(79 days)
No
The summary describes a passive RF coil for MRI, which is a hardware component for signal acquisition, not a software or processing device that would typically incorporate AI/ML. There is no mention of AI, ML, or image processing capabilities.
No
The device is described as being used for obtaining diagnostic images and yielding information useful in determining a diagnosis, not for treating a condition.
Yes
The device obtains "diagnostic images" and provides "information that can be useful in the determination of a diagnosis" when interpreted by a trained physician.
No
The device description clearly states it is a "receive-only phased array RF coil" composed of "flexible and rigid plastic housings" enclosing "coil elements and accessory electronics," indicating it is a hardware device.
Based on the provided information, the Prima III TotalSENSE Torso Coil is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of disease.
- Device Function: The Prima III TotalSENSE Torso 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 interact with or analyze biological specimens.
- Intended Use: The intended use is to obtain diagnostic images of internal anatomy using Magnetic Resonance Imaging. This is an in vivo (within the living body) imaging technique, not an in vitro (outside the living body) diagnostic test.
Therefore, the Prima III TotalSENSE Torso Coil is a medical device used for diagnostic imaging, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Prima III TotalSENSE Torso Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the abdominal and pelvic anatomy, including the liver, spleen, and renal arteries in Magnetic Resonance Imaging Systems. The Prima III TotalSENSE Torso Coil is designed for use with the Intera 3.0T MRI system manufactured by Philips Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.
The Prima III TotalSENSE Torso Coil is designed to provide Magnetic Resonance Images of the abdominal and pelvic anatomies. The Prima III TotalSENSE Torso Coil is designed for use with the Philips Intera 3.0T MRI scanner manufactured by Philips Medical Systems, Inc.
Anatomic Regions: the abdominal and pelvic anatomy, including the liver, spleen, and renal arteries
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.
Product codes
90 MOS
Device Description
The Prima III TotalSENSE Torso Coil is a six channel receive only phased array coil. The coil is composed of a flexible top and a rigid bottom piece which allow 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
abdominal and pelvic anatomy, including the liver, spleen, and renal arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
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Image /page/0/Picture/0 description: The image contains the text "k03 1365". The text is written in a handwritten style. The numbers are written in a clear and legible manner.
JUL 1 8 2003
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name: | Prima III TotalSENSE Torso 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 Prima III TotalSENSE Torso Coil is a receive- |
| only phased array RF coil, used for obtaining | |
| diagnostic images of the abdominal and pelvic | |
| anatomy, including the liver, spleen, and renal | |
| arteries in Magnetic Resonance Imaging Systems. | |
| The Prima III TotalSENSE Torso Coil is designed for | |
| use with the Intera 3.0T MRI system manufactured | |
| by Philips Medical Systems, Inc. The indications for | |
| use are the same as for standard MR Imaging. | |
| 8. Device Description: | The Prima III TotalSENSE Torso Coil is a six |
| channel receive only phased array coil. The coil is | |
| composed of a flexible top and a rigid bottom piece | |
| which allow 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. |
Please turn over
1
| Prima III TotalSENSE Torso Coil Product
Features | Comparison to predicate device or other 510(k)
cleared products |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: imaging of the abdominal
and pelvic anatomy, including the liver,
spleen, and renal arteries | -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. | -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 shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized bird or human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2003
Ms. Christie Shumaker Manager, QA and Regulatory USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K031365
Trade/Device Name: Prima III TotalSENSE Torso Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: April 28, 2003
Received: May 5, 2003
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 t 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):__Ko_3 i 3 ك
Device Name: Prima III TotalSENSE Torso Coil
Indications for Use: The Prima III TotalSENSE Torso Coil is designed to provide Magnetic Resonance Images of the abdominal and pelvic anatomies. The Prima III TotalSENSE Torso Coil is designed for use with the Philips Intera 3.0T MRI scanner manufactured by Philips Medical Systems, Inc.
| Anatomic Regions: the abdominal and pelvic anatomy, including the | |
|---|---|
| liver, spleen, and renal arteries | |
| 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)
Prescription Use OR (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 K031365