The Outlook 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 (TI), 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.

The MRGP Basic Package is designed to support and guide diagnostic interventional procedures, such as needle biopsies and drainages.

Device Description

The MRGP Basic Package is an optional hardware package for the Outlook and Outlook Proview systems. The package includes a foot pedal for starting scans from inside the scan room, kneeling pads for the physician, an MR compatible procedure light, a multipurpose coil with disposable protective coil coverings, and either an in-room LCD display or an in-room Large (36") Screen display. The package uses the standard software and sequences available with the Outlook and Outlook Proview systems.

AI/ML Overview

The provided document is a 510(k) summary for the Picker MR Guided Procedures (MRGP) Basic Package. This document aims to demonstrate substantial equivalence to existing legally marketed devices, rather than establishing acceptance criteria through a specific performance study against defined metrics.

Therefore, the document does not contain information typically associated with acceptance criteria and a study proving a device meets them in the way described in the prompt. Instead, it relies on a comparison table to show direct equivalence in technical parameters and indications for use.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

As this is a 510(k) submission demonstrating substantial equivalence, there are no explicitly stated "acceptance criteria" in the sense of performance thresholds the device must meet, nor a study proving it meets these. Instead, the "Substantial Equivalence Chart" presents a comparison of parameters between the new device (MRGP Basic Package) and two predicate devices (Outlook System Enhancement Package and Siemens MR Guided Procedure Package). The underlying "acceptance criterion" is that the parameters of the new device are "Same" or comparable to the predicate devices, implying equivalent safety and effectiveness.

Parameter	MR Guided Procedures (MRGP) Basic Package (New Device)	Outlook System Enhancement Package (Predicate)	Siemens MR Guided Procedure Package (Predicate)	Status (for MRGP)
System Compatibility	0.23T Outlook, 0.23T Outlook Proview	Not Applicable	0.2T Magnetom Open	Comparable
Magnet Homogeneity	Same (as Outlook System Enhancement)	(Not explicitly stated, assumed comparable)	$\pm$ 5 ppm @ 40 cm DSV (FWHM)	Equivalent
Magnet ramp time	Same as K974844 (Outlook System Enhancement)	6 minutes	Approx. 30 minutes	Equivalent
Gradient Design	Same as K974844 (Outlook System Enhancement)	16 mT/m peak, 25 mT/m/ms slew	15 mT/m peak, <17 mT/m/ms slew	Equivalent
Patient accessibility	Same as K974844 (Outlook System Enhancement)	44 cm gap, three sides access	40 cm gap, three sides access	Equivalent
Patient couch	Same (as Outlook System Enhancement)	Same (Detachable mobile couch)	Detachable mobile couch.	Equivalent
Patient positioning	Same (as Outlook System Enhancement)	Same (Laser localizer)	Laser localizer for positioning	Equivalent
Sequence type	Same as K974844 (Outlook System Enhancement)	2D/3D Gradient echo, FSE, Single-shot FSE	Rapid gradient echo imaging, FIS	Similar
Sequence capabilities	Same as K974844 (Outlook System Enhancement)	Dynamic imaging with auto start, keyhole	Continuous imaging with auto display, <600 ms	Similar
Sequence resolution	Same as K974844 (Outlook System Enhancement)	FOV 4-40cm, Slice 1-100mm, Matrix up to 512	FOV 4-40cm (2D), Slice 2-60mm (2D), Matrix 128,256,512 (2D)	Similar
In-room display & scan control	LCD (same as K974844), Large (36") Screen, Foot pedal	LCD (1024x768)	LCD (1024x1280), Foot pedal	Equivalent/Improved
RF coils	Same coils as K974844, Non-sterile coverings	Belt-shaped Multipurpose coils (40-136 cm)	Belt-shaped Multipurpose coil (109 cm)	Equivalent
Sterile drapes	User instructed, Not provided	None	Reusable cover (steam sterilized)	Different
Physician Ergonomics	Set of kneeling cushions	None	Chair	Different
Procedure Lighting	Adjustable MR compatible light	None	Flexible fiber-optic lamp	Different
Indications for Use	Support/guide diagnostic interventional procedures, e.g., needle biopsies, drainages	Standard MR imaging; No interventional indications	Support diagnostic interventional needle biopsies and drainages	Equivalent to Siemens predicate

The "Status" column indicates whether the MRGP Basic Package is "Same," "Equivalent," "Comparable," "Similar," or "Different" to the predicate devices based on the information provided in the table. The overall aim of this 510(k) is to demonstrate that any differences do not raise new questions of safety or effectiveness.

Regarding the specific questions about studies and ground truth:

Since this is a 510(k) for substantial equivalence, a formal performance study with acceptance criteria, ground truth establishment, and expert adjudication as might be conducted for a new-to-market device is not described in this document. The submission relies on technical comparisons to predicate devices that have already established safety and effectiveness.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The document does not describe a clinical performance study with a test set of data. The demonstration of equivalence is based on technical specifications and comparison to predicate devices.
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 / Not provided. No ground truth establishment by experts for a test set is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No adjudication of a test set is described.
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 / Not provided. This device is a hardware/software package for an MRI system, not an AI-assisted diagnostic tool. No MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided. This device is an MRI accessory package, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided. There is no mention of a ground truth for a performance study. Equivalence is primarily established through technical specifications and comparison to predicate devices. The "Indications for Use" for the new device align with the Siemens predicate, which implies similar clinical utility and expected diagnostic outcomes when interpreted by a trained physician. The safety is demonstrated by the "Same" or comparable technical parameters, suggesting that the well-understood safety profiles of the predicate devices apply.
The sample size for the training set:
- Not applicable / Not provided. No training set for an algorithm is mentioned as this device is not an AI/ML product requiring such a set.
How the ground truth for the training set was established:
- Not applicable / Not provided. No training set is mentioned.

Summary

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1183342

DEC 2 1 1998

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

1. General Information

Classification:	Class IIMagnetic Resonance Imaging (MRI) System
Common/Usual Name:	Magnetic Resonance Imaging (MRI) Option
Proprietary Name:	MR Guided Procedures (MRGP) Basic Package
Establishment Registration:	Manufacturer:Picker Nordstar, Inc.Ayritie 4, VantaaFIN-01510 Vantaa FinlandFDA Facility Registration: #9680194United States Representative:Picker International, Inc.World Headquarters595 Miner RoadHighland Heights, Ohio 44143FDA Owner Number: #1580240FDA Registration Number: #1525965
Performance Standards:	No applicable performance standards have beenissued under section 514 of the Food, Drug andCosmetic Act.

2. Intended Uses

The MRGP Basic Package is designed to support and guide diagnostic interventional procedures, such as needle biopsies and drainages.

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3. Device Description

Safety and Effectiveness 4.

The Picker MRGP Basic Package is substantially equivalent to the Siemens Magnetom Open MR Guided Procedures Package and the Picker Outlook System Enhancement Package. The following chart has been compiled to demonstrate this equivalence.

PICKER INTERNATIONAL, INC.

(MRGP)

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Substantial Equivalence Chart

Parameter	MR Guided Procedures(MRGP) Basic Package	Outlook System EnhancementPackage (Proview) - K974844	Siemens MR Guided ProcedurePackage - K955389
System Compatibility	0.23T Outlook,0.23T Outlook Proview	Not Applicable.	0.2T Magnetom Open
Magnet Homogeneity	Same.	Same.	$\pm$ 5 ppm @ 40 cm DSV (FWHM)
Magnet ramp time	Same as K974844.	6 minutes	Approx. 30 minutes
Gradient Design	Same as K974844.	Water-cooled gradient coils Peak strength - 16 mT/m Slew rate - 25 mT/m/ms	Water-cooled gradient coils Peak strength - 15 mT/m Slew rate - <17 mT/m/ms
Patient accessibility	Same as K974844.	Gap (couch-pole) - 44 cm Access from three sides	Gap (couch-pole) - 40 cm Access from three sides
Patient couch	Same.	Same.	Detachable mobile couch.
Patient positioning	Same.	Same.	Laser localizer for positioning
Sequence type	Same as K974844.	2D/3D Gradient echo, FSE, Single-shot FSE.	Rapid gradient echo imaging, FIS
Sequence capabilities	Same as K974844.	Dynamic imaging with auto start andkeyhole imaging capabilities.Typical reconstruction of 200 msper image.	Continuous imaging with automaticdisplay. Typical reconstruction ofless than 600 ms per image.
Sequence resolution	Same as K974844.	FOV- 4 to 40 cm Slice thickness - 2D: 1-100mm (0.1mm steps) 3D: 0.4-100mm (0.1mm steps) Matrix- up to 512	FOV - 4 to 40 cm (2D), 12 to 40 cm (3D) Slice thickness - 2D: 2-60mm (1 mm steps) 3D: ?? Matrix- 128, 256, 512 (2D)
Parameter	MR Guided Procedures(MRGP) Basic Package	Outlook System EnhancementPackage (Proview) - K974844	Siemens MR Guided ProcedurePackage - K955389
In-room display and scancontrol	Two types of in-room displaysavailable- 1) LCD same asK974844, 2) Large (36")Screen display with 1024x768resolution. Foot pedal alsoprovided to start scans.	In-room LCD display with1024x768 resolution.	In-room LCD display with1024x1280 resolution. Foot pedalalso provided to start scans.
RF coils	Same coils as K974844.Non-sterile protectivecoverings provided to preventdegradation of performancedue to fluid ingress.	Belt shaped Multipurpose coils withcircumferences ranging from 40 to136 cm.	Belt shaped Multipurpose coil witha circumference 109 cm.
Sterile drapes	User instructed to covermagnet poles with standardsterile drapes. Drapes notprovided with package.	None.	Reusable cover provided for magnetpoles. Can be steam sterilized.
Physician Ergonomics	Set of kneeling cushions	None.	Chair
Procedure Lighting	Adjustable MR compatiblelight on movable stand.	None.	Flexible fiber-optic lamp, attachedon a flexible arm at the magnetcover for sterile handling
Indications for Use	The MRGP Basic Package isdesigned to support and guidediagnostic interventionalprocedures, such as needlebiopsies and drainages.	Standard MR imaging indicationsfor use. No interventionalindications.	The MR-guided procedure packageis designed to support diagnosticinterventional needle biopsies anddrainages.

PICKER INTERNATIONAL, INC.

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PICKER INTERNATIONAL, INC.

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Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is black and the background is white. The text is centered in the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/4/Picture/3 description: The image shows a partial view of a logo or emblem, likely from a government or organizational context. The visible portion includes a stylized graphic of three wavy lines stacked on top of each other, possibly representing movement or flow. To the left of the graphic, there is a fragment of text, with only the letters 'DEPARTMEN' visible, suggesting that the full text is 'DEPARTMENT' followed by the name of the department or organization.

DEC 2 1 1998

Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 595 Miner Road Highland Heights, OH 44143 Re: K983342

MR Guided Procedures (MRGP) Basic Package Dated: September 21, 1998 Received: September 23, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LHN

Dear Dr. Keeler:

We have reviewed your Section 510(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 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). 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 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 requirements, 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 the Electronic Product 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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz. M.D. Acting 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): k 4 8 3 3 42

Magnetic Resonance Guided Procedures (MRGP) Basic Package Device Name:

Indications for Use:

The Outlook 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.

The MRGP Basic Package is designed to support and guide diagnostic interventional procedures, such as needle biopsies and drainages.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ghind h. Hyam
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 449742 510(k) Number .

Prescription Use 4 (Per 21 CFR 801.109)

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

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.