(25 days)
Not Found
No
The summary describes a passive receive-only coil for MRI, focusing on its physical design and intended use for image acquisition, with no mention of AI/ML processing or analysis of the acquired images.
No.
The device is used to produce images for diagnostic purposes, not for treating a condition or disease.
Yes.
Explanation: The device produces images that, when interpreted by a trained physician, yield information useful in determining a diagnosis.
No
The device description explicitly states it is a "multi-element phased array receive-only coil" enclosed in a plastic housing, indicating it is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to produce magnetic resonance images of the body. It is used in conjunction with an MRI system to visualize anatomical structures.
- Mechanism of Action: The device is a coil that receives magnetic resonance signals from the body. It does not perform any tests on biological samples (like blood, urine, or tissue) outside of the body.
- IVD Definition: IVD devices are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This is typically done by examining specimens derived from the human body.
This device is an imaging accessory used in conjunction with an MRI system, which is a medical imaging device. It is not designed to perform in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The Millennium III 3T 8-Channel 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 in Magnetic Resonance Imaging Systems. The Millennium III 3T 8-Channel Neurovascular Coil is designed for use with the 3.0T MRI systems manufactured by GE Medical Systems.
The Millennium III 3T 8-Channel 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 III 3T 8-Channel Neurovascular Coil is designed for use with the GE 3.0T scanner manufactured by GE Medical Systems, Inc.
The indications for use are the same as for standard imaging:
The 3.0T 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) display parameters (proton density, spin lattice relaxation time Ti, spin spin relaxation time T2) and (3) display the soft tissue structure of the body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
The Millennium III 3T 8-Channel Neurovascular Coil is a multi-element phased array receive-only coil. The coil is shaped to conform to the contours of the head and spine and has been designed to maximize comfort and ease of use. The elements and associated circuitry are enclosed in a housing made of plastic materials, which are fire rated and have 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
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.
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
Image /page/0/Picture/0 description: The image contains a sequence of alphanumeric characters, seemingly handwritten. The sequence starts with the letter 'K', followed by the number '04', and then the number '2342'. The characters are written in a dark, bold font, which contrasts with the light background.
SEP 2 4 2004
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name: | Millennium III 3T 8-Channel 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 Millennium III 3T 8-Channel 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 in Magnetic Resonance Imaging | |
| Systems. The Millennium III 3T 8-Channel | |
| Neurovascular Coil is designed for use with the 3.0T | |
| MRI systems manufactured by GE Medical Systems. | |
| 8. Device Description: | The Millennium III 3T 8-Channel Neurovascular Coil |
| is a multi-element phased array receive-only coil. | |
| The coil is shaped to conform to the contours of the | |
| head and spine and has been designed to maximize | |
| comfort and ease of use. The elements and | |
| associated circuitry are enclosed in a housing made | |
| of plastic materials, which are fire rated and have | |
| high impact and tensile strength. |
1
9. Safety and Effectiveness:
| Millennium III 3T 8-Channel
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 Phased Array
Neurovascular coil manufactured by USA Instruments,
Inc. (K001807) |
| Indications for Use: Identical to
routine MRI imaging | -Similar to the Millennium 9000 Phased Array
Neurovascular coil manufactured by USA Instruments,
Inc. (K001807) |
| Coil Enclosure Material:
Flame Retardant Polyurethane
Flame Retardant Polycarbonate
Delrin Acetal | -Similar those used in the Excalibur 9000 Total
SENSE Quad Array Head Coil (K022582) and QD
Head Speeder with NV Attachment (K041487), both
manufactured by USA Instruments, Inc. |
| Coil Design: Receive-only phased
array coil | -Similar to the Millennium 9000 Phased Array
Neurovascular coil manufactured by USA Instruments,
Inc. (K001807) |
| Decoupling: Switching diode
decoupling | -Similar to the Millennium 9000 Phased Array
Neurovascular coil manufactured by USA Instruments,
Inc. (K001807) |
| 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 Phased Array
Neurovascular coil manufactured by USA Instruments,
Inc. (K001807) |
| Radio Frequency Absorption: Coil is
a receive only coil and does not
transmit RF power | -Similar to the Millennium 9000 Phased Array
Neurovascular coil manufactured by USA Instruments,
Inc. (K001807) |
| 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 Phased Array
Neurovascular coil manufactured by USA Instruments,
Inc. (K001807) |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.
Public Health Service
SEP 2 4 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James Wrenn Manager, QA and Regulatory USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K042342 Trade/Device Name: Millennium III 3T 8-Channel Neurovascular Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II Product Code: 90 MOS Dated: August 27, 2004 Received: August 31, 2004
Dear Mr. Wrenn:
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 I va may, are crore, mains 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 that I Dri has 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 Section 510(k) I ms letter will anow you to obgen finding of substantial equivalence of your device to a legally premaired 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 If you desire specific advice 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 Additionally, for questions on the processe note the regulation entitled, "Misbranding Other of Compliance at (2017 97) 97 100 (21CFR Part 807.97) you may obtain. Other general by receice to premained nonitoansment (er the Act may be obtained from the Division of Small miorination on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Mandraotarors, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brygden
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 III 3T 8-Channel Neurovascular Coil
Indications for Use: The Millennium III 3T 8-Channel Neurovascular Coil is maileations for 0001 face tic Resonance Images of the brain, cervical spine, designed to provide magnetis Noo head, neck, and upper chest. The Millennium Son tissues and Vacoulatare of the I seesigned for use with the GE 3.0T scanner manufactured by GE Medical Systems, Inc.
Anatomic Regions: brain, cervical spine, 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 3.0T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, images that: (1) convolparameters (proton density, spin lattice relaxation time (2) doportu upon rime T2) and (3) display the soft tissue structure of the r r, spin spin rolaxation 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)
| Concurrence of CDHR, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Reproductive, Abdominal, and Radiological Devices | ||
| 510(k) Number | K042342 | |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |