K Number
K991115
Device Name
LINEAR SHOULDER COIL, MODEL 414GE-09
Date Cleared
1999-06-08

(68 days)

Product Code
Regulation Number
892.1000
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Magnetic resonance imaging (MRI) of the shoulder joint and surrounding tissue.
Device Description
Model 414GE-09 Linear Shoulder Coil. Compatible with GE Signa Profile 0.2 T MRI systems.
More Information

Not Found

Not Found

No
The summary describes a passive MRI coil, which is a hardware component used to acquire images. There is no mention of software, algorithms, or any processing that would suggest the use of AI/ML. The performance studies focus on basic imaging parameters of the coil itself.

No
The device is described as a Linear Shoulder Coil for Magnetic Resonance Imaging (MRI) of the shoulder joint. MRI coils are used to create images for diagnostic purposes, not to treat a condition.

No
The device is a coil for an MRI system, which is used for imaging. While imaging can be a part of the diagnostic process, the coil itself does not interpret images or provide a diagnosis. Its function is to facilitate the acquisition of images.

No

The device description explicitly states it is a "Linear Shoulder Coil," which is a hardware component used in MRI systems.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
  • Device Function: The description clearly states the device is a "Linear Shoulder Coil" for "Magnetic resonance imaging (MRI) of the shoulder joint and surrounding tissue." This device is used in conjunction with an MRI system to acquire images directly from the patient's body.
  • No Specimen Analysis: There is no mention of analyzing any biological specimens taken from the patient.

Therefore, based on the provided information, this device is an accessory for an MRI system used for in-vivo imaging, not an in-vitro diagnostic device.

N/A

Intended Use / Indications for Use

Magnetic resonance imaging (MRI) of the shoulder joint and surrounding tissue.

Product codes

90LNH

Device Description

Model 414GE-09 Linear Shoulder Coil. Compatible with GE Signa Profile 0.2 T MRI systems.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Magnetic Resonance Imaging (MRI)

Anatomical Site

Shoulder and other related joint structures.

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)

Not Found

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

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

K991115

JUN = 8 1999

510(k) Summary of Safety and Effectiveness

Device NameModel 414GE-09 Linear Shoulder Coil
ApplicabilityCompatible with GE Signa Profile 0.2 T MRI
systems
Reason for 510(k)New device
Classification NameMagnetic Resonance Diagnostic Device
Device Classification PanelRadiology
Device Classification Number892.1000
Product Code90LNH
Common NameMagnetic Resonance Imaging Coil
Proprietary NameModel 414GE-09 Linear Shoulder Coil
Establishment Registration Number2183683
Address of MFG FacilityIGC Medical Advances Inc.
10437 Innovation Drive
Milwaukee, WI 53226
Point of ContactThomas E. Tynes
Vice President - Operations
(414) 258-3808 Ext. 407
ClassificationClass II
Intended Uses
Diagnostic Uses2D, 3D imaging, proton density, T1 and T2
weighted imaging. 2D, 3D time of flight, phase
contrast imaging.
Anatomic RegionsShoulder and other related joint structures.

1

Standards

Performance StandardsNone Established under Section 514
Voluntary Safety StandardsUL 2601-1Medical Electrical Equipment,
Part 1: General Requirements for
Safety
UL 94Tests for Flammability of Plastic
Materials
IEC 601-1General Safety Requirements for
Medical Electrical Equipment

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 Signa Profile 0.2T MRI system operated with the Medical Advances Linear Shoulder Coil is substantially equivalent to the same system operated with the legally marketed predicate device 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 Signa Profile 0.2T MRI system operated with the Medical Advances Linear Shoulder Coil addressed in this PMN, has the same intended use and technological characteristics as the same system operated with the identified legally marketed predicate device. The use of this coil does not affect the GE Signa Profile 0.2T system safety parameter specifications.

3

Public Health Service

Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

DEPARTMENT OF HEALTH & HUM

JUN

Medical Advances, Inc.

10437 Innovation Drive

Milwaukee, Wisconsin 53226

Thomas E. Tynes Vice President, Operations

RE:

K991115 Model 414GE-09 Linear Shoulder Coil Dated: March 25, 1999 Received: April 1, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Mr. Tynes:

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 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/cdrh/dsmaldsmamain.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

4

Page ______________________

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Model 414GE Series: Linear Shoulder Coil

Indications for Use:

Magnetic resonance imaging (MRI) of the shoulder joint and surrounding tissue.

(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) NumberK991115
Prescription Use (Per 21 CFR 801.109)OROver-The-Counter Use (Optional Format 1-2-96)