(62 days)
The Infinion 0.6T MR Imaging System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
This submission describes the hardware and software changes for the Philips' 0.6T Open Magnetic Resonance Imaging system, the Infinion 0.6T.The package also includes additional imagin sequences and acquisition/construction techniques. However, the basic features are unchanged.
The provided document is a 510(k) premarket notification for the Philips Infinion 0.6T MR Imaging System. It describes the device and claims substantial equivalence to a predicate device (Philips Proview 0.23T System, K974844).
It's important to understand that a 510(k) submission for a Magnetic Resonance Imaging (MRI) system is primarily a demonstration of "substantial equivalence" to a predicate device, focusing on technological characteristics and intended use, rather than a clinical study proving an AI algorithm's performance against specific acceptance criteria like an AI/CADe device would.
Therefore, the typical acceptance criteria related to sensitivity, specificity, or reader performance improvements common for AI-powered diagnostic aids are not present in this document. This submission is for an MRI hardware and software system, not an AI algorithm performing a diagnostic interpretation.
However, based on the information provided, we can infer "acceptance criteria" through the lens of substantial equivalence and report on the "device performance" by comparing it to its predicate.
Here's the breakdown of what can be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for an MRI system asserting substantial equivalence, the "acceptance criteria" are implied by demonstrating that the new device's parameters are either the same as or generally improved compared to the predicate device, or meet established safety norms (like IEC 60601-2-33). The "reported device performance" is essentially the specifications of the Infinion 0.6T MR Imaging System compared to the Proview 0.23T System.
| Parameter (Acceptance Criteria, implied as "substantially equivalent to predicate" or "meets standard") | Infinion 0.6T MR Imaging System (Reported Device Performance) | Predicate Device - Philips Proview 0.23T System (K974844) |
|---|---|---|
| Computer Subsystem | ||
| Display/database system | Same as predicate. | Single display for system operation and image reviewing, workstation tower, moveable keyboard and mouse, CD-ROM. Allows for simultaneous scanning and image reconstruction/manipulation. Image storage via magneo-optical disk. |
| Network communications | DICOM Query/Retrieve, DICOM Modality WL Management. | Display/Database computer and scan reconstruction hardware connected together by fast Ethernet communications system. DICOM compliant for transfer of images to other systems. |
| Gradient Subsystem | ||
| Gradient Coils | Same as predicate. | Water-cooled self-shielded gradient system. |
| Max. Gradient Strength | 20 mT/m (Improved from predicate) | 16 mT/m (XY), 18 mT/m (Z) |
| Max. Slew Rate | 40 T/m/s (Improved from predicate) | 25 mT/m/msec (XY), 40 mT/m/msec (Z). |
| RF Subsystem | ||
| RF Amplifiers | Max power 9 kW. (Improved from predicate) | 5 kW solid state. |
| RF transmitter coils | Same as predicate, but with tuning adjusted to proton resonance at 0.6T field strength instead of 0.23 T, and with water cooling. | Upper and lower, planar coils, integrated in the magnet. |
| Receive only RF coils | Head (phased array two-channel) Head and Neck (phased array four-channel). Neck (phased array two-channel) Extremity (phased array two-channel) Body & Spine, different sizes (phased array two-channel) Multipurpose, different sizes (linear single-channel) | Head (phased array two-channel). Brain (phased array two-channel). Head and Neck (phased array four-channel, formerly Vascular Head and Neck). Neck (phased array two-channel). Extremity (phased array two-channel). Body and Spine, different sizes (phased array two-channel) Flexible Spine (phased array two-channel). Flexible Multipurpose, different sizes (linear single-channel). Small Extremity (phased array two-channel, earlier name Small Joints). Large Neck (phased array two-channel). |
| Receive only coil connection | All receive only coils plug into the RF connectors in both ends of the patient couch. | All receive only coils plug into the RF connector on the front of the magnet façade. |
| Magnet Subsystem | ||
| Magnet Type | 0.6 T superconducting (Significantly different, but compared for equivalence) | 0.23 T iron-core electromagnetic. |
| Patient Handling | ||
| Patient couch | Motorized movement in three orthogonal dimensions. Optional trolley. Couch w/capacity 220 kg. Remote control horizontal movement. (Improved capacity) | Computer and couch controlled patient transport system with 200 kg weight capacity. Optional couch with vertical movement. |
| Patient positioning | Same laser positioning marker. Additional automated stepping capabilities. | Laser positioning marker for accurate placement of patient at isocenter. |
| Patient communication | Same as predicate. | Two-way intercom system and hand-held audio alarm. |
| Magnet Enclosure | ||
| Magnet Façade | Same as predicate. | Fiberglass enclosure. |
| Controls | LCD display above bore, two keypads on either side of bore. (Improved/different from predicate) | LED display, control panel in upper front pole. |
| Power Distribution Subsystem | ||
| Subsystem components | Same as predicate. | Isolation transformer, transient suppression circuitry, and power distribution center all contained in a single cabinet. |
| Operating Software | ||
| Base Software | Same as predicate. | Windows 2000 based Graphical User Interface and scan / reconstruction software with multi-tasking capability. |
| Imaging sequences | Field Echo, Spin Echo, Dual Echo, Dual Spin Echo, Inversion Recovery, Dual Inversion Recovery, Fast Spin Echo, EXPRESS, CBASS, MRCP, MRA, STIR, FLAIR, TSHIRT, RF-FAST, CE-FAST, DWISE. (Expanded from predicate) | Field Echo, Spin Echo, Dual Echo, Inversion Recovery, Fast Spin Echo, CBASS, MRCP, MRA, STIR. |
| Acquisition and reconstruction techniques | Same as predicate, and additionally MAO, MAST, presaturation, chemical fat saturation, phase conjugate symmetry, read conjugate symmetry, true res, true slice, elliptic encoding, RAM, CODA, MTC, dynamic examination curve, contrast dynamic imaging, reconstruction filters, respiratory gating, multiplanar reconstruction, maximum intensity projection, phase correction, fat/water suppression, ADC map. (Expanded from predicate) | Presaturation, MAST, ODA, PCS, no phase wrap-around, no slice wrap around, dynamic imaging, cardiac gating, optimized bandwidth, turbo multislice. |
| Time Varying Magnetic Field Normal Operating Mode | According to 60601-2-33 FDISscript 2001-11-02. (References current safety standard) | dB/dt ≤ 20 T/s |
| First Level Controlled Operating Mode | According to 60601-2-33 FDISscript 2001-11-02. (References current safety standard) | Not applicable. |
| Radiofrequency Absorption Normal Operating Mode | Same as predicate. | Limited to a maximum level of 1.2 W/kg. |
| First Level Controlled Operating Mode | Same as predicate. | Limited to a maximum value of 3.2 W/kg. |
| Acoustic Noise Typical | 87 dBA (average), 102 dB (peak) | <85 dBA (average, normal clinical sequences) |
| Acoustic Noise Worst Case | 91 dBA (average), 104 dB (peak) | 84 dBA (average), 98 (peak) |
| Intended Use and Indications for Use | Same as predicate. | The Proview System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a 510(k) submission for an MRI system, not a clinical trial for an algorithm. There is no mention of a specific "test set," "sample size," or "data provenance" (country of origin, retrospective/prospective) in the context of evaluating diagnostic performance against ground truth. The submission relies on engineering specifications and comparison to a predicate device to establish substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
As there is no "test set" in the context of evaluating diagnostic performance of an AI algorithm, there is no mention of experts establishing ground truth for such a purpose. The device produces images, and the "ground truth" for its clinical utility is implied by its ability to produce diagnostic quality images, which is assessed through technical specifications and comparison to a legally marketed predicate MRI system. The document states that the images "yield information that can be useful in the determination of a diagnosis" when interpreted by a "trained physician."
4. Adjudication Method for the Test Set
Since there is no "test set" for diagnostic performance evaluation of an AI algorithm, there is no adjudication method described.
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
This document is for an MRI system, not an AI or CADe device. Therefore, no MRMC study was conducted, and no effect size for human reader improvement with AI assistance is reported.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This document describes an MRI imaging system, not an AI algorithm intended for standalone performance. Therefore, no standalone performance study was conducted. The device produces images for a trained physician to interpret.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the purpose of this 510(k) submission for an MRI system, the "ground truth" for its functionality and safety is based on engineering specifications, compliance with relevant safety standards (e.g., IEC 60601-2-33), and demonstrated equivalence to a legally marketed predicate MRI device. There isn't a "ground truth" in the diagnostic sense (like pathology or expert consensus on disease presence) because the device's role is to generate images, not to provide an automated diagnosis.
8. The Sample Size for the Training Set
This document is for an MRI system's hardware and embedded software. It is not an AI algorithm that requires a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI algorithm, there is no "training set" and no method for establishing its ground truth in the context of machine learning. The "ground truth" for the development of the MRI system would involve engineering principles, physics, and medical imaging standards to ensure functional and safe image acquisition.
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Kol 3858
SUMMARY OF SAFETY AND EFFECTIVENESS JAN 2 2 2002
(As required by 21 CFR 807.92)
JAN 2 2 2002
General Information 1.
| Classification: | Class IIMagnetic Resonance Imaging (MRI) System |
|---|---|
| Common/Usual Name: | Magnetic Resonance Imaging (MRI) System |
| Proprietary Name: | Infinion 0.6T MR Imaging System |
| Establishment Registration: | Manufacturer:Philips Medical Systems MR Technologies Finland, Inc.P.O. Box 185FIN-00511 Vantaa, FinlandPhone: +358-9-2535-9300Fax: +358-9-2535-9600FDA Facility Registraton #9680194United States Representative:Philips Medical Systems (Cleveland), Inc.595 Miner RoadHighland Heights, Ohio 44143Contact: Duane C. PraschanPhone: (440) 483-3000FDA Owner Number: #1580240FDA Registration Number: #1525965 |
| Performance Standards: | No applicable performance standards have been issuedunder section 514 of the Food, Drug and Cosmetic Act |
2. Intended Uses
The Infinion 0.6T MR Imaging System does not change the existing indications as defined below.
The Infinion 0.6T MR Imaging System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
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K013858
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3. Device Description
This submission describes the hardware and software changes for the Philips' 0.6T Open Magnetic Resonance Imaging system, the Infinion 0.6T.The package also includes additional imagin sequences and acquisition/construction techniques. However, the basic features are unchanged.
4. Safety and Effectiveness
The functionality included in Philips' Infinion 0.6T MR Imaging System is similar in technological characteristics and intended use to the Proview 0.23T MR. The following table has been created to demonstrate their substantial equivalence.
| Parameter | Infinion 0.6T MR Imaging System | Predicate Device - PhilipsProview 0.23T System (K974844) |
|---|---|---|
| Computer Subsystem | ||
| Display/database system: | Same. | Single display for system operation andimage reviewing, workstation tower,moveable keyboard and mouse, CD-ROM.Allows for simultaneous scanning and imagereconstruction/manipulation. Image storagevia magneo-optical disk. |
| Network communications: | DICOM Query/Retrieve, DICOMModality WL Management. | Display/Database computer and scanreconstruction hardware connected togetherby fast Ethernet communications system.DICOM compliant for transfer of images toother systems. |
| Gradient Subsystem | ||
| Gradient Coils: | Same. | Water-cooled self-shielded gradient system. |
| Max. Gradient Strength: | 20 mT/m | 16 mT/m (XY), 18 mT/m (Z) |
| Max. Slew Rate: | 40 T/m/s | 25 mT/m/msec (XY), 40 mT/m/msec (Z). |
| RF Subsystem | ||
| RF Amplifiers: | Max power 9 kW. | 5 kW solid state. |
| RF transmitter coils: | Same but with tuning adjusted to protonresonance at 0.6T field strength insteadof 0.23 T, and with water cooling. | Upper and lower, planar coils, integrated inthe magnet. |
| Parameter | Infinion 0.6T MR Imaging System | Predicate Device - PhilipsProview 0.23T System (K974844) |
| Receive only RF coils: | Head (phased array two-channel)Head and Neck (phased array four-channel).Neck (phased array two-channel)Extremity (phased array two-channel)Body & Spine, different sizes (phasedarray two-channel)Multipurpose, different sizes (linearsingle-channel) | Head (phased array two-channel).Brain (phased array two-channel).Head and Neck (phased array four-channel,formerly Vascular Head and Neck).Neck (phased array two-channel).Extremity (phased array two-channel).Body and Spine, different sizes (phased arraytwo-channel)Flexible Spine (phased array two-channel).Flexible Multipurpose, different sizes (linearsingle-channel).Small Extremity (phased array two-channel,earlier name Small Joints).Large Neck (phased array two-channel). |
| Receive only coil connection: | All receive only coils plug into the RFconnectors in both ends of the patientcouch. | All receive only coils plug into the RFconnector on the front of the magnet façade. |
| Magnet Subsystem | ||
| Magnet Type: | 0.6 T superconducting | 0.23 T iron-core electromagnetic. |
| Patient Handling | ||
| Patient couch: | Motorized movement in threeorthogonal dimensions. Optionaltrolley which can be used fortransporting the couch upper parttogether with the coil and patient.Couch weight capacity is 220 kg.Remote control of the couch inhorizontal direction. | Computer and couch controlled patienttransport system with 200 kg weight capacity.Optional couch with vertical movement. |
| Patient positioning: | Same laser positioning marker.Additional automated steppingcapabilities. | Laser positioning marker for accurateplacement of patient at isocenter. |
| Patient communication: | Same. | Two-way intercom system and hand-heldaudio alarm. |
| Magnet Enclosure | ||
| Magnet Façade: | Same. | Fiberglass enclosure. |
| Controls: | LCD display above bore capable ofdisplaying system status. Two keypadson either side of bore for systemcontrols. | LED display capable of display systemstatus. Control panel in upper front pole. |
| Power Distribution Subsystem | ||
| Subsystem components: | Same. | Isolation transformer, transient suppressioncircuitry, and power distribution center allcontained in a single cabinet. |
| Operating Software | ||
| Base Software: | Same. | Windows 2000 based Graphical UserInterface and scan / reconstruction softwarewith multi-tasking capability. |
| Infinion 0.6T MR Imaging System | Predicate Device – PhilipsProview 0.23T System (K974844) | |
| Parameter | ||
| Imaging sequencesMain features include: | Field Echo, Spin Echo, Dual Echo,Dual Spin Echo, Inversion Recovery,Dual Inversion Recovery, Fast SpinEcho, EXPRESS, CBASS, MRCP,MRA, STIR, FLAIR, TSHIRT, RF-FAST, CE-FAST, DWISE. | Field Echo, Spin Echo, Dual Echo, InversionRecovery, Fast Spin Echo, CBASS, MRCP,MRA, STIR. |
| Acquisition and reconstructiontechniquesMain features include: | Same and additionally MAO, MAST,presaturation, chemical fat saturation,phase conjugate symmetry, readconjugate symmetry, true res, true slice,elliptic encoding, RAM, CODA, MTC,dynamic examination curve, contrastdynamic imaging, reconstruction filters,respiratory gating, multiplanarreconstruction, maximum intensityprojection, phase correction, fat/watersuppression, ADC map. | Presaturation, MAST, ODA, PCS, no phasewrap-around, no slice wrap around, dynamicimaging, cardiac gating, optimizedbandwidth, turbo multislice. |
| Time Varying Magnetic FieldNormal Operating Mode: | According to 60601-2-33 FDISscript2001-11-02. | dB/dt ≤ 20 T/s |
| First Level ControlledOperating Mode: | According to 60601-2-33 FDISscript2001-11-02. | Not applicable. |
| Radiofrequency AbsorptionNormal Operating Mode: | Same. | Limited to a maximum level of 1.2 W/kg. |
| First Level ControlledOperating Mode: | Same. | Limited to a maximum value of 3.2 W/kg. |
| Acoustic NoiseTypical: | 87 dBA (average)102 dB (peak) | <85 dBA (average, normal clinicalsequences) |
| Worst Case: | 91 dBA (average)104 dB (peak) | 84 dBA (average)98 (peak) |
| Intended Use andIndications for Use | Same. | The Proview System is indicated for use as aNMR device that produces images that: (1)correspond to the distribution of protonsexhibiting NMR, (2) depend upon the NMRparameters (proton density, flow velocity,spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display thesoft tissue structure of the head and wholebody. When interpreted by a trainedphysician, these images yield informationthat can be useful in the determination of adiagnosis. |
Substantial Equivalence Chart
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2002
Mr. Duane Praschan Manager, Regulatory Affairs Philips Medical Systems 595 Miner Road HIGHLAND HEIGHTS OH 44143 Re: K013858
Trade/Device Name: Infinion 0.6T MR Imaging System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: November 16, 2001 Received: November 21, 2001
Dear Mr. Praschan:
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 (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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
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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Page 1 of 1
510(k) Number (if known): Ko 1 3 8 58
Infinion 0.6T MR Imaging System Device Name:
Indications for Use:
The Infinion 0.6T MR Imaging System does not change the existing indications as defined below.
The Infinion 0.6T MR Imaging System is indicated for use as a NMR device that produces i he mininon 0.0 I Wirk maging by seen lution of protons exhibiting NMR, (2) depend upon the Inlages that. (1) correspond to the distributiv, spin-lattice relaxation time (T1), and spin-spin North paraticiels (procent dealer) from volt tightig ; in the head and whole body. When iclaxation thire (12)) and (2) also images yield information that can be useful in the determination of a diagnosis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use | OR | Over-The-Counter Use | ||
|---|---|---|---|---|
| (Per 21 CFR 801.109) | ✓ | (Optional Format 1-2-96) |
Jansylf Brydon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K013858 |
|---|---|
| --------------- | ---------------- |
§ 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.