(85 days)
The Alpha 7000 Quadrature Wrist Coil is a receive-only quadrature RF coil, used for obtaining diagnostic images of the wrist and hand anatomy in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Quadrature Wrist Coil is designed for use with GE Signa (1.5 Tesla) MRI scanner manufactured by GE Medical Systems.
The Alpha 7000 Quadrature Wrist Coil is designed to provide Magnetic Resonance Images of the wrist and hand anatomy. The Alpha 7000 Quadrature Wrist Coil is designed for use with the GE Signa (1.5 Tesla) MRI Scanner.
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 Alpha 7000 Quadrature Wrist Coil consists of two volume RF coil elements in a quadrature design. The elements and the associated circuitry are enclosed in a durable housing made of polyurethane material, which is fire rated and has high impact and tensile strength.
The provided text describes a Medical Device Review for the Alpha 7000 Quadrature Wrist Coil, a magnetic resonance imaging accessory. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, many of the requested sections (2-7, 9) regarding a study to prove acceptance criteria cannot be extracted because such a study is not described.
Here's the information that can be extracted:
Acceptance Criteria and Device Performance (based on substantial equivalence)
| Parameter | Acceptance Criteria (Predicate Device Feature) | Reported Device Performance (Alpha 7000 Quadrature Wrist Coil) |
|---|---|---|
| Intended Use | Wrist and Hand Imaging Applications (Quadrature Wrist and Hand Coil MRI Devices Corp., K931008) | Wrist and Hand Imaging Applications |
| Indications for Use | Identical to routine MRI imaging (Quadrature Wrist and Hand Coil MRI Devices Corp., K931008; Profile 7000 Quadrature Volume Neck Coil USA Instruments, Inc., K964531) | Identical to routine MRI imaging: Provides Magnetic Resonance Images of the wrist and hand anatomy. Used with GE Signa (1.5 Tesla) MRI Scanner. Images provide information useful for diagnosis when interpreted by a trained physician, based on proton distribution and NMR parameters. |
| Coil Body Material | Lower Extremity Coil, Head Coil, and Vascular Head and Neck Coil, OUTLOOK MRI System Picker International, Inc. (K945827) - (implied safe and durable material) | Flame retardant Polyurethane (enclosed in a durable housing made of polyurethane material, which is fire rated and has high impact and tensile strength.) |
| Coil Design | Quadrature design (Profile 7000 Quadrature Volume Neck Coil USA Instruments, Inc., K964531) | Quadrature design (two volume RF coil elements in a quadrature design) |
| Decoupling | RF Chokes with Switching Diodes (Profile 7000 Quadrature Volume Neck Coil USA Instruments, Inc., K964531) | 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 (Profile 7000 Quadrature Volume Neck Coil USA Instruments, Inc., K964531) | 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 (Profile 7000 Quadrature Volume Neck Coil USA Instruments, Inc., K964531) | 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 (Profile 7000 Quadrature Volume Neck Coil USA Instruments, Inc., K964531) | Decoupling isolates coil elements from RF fields during RF transmission. Length of cable and stiffness do not permit looping. |
Study Details (or lack thereof, based on the provided text)
- Sample size used for the test set and the data provenance: Not applicable. The document describes a 510(k) premarket notification for demonstrating substantial equivalence based on device features and comparison to predicate devices, not a clinical study with a test set of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set or ground truth establishment is described. The document mentions "trained physician" in the context of interpreting images from the MRI system but not for an evaluation study of the device itself.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set is described.
- 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 device is an MRI coil accessory, not an AI-powered diagnostic tool. No MRMC study is described.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device (MRI coil), not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth for device performance is described as part of a review. The substantial equivalence relies on comparing technical features and intended use to existing, legally marketed devices.
- The sample size for the training set: Not applicable. This device is a hardware accessory and does not involve AI/machine learning requiring a training set.
- How the ground truth for the training set was established: Not applicable. As above, no training set is relevant for this device.
{0}------------------------------------------------
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | Alpha 7000 Quadrature Wrist Coil SEP - 5 1997 |
| 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 Alpha 7000 Quadrature Wrist Coil is a receive-onlyquadrature RF coil, used for obtaining diagnostic imagesof the wrist and hand anatomy in Magnetic ResonanceImaging systems. The indications for use are the same asfor standard MR Imaging. The Quadrature Wrist Coil isdesigned for use with GE Signa (1.5 Tesla) MRI scannermanufactured by GE Medical Systems. |
| 8. Device Description: | The Alpha 7000 Quadrature Wrist Coil consists of twovolume RF coil elements in a quadrature design. Theelements and the associated circuitry are enclosed in adurable housing made of polyurethane material, whichis fire rated and has high impact and tensile strength. |
:
ﺴﻨﺔ
ﺗﺤﺖ ﺍﻟﻤﺴﺘﺸﻔﻴﺔ ﺍﻟﻤﺘ
please turn over
{1}------------------------------------------------
9. Safety and Effectiveness
)
| Parameter | Features of Alpha7000Quadrature Wrist Coil | Same as Predicate Device |
|---|---|---|
| Intended Use | Wrist and Hand ImagingApplications | Quadrature Wrist and Hand CoilMRI Devices Corp.(K931008) |
| Indications for Use | Identical to routine MRIimaging | Quadrature Wrist and Hand CoilMRI Devices Corp.(K931008)Profile 7000 Quadrature Volume Neck CoilUSA Instruments, Inc.(K964531) |
| Coil Body Material | Flame retardantPolyurethane | Lower Extremity Coil, Head Coil, and VascularHead and Neck Coil, OUTLOOK MRI SystemPicker International, Inc.(K945827) |
| Coil Design | Quadrature design | Profile 7000 Quadrature Volume Neck CoilUSA Instruments, Inc.(K964531) |
| Decoupling | RF Chokes with SwitchingDiodes | Profile 7000 Quadrature Volume Neck CoilUSA Instruments, Inc.(K964531) |
| Prevention of RFBurns | Does not transmit RF PowerDecoupling isolates the coilelements from RF fieldsduring RF transmissionCoil elements and circuitryare enclosed in a non-conductive housing. | Profile 7000 Quadrature Volume Neck CoilUSA Instruments, Inc.(K964531) |
| Radio FrequencyAbsorption | Coil is a receive only coiland does not transmit RFpower | Profile 7000 Quadrature Volume Neck CoilUSA Instruments, Inc.(K964531) |
| Formation ofResonant Loops | Decoupling isolates coilelements from RF fieldsduring RF transmission.Length of cable and stiffnessdo not permit looping. | Profile 7000 Quadrature Volume Neck CoilUSA Instruments, Inc.(K964531) |
{2}------------------------------------------------
Image /page/2/Picture/17 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with three curved lines representing the wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1997
Rony Thomas Manager, Regulatory Affairs USA Instruments, Inc. 675-B Alpha Drive Highland Heights, Ohio 44143 Re:
K972205 Maximum 7000 Ouadrature Extremity Coil Dated: May 6, 1997 Received: June 12, 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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 (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 requirement, 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 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 yitzo 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 of the regulation of "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".
Sincerely yours,
h7liau Yi
Lillian 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
{3}------------------------------------------------
Page 1 of 1
510(k) Number (if known):
Device Name: Alpha 7000 Quadrature Wrist Coil
Indications for Use: The Alpha 7000 Quadrature Wrist Coil is designed to provide Magnetic Resonance Images of the wrist and hand anatomy. The Alpha 7000 Quadrature Wrist Coil is designed for use with the GE Signa (1.5 Tesla) MRI Scanner.
Anatomic Regions: Wrist and hand anatomy 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 K972205
Prescription Use X
(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.