(47 days)
Not Found
No
The description focuses on the physical components and function of an RF coil for MRI, with no mention of AI or ML for image processing or analysis.
No.
The device is used for obtaining diagnostic images of the cardiovascular system. It produces images that aid in diagnosis, rather than providing therapy.
Yes
The device is used for obtaining "diagnostic images" and the images it produces, "when interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis."
No
The device description clearly states it is a physical coil composed of flexible and rigid plastic housings enclosing coil elements and accessory electronics. This indicates it is a hardware device, 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 Spirit III TotalSENSE Cardiac Coil is an accessory for an MRI system. Its function is to receive radiofrequency signals from the patient's body during an MRI scan to produce images. It does not analyze biological samples.
- Intended Use: The intended use is to obtain diagnostic images of the cardiovascular system and other parts of the body using MRI. These images are then interpreted by a trained physician. This is a form of in vivo (within the living body) diagnostic imaging, not in vitro.
Therefore, the Spirit III TotalSENSE Cardiac Coil falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Spirit III TotalSENSE Cardiac Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the cardiovascular system in Magnetic Resonance Imaging Systems. The Spirit III TotalSENSE Cardiac Coil is designed for use with the Magnetom Trio 3.0T MRI system manufactured by Siemens Medical Solutions, Inc. The indications for use are the same as for standard MR Imaging.
The Spirit III TotalSENSE Cardiac Coil is designed to provide Magnetic Resonance Images of the cardiovascular system. The Spirit III TotalSENSE Cardiac Coil is designed for use with the Siemens Magnetom Trio 3.0T MRI scanner manufactured by Siemens Medical Solutions, 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) 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 (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
The Spirit III TotalSENSE Cardiac Coil is an eight element receive only phased array coil. The coil is composed of a flexible top piece and a rigid bottom piece. The flexible top piece allows for imaging of patients of different sizes. The open, patient friendly design minimizes claustrophobic effects and maximizes patient comfort. The coil elements and accessory electronics are enclosed in flexible and rigid plastic housings, which are fire rated. All rigid plastic housing parts have 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
cardiovascular system, head and whole body.
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
KD24187
SUMMARY OF SAFETY AND EFFECTIVENESS
FEB 0 4 2003
| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name: | Spirit III TotalSENSE Cardiac 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 Spirit III TotalSENSE Cardiac Coil is a receive- |
| only phased array RF coil, used for obtaining | |
| diagnostic images of the cardiovascular system in | |
| Magnetic Resonance Imaging Systems. The Spirit III | |
| TotalSENSE Cardiac Coil is designed for use with | |
| the Magnetom Trio 3.0T MRI system manufactured | |
| by Siemens Medical Solutions, Inc. The indications | |
| for use are the same as for standard MR Imaging. | |
| 8. Device Description: | The Spirit III TotalSENSE Cardiac Coil is an eight |
| element receive only phased array coil. The coil is | |
| composed of a flexible top piece and a rigid bottom | |
| piece. The flexible top piece allows for imaging of | |
| patients of different sizes. The open, patient friendly | |
| design minimizes claustrophobic effects and | |
| maximizes patient comfort. The coil elements and | |
| accessory electronics are enclosed in flexible and | |
| rigid plastic housings, which are fire rated. All rigid | |
| plastic housing parts have a high impact and tensile | |
| strength. |
Please turn over
. . . . . . .
1
| Spirit III TotalSENSE Cardiac Coil Product
Features | Comparison to predicate device or other 510(k)
cleared products |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: imaging of the
cardiovascular system | -Similar to the Vision 5000 Torso Coil manufactured by
USA Instruments, Inc. (K013594).
-Similar to the Insight Plus 9000 Phased Array Torso
and Pelvis Coil manufactured by USA Instruments, Inc.
(K001209). |
| Indications for Use: Identical to routine
MRI imaging. | -Similar to the Vision 5000 Torso Coil manufactured by
USA Instruments, Inc. (K013594).
-Similar to the Insight Plus 9000 Phased Array Torso
and Pelvis Coil manufactured by USA Instruments, Inc.
(K001209). |
| Coil Enclosure Material:
Flame Retardant Polyurethane
Vinyl Coated EVA foam
Flame Retardant Polycarbonate | - Similar to the Mark 5000 Quadrature Shoulder coil
manufactured by USA Instruments, Inc. (K013854) |
| Coil Design: Receive-only phased array
coil. | -Similar to the Insight Plus 9000 Phased Array Torso
and Pelvis Coil manufactured by USA Instruments, Inc.
(K001209). |
| Decoupling: Switching diode decoupling.
Additional RF fuses incorporated. | -Similar to the Insight Plus 9000 Phased Array Torso
and Pelvis Coil manufactured by USA Instruments, Inc.
(K001209). |
| 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 Insight Plus 9000 Phased Array Torso
and Pelvis Coil manufactured by USA Instruments, Inc.
(K001209). |
| Radio Frequency Absorption: Coil is a
receive only coil and does not transmit RF
power. | -Similar to the Insight Plus 9000 Phased Array Torso
and Pelvis Coil manufactured by USA Instruments, Inc.
(K001209). |
| 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 Insight Plus 9000 Phased Array Torso
and Pelvis Coil manufactured by USA Instruments, Inc.
(K001209). |
9. Safety and Effectiveness
.
:
2
Image /page/2/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 eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Christie Shumaker Manager, OA and Regulatory Affairs USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
FEB 0 4 2003
Re: K024187 Trade/Device Name: Spirit III TotalSENSE Cardiac Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: December 16, 2002 Received: December 19, 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
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
4
510(k) Number (if known): _ 长 ○ 2 41 87
Device Name: Spirit III TotalSENSE Cardiac Coil
Indications for Use: The Spirit III TotalSENSE Cardiac Coil is designed to provide Magnetic Resonance Images of the cardiovascular system. The Spirit III TotalSENSE Cardiac Coil is designed for use with the Siemens Magnetom Trio 3.0T MRI scanner manufactured by Siemens Medical Solutions, Inc.
Anatomic Regions: Cardiovascular system Nuclei Excited: Hydrogen
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) 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) OR Over-The-Counter Use Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)