← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K994040 # PHASED ARRAY KNEE AND FOOT COIL (K994040) _Usa Instruments, Inc. · MOS · Jan 18, 2000 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K994040 ## Device Facts - **Applicant:** Usa Instruments, Inc. - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** Jan 18, 2000 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use 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. ## Device Story Specialty receive-only RF coil for MRI systems; captures hydrogen nuclei signals from knee and foot anatomy. Device consists of two-part knee coil and attachable foot coil; housed in polyurethane, fiberglass, and ABS/PVC plastic. Operates as passive receive-only component; utilizes RF chokes and switching diodes for decoupling during RF transmission to prevent RF burns and resonant loops. Used in clinical MRI settings; operated by MRI technicians or radiologists. Output is raw signal data processed by host MRI scanner into diagnostic images. Provides high-resolution soft tissue visualization for physician diagnosis. ## Clinical Evidence Bench testing only. No clinical data provided. Safety and effectiveness established through comparison of design, materials, and electrical performance (decoupling, RF safety) to legally marketed predicate devices. ## Technological Characteristics Receive-only RF coil; two-channel phased array design. Materials: flame retardant polyurethane, fiberglass, ABS/PVC plastic alloy. Decoupling via RF chokes and switching diodes. Non-conductive housing. Designed for GE Signa HFO/i 0.7T MRI scanner. No internal software or active electronics. ## Regulatory 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). ## Special Controls *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. ## Predicate Devices - Leo 7000 Quadrature Knee Coil ([K971246](/device/K971246.md)) - Model 473SI-42D Quadrature Lower Extremity Coil ([K982496](/device/K982496.md)) - Mark 5000 Phased Array Shoulder Coil ([K983143](/device/K983143.md)) - Premier 7000 P/A CTL Spine Coil ([K980157](/device/K980157.md)) ## Reference Devices - GE Signa HFO/i (0.7 Tesla) MRI scanner ([K992746](/device/K992746.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 Drive
Aurora, Ohio 44202
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 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. | | 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 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. | Please turn over . {1}------------------------------------------------ ## 9. Safety and Effectiveness | Phased Array Knee and Foot Coil Product
Features | Comparison to predicate device or other 510(k)
cleared product | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use: Knee and Foot Imaging
Applications | -Similar to the Leo 7000 Quadrature Knee Coil
manufactured by USA Instruments, Inc. (K971246)
-Similar to the Model 473SI-42D Quadrature Lower
Extremity Coil manufactured by Medical Advances, Inc.
(K982496) | | Indications for Use: Identical to routine MRI
imaging | -Similar to the Leo 7000 Quadrature Knee Coil
manufactured by USA Instruments, Inc. (K971246) | | Coil Body Former Material: Flame retardant
Polyurethane, ABS/PVC Plastic Alloy, Glass
fiber reinforced polyester (Fiberglass) | -Similar to the Leo 7000 Quadrature Knee Coil
manufactured by USA Instruments, Inc. (K971246)
-Similar to the Premier 7000 P/A CTL Spine Coil
manufactured by USA Instruments, Inc. (K980157) | | Coil Design: Two Channel Phased Array
Receive Only Design | -Similar to the Mark 5000 Phased Array Shoulder Coil
manufactured by USA Instruments, Inc. (K983143) | | Decoupling: RF Chokes with Switching Diodes | -Similar to the Leo 7000 Quadrature Knee Coil
manufactured by USA Instruments, Inc. (K971246) | | 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 Leo 7000 Quadrature Knee Coil
manufactured by USA Instruments, Inc. (K971246) | | Radio Frequency Absorption: Coil is a receive
only coil and does not transmit RF power | -Similar to the Leo 7000 Quadrature Knee Coil
manufactured by USA Instruments, Inc. (K971246) | | Formation of Resonant Loops: Decoupling
isolates coil elements from RF fields during RF
transmission, Length of cable and stiffness does
not permit looping. | -Similar to the Leo 7000 Quadrature Knee Coil
manufactured by USA Instruments, Inc. (K971246) | {2}------------------------------------------------ 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. K994040 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 {3}------------------------------------------------ 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) | | |---------------------------------------|--| |---------------------------------------|--| OR | Over-The-Counter Use (Optional Format 1-2-96) | | |-----------------------------------------------|--| |-----------------------------------------------|--| --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K994040](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K994040) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com