(27 days)
The MEDRAD Phased Array Neurovascular Coil is a receive-only coil intended to be used with Siemens 1.5T MRI Scanners. The coil will facilitate complete MR imaging, including spectroscopy, of the intracranial/extracranial, neurovascular, skull base and C-spine regions without moving the patient or the coil; i.e., no scan room intervention.
The MEDRAD 8-Receiver Phased Array Neurovascular Coil for Siemens maintains a similar intended use, similar operational parameters, similar labeling and is used in a manner similar to the predicate device. It is a phased array receive-only coil with a region of interest from the vertex of the skull to the aortic arch. It is compatible with all phased array Siemens 1.5T platforms with 8-receiver capability and all Siemens system pulse sequences and appropriate imaging options. No external tuning or matching is necessary. The coil plugs into the Siemens MRI system by way of cable sockets in the patient table. Imaging configurations include High resolution Head, Neck, or Head + Neck (Full), depending on user-selected coil elements. The housing material is made from polyurethane; fire rated UL 94V-0. Comfort pad, positioning pads, and knee pad material is made from polyurethane foam sprayed with a Guardian coating and is fire rated to C-117. The table pad material is made from Ethylene Vinyl Acetate foam sprayed with a Guardian coating and is fire rated to C-117.
The provided text is a 510(k) summary for a medical device: "MEDRAD 8-Receiver Phased Array Neurovascular Coil for Siemens." This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any details typically found in a clinical study report for device effectiveness.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's what can be stated based on the given document:
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A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) summary. The document describes the device and compares its features to a predicate, but does not include quantitative performance metrics or acceptance criteria for those metrics.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document does not describe a clinical study with a test set. It describes a device and its similarity to a predicate.
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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. There is no mention of a test set or ground truth establishment.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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, not an AI-powered diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
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The sample size for the training set: Not applicable. The document does not describe a machine learning algorithm or a training set.
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How the ground truth for the training set was established: Not applicable.
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K052827
NOV - 1 2005
510(k) Summary
| OFFICIAL CONTACT: | Lisa A. EwingRegulatory Affairs SpecialistMEDRAD, INC.One Medrad DriveIndianola, PA 15051(412) 767-2400 Ext. 3780 |
|---|---|
| CLASSIFICATION NAME: | Magnetic Resonance Diagnostic Device(21 CFR 892.1000, Product Code MOS) |
| COMMON NAME(S): | Magnetic Resonance Coil |
| PROPRIETARY NAME: | MEDRAD 8-Receiver Phased ArrayNeurovascular Coil for Siemens |
| PREDICATE DEVICE: | MEDRAD 8-Receiver Phased ArrayNeurovascular Coil (K023569) |
| INTENDED USE: | The MEDRAD Phased Array Neurovascular Coilis a receive-only coil intended to be used withSiemens 1.5T MRI Scanners. The coil willfacilitate complete MR imaging, includingspectroscopy, of the intracranial/extracranial,neurovascular, skull base and C-spine regionswithout moving the patient or the coil; i.e., no scanroom intervention. |
| DEVICE DESCRIPTION AND COMPARISON TO UNMODIFIED PREDICATE: |
The MEDRAD 8-Receiver Phased Array Neurovascular Coil for Siemens maintains a similar intended use, similar operational parameters, similar labeling and is used in a manner similar to the predicate device.
The following comparison tables identify the similarities and differences between the new device and the predicate device.
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Comparison of MEDRAD 8-Receiver Phased Array Neurovascular Coil for GE (Predicate) and MEDRAD 8-Receiver Phased Array Neurovascular Coil for Siemens (Proposed)
| Feature | (Predicate)MEDRAD 8-Receiver PhasedArray Neurovascular Coil forGE | (Proposed)MEDRAD 8-Receiver PhasedArray Neurovascular Coil forSiemens |
|---|---|---|
| Coil Type | Phased array receive-only coil. | Phased array receive-only coil. |
| Region of Interest | Vertex of the skull to the aorticarch | Vertex of the skull to the aorticarch |
| Compatibility | All phased array GEMS 1.5TSigna Excite platforms with 8-receiver capability. All Signasystem pulse sequences andappropriate imaging options. | All phased array Siemens 1.5Tplatforms with 8-receivercapability. All Siemens systempulse sequences andappropriate imaging options. |
| Tuning | No external tuning, or matching,is necessary, since the coil ismatched to the recommendedanatomy of interest. | No external tuning, or matching,is necessary, since the coil ismatched to the recommendedanatomy of interest. |
| System Connection | Coil plugs into the GE MRIsystem by way of the phasedarray quick disconnect port. | Coil plugs into the Siemens MRIsystem by way of cable socketsin the patient table. |
| ImagingConfigurations | High resolution head, parallelimaging Fast Brain,Neurovascular, C-Spine (useroptional), Volume Neck (useroptional), high resolution Headand C-Spine (user optional) | High resolution Head, Neck, orHead + Neck (Full), dependingon user-selected coil elements |
Comparison of Patient-Contacting Materials in MEDRAD 8-Receiver Phased Array Neurovascular Coil for GE (Predicate) and MEDRAD 8-Receiver Phased Array Neurovascular Coil for Siemens (Proposed)
| (Predicate)MEDRAD 8-Receiver PhasedArray Neurovascular Coil forGE | (Proposed)MEDRAD 8-Receiver PhasedArray Neurovascular Coil forSiemens | |
|---|---|---|
| Housing | Housing material is made frompolyurethane; fire rated UL 94V-0 | Housing material is made frompolyurethane; fire rated UL 94V-0 |
| Comfort pad,positioning pads,knee pad | Comfort, positioning and kneepad material is made frompolyurethane foam sprayed witha Guardian coating and is firerated to C-117 | Comfort, positioning and kneepad material is made frompolyurethane foam sprayed witha Guardian coating and is firerated to C-117 |
| Table pad | N/A | Table pad material is made fromEthylene Vinyl Acetate foamsprayed with a Guardian coatingand is fire rated to C-117 |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Public Health Service
NOV - 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa A. Ewing Regulatory Affairs Specialist Medrad, Inc. One Medrad Drive INDIANOLA PA 15051-0780 Re: K052827
Trade/Device Name: MEDRAD 8-Receiver Phased Array Neurovascular Coil for Siemens Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 4, 2005 Received: October 7, 2005
Dear Ms. Ewing:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number:
Device Name:
MEDRAD 8-Receiver Phased Array Neurovascular Coil for Siemens
Indications for Use:
The MEDRAD Phased Array Neurovascular Coil is a receive-only coil intended to be used with Siemens 1.5T MRI Scanners. The coil will facilitate complete MR imaging, including spectroscopy, of the intracranial/extracranial, neurovascular, skull base and C-spine regions without moving the patient or the coil; i.e., no scan room intervention.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lygum
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number
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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.