MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL

K011608 · Medical Advances, Inc. · MOS · Aug 14, 2001 · Radiology

Device Facts

• Record ID: K011608
• Device Name: MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL
• Applicant: Medical Advances, Inc.
• Product Code: MOS · Radiology
• Decision Date: Aug 14, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the 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.

Device Story

Model 235GE-64 Multi Purpose Flex Array Coil is a specialized accessory for GE Signa 1.5T MRI systems. Device functions as a phased array receiver coil to capture magnetic resonance signals from specific anatomical regions: head, neck, and extremities. Coil is placed on or around the patient; it detects RF signals generated during the MRI scan sequence. Signals are transmitted to the host MRI system for image reconstruction. Used in clinical radiology settings by trained MRI technologists or radiologists. Output is processed into 2D/3D images, including proton density, T1/T2 weighted, time-of-flight, and phase contrast sequences. Clinicians use these images to visualize anatomy and pathology, aiding in diagnostic decision-making. Device provides high-resolution imaging capabilities for various joints and nerves, potentially improving diagnostic accuracy for musculoskeletal and neurological conditions.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and comparison of safety and imaging performance parameters against the predicate system configuration.

Technological Characteristics

Phased array receiver coil designed for GE Signa 1.5T MRI systems. Materials include flame-resistant CPAI-84 material. Complies with UL 2601-1 (Medical Electrical Equipment safety) and UL 94 (flammability). Operates as a passive signal receiver within the MRI environment. No internal energy source; connectivity is via proprietary interface to the GE Signa system.

Indications for Use

Indicated for MRI and MRA imaging of the head, upper neck, upper extremities, and lower extremities in patients, including pediatric populations, requiring diagnostic imaging of specified anatomical regions.

Regulatory Classification

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).

Special Controls

*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.

Submission Summary (Full Text)

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# 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: [phone] Facsimile: 425.482.1401 Establishment Registration Number: 3031699

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

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#### 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

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#### 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 |

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#### 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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)

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Page l of l

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

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

Indications for Use:

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.

(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)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96