Length Analysis, automatic slice-to-slice segmentation, papillary muscle identification, user-defined spoke wheel for results display, and various numerical and graphical results.
- 4D-THRIVE is an enhancement of the THRIVE package which combines THRIVE with 4D TRACKS, useful for fast, dynamic 3D abdominal and breast studies.
- Prospective Motion Correction (PMC) automatically accounts for subject motion by continually monitoring subject motion during the acquisition and modifying geometry parameters in real time. It is a feature of PRESTO Imaging and BOLD Imaging.
- Propeller eliminates the effects of patient and physiological motion through the combination of radial imaging and oversampling of data to correct for motion. It provides motion corrected images when applied with existing imaging methods (e.g. TSE or TFE).
- CMR Prepulse Imaging package enables cardiac triggered multi-slice dynamic imaging in combination with prepulses for image contrast manipulation. Cardiac MR Prepulse analysis provides analysis of these images.
- CMR IR-TFE T1 Imaging can be used for cardiac-triggered T1 analysis of myocardial tissue with full heart coverage. Cardiac MR IR-TFE T1 Imaging Assessment enables quantitative evaluation of inversion recovery over time.
- Cardiac MR Reporting provides a user-defined template to report the total cardiac MR case, including results obtained with extended MR WorkSpace analysis packages.
- Rapid Focus is a post-processing software package for viewing and analyzing dynamic magnetic resonance imaging (MRI) studies. It performs automatic registration of serial patient image acquisitions (2D or 3D), segments and labels tissue types, provides quantitative measurements of morphological features, and other post-processing functions (image subtractions, multi-planar reformats, maximum intensity projections, image averaging, discarding areas containing motion artifacts). It also provides accurate and reproducible measurements of segmented tissue volumes (VOI) and can display parametric image maps as color overlays. It can display previous studies from other modalities and includes an option to add annotations based on BI-RADS.
- Rapid Locus is a post-processing software package to support the use of interventional coils and MR stereo-tactic localization devices for MR-guided interventional procedures. It calculates the location and depth of a targeted region of interest based on MR images and fiducial coordinates.
- Interventional procedures: The Achieva, Intera and Panorama 1.0T systems can be used for imaging during interventional procedures when performed with MR-compatible devices.
- Achieva 3.0T mobile: It is possible for Achieva 3.0T systems to be built into a trailer.
The Release 2.5-series are based on the same software platform and hardware technology as their predicate devices.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Whole body; specifically mentioned: head, body, extremities, heart, abdomen, breast.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician / Clinical user; Not specified beyond that.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K043147, K041602, K052078, K013344
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
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).(b)
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.
0
XJR148-7491
Appendix IVa
JAN - 4 2007
Page 1 of 4
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 | |
| 5684 PC Best, Netherlands, | ||
| Registration No.: | 3003768277 | |
| Contact person: | Lynn Harmer | |
| Manager, regulatory Submissions | ||
| Tel: (425) 487-7312 | ||
| Fax: (425) 487-8666 | ||
| 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 | |
| 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.
1
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.
2
• 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.
3
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Page 4 of 4
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
4
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
5
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
Page 2 -
6
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