(81 days)
Not Found
No
The document describes standard MRI coils and their intended use for obtaining diagnostic images. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is used for obtaining diagnostic images of the knee and wrist/hand, which are then interpreted by a physician to aid in diagnosis, not for treating a disease or condition.
Yes
The device is used for "obtaining diagnostic images" and the images "yield information that can be useful in the determination of a diagnosis."
No
The device description explicitly states that the device is a "multi-element quadrature transmit-receive coil" with "coil elements and accessory electronics enclosed in a rigid plastic housing." This indicates a physical hardware component, not a software-only device.
Based on the provided text, 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 description clearly states that the Leo III Tx/Rx Quadrature Knee Coil and the Alpha III Tx/Rx Quadrature Wrist Coil are RF coils used in Magnetic Resonance Imaging (MRI) systems. Their purpose is to obtain diagnostic images of the knee, wrist, and hand.
- Imaging Modality: The input imaging modality is explicitly stated as Magnetic Resonance Imaging, which is an in vivo (within the living body) imaging technique, not an in vitro (outside the living body) diagnostic test.
- Intended Use: The intended use is to provide Magnetic Resonance Images that, when interpreted by a trained physician, can be useful in the determination of a diagnosis. This is consistent with medical imaging devices, not IVDs.
The device is a component of an MRI system, which is a medical imaging device used for diagnostic purposes, but it does not perform in vitro diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
The Leo III Tx/Rx Quadrature Knee Coil is a transmit-receive quadrature RF coil, used for obtaining diagnostic images of the knee and surrounding anatomy in Magnetic Resonance Imaging Systems. The Leo III Tx/Rx Quadrature Knee 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 Alpha III Tx/Rx Quadrature Wrist Coil is a transmit-receive quadrature RF coil, used for obtaining diagnostic images of the wrist and hand in Magnetic Resonance Imaging Systems. The Alpha III T/R Quadrature Wrist 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 Leo III Tx/Rx Quadrature Knee Coil is designed to provide Magnetic Resonance Images of the knee and surrounding anatomy. The Alpha III Tx/Rx Quadrature Wrist Coil is designed to provide Magnetic Resonance Images of the wrist and hand. The Leo III Tx/Rx Quadrature Knee Coil and the Alpha III Tx/Rx Quadrature Wrist Coil are designed for use with the Siemens Magnetom Trio 3.0T scanner manufactured by Siemens Medical Solutions.
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 vield 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 Leo III Tx/Rx Quadrature Knee Coil is a multi-element quadrature transmit-receive coil. The coil has a split top design with a latching device and a large open viewing window on the top. The open, patient friendly design eases patient handling and positioning 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.
The Alpha III T/R Quadrature Wrist Coil is a multi-element quadrature transmit-receive coil. The coil has a rigid enclosure with windows on top to facilitate patient handling. The open, patient friendly design eases patient handling and positioning 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
Knee and surrounding anatomy (for Leo III Tx/Rx Quadrature Knee Coil)
Wrist and hand (for Alpha III Tx/Rx Quadrature Wrist Coil)
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.
K002179, K971246, K972205, K001210
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
SUMMARY OF SAFETY AND EFFECTIVENESS
K023982
| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name: | Leo III Tx/Rx Quadrature Knee 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 Leo III Tx/Rx Quadrature Knee Coil is a |
| transmit-receive quadrature RF coil, used for | |
| obtaining diagnostic images of the knee and | |
| surrounding anatomy in Magnetic Resonance | |
| Imaging Systems. The Leo III Tx/Rx Quadrature | |
| Knee 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 Leo III Tx/Rx Quadrature Knee Coil is a multi- |
| element quadrature transmit-receive coil. The coil | |
| has a split top design with a latching device and a | |
| large open viewing window on the top. The open, | |
| patient friendly design eases patient handling and | |
| positioning 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
| Leo III Tx/Rx Quadrature Knee Coil
Product Features | Comparison to predicate device or other 510(k)
cleared products |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: Imaging of the knee and
surrounding anatomy. | - Similar to the Allegra 3.0Tesla TxRx Head coil
manufactured by USA Instruments, Inc. (K002179)
-Similar to the Leo 7000 Knee Coil manufactured
by USA Instruments, Inc. (K971246) |
| Indications for Use: Identical to routine
MRI imaging. | - Similar to the Allegra 3.0Tesla TxRx Head coil
manufactured by USA Instruments, Inc. (K002179)
-Similar to the Leo 7000 Knee Coil manufactured
by USA Instruments, Inc. (K971246) |
| Coil Enclosure Material:
Flame Retardant Polyurethane
Flame Retardant Polycarbonate
Kydex Acyrlic/PVC
Delrin Acetal | - Similar to the Hi-Res 9000 Phased Array Carotid
Coil manufactured by USA Instruments, Inc.
(K001210) |
| Coil Design: 12 z-inductor transmit
receive quadrature coil. | - Similar to the Allegra 3.0Tesla TxRx Head coil
manufactured by USA Instruments, Inc. (K002179) |
| Decoupling: This is a transmit and
receive coil. There is no decoupling, the
Transmit / Receive Switch is actively
switched during transmit and receive
modes. | - Similar to the Allegra 3.0Tesla TxRx Head coil
manufactured by USA Instruments, Inc. (K002179) |
| Prevention of RF Burns: The coil's
transmit /receive switch uses pin diodes
to isolate the receive channel from the
transmit channel; coil elements and
circuitry are enclosed in a non-
conductive housing. | - Similar to the Allegra 3.0Tesla TxRx Head coil
manufactured by USA Instruments, Inc. (K002179) |
| Radio Frequency Absorption: Power
deposition during imaging is limited by
SAR algorithm | - Similar to the Allegra 3.0Tesla TxRx Head coil
manufactured by USA Instruments, Inc. (K002179) |
| Formation of Resonant Loop: Active
diodes and fast RF blowing fuses
isolate the coil elements from RF fields;
length of cable and stiffness does not
permit looping | - Similar to the Allegra 3.0Tesla TxRx Head coil
manufactured by USA Instruments, Inc. (K002179) |
2
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name: | Alpha III Tx/Rx Quadrature Wrist 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 Alpha III Tx/Rx Quadrature Wrist Coil is a |
| transmit-receive quadrature RF coil, used for | |
| obtaining diagnostic images of the wrist and hand in | |
| Magnetic Resonance Imaging Systems. The Alpha | |
| III T/R Quadrature Wrist 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 Alpha III T/R Quadrature Wrist Coil is a multi- |
| element quadrature transmit-receive coil. The coil | |
| has a rigid enclosure with windows on top to | |
| facilitate patient handling. The open, patient friendly | |
| design eases patient handling and positioning 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
3
9. Safety and Effectiveness
| Alpha III Tx/Rx Quadrature Wrist Coil
Product Features | Comparison to predicate device or other 510(k)
cleared products |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: Imaging of the wrist and
hand | -Similar to the Alpha 7000 Wrist Coil manufactured
by USA Instruments, Inc. (K972205) |
| Indications for Use: Identical to routine
MRI imaging. | -Similar to the Alpha 7000 Wrist Coil manufactured
by USA Instruments, Inc. (K972205)
-Similar to the Allegra 3.0Tesla TxRx Head coil
manufactured by USA Instruments, Inc. (K002179) |
| Coil Enclosure Material:
Flame Retardant Polyurethane
Flame Retardant Polycarbonate
Kydex Acrylic/PVC
Delrin Acetal | - Similar to the Hi-Res 9000 Phased Array Carotid
Coil manufactured by USA Instruments, Inc.
(K001210) |
| Coil Design: 2 element saddle transmit
receive quadrature coil.
Decoupling: This is a transmit and
receive coil. There is no decoupling, the
Transmit / Receive Switch is actively
switched during transmit and receive
modes. | - Similar to the Allegra 3.0Tesla TxRx Head coil
manufactured by USA Instruments, Inc. (K002179)
- Similar to the Allegra 3.0Tesla TxRx Head coil
manufactured by USA Instruments, Inc. (K002179) |
| Prevention of RF Burns: The coil's
transmit /receive switch uses pin diodes
to isolate the receive channel from the
transmit channel; coil elements and
circuitry are enclosed in a non-
conductive housing. | - Similar to the Allegra 3.0Tesla TxRx Head coil
manufactured by USA Instruments, Inc. (K002179) |
| Radio Frequency Absorption: Power
deposition during imaging is limited by
SAR algorithm | - Similar to the Allegra 3.0Tesla TxRx Head coil
manufactured by USA Instruments, Inc. (K002179) |
| Formation of Resonant Loop: Active
diodes and fast RF blowing fuses
isolate the coil elements from RF fields;
length of cable and stiffness does not
permit looping | - Similar to the Allegra 3.0Tesla TxRx Head coil
manufactured by USA Instruments, Inc. (K002179) |
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Christie Shumaker Manager OA and Regulatory USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
FEB 2 1 2003
Re: K023982 Trade/Device Name: Leo III Tx/Rx Quadrature Knee Coil and Alpha III Tx/Rx Quadrature Wrist Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: November 27, 2002 Received: December 2, 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. Iisting 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.
5
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
6
Page 1 of 1
510(k) Number (if known):__ Anatomic Regions: Leo III Tx/Rx Quadrature Knee Coil: Knee and surrounding Anatomy Alpha IIII Tx/Rx Quadrature Wrist Coil: Wrist and Hand 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 vield 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) | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K023982 |