(50 days)
The Phased Array Knee and Foot Coil is a specialty receive-only RF coil, used for obtaining diagnostic images of the knee and foot anatomy in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Phased Array Knee and Foot Coil is designed for use with GE Signa HFO/i (0.7 Tesla) MRI scanner (K992746) manufactured by GE Medical Systems.
The Phased Array Knee and Foot Coil is designed to provide Magnetic Resonance Images of the knee and foot anatomies. The Phased Array Knee and Foot Coil has been designed for use with the GE Signa HFO/i 0.7T scanner.
Anatomic Regions: Knee and Foot Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Signa HFO/i 0.7T 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.
The Knee and Foot Coil package consists of a knee coil (two sizes: small and large) and an attachable foot coil. The electrical circuitry is enclosed in a durable housing assembly made of polyurethane, fiberglass, and ABS/PVC plastic alloy, which are fire rated and have high impact and tensile strength. The Knee Coil is mechanically split into two halves for easier coil handling and more accurate positioning of the patient's knee in the coil. The Foot Coil is contoured to accommodate the foot and is mechanically attached to the knee coil.
The provided document is a 510(k) summary for the "Legend 5000 Phased Array Knee and Foot Coil," an accessory for Magnetic Resonance Imaging systems, and does not describe a study that proves the device meets specific performance acceptance criteria in the way a clinical study for a new AI diagnostic would.
Instead, the document establishes substantial equivalence to predicate devices based on similarities in intended use, indications for use, materials, design, and safety features. The "Safety and Effectiveness" section outlines product features and compares them to legally marketed predicate devices, implying that if the new device shares similar characteristics and functions, it is considered safe and effective for its stated purpose.
Therefore, the requested information elements (acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, and training set details) are not applicable or not explicitly stated in this type of regulatory submission for an MRI accessory. This document focuses on demonstrating equivalence rather than proving performance against specific quantitative metrics through a clinical study.
Here's a breakdown of why these elements are largely absent or not directly addressed:
- Acceptance Criteria & Reported Performance: This document doesn't define specific numerical acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity, AUC) or report quantitative performance metrics related to image quality or diagnostic yield for the coil itself. The acceptance is based on the comparison to predicate devices and the general understanding that it produces diagnostic images similar to standard MR imaging.
- Sample Size (Test Set) & Data Provenance: Not applicable. There's no "test set" of patient data in the context of a diagnostic AI study. The performance is inferred from the device's design and mechanism mirroring existing approved devices.
- Number of Experts & Qualifications (Ground Truth): Not applicable. Ground truth as understood in diagnostic AI (e.g., expert consensus on disease presence) is not established or used here. The document relies on the established safety and efficacy of the predicate MRI systems and coils.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study assesses human reader performance with and without an AI aid, which is not the purpose of this submission for an MRI coil.
- Standalone (Algorithm Only) Performance Study: Not applicable. The device is a hardware accessory (RF coil), not an autonomous diagnostic algorithm.
- Type of Ground Truth Used: Not applicable. No "ground truth" (e.g., pathology, outcomes data) for clinical diagnosis is being established for this device's performance in a study detailed here. The ground truth for MRI imaging, in general, is its ability to visualize anatomical structures and pathologies, which is well-established for the predicate devices.
- Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable. This device is not an AI algorithm that undergoes a "training" phase with a dataset.
In summary, the 510(k) approval for this MRI accessory is granted based on its substantial equivalence to previously cleared devices, rather than a clinical study demonstrating performance against specific quantitative acceptance criteria. The "studies" that support its safety and effectiveness are primarily engineering and design comparisons to predicate devices, ensuring that it operates within known safety parameters and produces images compatible with diagnostic interpretations already established for MRI.
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K9G 4C 40
JAN 18 2000 SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | Legend 5000 Phased Array Knee and Foot Coil |
| 3. Classification : | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc.1515 Danner DriveAurora, Ohio 44202Telephone: 330-562-1000; Fax: 330-562-1422. |
| 6. Performance Standard: | No applicable performance standards have been issuedunder Section 514 of the Food, Drug and Cosmetic Act. |
| 7. Intended Use: | The Phased Array Knee and Foot Coil is a specialtyreceive-only RF coil, used for obtaining diagnostic imagesof the knee and foot anatomy in Magnetic ResonanceImaging systems. The indications for use are the same asfor standard MR Imaging. The Phased Array Knee andFoot Coil is designed for use with GE Signa HFO/i (0.7Tesla) MRI scanner (K992746) manufactured by GEMedical Systems. |
| 8. Device Description: | The Knee and Foot Coil package consists of a knee coil(two sizes: small and large) and an attachable foot coil.The electrical circuitry is enclosed in a durable housingassembly made of polyurethane, fiberglass, andABS/PVC plastic alloy, which are fire rated and havehigh impact and tensile strength. The Knee Coil ismechanically split into two halves for easier coilhandling and more accurate positioning of the patient'sknee in the coil. The Foot Coil is contoured toaccommodate the foot and is mechanically attached tothe knee coil. |
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9. Safety and Effectiveness
| Phased Array Knee and Foot Coil ProductFeatures | Comparison to predicate device or other 510(k)cleared product |
|---|---|
| Intended Use: Knee and Foot ImagingApplications | -Similar to the Leo 7000 Quadrature Knee Coilmanufactured by USA Instruments, Inc. (K971246)-Similar to the Model 473SI-42D Quadrature LowerExtremity Coil manufactured by Medical Advances, Inc.(K982496) |
| Indications for Use: Identical to routine MRIimaging | -Similar to the Leo 7000 Quadrature Knee Coilmanufactured by USA Instruments, Inc. (K971246) |
| Coil Body Former Material: Flame retardantPolyurethane, ABS/PVC Plastic Alloy, Glassfiber reinforced polyester (Fiberglass) | -Similar to the Leo 7000 Quadrature Knee Coilmanufactured by USA Instruments, Inc. (K971246)-Similar to the Premier 7000 P/A CTL Spine Coilmanufactured by USA Instruments, Inc. (K980157) |
| Coil Design: Two Channel Phased ArrayReceive Only Design | -Similar to the Mark 5000 Phased Array Shoulder Coilmanufactured by USA Instruments, Inc. (K983143) |
| Decoupling: RF Chokes with Switching Diodes | -Similar to the Leo 7000 Quadrature Knee Coilmanufactured by USA Instruments, Inc. (K971246) |
| Prevention of RF Burns: Does not transmit RFPower, Decoupling isolates the coil elementsfrom RF fields during RF transmission, Coilelements and circuitry are enclosed in a non-conductive housing. | -Similar to the Leo 7000 Quadrature Knee Coilmanufactured by USA Instruments, Inc. (K971246) |
| Radio Frequency Absorption: Coil is a receiveonly coil and does not transmit RF power | -Similar to the Leo 7000 Quadrature Knee Coilmanufactured by USA Instruments, Inc. (K971246) |
| Formation of Resonant Loops: Decouplingisolates coil elements from RF fields during RFtransmission, Length of cable and stiffness doesnot permit looping. | -Similar to the Leo 7000 Quadrature Knee Coilmanufactured by USA Instruments, Inc. (K971246) |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2000
Rony Thomas Manager, Regulatory Affairs USA Instruments, Inc. 1515 Danner Drive Aurora, Ohio 44202
Re:
Legend 5000 Phased Array Knee and Foot Coil Dated: November 22, 1999 Received: November 29, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Mr. Thomas:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 dass III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CART Daniel O. Schultz, M.D.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _ K99 40 40 40
Device Name: Phased Array Knee and Foot Coil
Indications for Use: The Phased Array Knee and Foot Coil is designed to provide Magnetic Resonance Images of the knee and foot anatomies. The Phased Array Knee and Foot Coil has been designed for use with the GE Signa HFO/i 0.7T scanner.
Anatomic Regions: Knee and Foot Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Signa HFO/i 0.7T 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)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K994040 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | |
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| --------------------------------------- | -- |
OR
| Over-The-Counter Use (Optional Format 1-2-96) | |
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§ 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.