(67 days)
Not Found
No
The document describes specialty coils for existing MR systems and focuses on image acquisition and quality metrics (SNR, uniformity), with no mention of AI/ML for image processing or interpretation.
No
The device is a diagnostic MR coil used for imaging and does not provide therapeutic intervention.
No
The provided text explicitly states that the specialty coils are "intended for use in conjunction with the MAGNETOM Aera 1.5T & MAGNETOM Skyra 3T MR Systems, Magnetic Resonance Diagnostic Devices (MRDD)". This indicates that the coils themselves are components used with diagnostic devices, rather than being diagnostic devices on their own.
No
The device description explicitly states that the device is "specialty coils," which are hardware components used in conjunction with MR systems.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a specialty coil used in conjunction with an MRI system. Its function is to improve the quality of the magnetic resonance images of specific anatomical sites (shoulder, hand/wrist, foot/ankle).
- Intended Use: The intended use is to produce images of the internal structure and/or function of the body, which are then interpreted by a trained physician to assist in diagnosis. This is a function of the imaging system itself, not a test performed on a biological sample.
The device is an accessory to a Magnetic Resonance Diagnostic Device (MRDD), which is a type of medical imaging equipment, not an IVD.
N/A
Intended Use / Indications for Use
The specialty coils are indicated for use in conjunction with the MAGNETOM Aera 1.5T & MAGNETOM Skyra 3T MR Systems, Magnetic Resonance Diagnostic Devices (MRDD), that produce transverse, sagittal, coronal and oblique cross sectional images, and display the internal structure and/or function of the body. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
Product codes
MOS
Device Description
The specialty coils are intended to be used in conjunction with the MAGNETOM Aera 1.5T & MAGNETOM Skyra 3T MR Systems, Magnetic Resonance Diagnostic Devices. These coils will be used to present images which reflect the spatial distribution and the other physical parameters derived from the images may also be produced.
The specialty coils will include: Shoulder Large 16, Shoulder Small 16, Hand/Wrist 16 and Foot/ Ankle 16 for the existing MAGNETOM Aera 1.5T & MAGNETOM Skyra 3T MR Systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Diagnostic Devices (MRDD)
Anatomical Site
Body, Shoulder, Hand/Wrist, Foot/Ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory testing was performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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Section 5: 510(k) Summary
510(k) Summary ഗ
JAN 1 1 2011
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR & 807.92.
l. General Information
| Establishment | Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway
Malvern, PA 19355 |
| --------------- | -------------------------------------------------------------------------------------- |
|---|
Registration Number 2240869
Manufacturer Siemens Mindit Magnetic Resonance Ltd.
Siemens MRI Center, Gaoxin C. Ave. 2nd Hi-Tech Industrial Park, ShenZhen 518057, PR. China
Registration Number 3004754211
Contact
Alicia Bustos-Juergensen Technical Specialist, Regulatory Submissions 51 Valley Stream Parkway Malvern, PA 19355 Phone: (610) 448-4056 Fax: (610) 448-1787 E-mail address: alicia.bustos-juergensen@siemens.com
| Device Name | Trade Name: | Specialty Coils for MAGNETOM
Aera 1.5T & MAGNETOM Skyra 3T
MR Systems |
|-------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| | Classification Name:
Device Class:
Product Code:
Classification Panel: | Coil, Magnetic Resonance Specialty
Class II 21 CFR § 892.1000
MOS
Radiology |
Performance Standards
None established under Section 514 the Food, Drug, and Cosmetic Act.
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ll. Safety and Effectiveness Information Supporting Substantial Equivalence.
Intended Use
The specialty coils are indicated for use in conjunction with the MAGNETOM Aera 1.5T & MAGNETOM Skyra 3T MR Systems, Magnetic Resonance Diagnostic Devices (MRDD), that produce transverse, sagittal, coronal and oblique cross sectional images, and display the internal structure and/or function of the rody. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
Device Description
The specialty coils are intended to be used in conjunction with the MAGNETOM Aera 1.5T & MAGNETOM Skyra 3T MR Systems, Magnetic Resonance Diagnostic Devices. These coils will be used to present images which reflect the spatial distribution and the other physical parameters derived from the images may also be produced.
The specialty coils will include: Shoulder Large 16, Shoulder Small 16, Hand/Wrist 16 and Foot/ Ankle 16 for the existing MAGNETOM Aera 1.5T & MAGNETOM Skyra 3T MR Systems.
Substantial Equivalence
Siemens believes that, within the meaning of the Safe Medical Device Act of 1990, the MAGNETOM Aera 1.5T & MAGNETOM Skyra 3T Systems with specialty coils are substantially equivalent to the following cleared medical devices:
| Predicate Device Name | FDA Clearance
Number | FDA Clearance
Date |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-----------------------|
| Siemens MAGNETOM ESSENZA 1.5 T
(Focus Shoulder Array Coil) | K071925 | Aug 14, 2007 |
| Siemens MAGNETOM ESSENZA 1.5 T
(Focus Shoulder Array Coil, Small,
8-Channel Wrist Coil,
8-Channel Foot-Ankle Coil) | K083166 | Jan 13, 2009 |
| Siemens MAGNETOM Verio 3T
(Large 4-Channel Shoulder Array Coil,
Small 4-Channel Shoulder Array Coil,
8- Channel Wrist Coil,
8-Channel Foot -Ankle Coil) | K072237 | Oct 10, 2007 |
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General Safety and Effectiveness Concerns:
The following safety and performance parameters:
[Safety] -Maximum Static Field -Rate of Change of Magnetic Field -RF Power Deposition -Acoustic Noise Level
[Performance] -Geometric Distortion -Slice Profile, Thickness and Gap -High Contrast Spatial Resolution
Specified by the FDA Guidance document for MR Diagnostic Devices are unaffected by the modifications described within this notification.
The following parameters were considered for the new Specialty Coils:
(Safetvl -Biocompatibility
[Performance] -Signal to Noise Ratio -Image Uniformity
No new materials were used for the new specialty coils compared to their predicate devices. Therefore no new biocompatibility tests were performed. Signal to Noise Ratio (SNR) and image uniformity tests were performed for the new specialty coils and the results presented in this submission show that they are equivalent with the predicate devices.
Conclusion as to Substantial Equivalence
Laboratory testing was performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to effectiveness.
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The text is in all caps and is written in a sans-serif font.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room – WO66-G609 Silver Spring, MD 20993-0002
Ms. Alicia Bustos-Jeurgensen Regulatory Technical Specialist Siemens Medical Solutions USA. Inc. 51 Valley Stream Parkway MALVERN PA 19355
JAN 1 1 2011
Re: K103275
Trade/Device Name: Specialty Coils for MAGNETOM Aera 1.5T & MAGNETOM Skyra 3T MR Systems
Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 4, 2010 Received: November 5, 2010
Dear Ms. Bustos-Jeurgensen:
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. Insting 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
4
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 (21 CFR Parts 801 and 809), please contact the Office of In Viro 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/ReportalProblem/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.
signature
David G. Brown, Ph.D. Acting 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 4
510(k) Number (if known) K103x275
03275
JAN 1 1 2011
Specialty Coils for MAGNETOM Aera 1.5T & MAGNETOM Device Name: Skyra 3T MR Systems
Indications for Use:
The specialty coils are indicated for use in conjunction with the MAGNETOM Aera 1.5T & MAGNETOM Skyra 3T Systems, magnetic resonance diagnostic devices (MRDD), which produce transverse, sagittal, coronal and oblique cross sectional images, and display the internal structure and/or function of the body.
These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
The intended use of the Aera and Skyra Systems is not affected by the use of the new specialty coils.
Prescription Use × (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 In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K163275
Siemens 510(k) Premarket Notification Specialty Coils for MAGNETOM Aera 1.5T & MAGNETOM Skyra 3T MR Systems