(81 days)
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Not Found
No
The document describes an MRI coil, which is a hardware component for image acquisition, and does not mention any software or processing capabilities that would involve AI/ML.
No
This device is described as an MRI coil used for imaging various anatomical sites, including pediatric applications. Its intended use is for diagnostics (MRI/MRA), not for treating conditions.
No
Explanation: This device is a Multi Purpose Flex Array Coil for MRI systems, which is an accessory used to acquire imaging data. While MRI is a diagnostic imaging modality, the coil itself does not interpret or diagnose; it facilitates the acquisition of images that a physician then interprets for diagnosis.
No
The device description explicitly states "Multi Purpose Flex Array 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a "Multi Purpose Flex Array Coil" used for Magnetic Resonance Imaging (MRI) and Magnetic Resonance Angiography (MRA). These are imaging techniques that create pictures of the inside of the body using magnetic fields and radio waves.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples. Its function is to acquire imaging data from the patient's body directly.
Therefore, this device falls under the category of medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
90MOS
Device Description
Model 235GE-64: Multi Purpose Flex Array Coil
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA)
Anatomical Site
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
Indicated Patient Age Range
Pediatric applications.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The GE 1.5T Signa MRI system operated with the Medical Advances Multi Purpose Flex Array Coil is 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
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 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
AUG 1 4 2001
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
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:
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