(78 days)
Not Found
No
The summary describes a passive RF coil for MRI, which is a hardware component. There is no mention of software, algorithms, or any processing that would suggest AI/ML.
No
The device is used for obtaining diagnostic images, which inherently aids in diagnosis rather than providing therapy.
Yes
The device aids in obtaining diagnostic images, which when interpreted by a trained physician, yield information useful in determining a diagnosis.
No
The device description explicitly states it is a "receive-only phased array RF coil" with "coil elements and accessory electronics enclosed in a rigid plastic housing," indicating it is a hardware component for an MRI system, not software only.
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 Excalibur 9000 TotalSENSE™ Quad Array Head 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.
- Intended Use: The intended use is to obtain diagnostic images of the brain, upper cervical spine, and the soft tissues and vasculature of the head and neck. This is an in vivo (within the living body) diagnostic process, not an in vitro process.
- No Sample Analysis: The device does not analyze samples taken from the body. It interacts directly with the patient's body to acquire data for imaging.
Therefore, the Excalibur 9000 TotalSENSE™ Quad Array Head Coil is a medical device used for in vivo diagnostic imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Excalibur 9000 TotalSENSE™ Quad Array Head Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the brain, upper cervical spine, and the soft tissues and vasculature of the head and neck in Magnetic Resonance Imaging Systems. The Excalibur 9000 TotalSENSE™ Quad Array Head Coil is designed for use with the ExcelArt 1.5T MRI system manufactured by Toshiba Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.
The Excalibur 9000 TotalSENSE™ Quad Array Head Coil is designed to provide Magnetic Resonance Images of the brain, upper cervical spine, and the soft tissues and vasculature of the head and neck. The Excalibur 9000 TotalSENSE™ Quad Array Head Coil is designed for use with the Toshiba 1.5T scanner manufactured by Toshiba Medical Systems.
Anatomic Regions: brain, upper cervical spine, and the soft tissues and vasculature of the head and neck. Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 1.5T 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 Excalibur 9000 TotalSENSE™ Quad Array Head Coil is a multi-element quadrature phased array, receive-only coil. The coil consists of three sections: a main coil base, a sliding head section, and a removable chin coil section. The open, patient friendly 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, upper cervical spine, and the soft tissues and vasculature of the head and neck
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)
Reference Device(s)
Not Found
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
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | Excalibur 9000 TotalSENSE™ Quad Array Head |
| 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 Excalibur 9000 TotalSENSE™ Quad Array |
| Head Coil is a receive-only phased array RF coil, | |
| used for obtaining diagnostic images of the brain, | |
| upper cervical spine, and the soft tissues and | |
| vasculature of the head and neck in Magnetic | |
| Resonance Imaging Systems. The Excalibur 9000 | |
| TotalSENSE™ Quad Array Head Coil is designed for | |
| use with the ExcelArt 1.5T MRI system | |
| manufactured by Toshiba Medical Systems, Inc. The | |
| indications for use are the same as for standard MR | |
| Imaging. | |
| 8. Device Description: | The Excalibur 9000 TotalSENSE™ Quad Array |
| Head Coil is a multi-element quadrature phased | |
| array, receive-only coil. The coil consists of three | |
| sections: a main coil base, a sliding head section, | |
| and a removable chin coil section. The open, patient | |
| friendly 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
1
9. Safety and Effectiveness
| Excalibur 9000 TotalSENSE™ Quad
Array Head Coil | Comparison to predicate device or other 510(k)
cleared products | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Intended Use: Imaging of the brain,
upper cervical spine and the soft
tissues and vasculature of the head and
neck. | -Similar to the Millennium 9000 Phased Array
Neurovascular Coil manufactured by USA
Instruments, Inc. (K001870) | | |
| Indications for Use: Identical to routine
MRI imaging. | -Similar to the Millennium 9000 Phased Array
Neurovascular Coil manufactured by USA
Instruments, Inc. (K001870) | | |
| Coil Enclosure Material:
Acetal
Polycarbonate
Polyurethane | - Similar to the Millennium 9000 Phased Array
Neurovascular Coil manufactured by USA
Instruments, Inc. (K001870)
-Similar to the Profile 7000 Quadrature Volume
Neck Coil manufactured by USA Instruments. Inc.
(K964531) | | |
| Coil Design: Receive-only quadrature
phased array coil. | - Similar to the Millennium 9000 Phased Array
Neurovascular Coil manufactured by USA
Instruments, Inc. (K001870) | | |
| Decoupling: Switching diode
decoupling. | -Similar to the Millennium 9000 Phased Array
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 Phased Array
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 Phased Array
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 Phased Array
Neurovascular Coil manufactured by USA
Instruments, Inc. (K001870) | | |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" around the edge. In the center of the logo is a stylized image of a person with their arms outstretched. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2002
Ms. Christie Shumaker Manager OA and Regulatory USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K022582
Trade/Device Name: Excalibur 9000 TotalSENSE Quad Head Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II
Product Code: 90 MOS Dated: August 2, 2002 Received: August 5, 2002
Dear Ms. Shumaker:
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
Page 2
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. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number (if known): K024582
Device Name: Excalibur 9000 TotalSENSE™ Quad Array Head Coil
Indications for Use: The Excalibur 9000 TotalSENSE™ Quad Array Head Coil is designed to provide Magnetic Resonance Images of the brain, upper cervical spine, and the soft tissues and vasculature of the head and neck. The Excalibur 9000 TotalSENSE™ Quad Array Head Coil is designed for use with the Toshiba 1.5T scanner manufactured by Toshiba Medical Systems.
Anatomic Regions: brain, upper cervical spine, and the soft tissues and vasculature of the head and neck. Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 1.5T 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Nancy Chrogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022582