The Picker International ASSET system is intended 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.

Device Description

The ASSET APOLLO MR system includes the following enhancements: a water cooled gradient system, increased gradient performance, increased scan/reconstruction rates, and a user selectable bandwidth option.

AI/ML Overview

This 510(k) submission (K971884) for the ASSET APOLLO Magnetic Resonance Imaging System focuses on demonstrating substantial equivalence to previously cleared predicate devices (ASSET K933835 and EDGE/VISTA K964626) rather than presenting a performance study with specific acceptance criteria and detailed statistical analysis as might be seen for a novel device or AI algorithm.

The core argument is that the ASSET APOLLO retains the same intended use and fundamentally similar technological characteristics to its predicates, with enhancements that do not raise new questions of safety or effectiveness. Therefore, there are no explicit acceptance criteria for device performance based on a new study outlined in this document, nor is there a study described that "proves the device meets the acceptance criteria" in the traditional sense of evaluating an algorithm's diagnostic accuracy.

The provided information primarily details the technical specifications of the ASSET APOLLO and compares them to the predicate devices to establish substantial equivalence.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Parameter	Acceptance Criteria (Implicit from Predicate Equivalence)	Reported ASSET APOLLO Performance
Intended Use	Same as predicate ASSET system	Same as predicate ASSET system
Computer Subsystem	Equivalent to or improved over predicate K964626	Same as K964626
Image Storage (Short Term)	Equivalent to predicate ASSET (K933835)	Magnetic Disk
Image Storage (Archival)	Equivalent to predicate ASSET (K933835)	Optical Disk
Gradient Coils	Water-cooled self-shielded design, similar to K964626	Water-cooled self-shielded
Max. Gradient Strength	Equal to or greater than predicate ASSET (10 mT/m) and within range of K964626 (16, 20, 27 mT/m)	16 mT/m
Max. Slew Rate	Equal to or greater than predicate ASSET (18 mT/m/msec) and within range of K964626 (25, 40, 72 mT/m/msec)	25 mT/m/msec
Gradient Amps	Equivalent to or improved over predicate ASSET and K964626	150 A RMS, 300 A peak, 400 V
DTR Spectrometer	Equivalent to predicate ASSET (K933835)	Same as K964626
RF Amplifiers	Single frequency, 5.0 kW (improved over K933835's 2.5 kW)	Single frequency 5.0 kW
Body Coil	Equivalent to predicate ASSET (K933835)	Same as K933835
Head Coil	Equivalent to predicate ASSET (K933835)	Same as K933835
Optional Receive Only Coil Connection	Equivalent to predicate ASSET (K933835)	Same as K933835
Transmit/Receive Box	Equivalent to predicate ASSET (K933835)	Same as K933835
Magnet Subsystem	Equivalent to predicate ASSET (K933835)	Same as K933835
Patient Handling	Equivalent to predicate ASSET (K933835)	Same as K933835
Magnet Facade	Equivalent to predicate ASSET (K933835)	Same as K933835
Power Distribution Subsystem	Equivalent to predicate ASSET (K933835)	Same as K933835
Operating Software	Equivalent to predicate K964626	Same as K964626
Operational Features	Equivalent to predicate ASSET (K933835)	Same as K933835
Standard Imaging Sequences	Equivalent to predicate ASSET, with addition of AcuScan package	Same standard imaging sequences with AcuScan
Acquisition and Reconstruction Techniques	Equivalent to predicate K964626	Same as K964626
Optional Receive Only Coils and Accessories	Equivalent to predicate ASSET (K933835)	Same as K933835
Software Options	All options available on predicates; new options are incremental	Angiography, Cardiac Imaging, VFASE, GRaSE, EPI
Time Varying Magnetic Field (dB/dt)	Normal Operating Mode: ≤ 40 T/s (as K964626); First Controlled Operating Mode: ≤ 60 T/s (as K964626). Note: K933835 was ≤ 20 T/s, hence ASSET APOLLO is an improvement/equivalent to higher standard.	Same as K964626 (Normal: ≤40 T/s, First Controlled: 40 T/s < dB/dt ≤ 60 T/s)
Radiofrequency Absorption (SAR)	Normal Operating Mode: ≤ 1.2 W/kg (as K964626); First Level Controlled Operating Mode: ≤ 3.2 W/kg (as K964626). Note: K933835 was First Level ≤ 2.4 W/kg, hence ASSET APOLLO is an improvement/equivalent to higher standard.	Same as K964626 (Normal: ≤ 1.2 W/kg, First Level Controlled: ≤ 3.2 W/kg)
Acoustic Noise (average)	Generally equal to or lower than predicates (e.g., K933835 average: 83.8 dBA, K964626 average: 80.6 dBA)	Typical: 71.7 dBA, Worst Case: 88.8 dBA
Acoustic Noise (peak)	Generally equal to or lower than predicates (e.g., K933835 peak: 96.8 dB, K964626 peak: 93.3 dB)	Typical: 82.9 dB, Worst Case: 96.3 dB

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 is for a hardware and software upgrade to an MRI system, demonstrating substantial equivalence to existing devices. It does not involve a clinical study with a "test set" of patient data for evaluating diagnostic performance metrics in the way an AI algorithm might. The evaluation relies on comparing technical specifications and safety features.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical "ground truth" was established as part of a performance study for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical "ground truth" or adjudication of diagnostic findings was performed.

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 diagnostic device, but an MRI system upgrade. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is an MRI system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No ground truth was used as part of a performance study for this submission. The "ground truth" for this submission is the established safety and effectiveness of the existing predicate MRI devices.

8. The sample size for the training set

Not applicable. This is an MRI system submission, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this is not an AI algorithm submission.

Summary

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K971884

AUG 2 0

SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)

1.	General InformationClassification:	Class II - Magnetic Resonance Imaging System
	Common/Usual Name:	Magnetic Resonance Imaging System
	Proprietary Name:	ASSET APOLLO
	Establishment Registration:	Picker International, Inc.World Headquarters595 Miner RoadHighland Heights, Ohio 44143FDA 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 ASSET APOLLO does not change the existing intended use for the ASSET system as defined below.

3. Device Description

4. Safety and Effectiveness

The ASSET APOLLO is similar in technological characteristics and intended use to the standard ASSET system and the EDGE/VISTA system enhancement package. The following chart has been created to demonstrate their substantial equivalence.

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SUBSTANTIAL EQUIVALENCE CHART

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ITEM	ASSET APOLLO	Predicate DeviceASSET (K933835)	Predicate DeviceEDGE/VISTA with SystemEnhancement Package(K964626)
Computer Subsystem	Same as K964626.	Display/Database computer andscan reconstruction hardwareconnected together by a dedicatedEthernet communications system.Allows for simultaneous scanningand imagereconstruction/manipulation.Single monitor for systemoperation and image review.Second Ethernet interface allowsfor communication with systemson the external network.	Display/database computer,monitor and Ethernetcommunications systems.Ethernet communications linkcomplies with DICOM v3.0 toallow image transfer to other MR,CT, Nuclear, workstation systemsand cameras. Optional packagesavailable for increased imagereconstruction rates.
Image StorageShort Term:Archival:	Same.Same.	Magnetic DiskOptical Disk	Magnetic DiskOptical Disk
ITEM	ASSET APOLLO	Predicate DeviceASSET (K933835)	Predicate DeviceEDGE/VISTA with SystemEnhancement Package(K964626)
Gradient SubsystemGradient Coils:	Water-cooled self-shieldedgradient system. Phosphorous-bronze RF screen.	Self-shield gradient coil designedfor Magnex 0.5T activelyshielded magnet. Copper RFscreen.	Water-cooled self-shieldedgradient system for allperformance levels. Stainless steelRF screen.
Max. Gradient Strength	16 mT/m	10 mT/m	16, 20 or 27 mT/m
Max. Slew Rate	25 mT/m/msec	18 mT/m/msec	25, 40, 72 mT/m/msec
Gradient Amps:	150 A RMS, 300 A peak, 400 V	Single high current driveamplifier per axis.	150 A RMS, 300 A peak, 400 Vor270 A RMS, 440 A peak, 600 V
RF Subsystem
DTR Spectrometer:	Same.	Single channel with fast samplingADC and additional digitalfiltering. Three additionalreceive channels are available asan option.	Single Channel with fast samplingADC and additional digitalfiltering. Three additional receivechannels are available as anoption.
RF Amplifiers:	Single frequency 5.0 kW RFamplifier.	Single frequency 2.5 kW RFamplifier.	Single frequency RF amplifiers.
Body Coil	Same as K933835.	57 cm quadrature multi-conductor transmit/receive.	61 cm quadrature multi-conductortransmit/receive coil.
ITEM	ASSET APOLLO	Predicate DeviceASSET (K933835)	Predicate DeviceEDGE/VISTA with SystemEnhancement Package(K964626)
Head Coil	Same.	Quadrature multi-conductorreceive only.	Quadrature multi-conductorreceive only.
Receive Only Coil Connection	Same.	All receive only coils plug intosingle couch RF connector.	All receive only coils plug intosingle couch RF connector.
Transmit/Receive Box	Same.	Four receive channels in system.(1 standard, 4 optional)	Four receive channels in system.(1 standard, 4 optional)
Magnet Subsystem	Same as K933835.	Actively shielded magnet offeredat 0.5 T.	Active Shield Magnets offered at1.5 T and 1.0 T.
Patient Handling	Same as K933835.	Horizontal motion only,computer controlled patienttransport system.	Computer controlled patienttransport system with vertical andhorizontal motion.
Magnet Facade	Same.	Cylindrical fiberglass enclosure.	Cylindrical fiberglass enclosure.
Power Distribution Subsystem	Same.	Isolation transformer, transientsuppression circuitry, and powerdistribution center all containedin a single cabinet.	Isolation transformer, transientsuppression circuitry, and powerdistribution center all contained ina single cabinet.
ITEM	ASSET APOLLO	Predicate DeviceASSET (K933835)	Predicate DeviceEDGE/VISTA with SystemEnhancement Package(K964626)
Operating Software	Same as K964626.	UNIX - X Windows basedoperating software. GraphicalUser Interface - windows andMulti-tasking capabilityprovided.	UNIX - X Windows basedoperating software. GraphicalUser Interface - windows andmulti-tasking capability provided
		SCAN, VIEW, FILM, andUTILITIES operations allaccessed from single console.	SCAN, VIEW, FILM andUTILITIES operations allaccessed from single console.
		Able to switch between on-goingtasks.	Able to switch between on-goingtasks.
Operational Features	Same.	SCAN capabilities include: Pilotpositioning on three differentreference images. Preloadedanatomical protocol categories.	SCAN capabilities include: Pilotpositioning on three differentreference images. Preloadedanatomical protocol categories.
		VIEW capabilities include:Multiplanar reconstruction andcurvilinear reformatting.	VIEW capabilities include: Multiplanar reconstruction andcurvilinear reformatting.
		FILM capabilities include: abilityto set film formats and load printqueue directly fromDisplay/Database computer.	FILM capabilities include: abilityto set film formats and load printqueue directly fromDisplay/Database computer.
ITEM	ASSET APOLLO	Predicate DeviceASSET (K933835)	Predicate DeviceEDGE/VISTA with SystemEnhancement Package(K964626)
Standard Imaging Sequences	Same standard imagingsequences with the addition of theAcuScan package.	2DFT: Field Echo, Spin Echo,Multiple Echo, InversionRecovery and FAST.3DFT: FAST	2DFT: Field Echo, Spin Echo,Multiple Echo, InversionRecovery and FAST.3DFT: FAST
Acquisition and ReconstructionTechniques	Same as K964626.	Main features include:Presaturation, phase conjugatesymmetry, TrueRes, TrueSlice,and Geometric DistortionCorrection.	Main features include:Presaturation, phase conjugatesymmetry, TrueRes and TrueSlice.

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ITEM	ASSET APOLLO	Predicate DeviceASSET (K933835)	Predicate DeviceEDGE/VISTA with SystemEnhancement Package(K964626)
Optional Receive Only Coilsand Accessories	Same as K933835.	Large Joint CoilSmall Joint CoilVolume Neck CoilQuad Spine Coil and PositionerBilateral TMJ Coil (Linear andPhased Array versions)Bilateral Breast CoilGeneral Purpose Flex CoilC/T/L Phased ArrayPelvic Phased ArrayFlexible Body Coil - QuadratureQuadrature Wrist CoilQuadrature Lower Extremity CoilCoil Combiner	Large Joint CoilSmall Joint CoilVolume Neck CoilQuad Spine Coil and PositionerBilateral TMJ Coil (Linear andPhased Array versions)Bilateral Breast CoilGeneral Purpose Flex CoilC/T/L Phased ArrayPelvic Phased ArrayFlexible Body Coil (Quadratureand Phased Array versions)Quadrature Wrist CoilQuadrature Lower Extremity CoCoil CombinerHead-Neck Vascular Phased AShoulder Phased Array
ITEM	ASSET APOLLO	Predicate DeviceASSET (K933835)	Predicate DeviceEDGE/VISTA with SystemEnhancement Package(K964626)
Software Options	Angiography	Angiography	Angiography
	Cardiac Imaging	Cardiac Imaging	Cardiac Imaging
	Variable Fast Spin EchoSequences (2, 4, 8, 16, 32, 48 and64 echo sequences)	Variable Fast Spin EchoSequences.	Variable Fast Spin Echo (2, 4, 8,16, 32, 48 and 64 echo sequences)
	Gradient-Recalled and Spin-Echo(GRaSE) Technique	Gradient-Recalled and Spin-Echo(GRaSE) Technique	Gradient-Recalled and Spin-Echo(GRaSE) Technique
	Echo Planar Imaging	Echo Planar Imaging	Echo Planar Imaging
Time Varying Magnetic Field	Same as K964626.	Not to exceed 20 T/s.	Normal Operating Mode:dB/dt ≤ 40 T/s
			First Controlled Operating Mode:40 T/s < dB/dt ≤ 60 T/s
Radiofrequency Absorption	Same as K964626.	Normal Operating Mode: Limitedto a maximum level of 1.2 W/kg.	Normal Operating Mode:Limited to a maximum level of1.2 W/kg.
		First Level Controlled OperatingMode: Limited to a maximumvalue of 2.4 W/kg.	First Level Controlled OperatingMode: Limited to a maximumvalue of 3.2 W/kg.
ITEM	ASSET APOLLO	Predicate DeviceASSET (K933835)	Predicate DeviceEDGE/VISTA with SystemEnhancement Package(K964626)
Acoustic Noise
Typical	71.7 dBA (average)82.9 dB (peak)	83.8 dBA (average)96.8 dB (peak)	80.6 dBA (average)93.3 dB (peak)
Worst Case	88.8 dBA (average)96.3 dB (peak)	98.2 dBA (average)108.2 dB (peak)	115.1 dBA (average)123.8 dB (peak)
Intended Use	Same.	The Picker International ASSETsystem is intended for use as aNMR device that producesimages that: (1) correspond to thedistribution of protons exhibitingNMR, (2) depend upon the NMRparameters (proton density, flowvelocity, spin-lattice relaxationtime (T1), and spin-spinrelaxation time (T2)) and (3)display the soft tissue structure ofthe head and whole body. Wheninterpreted by a trained physician,these images yield informationthat can be useful in thedetermination of a diagnosis.	The Picker International EDGE /VISTA systems are intended foruse as a NMR devices thatproduce images that: (1)correspond to the distribution ofprotons 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 tissuestructure of the head and wholebody. When interpreted by atrained physician, these imagesyield information that can beuseful in the determination of adiagnosis.

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PICKER INTERNATIONAL, INC.

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Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three stripes representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 5500 Avion Park Drive Highland Heights, Ohio 44143 Re:

K971884 ASSET APOLLO (MRI System) Dated: May 12, 1997 Received: May 22, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

AUG 20 1997

Dear Dr. Keeler:

We have reviewed your Section SI0(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in צוות diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/edri/dsmamain.html"

Sincerely yours.

William Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): __Ka7 1884

Device Name: ASSET APOLLO

- Indications for Use:

The ASSET APOLLO does not change the existing intended use and indications for the ASSET system as defined below.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David L. Shapiro

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)
✓

Over-The-Counter Use _ (Optional Format 1-2-96)

Regulation Number and Section

§ 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.