Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the Head: Magical lobes (hippocampus), internal auditory canals, orbits and anterior optic pathways, I chiporal loocs (inppooaliffalo), interesonance angiography (MRA). Upper Neck: Skull base, Cranio-cervical junction, cervical carotid artery. Upper Extremities: Shoulder, Craino-cavicular (AC) joint, elbow, peripheral nerves. Lower Extremities: Knee, ankle and Achilles tendon, foot. Pediatric applications.

Device Description

Model 235GE-64: Multi Purpose Flex Array Coil. Compatible with GE Signa 1.5T MRI systems with Phased Array option.

AI/ML Overview

The provided documentation details a 510(k) summary for the Model 235GE-64: Multi Purpose Flex Array Coil, a magnetic resonance specialty coil. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, primarily focusing on safety and imaging performance.

Here's an analysis of the acceptance criteria and the study characteristics:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Model 235GE-64 coil are based on demonstrating "no change" compared to the predicate device when used in conjunction with the GE 1.5T Signa MRI system. This implies that the device's performance should be equivalent to that of the predicate, and not degrade the existing system's capabilities.

Parameter	Acceptance Criteria (Expected Performance)	Reported Device Performance (with Model 235GE-64 Coil)
Safety Parameters
Maximum Static Magnetic Field	No change from predicate	No change
Rate of Magnetic Field Change	No change from predicate	No change
RF Power Deposition	No change from predicate	No change
Acoustic Noise Levels	No change from predicate	No change
Biocompatibility	No change from predicate	No change
Imaging Performance Parameters
Specification Volume	No change from predicate	No change
Signal-to-Noise Ratio	No change from predicate	No change
Image Uniformity	No change from predicate	No change
Geometric Distortion	No change from predicate	No change
Slice Thickness and Gap	No change from predicate	No change
High Contrast Spatial Resolution	No change from predicate	No change

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for any test set (e.g., number of patients, number of images). It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective nature). The evaluation appears to be based on engineering and performance testing against established MRI system specifications rather than clinical data from a specific test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the involvement of experts to establish a ground truth for a test set. This type of FDA submission (510(k) for a coil) typically relies on technical specifications and comparisons rather than expert-derived ground truth from a clinical study.

4. Adjudication Method for the Test Set

As no specific test set requiring expert ground truth is described, there is no mention of an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described in this 510(k) summary. The study focuses on the coil's technical performance and safety equivalence, not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

This device is a magnetic resonance imaging coil, not an AI algorithm. Therefore, a standalone (algorithm only) performance study was not performed.

7. Type of Ground Truth Used

The "ground truth" for this submission is implicitly the performance specifications and safety limits of the predicate MRI system and its existing coils. The goal is to demonstrate that the new coil does not degrade these established parameters. There is no mention of pathology, outcome data, or expert consensus used as ground truth in a clinical sense.

8. Sample Size for the Training Set

Since this is a physical medical device (an MRI coil) and not an AI algorithm, there is no concept of a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this question is not applicable.

Summary

{0}------------------------------------------------

AUG 1 4 2001

510(k) Summary of Safety and Effectiveness

K011608

Device Name

Applicability

Reason for 510(k)

Classification Name

Device Classification Panel

Device Classification Number

Product Code

Common Name

Proprietary Name

Establishment Registration Number

Address of MFG Facility

Model 235GE-64: Multi Purpose Flex Array Coil

Compatible with GE Signa 1.5T MRI systems with Phased Array option

New indication for use

Magnetic Resonance Diagnostic Device

Radiology

892.1000

90MOS

Magnetic Resonance Specialty

Model 235GE-64: Multi Purpose Flex Array Coil

2183683

Device manufactured for IGC-Medical Advances Inc. and UltraImage Corporation by:

SeaMED Corporation 21621 30th Avenue N.E. Bothell, WA 98021 Telephone: 425.482.1300 Facsimile: 425.482.1401 Establishment Registration Number: 3031699

Contact: Ms. Marcia Page, VP, Quality and Regulatory Affairs

{1}------------------------------------------------

Points of Contact

Classification

Intended Uses

Diagnostic Uses

Anatomic Regions

Standards

Performance Standards

Voluntary Safety Standards

IGC-Medical Advances Inc. Michael J. Leigh Director of Operations 414.258.3808 Ext. 206

UltraImage Corporation, a Pathway Medical Technologies Company Louise C. Myers Senior Director, Regulatory Affairs 425.497.0372

Class II

2D, 3D imaging, proton density, T1 and T2 weighted imaging. 2D, 3D time of flight, phase contrast imaging.

Head: Temporal lobes (hippocampus), internal auditory canals, orbits and anterior optic pathways, cranial nerves, intracranial magnetic resonance angiography (MRA) Upper Neck: Skull base, Cranio-cervical junction, cervical carotid artery Upper Extremities: Shoulder, acromioclavicular (AC) joint, elbow, peripheral nerves Lower Extremities: Knee, ankle and Achilles tendon, foot Pediatric applications.

None Established under Section 514

UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety
Tests for Flammability of Plastic UL 94 Materials

General Safety Requirements for IEC 601-1 Medical Electrical Equipment

Specification for Flame Resistant CPAI-84 Material Used in Camping Tentage

{2}------------------------------------------------

Overview

The Radiology Devices Panel considered potential concerns regarding the safe and effective The Nadlorgy Devices Funer combiness when they recommended reclassification operation of Magnetic 1080. After reclassification, the FDA's Center for Devices and to Class if on July 21, 1984) released a draft guidance document for the content and review of Magnetic Resonance Diagnostic Device premarket notification submissions that offered Magical resollance Diagnoute De to considerable technological advances in MRDDs, CDRH Clarineation of these concerns. Due it on November 14, 1998. The following is a summary of Issued an updated gurdained within this premarket notification that addresses these concerns:

The GE 1.5T Signa MRI system operated with the Medical Advances Multi Purpose Flex Array The OL 1.91 bigma MICL of equivalent to the same system operated with the legally marketed predicate devices listed in section 4.0, 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
RF Power Deposition:	No change
Acoustic Noise Levels:	No change
Biocompatibility:	No change

Imaging Performance Parameters

Specification Volume:	No change
Signal-to-Noise Ratio:	No change
Image Uniformity:	No change
Geometric Distortion:	No change
Slice Thickness and Gap:	No change
High Contrast Spatial Resolution:	No change

{3}------------------------------------------------

General Safety and Effectiveness Concerns

The device contains instructions for use. It includes indications for use, precautions, cautions, contraindications, warnings and quality assurance testing. This information assures safe and effective use of the device.

Substantial Equivalence Summary

The GE 1.5T Signa MRI system operated with the Medical Advances Multi Purpose Flex Array Coil addressed in this PMN, has the same intended use and technological characteristics as the same system operated with the identified legally marketed predicate devices. The use of these coils does not affect the GE Signa system safety parameter specifications.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2001

Mr. Michael Leigh Director of Operations IGC Medical Advances, Inc. 10437 Innovation Dr. MILWAUKEE WI 53226

Re: K011608

Model 235GE-64: Multi Purpose Flex Array Coil (MRI specialty coil) Dated: May 24, 2001 Received: May 25, 2001-Regulatory Class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Mr. Leigh:

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 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 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) 594-4639. 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 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.

Nancy C. hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure (s)

{5}------------------------------------------------

Page l of l

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Model 235 Series: Medical Advances Multi Purpose Flex Array Coil

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number	K011608
---------------	---------

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.