(220 days)
Not Found
No
The document describes a passive component (an MR coil) and does not mention any software or algorithms that would incorporate AI/ML.
No
The device is described as a "magnetic resonance diagnostic device" used to produce images for diagnosis, not for treating conditions.
Yes
The text explicitly states that the device "is indicated for use as a magnetic resonance diagnostic device (MRDD)" and that the images it produces "provide information that can be useful in determining a diagnosis."
No
The device description clearly identifies the device as a "14-Channel Extremity Coil," which is a physical hardware component used in conjunction with an MRI scanner. It is not described as software.
Based on the provided text, 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 or other conditions.
- Device Function: The description clearly states that this device is a coil used in conjunction with an MRI scanner to produce images of the human body (knee, foot, ankle, hand, and wrist). It works by detecting the spatial distribution of protons exhibiting magnetic resonance.
- No Sample Analysis: There is no mention of analyzing samples taken from the body. The device interacts directly with the body to generate images.
Therefore, this device falls under the category of a medical imaging device, specifically a component for a Magnetic Resonance Diagnostic Device (MRDD), rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The new 14-Channel Extremity Coil is indicated for use in conjunction with the 1.5T MAGNETOM ESSENZA, in the MR examination of the human knee, foot, ankle, hand and wrist.
Used in the MAGNETOM ESSENZA, the 14-Channel Extremity Coil is indicated for use as a magnetic resonance diagnostic device (MRDD) to produce transverse, sagittal, coronal and oblique cross sectional images that display the internal structure and/or function of the knee, foot, ankle, hand and wrist.
When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
The intended use of the MAGNETOM ESSENZA is not affected in any way by the use of the new 14-Channel Extremity Coil.
Product codes
MOS
Device Description
The new 14-Channel Extremity Coil is indicated for use in conjunction with the 1.5T MAGNETOM ESSENZA, in the MR examination of the human knee, foot, ankle, hand and wrist.
Used in the MAGNETOM ESSENZA, the 14-Channel Extremity Coil is indicated for use as a magnetic resonance diagnostic device (MRDD) to produce transverse, sagittal, coronal and oblique cross sectional images that display the internal structure and/or function of the knee, foot, ankle, hand and wrist.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
human knee, foot, ankle, hand and wrist.
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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Healthcare
AUG 2 7 2010
Attachment B - 510(k) Summary
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.
I. General Information
| Establishment | Siemens Medical SolutionsUSA, 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 | Kim Rendon
Manager, Regulatory/Clinical Affairs
51 Valley Stream Parkway, MS G01
Malvern, PA 19355
Phone: (610) 717-8085
Fax: (610) 448-1787
E-mail address: kimberly.rendon@siemens.com |
| Device Name | Trade Name: 14-Channel Extremity Coil for
1.5T MAGNETOM ESSENZA
Classification Name: Coil, Magnetic Resonance Specialty
Device Class: Class II 21 CFR § 892.1000
Product Code: MOS
Classification Panel: Radiology |
| Performance Standards | None established under Section 514 the Food, Drug, and Cosmetic Act. |
K100141 - MAGNETOM Essenza 14-Channel Extremity Coil
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II. Safety and Effectiveness Information Supporting Substantial Equivalence.
Intended Use
The new 14-Channel Extremity Coil is indicated for use in conjunction with the 1.5T MAGNETOM ESSENZA, in the MR examination of the human knee, foot, ankle, hand and wrist.
Used in the MAGNETOM ESSENZA, the 14-Channel Extremity Coil is indicated for use as a magnetic resonance diagnostic device (MRDD) to produce transverse, sagittal, coronal and oblique cross sectional images that display the internal structure and/or function of the knee, foot, ankle, hand and wrist.
When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
The intended use of the MAGNETOM ESSENZA is not affected in any way by the use of the new 14-Channel Extremity Coil.
Device Description
The new 14-Channel Extremity Coil is indicated for use in conjunction with the 1.5T MAGNETOM ESSENZA, in the MR examination of the human knee, foot, ankle, hand and wrist.
Used in the MAGNETOM ESSENZA, the 14-Channel Extremity Coil is indicated for use as a magnetic resonance diagnostic device (MRDD) to produce transverse, sagittal, coronal and oblique cross sectional images that display the internal structure and/or function of the knee, foot, ankle, hand and wrist.
Substantial Equivalence
Siemens believes that, within the meaning of the Safe Medical Device Act of 1990, the 14-Channel Extremity Coil is substantially equivalent to the QED TxRx 15Ch Knee Coil 1.5T.
| Predicate Device Name | FDA Clearance
Number | FDA Clearance
Date |
|-------------------------------------|-------------------------|-----------------------|
| TxRx 15Ch Knee Coil 1.5T .
(QED) | K082636 | Sep. 25, 2008 |
General Safety and Effectiveness Concerns:
The following are the safety and performance parameters:
K100141 - MAGNETOM Essenza 14-Channel Extremity Coil
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Healthcare
Safety
-Maximum Static Field -Rate of Change of Magnetic Field -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 14-Channel Extremity Coil:
Safety -RF Power Deposition -Biocompatibility
Performance -Signal to Noise Ratio -Image Uniformity
No new materials were used for the new 14-Channel Extremity Coil compared to the predicate device. Therefore no new biocompatibility tests were performed. Signal to Noise Ratio (SNR), image uniformity and SAR tests were performed for the new 14-Channel Extremity Coil 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a caduceus or a representation of human figures.
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. Judith Campbell Regulatory Technical Specialist Siemens Medical Solution USA, Inc. 51 Valley Stream Parkway MALVERN PA 19355
AUG 2 7 2010
Re: K100141
Trade/Device Name: 14-Channel Extremity Coil for MAGNETOM ESSENZA Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: August 6, 2010 Received: August 9, 2010
Dear Ms. Campbell:
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 (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 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,
Donald J. Trump
Donald J. St.Pierre 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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Attachment A - Indications for Use
510(k) Number (if known): K100141
Device Name: 14-Channel Extremity Coil for MAGNETOM ESSENZA
Indications for Use:
The intended use of the new 14-Channel Extremity Coil is, in conjunction with THE 1.5T MAGNETOM ESSENZA Magnetic Resonance Scanner, the MR examination of the human knee, foot, ankle, hand and wrist.
Used in the MAGNETOM ESSENZA, the 14-Channel Extremity Coil is indicated for use as a magnetic resonance diagnostic device (MRDD) to produce transverse, sagittal, coronal and oblique cross sectional images that display the internal structure and/or function of the knee, foot, ankle, hand and wrist. The images produced by the MAGNETOM ESSENZA with the, 14-Channel Extremity Coil reflects the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.
When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
The intended use of the MAGNETOM ESSENZA is not affected in any way by the use of the new 14-Channel Extremity Coil.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (0) O J V D
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K100141
K100141 - MAGNETOM Essenza 14-Channel Extremity Coil