Who is the manufacturer of 3D APT?

Philips Medical Systems Nederland B.V. filed the 510(k) submission for 3D APT (K172920).

What is the FDA product code for 3D APT?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for 3D APT?

510(k) clearance (submission type: Abbreviated).

What are the predicate devices for 3D APT?

Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116).

Who can help prepare an FDA 510(k) submission like 3D APT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

3D APT

K172920 · Philips Medical Systems Nederland B.V. · LNH · Jan 22, 2018 · Radiology

Device Facts

Record ID	K172920
Device Name	3D APT
Applicant	Philips Medical Systems Nederland B.V.
Product Code	LNH · Radiology
Decision Date	Jan 22, 2018
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended 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).

Device Story

3D APT is a software option for Philips Ingenia 3.0T/3.0T CX MR systems; utilizes frequency-selective magnetization transfer effects to image amide proton distribution/protein density. Input: MR signals acquired via frequency-selective RF pulses (1-2s duration) at ±3.5 ppm offsets; MultiTransmit system alternates excitation across 2 channels. Processing: 3D DIXON TSE readout; B0 inhomogeneity correction; signal subtraction between ±3.5 ppm offsets to isolate amide proton signal. Output: APTw images displayed with color scale. Used in clinical settings by radiologists/physicians; assists in diagnosis and therapy planning by visualizing protein density variations. Benefits: provides non-invasive contrast reflecting molecular protein content.

Clinical Evidence

Bench testing only. Verification and validation testing performed to demonstrate compliance with international and FDA-recognized consensus standards. No clinical data provided.

Technological Characteristics

Software-based MR imaging feature. Employs frequency-selective saturation RF pulses (1-2s) and 3D DIXON TSE readout. Features B0 inhomogeneity correction and MultiTransmit RF system (2-channel). Connectivity: Integrated into Philips Ingenia 3.0T/3.0T CX MR systems. Output: Color-scaled APTw images.

Indications for Use

Indicated for use in magnetic resonance imaging of the brain to assist trained physicians in diagnosis and therapy planning.

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

Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116)

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Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo is a stylized representation of a human figure, while the FDA part includes the acronym "FDA" in blue, followed by "U.S. FOOD & DRUG" in a larger font size and "ADMINISTRATION" in a smaller font size below. 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); {1}------------------------------------------------ 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 {2}------------------------------------------------ ### 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) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. Philips Medical Systems Nederland B.V. Magnetic Resonance Imaging 3D APT K172920 # 3D APT ## Section 005 # 510(k) Summary {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out. ### 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 | | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is white, providing a strong contrast to the blue text. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters against a white background. The font is sans-serif and the letters are evenly spaced. The word is horizontally oriented and centered in the image. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and aligned horizontally. The font is sans-serif and appears to be a standard typeface. | 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. |