(119 days)
Not Found
No
The description focuses on the technical aspects of image acquisition and reconstruction based on magnetization transfer effects, with no mention of AI or ML algorithms for image analysis, interpretation, or processing.
No.
The device is described as a software option for MRI systems that derives images reflecting the spatial distribution of amide protons, which may assist a physician in diagnosis and therapy planning. It is an imaging tool, not a device that directly administers therapy or performs a therapeutic function.
Yes
Explanation: The "Intended Use / Indications for Use" section states that "3D APT images may assist a trained physician in diagnosis and therapy planning," indicating its role in the diagnostic process.
No
The device is described as a "software option intended for use on Ingenia 3.0T and Ingenia 3.0T CX MR Systems." This indicates it is a software component that integrates with and relies on existing MRI hardware systems, rather than being a standalone software-only device. The description also details hardware-related aspects like "RF-shimmed saturation" and "MultiTransmit system," further suggesting it's not purely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: This device is a software option for an MRI system. It is used to acquire and process images within the body (in vivo) to assist in diagnosis and therapy planning. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "magnetic resonance imaging of the brain" and that the images "may assist a trained physician in diagnosis and therapy planning." This is consistent with an in vivo imaging device, not an in vitro diagnostic.
Therefore, this device falls under the category of a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
Amide Proton Transfer weighted imaging (3D APT) is a software option intended for use on Ingenia 3.0T and Ingenia 3.0T CX MR Systems. 3D APT is indicated for use in magnetic resonance imaging of the brain. 3D APT consists of an acquisition and reconstruction technique employing frequency-selective magnetization transfer effects to derive images reflecting the spatial distribution of amide protons, and thereby protein density. 3D APT images may assist a trained physician in diagnosis and therapy planning. APTW can be combined with multi-coil acceleration approaches (SENSE).
Product codes (comma separated list FDA assigned to the subject device)
LNH, LNI
Device Description
3D Amide Proton Transfer (3D APT) is an extension of off-resonance magnetization transfer imaging.
3D APT images display a spatial distribution of amide protons. The RF-shimmed saturation is generated by alternating excitation from the 2 channels of the MultiTransmit system.
3D APT images are obtained by subtracting the saturated image intensity at the 2 mirrored frequency offsets relative to the water frequency (±3.5 ppm). Parameters are optimized to null the difference signal for normal brain tissue.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
A trained physician
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.
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.
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Philips Medical Systems Nederland B.V. % Susan Quick Regulatory Affairs Specialist Philips Medical Systems (Cleveland) Inc. 595 Miner Rd CLEVELAND OH 44143
January 22, 2018
Re: K172920
Trade/Device Name: 3d Apt Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI Dated: December 22, 2017 Received: December 26, 2017
Dear Susan Ouick:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert A. Ochs, Ph.D.
For
For
Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172920
Device Name 3D APT
Indications for Use (Describe)
Amide Proton Transfer weighted imaging (3D APT) is a software option intended for use on Ingenia 3.0T and Ingenia 3.0T CX MR Systems. 3D APT is indicated for use in magnetic resonance imaging of the brain. 3D APT consists of an acquisition and reconstruction technique employing frequency-selective magnetization transfer effects to derive images reflecting the spatial distribution of amide protons, and thereby protein density. 3D APT images may assist a trained physician in diagnosis and therapy planning. APTW can be combined with multi-coil acceleration approaches (SENSE).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Philips Medical Systems Nederland B.V. Magnetic Resonance Imaging 3D APT K172920
3D APT
Section 005
510(k) Summary
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510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | September 30, 2017 | |
|---|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| Veenpluis 4-6, 5684 PC, Best, The Netherlands | ||
| Establishment Registration Number: 3003768277 | ||
| Primary Contact | ||
| Person: | Susan Quick | |
| Regulatory Affairs Specialist | ||
| Phone: (440) 483-2291 | ||
| E-mail: susan.quick@philips.com | ||
| Secondary Contact | ||
| Person | Jan van de Kerkhof | |
| Sr Manager Regulatory Affairs | ||
| Phone: +31 6 13300542 | ||
| E-mail: jan.van.de.kerkhof@philips.com | ||
| Device Name: | Amide Proton Transfer weighted MRI (3D APT) | |
| Classification: | Classification name: | Magnetic Resonance Diagnostic |
| device (MRDD) | ||
| Classification Regulation: | 21CFR 892.1000 | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Primary Product Code: | LNH, LNI | |
| Primary Predicate Device: | Trade name: | Ingenia 1.5T, Ingenia 1.5T S and |
| Ingenia 3.0T R5.3 | ||
| Manufacturer: | Philips Medical Systems | |
| Nederland B.V. | ||
| 510(k) Clearance: | K163116, January 6, 2017 | |
| Classification Regulation: | 21CFR 892.1000 | |
| Classification name: | Magnetic Resonance Diagnostic | |
| Device (MRDD) | ||
| Classification Panel: | Radiology | |
| Device class | Class II | |
| Product Code: | LNH, LNI | |
| Product Code: | LNH, LNI | |
| Device Description: | 3D Amide Proton Transfer (3D APT) is an extension of off-resonance magnetization transfer imaging. |
3D APT images display a spatial distribution of amide protons. The RF-shimmed saturation is generated by alternating excitation from the 2 channels of the MultiTransmit system.
3D APT images are obtained by subtracting the saturated image intensity at the 2 mirrored frequency offsets relative to the water frequency (±3.5 ppm). Parameters are optimized to null the difference signal for normal brain tissue. | |
| Indications for Use: | 3D Amide Proton Transfer weighted MRI (3D APT) is a software feature intended for use on Ingenia 3.0T (70cm) and Ingenia 3.0T CX (60cm) MR Systems. It's indicated for use in magnetic resonance imaging of the brain.
Amide Proton Transfer weighted imaging (3D APT) is a software option intended for use on Ingenia 3.0T and Ingenia 3.0T CX MR Systems. 3D APT is indicated for use in magnetic resonance imaging of the brain. 3D APT consists of an acquisition and reconstruction technique employing frequency-selective magnetization transfer effects to derive images reflecting the spatial distribution of amide protons, and thereby protein density. 3D APT images may assist a trained physician in diagnosis and therapy planning. APTW can be combined with multi-coil acceleration approaches (SENSE). | |
| Design Features and
Fundamental Scientific
Technology: | 3D Amide Proton Transfer (3D APT) is an MR imaging technology where saturation of the water signal using the magnetization transfer effect generates the contrast. Protons bound to macromolecules, specifically amide protons, exchange with the free water pool. Selective narrow-band excitation at the amide proton resonance frequency is used to detect signal differences exclusively associated with the amide protons. This is achieved by a controlled, frequency-selective RF irradiation to saturate protons resonating at +3.5 ppm (the amide proton resonance frequency), and comparing the resulting signal level to that observed when irradiating at -3.5 ppm.
The feature consists of:
Frequency selective saturation RF pulses (1-2 s duration), alternating between the two channels of the MultiTransmit RF system, at multiple offset frequencies 3D DIXON TSE readout Signal difference calculation between +3.5 ppm and -3.5 ppm to derive the APTw image B0 inhomogeneity correction embedded into the APTw calculation Color scale (rainbow) to display APTw signals between | |
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| Substantial Equivalence | The proposed 3D Amide Proton Transfer (3D APT) is
substantially equivalent to the Magnetization Transfer
functionality (MTC and MTR) of the legally marketed primary
predicate device, Ingenia 1.5T, Ingenia 1.5T S and Ingenia
3.0T R5.3 (K163116, January 6, 2017) and has the same
primary indications for use with respect to the following:
• Software feature intended for use on the Ingenia 3.0T
(70cm) and Ingenia 3.0T CX (60cm) MR Systems
• Use in magnetic resonance imaging of the brain
• Consists of an image acquisition and reconstruction
technique with B0 correction and difference signal
determination |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The proposed 3D Amide Proton Transfer (3D APT) is
substantially equivalent to the legally marketed primary
predicate device, Ingenia 1.5T, Ingenia 1.5T S and Ingenia
3.0T R5.3 (K163116, January 6, 2017) in terms of design
features, fundamental scientific technology, indications for
use, and safety and effectiveness. Additionally, substantial
equivalence was demonstrated with non-clinical performance
(verification and validation) tests, which complied with the
requirements specified in the international and FDA-
recognized consensus standards and device-specific
guidance. The results of these tests demonstrate that the
proposed 3D Amide Proton Transfer (3D APT) meets the
acceptance criteria and is adequate for its intended use. |