(79 days)
No
The document describes a passive RF coil for MRI, which is a hardware component for signal reception. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The description focuses on the physical design and function of the coil.
No
The device is described as a receive-only RF coil used for obtaining diagnostic images, which is an imaging function, not a therapeutic one. It yields information for diagnosis, not treatment.
No
The device is a receive-only coil for an MRI system, which produces images. The "intended use" states that a "trained physician" can interpret these images to "yield information that can be useful in the determination of a diagnosis," but the device itself does not perform the diagnosis.
No
The device description clearly states it is a physical coil with enclosed electronics and rigid plastic housing, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are 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 Neurovascular Coil is a component of an MRI system. Its function is to receive radiofrequency signals from the patient's body during an MRI scan to create images. It does not analyze biological specimens.
- Intended Use: The intended use is to obtain diagnostic images of the brain, cervical spine, soft tissues, and vasculature. This is a function of an imaging device, not an IVD.
- Input: The input is the patient's body within the MRI scanner, not a biological specimen.
- Output: The output is diagnostic images, not the results of a laboratory test on a specimen.
The device is clearly described as a component of an MRI system used for in vivo imaging (imaging within the living body), which is distinct from in vitro diagnostics (diagnostics performed outside the body on specimens).
N/A
Intended Use / Indications for Use
The Neurovascular Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest extending to the cardiac region in Magnetic Resonance Imaging Systems. The Millennium 5000 Neurovascular Coil is designed for use with the Altaire 0.7T MRI system manufactured by Hitachi Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.
The Millennium 5000 Phased Array Neurovascular Coil is designed to provide Magnetic Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest. The Millennium 5000 Phased Array Neurovascular Coil is designed for use with the Altaire 0.7T scanner manufactured by Hitachi Medical Systems.
The 0.7T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
Product codes
90 MOS
Device Description
The Millennium 5000 Phased Array Neurovascular Coil is a 4-element quadrature phased array, receive-only coil. The coil consists of three sections: a main coil base, an open designed head former, and a detachable chest plate. The split-top, three piece design minimizes claustrophobic effects and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest extending to the cardiac region, head and whole body.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Per 21 CFR 801.109). When interpreted by a trained physician.
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)
Reference Device(s)
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
Koz 1141
JUN 2 7 2002
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | Millennium 5000 Phased Array Neurovascular Coil |
| 3. Classification : | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc., |
| 1515 Danner Drive | |
| Aurora, Ohio 44202, USA | |
| Telephone: 330-562-1000; Fax: 330-562-1422. | |
| 6. Performance Standard: | No applicable performance standards have been |
| issued under Section 514 of the Food, Drug and | |
| Cosmetic Act. | |
| 7. Intended Use: | The Neurovascular Coil is a receive-only phased |
| array RF coil, used for obtaining diagnostic images | |
| of the brain, cervical spine, soft tissues and | |
| vasculature of the head, neck and upper chest | |
| extending to the cardiac region in Magnetic | |
| Resonance Imaging Systems. The Millennium 5000 | |
| Neurovascular Coil is designed for use with the | |
| Altaire 0.7T MRI system manufactured by Hitachi | |
| Medical Systems, Inc. The indications for use are | |
| the same as for standard MR Imaging. | |
| 8. Device Description: | The Millennium 5000 Phased Array Neurovascular |
| Coil is a 4-element quadrature phased array, | |
| receive-only coil. The coil consists of three sections: | |
| a main coil base, an open designed head former, | |
| and a detachable chest plate. The split-top, three | |
| piece design minimizes claustrophobic effects and | |
| maximizes patient comfort. The coil elements and | |
| accessory electronics are enclosed in a rigid plastic | |
| housing, which is fire rated and has a high impact | |
| and tensile strength. |
Please turn over
USA Instruments, Inc.
1
9. Safety and Effectiveness
| Millennium 5000 Phased Array
Neurovascular Coil product features | Comparison to predicate device or other 510(k)
cleared products |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: Imaging of the brain,
cervical spine, soft tissues and
vasculature of the head, neck, and
upper chest | -Similar to the Millennium 9000 Neurovascular Coil
manufactured by USA Instruments, Inc. (K001870)
-Similar to the Medrad PA Neurovascular Coil
manufactured by Medrad, Inc.(K984257) |
| Indications for Use: Identical to routine
MRI imaging | -Similar to the Millennium 9000 Neurovascular Coil
manufactured by USA Instruments, Inc. (K001870) |
| Coil Enclosure Material:
Polyurethane
Polycarbonate | -Similar to the Magna 5000 PA CTL Spine Coil
manufactured by USA Instruments, Inc.(K994345
& K000002)
-Similar to the Millennium 9000 Neurovascular Coil
manufactured by USA Instruments, Inc. (K001870) |
| Coil Design: Receive-only phased
array coil | -Similar to the Millennium 9000 Neurovascular Coil
manufactured by USA Instruments, Inc. (K001870) |
| Decoupling: Switching diode
decoupling | -Similar to the Millennium 9000 Neurovascular Coil
manufactured by USA Instruments, Inc. (K001870) |
| Prevention of RF Burns: Does not
transmit RF power; decoupling isolates
the coil elements from RF fields during
RF transmission; coil elements and
circuitry are enclosed in a non-
conductive housing. | -Similar to the Millennium 9000 Neurovascular Coil
manufactured by USA Instruments, Inc. (K001870) |
| Radio Frequency Absorption: Coil is a
receive only coil and does not transmit
RF power. | -Similar to the Millennium 9000 Neurovascular Coil
manufactured by USA Instruments, Inc. (K001870) |
| Formation of Resonant Loop:
Decoupling isolates the coil elements
from RF fields during RF transmission;
length of cable and stiffness does not
permit looping | -Similar to the Millennium 9000 Neurovascular Coil
manufactured by USA Instruments, Inc. (K001870) |
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, with three curved lines above them, resembling a stylized wing or banner.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2002
Re: K021141
Trade/Device Name: Millennium 5000 Phased Arrav Neurovascular Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II
Product Code: 90 MOS Dated: April 8, 2002 Received: April 9, 2002
Dear Ms. Shumaker:
Ms. Christie Shumaker
USA Instruments, Inc ·
AURORA OH 44202
1515 Danner Drive
OA and Regulatory Manager
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 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.
3
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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
4
510(k) Number (if known):_
Device Name: Millennium 5000 Phased Array Neurovascular Coil
Indications for Use: The Millennium 5000 Phased Array Neurovascular Coil is designed to provide Magnetic Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest. The Millennium 5000 Phased Array Neurovascular Coil is designed for use with the Altaire 0.7T scanner manufactured by Hitachi Medical Systems.
Anatomic Regions: Soft tissues and vasculature of the head, neck and upper chest. Hydrogen Nuclei Excited:
The indications for use are the same as for standard imaging:
The 0.7T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use | ✓ (Per 21 CFR 801.109) |
|---|---|
| OR | |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K021141 |
|---|---|
| --------------- | --------- |
Concurrence of CDRH, Office of Device Evaluation (ODE)