(78 days)
The Leo 7000 Quadrature Knee Coil is a receive-only quadrature RF coil, used for obtaining diagnostic images of the knee anatomy in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Quadrature Knee Coil is designed for use with GE Signa (1.5 Tesla) MRI scanner manufactured by GE Medical Systems.
The Leo 7000 Quadrature Knee Coil is designed to provide Magnetic Resonance Images of the knee anatomy. The Leo 7000 Quadrature Knee Coil is designed for use with the GE Signa (1.5 Tesla) MRI Scanner.
The indications for use are the same as for standard imaging:
The GE Signa 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 Leo 7000 Quadrature Knee Coil is a bird-cage resonator. The electrical circuitry is enclosed in a durable housing assembly made of polyurethane material, which is fire rated and has high impact and tensile strength. The Leo 7000 Quadrature Knee Coil is a quadrature volume coil with a split-top design.
The provided text describes a 510(k) submission for a Magnetic Resonance Imaging Accessory, specifically the Leo 7000 Quadrature Knee Coil. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a formal clinical study with ground truth. Therefore, many of the requested categories (2-9) are not directly applicable or explicitly stated in this type of submission.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from predicate device comparison) | Reported Device Performance (for Leo 7000 Quadrature Knee Coil) |
|---|---|---|
| Intended Use | Knee Imaging Applications (Predicate Device: MR Quadrature Knee Coils, Hitachi Medical Systems (K914263)) | Knee Imaging Applications |
| Indications for Use | Identical to routine MRI imaging (Predicate Device: Lower Extremity Coil, OUTLOOK MRI System, Picker International, Inc. (K945827)) | Identical to routine MRI imaging (Knee anatomy) |
| Coil Body Former Material | (Predicate Device: Lower Extremity Coil, Head Coil, and Vascular Head and Neck Coil, OUTLOOK MRI System, Picker International, Inc. (K945827)) | Flame retardant Polyurethane |
| Coil Design | (Predicate Device: Quadrature head coil and Quadrature MRA coil, HI-STAR MRI system, Health Images, Inc. (K944724)) | Quadrature receive-only, bird-cage resonator |
| Decoupling | (Predicate Device: Lower Extremity Coil, OUTLOOK MRI System, Picker International, Inc. (K945827)) | RF Chokes with Switching Diodes |
| 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 (Predicate Device: Profile 7000 C-Spine Coils, US ASIA Instruments, Inc. (K943440)) | 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. |
| Radio Frequency Absorption | Coil is a receive only coil and does not transmit RF power (Predicate Device: Profile 7000 C-Spine Coils, US ASIA Instruments, Inc. (K943440)) | Coil is a receive only coil and does not transmit RF power |
| Formation of Resonant Loops | Decoupling isolates coil elements from RF fields during RF transmission. Length of cable and stiffness do not permit looping. (Predicate Device: Profile 7000 C-Spine Coils, US ASIA Instruments, Inc. (K943440)) | Decoupling isolates coil elements from RF fields during RF transmission. Length of cable and stiffness do not permit looping. |
Study Information (Based on 510(k) Submission):
The document provided is a 510(k) Premarket Notification, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This process typically relies on comparing technical characteristics and performance to existing, approved devices, rather than conducting new, large-scale clinical trials with acceptance criteria in the traditional sense of a clinical study assessing diagnostic performance.
The "study" in this context is a comparison to predicate devices to demonstrate substantial equivalence, as detailed in section 9, "Safety and Effectiveness," which primarily focuses on technical and functional comparisons.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not describe a specific "test set" or clinical data. The submission relies on demonstrating substantial equivalence to predicate devices based on design and technical specifications. There are no mentions of patient data, data provenance, or study design for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No "test set" requiring expert ground truth establishment is described in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No "test set" requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a passive medical device (MRI coil), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for device performance as typically understood in diagnostic studies. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices to which it is compared.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a "training set."
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JUN 20 1997
SUMMARY OF SAFETY AND EFFECTIVENESS K971246
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | Leo 7000 Quadrature Knee Coil |
| 3. Classification : | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc., 675-B Alpha Drive,Highland Heights, Ohio 44143, USATelephone: 216-442-5920; Fax: 216-442-5919. |
| 6. Performance Standard: | No applicable performance standards have been issuedunder Section 514 of the Food, Drug and Cosmetic Act. |
| 7. Intended Use: | The Leo 7000 Quadrature Knee Coil is a receive-onlyquadrature RF coil, used for obtaining diagnostic imagesof the knee anatomy in Magnetic Resonance Imagingsystems. The indications for use are the same as forstandard MR Imaging. The Quadrature Knee Coil isdesigned for use with GE Signa (1.5 Tesla) MRI scannermanufactured by GE Medical Systems. |
| 8. Device Description: | The Leo 7000 Quadrature Knee Coil is a bird-cageresonator. The electrical circuitry is enclosed in adurable housing assembly made of polyurethanematerial, which is fire rated and has high impact andtensile strength. The Leo 7000 Quadrature Knee Coil is aquadrature volume coil with a split-top design. |
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9. Safety and Effectiveness
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| Parameter | LEO 7000 QuadratureKnee Coil | Same as Predicate Device |
|---|---|---|
| Intended Use | Knee Imaging Applications | MR Quadrature Knee CoilsHitachi Medical Systems(K914263)Lower Extremity Coil,OUTLOOK MRI SystemPicker International, Inc.(K945827) |
| Indications for Use | Identical to routine MRIimaging | Lower Extremity Coil, OUTLOOK MRI SystemPicker International, Inc.(K945827)Profile 7000 C-Spine Coils,US ASIA Instruments, Inc.(K943440) |
| Coil Body Former Material | Flame retardant Polyurethane | Lower Extremity Coil, Head Coil, and Vascular Head and NeckCoil, OUTLOOK MRI SystemPicker International, Inc.(K945827) |
| Coil Design | Quadrature receive-only, bird-cageresonator | Quadrature head coil and Quadrature MRA coil, HI-STAR MRIsystem, Health Images, Inc.(K944724) |
| Decoupling | RF Chokes with Switching Diodes | Lower Extremity Coil, OUTLOOK MRI SystemPicker International, Inc.(K945827)Flexible Phased Array Spine Coil, Picker International, Inc.(K960497) |
| Prevention of RF Burns | Does not transmit RF PowerDecoupling isolates the coilelements from RF fields during RFtransmissionCoil elements and circuitryare enclosed in a non-conductivehousing. | Profile 7000 C-Spine CoilsUS ASIA Instruments, Inc.(K943440)Lower Extremity Coil, OUTLOOK MRI SystemPicker International, Inc.(K945827) |
| Radio FrequencyAbsorption | Coil is a receive only coil and does nottransmit RF power | Profile 7000 C-Spine Coils,US ASIA Instruments, Inc.(K943440) |
| Formation of ResonantLoops | Decoupling isolates coil elements fromRF fields during RF transmission.Length of cable and stiffnessdo not permit looping. | Profile 7000 C-Spine Coils,US ASIA Instruments, Inc.(K943440)Flexible Phased Array Spine CoilPicker International, Inc.(K960497) |
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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. In the center of the circle, there is a stylized symbol that appears to be three overlapping human profiles or figures. The image is black and white and has a slightly grainy texture.
JUN 20 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Rony Thomas Manager, Regulatory Affairs USA Instruments, Inc. 675-B Alpha Drive Highland Heights, Ohio 44143 Re: K971246 Leo 7000 Quadrature Knee Coil Dated: April 2, 1997 Received: April 3, 1997 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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device in be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 does not affect any obligation you might have under sections 51 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 10(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 this, 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 vite diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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 entiled, "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/dsmamain.html". i
Sincerely yours,
Lillian Yin, Ph.D.
Lilian Yin, Ph.D. 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):
Device Name: Leo 7000 Quadrature Knee Coil
Indications for Use: The Leo 7000 Quadrature Knee Coil is designed to provide Magnetic Resonance Images of the knee anatomy. The Leo 7000 Quadrature Knee Coil is designed for use with the GE Signa (1.5 Tesla) MRI Scanner.
Anatomic Regions: Knee Joint Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The GE Signa 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 | K971246 | ||
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use(Optional Format 1-2-96) |
§ 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.