(32 days)
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 "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No.
The device is described as a "Phased Array Musculoskeletal Flex Coil Package" used for "Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA)". Its purpose is to acquire images, not to treat a medical condition.
Yes
The device is described as a coil package compatible with MRI systems for imaging various anatomical structures, and MRI/MRA are diagnostic imaging modalities used to detect, diagnose, and monitor diseases.
No
The device description explicitly states it is a "Phased Array Musculoskeletal Flex Coil Package" consisting of physical coils, which are hardware components 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 anatomical structures. This is an in vivo imaging technique, meaning it is performed on a living organism.
- Device Description: The device is a coil package used with an MRI system. MRI coils are components of the imaging equipment, not devices used to test samples of bodily fluids or tissues outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Use in a laboratory setting
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used to create images of the body directly.
N/A
Intended Use / Indications for Use
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the bones, soft tissue, musculoskeletal structures and vascular structures of the upper and lower extremities.
Product codes (comma separated list FDA assigned to the subject device)
90LNH, 90MOS
Device Description
Model 545GE-64 Phased Array Musculoskeletal Flex Coil Package consisting of Model 543GE-64 Phased Array Upper Extremity Flex Coil and Model 544GE-64 Phased Array Lower Extremity Flex 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
Bones, soft tissue, musculoskeletal structures and vascular structures in the upper and lower extremities
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): 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
K983/09
510(k) Summary of Safety and Effectiveness
| Labels | Values |
|---|---|
| Device Name | Model 545GE-64 Phased Array Musculoskeletal Flex Coil Package consisting of Model 543GE-64 Phased Array Upper Extremity Flex Coil and Model 544GE-64 Phased Array Lower Extremity Flex Coil |
| Applicability | Compatible with GE Signa 1.5T MRI systems with Phased Array option |
| Reason for 510(k) | New device |
| Classification Name | Magnetic Resonance Diagnostic Device |
| Device Classification Panel | Radiology |
| Device Classification Number | 892.1000 |
| Product Code | 90LNH |
| Common Name | Magnetic Resonance Imaging Coil |
| Proprietary Name | Model 545GE-64 Phased Array Musculoskeletal Flex Coil Package consisting of Model 543GE-64 Phased Array Upper Extremity Flex Coil and Model 544GE-64 Phased Array Lower Extremity Flex Coil |
| Establishment Registration Number | 2183683 |
| Address of MFG Facility | Medical Advances, Inc. 10437 Innovation Drive Milwaukee, WI 53226 |
| Point of Contact | Thomas E. Tynes Vice President - Operations (414) 258-3808 Ext. 407 |
| Classification | Class II |
| Intended Uses | |
| Diagnostic Uses | 2D, 3D imaging, proton density, T1 and T2 weighted imaging. 2D, 3D time of flight, phase contrast imaging. |
1
Anatomic Regions
Bones, soft tissue, musculoskeletal structures and * vascular structures in the upper and lower extremities
Standards
| Performance Standards | None Established under Section 514 | |
|---|---|---|
| Voluntary Safety Standards | UL 544 | Medical and Dental Equipment |
| UL 94 | Tests for Flammability of Plastic | |
| Materials | ||
| IEC 601-1 | General Safety Requirements for | |
| Medical Electrical Equipment | ||
| CPAI-84 | Specification 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 Musculoskeletal Flex Coil Package is substantially 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 |
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 Musculoskeletal Flex Coil Package 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.
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 an abstract design of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 6 10008
Thomas E. Tynes Vice President-Operations Medical Advances. Inc. 10437 Innovation Drive Milwaukee, WI 53226
Re: K983109
Model 545GE-64 Phased Array Musculoskeletal Flex Coil Package consisting of Model 543GE-64 Dated: September 3, 1998 Received: September 4, 1998 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 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 Fecteral 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 Ouality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic OS 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 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. "Misoranding 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/oddfb/dsmaldsmam.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph, D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): 长983009
Device Name: Model 545 Series: Phased Array Musculoskeletal Flex Coil Package consisting of 543 Series Phased Array Upper Extremity Flex Coil and 544 Series Phased Array Lower Extremity Coil
Indications for Use:
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the bones, soft tissue, musculoskeletal structures and vascular structures of the upper and lower extremities.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Gamil H. Siganon
(Division Sign-Off) Division of Reproductive, Abdominal, B and Radiological Deyi 510(k) Number
Prescription Use _ X (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)