(43 days)
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No
The summary describes a body coil for an MRI system, which is a hardware component. There is no mention of software, algorithms, or any terms related to AI/ML.
No
The device is a body coil for an MRI system, which is used for diagnostic imaging rather than treating a medical condition. Its intended use states "magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA)."
Yes
This device, a body coil for an MRI system, is used to acquire images for diagnostic purposes. The "Summary of Performance Studies" explicitly states that it falls "within the Class II definition of Magnetic Resonance Diagnostic Device."
No
The device description explicitly states it is a "RAPID Body 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The provided information describes a magnetic resonance imaging (MRI) coil. This is a component of an MRI system used to generate and receive radiofrequency signals to create images of the inside of the body.
- Intended Use: The intended use is for imaging of anatomical structures within the body. This is an in vivo (within the living body) diagnostic imaging procedure, not an in vitro test on a sample.
The device is a tool used in a medical imaging procedure, which is distinct from an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures within the anatomic regions from the chest to the pelvic region.
Product codes
90MOS
Device Description
Model 554HI-12 RAPID Body Coil Compatible with Hitachi AIRIS-Elite MR Systems
Mentions image processing
2D, 3D imaging, proton density, T1 and T2 weighted imaging. 2D, 3D time-of-flight, phase contrast imaging, RAPID (parallel imaging) compatibility.
Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
From the chest to the pelvic region -- including, but not limited to the liver, spleen, pancreas, gallbladder, peritoneum, renal/adrenal structures, torso vasculature, bladder, uterus, ovaries, and prostate. Additionally, musculoskeletal structures, soft tissue and vascular structures within the anatomic regions from the chest to the pelvic region.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.
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Image /page/0/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically 'K033292'. The characters are written in a bold, sans-serif font, and they appear to be handwritten or printed with a slightly rough or uneven texture. The sequence is presented in a single line, with each character clearly distinguishable.
NOV 2 6 2003
510(k) Summary of Safety and Effectiveness
| Device Name | Model 554HI-12 RAPID Body Coil |
|---|---|
| Applicability | Compatible with Hitachi AIRIS-Elite MR Systems |
| Reason for 510(k) | New device |
| Classification Name | Magnetic Resonance Diagnostic Device |
| Device Classification Panel | Radiology |
| Device Classification Number | 892.1000 |
| Product Code | 90MOS |
| Common Name | Magnetic Resonance Imaging Coil |
| Proprietary Name | Model 554HI-12 RAPID Body Coil |
| Establishment Registration Number | 2183683 |
| Address of MFG Facility | IGC-Medical Advances Inc. |
| 10437 Innovation Drive | |
| Milwaukee, WI 53226 | |
| Point of Contact | Anthony Dietzler |
| Quality Assurance Engineer | |
| (414) 258-3808 Ext. 255 | |
| 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, RAPID (parallel imaging) | |
| compatibility. | |
| Anatomic Regions | From the chest to the pelvic region -- including, but |
| not limited to the liver, spleen, pancreas, | |
| gallbladder, peritoneum, renal/adrenal structures, | |
| torso vasculature, bladder, uterus, ovaries, and | |
| prostate. |
1
Standards
Performance Standards
Voluntary Safety Standards
| None Established under Section 514 | |
|---|---|
| UL 2601-1 | Medical Electrical Equipment, Par |
| General Requirements for Safety | |
| UL 94 | Tests for Flammability of Plastic |
| Materials |
I.
IEC 601-1 General 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 (CDRH) released a draft guidance document for the content and review of Magnetic Resonance Diagnostic Device premarket notification submissions that offered clarification of these concerns. Due to considerable technological advances in MRDDs, CDRH issued an updated guidance document on November 14, 1998. The following is a summary of the information contained within this premarket notification that addresses these concerns:
The Hitachi AIRIS-Elite 0.3T MRI system, operated with the Medical Advances RAPID Body Coil, is substantially equivalent to the GE Signa 0.5T 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 due to coil |
|---|---|
| Rate of Magnetic Field Strength Change: | No change due to coil |
| RF Power Deposition: | No change |
| Acoustic Noise Levels: | No change due to coil |
| Biocompatibility: | No change |
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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 Hitachi AIRIS-Elite 0.3T MRI system operated with the Medical Advances RAPID Body Coil addressed in this PMN, has the same intended use and technological characteristics as the GE Signa 1.5T system operated with the identified legally marketed predicate device. The use of this coil does not affect the Hitachi AIRIS-Elite 0.3T system safety parameter specifications.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines that suggest the head, body, and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 26 2003
Mr. R. Jerry Frohlich Manager IGC Medical Advances, Inc. 10437 Innovation Drive MILWAUKEE WI 53226
Re: K033292
Trade/Device Name: Airis-Elite Rapid Body Coil Model 554HI-12 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: October 10, 2003
Received: October 27, 2003
Dear Mr. Frohlich:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): Ko 3 32 92
Model 554HI-12: 0.3T RAPID Body Coil Device Name:
Indications for Use:
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures within the anatomic regions from the chest to the pelvic region.
(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, and Radiological Devices | |
|---|---|
| 510(k) Number | K033292 |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|