(144 days)
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No
The summary describes a passive RF coil for MR imaging and does not mention any AI/ML components or image processing capabilities.
No
The device is described as a receive-only RF coil for MR imaging, and its function is for imaging, not treatment. While it "can be used in conjunction with the InSightec Focused UltraSound (MRgFUS) treatment," the coil itself is not the therapeutic component.
No
This device is described as a receive-only RF coil for MR imaging, and its function is to acquire images. It does not perform analysis or provide a diagnosis itself.
No
The device description explicitly states it is a "receive only RF coil," which is a hardware component used in MRI systems.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that the MRgFUS Phase Array Pelvic Coil is a "receive only RF coil, designed for MR imaging of the pelvis and hips." It is a component used in an MRI system to acquire images of the body.
- No mention of samples or analysis: There is no indication that this device interacts with or analyzes biological samples. Its purpose is to facilitate the imaging process within the body.
Therefore, the device falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MRgFUS Phase Array Pelvic Coil (the MRgFUS PA Coil) is a receive only RF coil, designed for MR imaging of the pelvis and hips. The MRgFUS Coil is designed for use with the GE 1.5 T MRI systems manufactured by GE Medical Systems. The Pelvic Phase Array Coil can be used in conjunction with the InSightec Focused UltraSound (MRgFUS) treatment.
Product codes
MOS
Device Description
The MRgFUS Phase Array Pelvic Coil (the MRgFUS PA Coil) is a receive only RF coil, designed for MR imaging of the pelvis and hips.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
MR imaging
Anatomical Site
pelvis and hips
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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Image /page/0/Picture/0 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" around the perimeter. Inside the circle is an image of an eagle with its wings spread, clutching a caduceus in its talons. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Ori Lubin Regulatory Affairs and Clinical Trials Manager InSightec 5 Nahum Heth St. Tirat Carmel 39120 ISRAEL
- 9 2011
Re: K111060
Trade/Device Name: MRgFUS PA Pelvic Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: June 28, 2011 Received: August 12, 2011
Dear Mr. Lubin:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
1
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 (2) CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
Following is the proposed intended use for the MRgFUS PA Pelvic Coil:
The MRgFUS Phase Array Pelvic Coil (the MRgFUS PA Coil) is a receive only RF coil, designed for MR imaging of the pelvis and hips.
The MRgFUS Coil is designed for use with the GE 1.5 T MRI systems manufactured by GE Medical Systems.
The Pelvic Phase Array Coil can be used in conjunction with the InSightec Focused UltraSound (MRgFUS) treatment.
Prescription Use > AND/OR (Part 21 CFR 801 Subpart D) .
Over-The-Counter Use (21 CFR 801 Subpart C)
Mary Patel
510K Kilo D