(28 days)
No
The summary describes a passive hardware component (an MRI coil) and does not mention any software or algorithms that would utilize AI/ML for image processing, analysis, or other functions.
No
The device is described as a diagnostic imaging device used to produce images for diagnosis, not for therapeutic purposes.
Yes
The text explicitly states: "it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis."
No
The device description explicitly states it is an "8-channel phased array coil" with physical components (bottom and top arrays, cables) and is tuned to a specific frequency, indicating it is a hardware device.
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 Noras OR Head Coil 3T is a component of a Magnetic Resonance (MR) scanner. Its function is to acquire MR images of the human brain and head.
- Method of Use: The device works by interacting with the patient's body directly (in vivo) to generate images, not by analyzing samples taken from the body (in vitro).
- Intended Use: The intended use clearly states "MR examination of the human brain" and "diagnostic imaging device to produce... images of the internal structures of the head." This is consistent with in vivo imaging, not in vitro testing.
Therefore, the Noras OR Head Coil 3T is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Noras OR Head Coil 3T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging).
Used in the 3T MAGNETOM Systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head.
When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
90MOS
Device Description
The Noras OR Head Coil 3T is an 8-channel phased array coil. The coil is divided into a bottom and a top array of 4 channels each. Each-channel is tuned to the Larmor frequency of the 1H spin in a magnetic field of 3T, 123.2 MHz. Each coil is connected to the MAGNETOM system by a separate cable.
Use of the Noras OR Head Coil 3T requires the Noras OR Head Holder (K071179 April 30, 2007).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Scanner
Anatomical Site
human brain, head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician, operating room
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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K091546
page 1 of 4
510(k) Summary
JUN 2 4 2009
Noras OR Head Coil 3T
Date of Summary Preparation: April 30, 2009
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
1. General Information
Importer/Distributor Name and Address Noras MRI products GmbH Leibnizstr.4 97204 Hoechberg / Germany
ERN: 3004929307 Owner/Operator Number: 9071737
Manufacturing Site Name and Address Noras MRI products GmbH Leibnizstr.4 97204 Hoechberg / Germany
ERN: 3004929307 Owner/Operator Number: 9071737
2. Contact Person
Zahed Sedighiani Regulatory Affairs Manager Noras MRI products GmbH Leibnizstr.4 97204 Hoechberg Germany Tel: (+49) 931 / 29927-17 Fax: (+49) 931 / 29927-20 zahed.sedighiani@noras.de
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K091546
Page 2 of 4
Device Name and Classification 3.
Trade Name: OR Head Coil 3T Common Name: OR Head Coil 3T Classification Name: Magnetic Resonance Diagnostic Device Classification Panel: Radiology 21 CFR § 892.1000 CFR Number: Device Class: Product Code: 90MOS
Device Description 4.
The Noras OR Head Coil 3T is an 8-channel phased array coil. The coil is divided into a bottom and a top array of 4 channels each. Each-channel is tuned to the Larmor frequency of the 1H spin in a magnetic field of 3T, 123.2 MHz. Each coil is connected to the MAGNETOM system by a separate cable.
Image /page/1/Picture/5 description: The image shows two headbands with wires and connectors. The headbands are curved and appear to be made of a dark material. Each headband has a wire that extends from it, terminating in a connector. The connectors are rectangular and have multiple pins or contacts. The background is black, which makes the headbands and connectors stand out.
Use of the Noras OR Head Coil 3T requires the Noras OR Head Holder (K071179 April 30, 2007). The pictures below show the complete set.
Image /page/1/Figure/7 description: The image contains two separate pictures. The picture on the left shows a complex mechanical device with multiple components and wires. The picture on the right shows a similar mechanical device, but with a different configuration and a visible arrow at the bottom.
Special 510(k) Noras MRI products GmbH OR Head Coil 3T April 30, 2009
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K091546
Page 3 of 4
5. Intended Use
The intended use of the Noras OR Head Coil 3T is the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. It can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI.
6. Substantial Equivalence
Noras MRI products GmbH believes that, within the meaning of the Safe Medical Devices Act of 1990, the 8-channel phased array Noras OR Head Coil 3T for the Magnetom Systems is substantially equivalent to the following coil:
| Predicate Device Name and
Manufacturer | 510(k)
Number | Clearance Date | Product
Code | Comparable
Properties |
|-------------------------------------------------------------------------------------------------------------|------------------|------------------|-----------------|-----------------------------------------|
| Noras OR Head Coil 1,5T | K060758 | March 21, 2006 | 90MOS | Proton imaging |
| MRI Devices Corporation (now
known as Invivo Corporation)
High Resolution Head Coil
Model HRH-63-8 | K013159 | October 16, 2001 | 90MOS | High Resolution
Head Imaging
fMRI |
Summary of Technological Characteristics of the Principal Device as 7. Compared with the predicate Device
Although the MRI Devices High Resolution Head Coil is limited for use outside the operating room, we believe that all top coils are substantially equivalent.
General Safety and Effectiveness Concerns 8.
The Noras OR Head Coil 3T will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the IEC standards for safety issues with the Magnetic Resonance Imaging Devices, IEC 60601-2-33:2002, This will assure that the performance of this device can be considered safe and effective when used with the currently available MAGNETOM 3T systems Trio a Tim and Verio.
3
The NEMA Tests can be found in Appendix C. The NEMA Tests were done on software platform version VB15A. We have included the Common Risk Analysis for syngo MR2006A, which is the same functionality as syngo platform MR 2004A. We believe the NEMA tests on Trio a Tim are applicable to Verio system.
Conclusion as to Substantial Equivalence 9.
Noras MRI products GmbH believes that, within the definition of the Safe Medical Devices Act of 1990, the 8-channel phased array Noras OR Head Coil 3T is substantially equivalent to the predicate device listed above.
Hubert Noras
Hubert Noras
President
-
- 09
April 30, 2009
- 09
4
DEPARTMENT OF HEALTH & HUMAN SERVICES ... . .
_Public Health Service .
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 24 2009
Mr. Zahed Sedighiani Regulatory Affairs Manager Noras MRI Products GmbH Leibnizstr. 4. Hoechberg 97204 GERMANY .
Re: K091546
Trade/Device Name: Noras OR Head Coil 3T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: April 30, 2009 Received: May 27, 2009
Dear Mr. Sedighiani:
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 (PMA), it may be subject to 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); medical device reporting (reporting of medical
5
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Iarina M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): Ko f 15 yc
Device Name: Noras OR Head Coil 3T
Indications for Use:
The intended use of the Noras OR Head Coil 3T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging).
Used in the 3T MAGNETOM Systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head.
When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| AND/OR | Over-The-Counter Use (21 CFR 801 Subpart C) |
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
| 510(k) Number | K091546 |
|---|---|
| --------------- | --------- |
Special 510(k) Noras MRI products GmbH OR Head Coil 3T April 30, 2009