(63 days)
The ACHIEVA R4 1.5T and ACHIEVA R4 3.0T 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 R4 1.5T and ACHIEVA R4 3.0T 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.
The next generation Philips MR platform consists of either a 1.5T or 3.0T field generating superconducting unit. The radiofrequency receive chain consists of multiple coil types delivering a simplified and unique data acquisition system. The system is configured with a time-varying magnetic field system (gradients). Additional RF transmission is provided through an integrated RF body coil. The base software for the above mentioned system will be called Release 4. The magnetic resonance diagnostic device is used to produce cross-sectional images, spectroscopic imaging and/or spectra in any orientation of the internal structures of the whole body. These images when interpreted by a trained physician, yield information that may assist in a diagnosis. In addition, the device provides the 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.
This submission is a 510(k) Pre-Market Notification for a Magnetic Resonance Diagnostic Device (MRDD). Unlike AI/ML device submissions, which often involve specific performance metrics like sensitivity and specificity, this type of submission focuses on demonstrating substantial equivalence to a predicate device. Therefore, the typical "acceptance criteria" and "device performance" in terms of clinical accuracy are not directly applicable in the same way. The "study" here refers to the comparisons made to establish substantial equivalence.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for an MRDD, the "acceptance criteria" and "reported device performance" are primarily focused on demonstrating that the new device (ACHIEVA R4 1.5T and ACHIEVA R4 3.0T) is equivalent to its predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.
| Acceptance Criteria (Implicit for MRDD 510(k)) | Reported Device Performance / Declaration |
|---|---|
| Intended Use Equivalence: The device must have the same intended use as the predicate device(s). | The ACHIEVA R4 1.5T and ACHIEVA R4 3.0T 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 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. This mirrors the stated intended use of the primary predicate device (K063559 and K043147). |
| Technological Characteristics Equivalence: The device must have similar technological characteristics or any differences must not raise new questions of safety or effectiveness. | The next generation Philips MR platform consists of either a 1.5T or 3.0T field generating superconducting unit. The radiofrequency receive chain consists of multiple coil types delivering a simplified and unique data acquisition system. The system is configured with a time-varying magnetic field system (gradients). Additional RF transmission is provided through an integrated RF body coil. The base software for the above mentioned system will be called Release 4. These descriptions indicate a successor model with enhancements over the predicate devices (ACHIEVA 1.5T and ACHIEVA 3.0T MR systems Release 2.5-series). The submission implicitly argues these enhancements do not alter the fundamental technological characteristics to a degree that compromises safety or effectiveness. |
| Safety and Effectiveness Equivalence: The device must be as safe and effective as the legally marketed predicate device(s). | "The ACHIEVA R4 1.5T and ACHIEVA R4 3.0T do not induce any other risks than already indicated for their predicate devices with the same safety and effectiveness." and "It is the opinion of Philips Medical Systems that the Philips ACHIEVA R4 1.5T and ACHIEVA R4 3.0T are substantially equivalent to their predicate device ACHIEVA 1.5T and ACHIEVA 3.0T MR systems Release 2.5-series." The performance standards referenced (NEMA voluntary standards, FDA MR Diagnostic Device Guidance, UL and IEC 60601) support the claim of safety and effectiveness. |
| Predicate Device Identification: Clear and appropriate identification of predicate devices. | The predicate devices are clearly identified as ACHIEVA 1.5T and ACHIEVA 3.0T MR systems Release 2.5-series with FDA references K063559, K043147, K041602, K052078, and K013344. |
| Use with imaging agents: Consistent or equivalent use of imaging agents. | The subject device indicates "gadolinium-based contrast media" for imaging agent use, which is consistent with the predicate devices that state "any gadolinium-based contrast agent." |
The subsequent points (2-9) are typical for AI/ML device studies involving clinical validation. For this specific 510(k) submission for an MRDD, these points are largely not applicable in the context of a dedicated clinical performance study as one would see for an AI algorithm. The determination of substantial equivalence for an MR Diagnostic Device typically relies on a comparison of technical specifications, intended use, and a demonstration that any technological differences do not raise new questions of safety or effectiveness. There is no mention of a separate "test set" or "ground truth" derived by experts for clinical performance evaluation of the device's diagnostic output as if it were an AI algorithm.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission does not describe a clinical performance study with a test set in the conventional sense used for AI/ML algorithms. Equivalence is based on comparison to predicate devices and adherence to performance standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No ground truth establishment by experts for a test set is described. The "ground truth" here is the established safety and effectiveness of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or corresponding adjudication method is discussed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI-assisted device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a Magnetic Resonance Diagnostic Device (hardware and integrated software for image acquisition/reconstruction), not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this 510(k) is the regulatory acceptance and established safety/effectiveness of the predicate MR systems themselves, demonstrated through their successful clearance and long-term use.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no training set mentioned. The development process for an MRI system involves engineering design, testing against technical specifications, and adherence to regulatory standards rather than machine learning training.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML algorithm, there is no discussion of how ground truth was established for it.
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Image /page/0/Picture/0 description: The image shows the text "Appendix 12" on the left side of the image. On the top right of the image is the text "K110151". Below that text is the text "P'1/2".
MAR 2 2 2011 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 4-65684 PC Best, Netherlands, |
| Registration No.: | 3003768277 |
| Contact person: | Lynn HarmerManager, Regulatory AffairsTel: (425) 487-7312Fax: (425) 487-8666Lynn.Harmer@Philips.com |
| Date Prepared: | December 8, 2010 |
| Device (Trade) Name: | ACHIEVA R4 1.5T and ACHIEVA R4 3.0T(aka Ingenia) |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Regulatory Number: | 892.1000 |
| Classification: | Class II |
| Product code: | 90L--NH90L--NI90M--OS |
| Performance standards: | NEMA voluntary standards, FDA MR Diagnostic DeviceGuidance, UL and IEC 60601 appropriate safety standardand/or draft standards are used. |
Predicate Device(s):
The ACHIEVA R4 1.5T and ACHIEVA R4 3.0T with enhancements are the successors of their predicate devices ACHIEVA 1.5T and ACHIEVA 3.0T MR systems Release 2.5-series (FDA references K063559, K043147, K041602, K052078 and K013344.)
Intended Use:
The ACHIEVA R4 1.5T and ACHIEVA R4 3.0T 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 R4 1.5T and ACHIEVA R4 3.0T 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: 1
The next generation Philips MR platform consists of either a 1.5T or 3.0T field generating superconducting unit. The radiofrequency receive chain consists of multiple coil types delivering a simplified and unique data acquisition system. The system is configured with a time-varying magnetic field system (gradients). Additional RF transmission is provided through an integrated RF body coil. The base software for the above mentioned system will be called Release 4.
The magnetic resonance diagnostic device is used to produce cross-sectional images, spectroscopic imaging and/or spectra in any orientation of the internal structures of the whole body. These images when interpreted by a trained physician, yield information that may assist in a diagnosis. In addition, the device provides the 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.
General Safety and Effectiveness 2
The ACHIEVA R4 1.5T and ACHIEVA R4 3.0T do not induce any other risks than already indicated for their predicate devices with the same safety and effectiveness.
Substantial Equivalence 8
It is the opinion of Philips Medical Systems that the Philips ACHIEVA R4 1.5T and ACHIEVA R4 3.0T are substantially equivalent to their predicate device ACHIEVA 1.5T and ACHIEVA 3.0T MR systems Release 2.5-series.
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510(k) Contrast Agent Use Form
K110151
.
| Date | Monday, March 21, 2011 |
|---|---|
| Reviewer | Jana Delfino |
| Sponsor | Philips Medical Systems Nederland BV |
| Device | Achieva R4 1.5T and Achieva R4 3.0T MR Systems |
| IFU | "The ACHIEVA R4 1.5T and ACHIEVA R4 3.0T are magnetic resonance diagnosticdevices that produce cross-sectional images, spectroscopy images, and/or spectra inany orientation of the internal structure of the whole body. These images, wheninterpreted by a trained physician, yield information that may assist in diagnosis.In addition, the ACHIEVA R4 1.5T and ACHIEVA R4 3.0T devices provide capabilitiesto perform interventional procedure sin the head, body and extremities, which may befacilitated by MR techniques, such as real time imaging. Such procedures must beperformed with MR compatible instrumentation as selected and evaluated by theclinical user." |
| ImagingAgent Use | gadolinium-based contrast media |
| Was an outstanding drug issue letter sent after a previous submission? | No |
Predicate Device:
| 510(k) Number | K063559 |
|---|---|
| IFU | "The ACHIEVA, INTERA, and PANORMA 1.0T Release 2.5 series are magneticresonance diagnostic devices that produce cross-sectional images, spectroscopyimages 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 mayassist in the diagnosis.In addition, these devices provide capabilities to perform interventional procedures inthe head, body and extremities, which may be facilitated by MR techniques, such asreal time imaging. Such procedures must be performed with MR compatibleinstrumentation as selected and evaluated by the clinical user." |
| Imaging AgentUse | any gadolinium-based contrast agent |
Second Predicate (if applicable):
| 510(k) Number | K043147 |
|---|---|
| IFU | "The ACHIEVA family consists of diagnostic devices that produce cross-sectionalimages, spectroscopy images and/or spectra in any orientation of the internalstructure of the whole body. These images when interpreted by a trained physician,yield information that may assist in diagnosis." |
| Imaging Agent Use | any gadolinium-based contrast agent |
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Third Predicate (if applicable):
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Fourth Predicate (if applicable):
| 510(k) Number | |
|---|---|
| IFU | |
| Imaging Agent | |
| Use |
·
, ·
.
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Image /page/4/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol appears to be a stylized representation of a human figure or a caduceus, a symbol associated with medicine and healthcare.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Lynn Harmer Senior Manager, Regulatory Affairs . Philips Healthcare 22100 Bothell Everett Highway BOTHELL, WASHINGTON 98021
MAR 2 2 2011
Re: K110151
Trade/Device Name: Achieva R4 1.5T and Achieva R4 3.0T MR Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH Dated: January 14, 2011 Received: January 18, 2011
Dear Ms. Harmer
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 rinketed predicate device results in a classification for your device and thus, percorts your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to previously as ( notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolli fire (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Statil
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for use
KIIDISI
510(k) Number (if known):
Device Name :
ACHIEVA R4 1.5T and ACHIEVA R4 3.0T
Indication For Use :
The ACHIEVA R4 1.5T and ACHIEVA R4 3.0T 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 R4 1.5T and ACHIEVA R4 3.0T 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 X (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)
Mary Sastl 22/11
(Division Sign-Off)
Division of Radiological Devices
Office of in Vitro Diagnostic Device Evamation and Safety
§ 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.