(88 days)
The Quadrature Extremity Coil is a receive-only quadrature RF coil, used for obtaining diagnostic images of the elbow anatomy in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Quadrature Extremity Coil is designed for use with GE Signa (1.5 Tesla) MRI scanner manufactured by GE Medical Systems.
The Quadrature Extremity Coil consists of two volume RF coil elements in a quadrature design. The elements and circuitry are enclosed in a durable covering made of vinyl naughahyde which is fire rated.
The provided text describes a Magnetic Resonance Imaging Accessory, specifically the Maxim 7000 Quadrature Extremity Coil, and compares its safety and effectiveness to predicate devices. However, the document does not contain information about acceptance criteria, device performance metrics, or a study design to prove these criteria.
Therefore, I cannot fulfill the request as the necessary information is absent in the provided text. The document focuses on comparing the design and features of the new device to previously cleared devices (predicates) to establish substantial equivalence for regulatory purposes, rather than detailing specific performance criteria or a study that rigorously tests against them.
Here's why I cannot provide the requested information based on the input:
- No Acceptance Criteria or Reported Performance: The document lists various design and safety features but does not define quantitative acceptance criteria for image quality, diagnostic accuracy, signal-to-noise ratio, or any other performance metric. Consequently, there are no "reported device performance" figures to populate against such criteria.
- No Study Description: There is no mention of a clinical trial, technical validation study, or any other type of study that would involve a test set, expert readers, ground truth establishment, or statistical analysis.
- Sample Size (Test Set/Training Set): No sample sizes are provided for any dataset.
- Data Provenance: No information about the origin of data (if any were used for testing) is present.
- Number of Experts/Qualifications: No experts are mentioned as being involved in assessing performance or establishing ground truth.
- Adjudication Method: Not applicable as no assessment is described.
- MRMC Comparative Effectiveness Study: Not mentioned.
- Standalone Performance: Not mentioned.
- Type of Ground Truth: Not applicable as no ground truth is established or used.
- Training Set Sample Size/Ground Truth: Not applicable.
The provided text is a summary of safety and effectiveness, which, in the context of a 510(k) submission, primarily focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, and fundamental operating principles, rather than presenting a detailed performance study with quantitative results against specific criteria.
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SUMMARY OF SAFETY AND EFFECTIVENESS
FEB 2 8 1997
Comments of cases of program Microsoft
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | Maxim 7000 Quadrature Extremity 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 Quadrature Extremity Coil is a receive-onlyquadrature RF coil, used for obtaining diagnostic imagesof the elbow anatomy in Magnetic Resonance Imagingsystems. The indications for use are the same as forstandard MR Imaging. The Quadrature Extremity Coil isdesigned for use with GE Signa (1.5 Tesla) MRI scannermanufactured by GE Medical Systems. |
| 8. Device Description: | The Quadrature Extremity Coil consists of twovolume RF coil elements in a quadrature design. Theelements and circuitry are enclosed in a durablecovering made of vinyl naughahyde which is fire rated. |
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9. Safety and Effectiveness
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| Parameter | Quadrature ElbowCoil | Predicate |
|---|---|---|
| Intended Use | Elbow Imaging Applications | General Purpose Flex Coil(K944469) marketed byPicker International |
| Indications for Use | Identical to routine MRI imaging | General Purpose Flex Coil(K944469) marketed byPicker International |
| Coil Enclosure Material | Vinyl Fabric | Flexible Spine Coil(K960497) marketed byPicker International |
| Coil Design | Quadrature design | Profile 7000 C-spine Coil(K943440) marketed by USAsia Instruments. Inc. |
| Decoupling | Switching Diode decoupling | Profile 7000 C-spine Coil(K943440) marketed by USAsia Instruments. Inc. |
| Prevention of RF Burns | Does not transmit RF Power | Profile 7000 C-spine Coil(K943440) marketed by USAsia Instruments. Inc. |
| Decoupling isolates the coil elements from RF during RF transmission | ||
| Coil elements and circuitry is enclosed in a non-conductive material. | ||
| Radio Frequency Absorption | Coil is a receive only coil and does not transmit RF | Profile 7000 C-spine Coil(K943440) marketed by USAsia Instruments. Inc. |
| Formation of Resonant Loop | Decoupling isolates the coil elements from RF during RF transmission | Profile 7000 C-spine Coil(K943440) marketed by USAsia Instruments. Inc. |
| Length of cable and stiffness does not permit looping |
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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.