Magnetic Resonance Imaging (MRI), Magnetic Resonance Angiography (MRA) and Proton Spectroscopy of the pediatric head, body and extremities. This device is used in conjunction with a General Electric 1.5 Tesla MRI System. Proton Spectroscopy is used in conjunction with the PROBE (Proton Brain Exam) option.

Device Description

Model 1300GE-64 - Pediatric Positioner. Compatible with GE Signa 1.5T MRI Systems. MRI Accessory.

AI/ML Overview

The provided text describes a 510(k) summary for the "Model 1300GE-64 - Pediatric Positioner." This document focuses on demonstrating substantial equivalence to predicate devices, primarily through safety and imaging performance parameter comparisons. It does not describe a study performed to establish acceptance criteria for the device itself or analyze its diagnostic performance.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and reported device performance (beyond "no change" relative to predicate).
Sample size used for the test set and data provenance.
Number of experts and their qualifications for ground truth establishment.
Adjudication method for the test set.
MRMC comparative effectiveness study or effect size.
Standalone performance study.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
Sample size for the training set.
How ground truth for the training set was established.

Based on the provided text, the device is a "Pediatric Positioner" intended for use with a GE Signa 1.5T MRI System. The "study" described is essentially a comparison to legally marketed predicate devices to establish substantial equivalence concerning safety and imaging performance.

Here's an analysis of what can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance:

The acceptance criteria are implicitly that the device should not change the performance or safety parameters of the MRI system when compared to using legally marketed predicate devices.

Acceptance Criteria (Implicit)	Reported Device Performance
Maximum Static Magnetic Field: No change	No change
Rate of Magnetic Field Strength Change: No change	No change
RF Power Deposition: No change when used in accordance with operator instructions	No change when used in accordance with operator instructions
Acoustic Noise Levels: No change	No change
Biocompatibility: No change	No change
Specification Volume: No change	No change
Signal-to-Noise Ratio: No change (within measurement error)	No change (within measurement error)
Image Uniformity: No change (within measurement error)	No change (within measurement error)
Geometric Distortion: No change	No change
Slice Thickness and Gap: No change	No change
High Contrast Spatial Resolution: No change	No change

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable/not provided. This is a comparison to predicate devices' specifications, not a study involving a test dataset of patient images.
Data Provenance: Not applicable/not provided.

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

Not applicable. Ground truth for diagnostic performance is not established as this is a device accessory comparison.

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

Not applicable.

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:

No, an MRMC comparative effectiveness study was not done. This device is a passive pediatric positioner, not an AI or diagnostic imaging algorithm.

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

Not applicable. This is a passive medical device accessory, not an algorithm.

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

Not applicable for diagnostic performance. The "ground truth" for this submission is the established safety and performance parameters of the GE Signa 1.5T MRI System when used with legally marketed predicate devices.

8. The sample size for the training set:

Not applicable. This is not an AI/algorithm.

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

Not applicable. This is not an AI/algorithm.

Summary

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4.0 Attachment 2:	510(K) Summary of Safety and Effectiveness
Device Name:	Model 1300GE-64 - Pediatric Positioner
Applicability:	Compatible with GE Signa 1.5T MRI Systems
Reason for 510(k):	New device
Classification Name:	Magnetic Resonance Diagnostic Device
Device Classification Panel:	Radiology
Device Classification Number:	892.1000
Product Code:	90MOS
Common Name:	MRI Accessory
Proprietary Name:	Model 1300GE-64 - Pediatric Positioner
Establishment RegistrationNumber:	2134565
Address of MFG Facility:	Midwest RF, LLC535 Norton DriveHartland, WI 53029
Classification:	Class II
Intended Uses:
Diagnostic Uses:	2D, 3D imaging, proton density, T1 and T2weighted imaging, 2D, 3D time of flight, phasecontrast imaging. Proton spectroscopy.
Anatomic Regions:	Pediatric head, body and extremities.

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Standards:

Performance Standards: None established under Section 514 Voluntary Safety Standards: UL-94 Tests for Flammability of Plastic Materials for Parts in Devices and Appliances International Electrotechnical Commission. IEC-60601-1

IEC-60601-2-33 International Electrotechnical Commission, Part 2: particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis
Requirements for Safety

Medical Electrical Equipment, Part 1: General

Overview

The Radiology Devices Panel considered potential concerns regarding the safe and effective operation of Magnetic Resonance Diagnostic Devices when thev recommended reclassification to Class II on July 27, 1987. After reclassification. the FDA's Center for Devices and Radiological Health (CDRH) released a draft guidance document for the content and review of Magnetic Resonance Diagnostic Device premarket notification submissions that offered clarification of these concerns. Due to considerable technological advances in MRDDs. CDRH issued an updated guidance document on November 14, 1998. The following is a summary of the information contained within this premarket notification that addresses these concerns:

The GE Signa 1.5T MRI System, operated with the Midwest RF Pediatric Positioner, is substantially equivalent to the GE Signa 1.5T MRI System operated with the legally market predicated devices listed in Attachment 8 of this PMN, within the Class II definition of Magnetic Resonance Diagnostic Device with respect to the safety parameter action levels:

Safety Parameters

Maximum Static Magnetic Field: No change

Rate of Magnetic Field Strength Change: No change

Pediatric Positioner

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RF Power Deposition:	No change when used inaccordance with operatorinstructions
Acoustic Noise Levels:	No change
Biocompatibility:	No change
Imaging Performance Parameters
Specification Volume:	No change
Signal-to-Noise Ratio:	No change (within measurementerror)
Image Uniformity:	No change (within measurementerror)
Geometric Distortion:	No change
Slice Thickness and Gap:	No change
High Contrast Spatial Resolution:	No change

General Safety and Effectiveness Concerns

The device contains detailed instructions for use. It includes indications for use, precautions, cautions, contraindications, warnings and quality assurance testing.

Substantial Equivalence Summary

The GE Signa 1.5T MRI System, operated with the Midwest RF Pediatric Positioner addressed in this PMN, has the same intended use and technological characteristics as the GE Signa 1.5T MRI System operated with the legally market predicated devices. The use of this device does not alter the GE Signa 1.5T MRI System safety parameter specifications.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Pediatric Positioner

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 2003

Mr. Helmut Keidl CEO Midwest R.F., LLC 535 Norton Drive HARTLAND WI 53209 Re: K030317 Trade/Device Name: Model 1300GE-64

Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: January 28, 2003 Received: January 30, 2003

Dear Mr. Keidl:

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 r 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 Section 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 the 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" (21CFR Part 807.97) you may obtain. 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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5.0 Statement of Indication for Use Attachment 3:

510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________

Pediatric Positioner, Model # 1300GE-64 Device Name:

Indications For Use:

(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, ENT,and Radiological Devices
510(K) Number

Prescription Use (Per 21 CFR 801.109) OR Over-the Counter Use (Optional Format 1-2-96)

Name	Nancy Brogdon
(Division Sign-Off)Division of Reproductive, Abdominal,and Radiological Devices
510(k) Number	K030317

Pediatric Positioner

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.