K Number
K983222
Device Name
PHASED ARRAY CERVICAL SPINE COIL, MODEL #125GE-64
Date Cleared
1998-10-08

(23 days)

Product Code
Regulation Number
892.1000
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the cervical spine, soft tissue and vascular structures of the neck.
Device Description
Model 125GE-64 Phased Array Cervical Spine Coil. Compatible with GE Signa 1.5T MRI systems with Phased Array option.
More Information

Not Found

Not Found

No
The summary describes a physical MRI coil, not software or processing that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or performance studies related to algorithmic performance.

No
The device is described as a "Phased Array Cervical Spine Coil" used for "Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA)". It is a component compatible with MRI systems, which are diagnostic imaging devices, not therapeutic devices. Its purpose is to acquire images, not to treat a condition.

No
The Model 125GE-64 Phased Array Cervical Spine Coil is an accessory used for acquiring MRI and MRA images, not for interpreting those images or making a diagnosis. Its function is to facilitate imaging, not diagnose.

No

The device description clearly states it is a "Phased Array Cervical Spine Coil," which is a hardware component used in MRI systems.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the cervical spine, soft tissue and vascular structures of the neck." This describes an imaging procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
  • Device Description: The device is a "Phased Array Cervical Spine Coil" for use with an MRI system. This is a component of an imaging system, not a device used to analyze biological samples.
  • Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in biological samples
    • Providing information for diagnosis, monitoring, or screening based on sample analysis.

In summary, the device is an accessory for an MRI system, which is an imaging modality used to visualize structures within the body. This falls under the category of medical imaging devices, not in vitro diagnostic devices.

N/A

Intended Use / Indications for Use

Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the cervical spine, soft tissue and vascular structures of the neck.

Product codes (comma separated list FDA assigned to the subject device)

90LNH

Device Description

Model 125GE-64 Phased Array Cervical Spine Coil
Compatible with GE Signa 1.5T MRI systems with Phased Array option

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Magnetic Resonance Imaging (MRI)

Anatomical Site

Cervical spine, soft tissue and vascular structures of the neck.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The Radiology Devices Panel considered potential concerns regarding the safe and effective operation of Magnetic Resonance Diagnostic Devices when they recommended reclassification to Class II on July 27, 1987. After reclassification, the FDA's Center for Devices and Radiological Health released a draft guidance document for the content and review of Magnetic Resonance Diagnostic Device premarket notification submissions that offered clarification of these concerns. The following is a summary of the information contained within this premarket notification that addresses these concerns:

The GE 1.5T Signa MRI system operated with the Medical Advances Phased Array Cervical Spine Coil is substantially equivalent to the same system 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

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

182222

510(k) Summary of Safety and Effectiveness

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

Point of Contact

Classification

Intended Uses

Diagnostic Uses

Anatomic Regions _____________________________________________________________________________________________________________________________________________________________

Model 125GE-64 Phased Array Cervical Spine Coil

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

New device

Magnetic Resonance Diagnostic Device

Radiology

892.1000

90LNH

Magnetic Resonance Imaging Coil

Model 125GE-64 Phased Array Cervical Spine Coil

2183683

Medical Advances, Inc. 10437 Innovation Drive Milwaukee, WI 53226

Thomas E. Tynes Vice President - Operations (414) 258-3808 Ext. 407

Class II

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

Cervical spine, soft tissue and vascular structures of the neck.

1

Standards

Performance StandardsNone Established under Section 514
Voluntary Safety StandardsUL 544Medical and Dental Equipment
UL 94Tests for Flammability of Plastic
Materials
IEC 601-1General Safety Requirements for
Medical Electrical Equipment
CPAI-84Specification for Flame Resistant
Material Used in Camping Tentage

Overview

The Radiology Devices Panel considered potential concerns regarding the safe and effective operation of Magnetic Resonance Diagnostic Devices when they recommended reclassification to Class II on July 27, 1987. After reclassification, the FDA's Center for Devices and Radiological Health released a draft guidance document for the content and review of Magnetic Resonance Diagnostic Device premarket notification submissions that offered clarification of these concerns. The following is a summary of the information contained within this premarket notification that addresses these concerns:

The GE 1.5T Signa MRI system operated with the Medical Advances Phased Array Cervical Spine Coil is substantially equivalent to the same system 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

2

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

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 Phased Array Cervical Spine 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 this coil does not affect the GE Signa system safety parameter specifications.

3

Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1098 OCT

Thomas E. Tynes Vice President-Operations Medical Advances, Inc. 10437 Innovation Drive Milwaukee, WI 53226

Re: K983222

Phased Array Cervical Spine Coil (Model 125GE-64) Dated: September 14, 1998 Received: September 15, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Mr. Tynes:

We have reviewed your Section 510/12 notification of intent to market the device referenced above and we have deiermined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drag 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/odri/dsmaldsmamain.html".

Sincerely yours,

William Yin

Director, Division of Reproductiv Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

Page ___ 1___ of ___ 1 ___ 1

510(k) Number (if known): _ 《98 3 2 2 2 2 - --------

Device Name:___________ Model 125 Series: Phased Array Cervical Spine Coil

Indications for Use:

Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the cervical spine, soft tissue and vascular structures of the neck.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Symm

(Division Sign-Off) 4 Division of Reproductive, Abdominal, ENT, and Radiological Devis 510(k) Number

Prescription Use
(Per 21 CFR 801.109) ✓

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)