The Picker International Eclipse/Polaris systems are 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.

Device Description

The Picker iPass Bolus Tracking option improves image quality by coordinating the arrival of the contrast agent with the collection of the data for the center of k-space. The option also includes an auto-voice feature to assist the technician in communicating with the patient.

AI/ML Overview

The provided text describes the iPass Bolus Tracking MRI System. However, it does not include specific acceptance criteria or an analytical study proving the device meets those criteria in the way typically expected for a medical device performance study (e.g., sensitivity, specificity, accuracy metrics compared to a ground truth).

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Picker Eclipse/Polaris system K964626). The "study" presented is a comparison table highlighting the similarities and differences in technological characteristics and intended use.

Therefore, many of the requested fields cannot be filled as they pertain to a different type of performance study.

Here's the breakdown based on the provided text:

Acceptance Criteria and Device Performance

The "acceptance criteria" here are implicitly centered around demonstrating substantial equivalence to the predicate device. The performance is reported in terms of functional parity or improvement.

Acceptance Criterion (Implicit)	Reported Device Performance (iPass Bolus Tracking)
Functional Equivalence: Sequence Capabilities/Requirements	Same as predicate (2D RF-FAST sequence, Volume contrast enhanced angio sequence).
Functional Equivalence: Simulate Scan Feature	Same simulate-scan feature is used, now also to improve image quality of contrast enhanced angiography scans (predicate used it for single-shot EPI sequences). This implies improved functionality.
Functional Equivalence/Improvement: ROI Analysis	Software automatically calculates average pixel intensity of the ROI and reports when a 30% increase in this value occurs (predicate required manual analysis). This is an automation improvement.
Functional Equivalence/Improvement: Bolus Arrival Time	Software automatically calculates arrival time based on ROI analysis, with manual override possible (predicate required user to manually determine arrival time). This is an automation improvement.
Functional Equivalence/Improvement: Intercom Capabilities	AutoVoice feature instructs the patient and/or technician during scan (predicate relied on technician communicating via intercom). This is an automation improvement.
Equivalence: Intended Use and Indications for Use	Same as predicate: "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."

Study Details

Sample size used for the test set and the data provenance: Not applicable. The document describes a comparison against a predicate device's specifications and functionality, not a clinical study with a test set of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established by experts for a test set in the context of a performance study. The "ground truth" for the comparison is the established functionality and specifications of the predicate device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is not an AI algorithm for diagnostic assistance to human readers. It is an MRI system option to improve image quality and workflow.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device's improvements (automated ROI analysis, bolus arrival time calculation, AutoVoice) represent automated functionalities. In that sense, its "standalone" performance is described by its ability to perform these tasks (e.g., automatically calculate a 30% increase in pixel intensity, automatically calculate arrival time). There are no specific quantitative metrics (like sensitivity/specificity) for these automated functions provided in this document, other than stating they occur automatically.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this submission is implicitly the established and approved specifications, performance, and indications for use of the predicate device (Picker Eclipse/Polaris system K964626).
The sample size for the training set: Not applicable. This document does not describe a training set as would be relevant for a machine learning or AI-based device. It describes an MRI system option that coordinates contrast agent arrival and includes an auto-voice feature.
How the ground truth for the training set was established: Not applicable.

Summary

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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:	iPass Bolus Tracking
Establishment Registration:	Picker International, Inc.World Headquarters595 Miner RoadHighland Heights, Ohio 44143Contact: Elaine K. Keeler, Ph.DPhone: (440) 473-3000
	FDA 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 iPass Bolus Tracking option does not change the existing intended use and indications for the Eclipse/Polaris systems as defined below.

3. Device Description

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Safety and Effectiveness 4.

The Picker iPass Bolus Tracking option is similar in technological characteristics and intended use to the Picker Eclipse/Polaris system. The following table has been created to demonstrate their substantial equivalence.

Parameter	iPass Bolus Tracking	Predicate Device - Eclipse / Polarissystem (K964626)
Sequence Capabilities /Requirements	Same.	2D RF-FAST sequence, Volumecontrast enhanced angio sequence.
Simulate Scan Feature	Same simulate-scan feature is nowalso used to improve imagequality of contrast enhancedangiography scans.	Software uses a simulate-scan featureto improve image quality of single-shot EPI sequences.
ROI Analysis	Software automatically calculatesaverage pixel intensity of the ROIand reports when a 30% increasein this value occurs.	User can draw a ROI and calculatethe average pixel intensity. Thismanual analysis can be repeated on aseries of scans to determine when anincrease occurs.
Bolus Arrival TimeCalculation	Software automatically calculatesarrival time based on ROIanalysis. Manual override ispossible.	User manually determines arrival timebased on ROI analysis.
Intercom Capabilities	AutoVoice feature instructs thepatient and/or technician duringscan.	Technician can communicate with thepatient via intercom during scan.
Intended Use andIndications for Use	Same.	The Picker InternationalEclipse/Polaris systems are indicatedfor use as a NMR device thatproduces images that: (1) correspondto the distribution of protonsexhibiting NMR, (2) depend upon theNMR parameters (proton density,flow velocity, spin-lattice relaxationtime (T1), and spin-spin relaxationtime (T2)) and (3) display the softtissue structure of the head and wholebody. When interpreted by a trainedphysician, these images yieldinformation that can be useful in thedetermination of a diagnosis.

Substantial Equivalence Chart

PICKER INTERNATIONAL, INC.

(IPASS)

I - 2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or flames.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 7 1999

Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143

Re:

K992412 iPass Bolus Tracking MRI System Dated: July 15, 1999 Received: July 20, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH

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). 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 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 requlations.

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 requlation 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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Page 1 of 1

510(k) Number (if known):

iPass Bolus Tracking Device Name:

Indications for Use:

(Per 21 CFR 801.109)

The iPass Bolus Tracking option does not change the existing intended use and indications for the Eclipse/Polaris systems as defined below.

The Picker International Eclipse/Polaris systems are 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dey 510(k) Number Prescription Use OR 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.