(45 days)
No
The summary describes a standard MRI head coil and its technical specifications. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a "diagnostic imaging device" used to produce images for determining diagnosis, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a diagnostic imaging device" and that the images it produces "can be useful in determining diagnosis."
No
The device description explicitly details hardware components (8-channel phased array coil, cables) and its function is to acquire MR images, which is a hardware-dependent process. The summary also mentions performance studies related to NEMA and IEC standards for hardware safety and performance.
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: The Noras OR head coil 1.5 T is a component of a Magnetic Resonance (MR) scanner. It is used to acquire images of the human brain and head directly from the patient's body.
- Intended Use: The intended use clearly states it's for "MR examination of the human brain" and "diagnostic imaging device to produce... images of the internal structures of the head." This involves imaging the patient directly, not analyzing a sample taken from the patient.
Therefore, based on the provided information, the Noras OR head coil 1.5 T is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Noras OR head coil 1.5 T 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 1.5T 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
MOS
Device Description
The OR Head Coil 1.5T 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 1.5T, 63.6 MHz. Each coil is connected to the MAGNETOM system by a separate cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
human brain, head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room
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)
Not Found
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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Image /page/0/Picture/0 description: The image shows the word "NORAS" in large, bold, black letters. The letters are slightly slanted to the right. There is a black line underneath the word, and the bottom of the image is cut off.
Image /page/0/Picture/1 description: The image shows a logo with the words "RÖNTGEN- UND MEDIZINTECHNIK" in bold, black letters. Below the text is a thick, black line. Underneath the line, there is some illegible text that appears to be handwritten, with the number 0758 being the only part that is legible.
510(k) Summary
OR Head Coil 1.5T
MAY - 5 2006
Date of Summary Preparation: March 15, 2006
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
- General Information 1.
- Importer/Distributor Name and Address Siemens Medical Solutions, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Establishment Registration Number 2240869
Manufacturing Site Name and Address Noras Röntgen- und Medizintechnik GmbH Leibnizstrasse 4 97204 Höchberg Germany
Establishment Registration Number Establishment Registration 3004929307
Owner/Operator 9071737
Contact Person 2.
Judy Campbell Siemens Medical Solutions, Inc. 51 Valley Stream Parkway, E-50 Malvern, PA 19355 Telephone: (610) 448-4918 (610) 448-1787 Fax: Email Address: judith.campbell@siemens.com
CONFIDENTIAL
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Image /page/1/Picture/0 description: The image shows the word "NORAS" in large, bold, black letters. Below the word, there is some text that is partially obscured. The text appears to be related to the word "NORAS", possibly providing a definition or context. The overall image has a high-contrast look, with the black text standing out against a lighter background.
Image /page/1/Picture/1 description: The image shows the words "RÖNTGEN- UND MEDIZINTECHNIK" in bold, black font. The words are stacked on top of each other, with "RÖNTGEN- UND" on the top line and "MEDIZINTECHNIK" on the bottom line. The background is white.
Trade Name: Common Name: Classification Name: Classification Panel: CFR Number: Device Class: Product Code:
OR Head Coil 1. OR Head Coil 1.5 Magnetic Resonance Diagnostic Device Radiology 21 CFR § 892.1000 ============================================================================================================================================================================== 90MOS
4. Device Description
The OR Head Coil 1.5T 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 1.5T, 63.6 MHz. Each coil is connected to the MAGNETOM system by a separate cable.
Image /page/1/Picture/6 description: The image shows two curved, gray objects with multiple holes. Each object has a cable attached to it, and the cables are connected to rectangular connectors. The connectors appear to be of different types. The background is black, which makes the objects stand out.
Use of the OR Head Coil 1.5T requires the Siemens OR Head Holder. The pictures below show the complete set.
Image /page/1/Picture/8 description: The image contains two photos of a football helmet. The photo on the left shows the helmet from the side, and the photo on the right shows the helmet from the front. The helmet is dark in color and has a face mask. There are some white dots on the top of the helmet.
Traditional 510(k) Noras Rontgen- Und Medizintechnik GmbH OR Head Coil 1.5T March 16, 2006
CONFIDENTIAL
000 05
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Image /page/2/Picture/0 description: The image shows a logo with the text "RÖNTGEN- UND MEDIZINTECHNIK" in bold, black letters. The text is stacked in two lines, with "RÖNTGEN- UND" on the top line and "MEDIZINTECHNIK" on the bottom line. To the left of the text is a stylized graphic that resembles a triangle with a horizontal line extending from its base. The logo appears to be for a company or organization related to X-ray and medical technology.
The intended use of the Noras OR Head Coil ST 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 and Siemens believe that, within the meaning of the Safe Medical Devices Act of 1990, the 8-channel phased array OR head coil 1.5T for the Magnetom Systems is substantially equivalent to the following coil:
| Coil Name | Pemarket Notification | Clearance Date |
|---|---|---|
| MRI Devices | ||
| Corporation (Now | ||
| Known as Invivo | ||
| Corporation) | ||
| High Resolution Head | ||
| Coil -Model HRH-63-8 | K013159 | October 16, 2001 |
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 both coils are substantially equivalent.
General Safety and Effectiveness Concerns 8.
The OR Head Coil 1.5T 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 1.5T systems.
The NEMA Tests can be found in Appendix C. The NEMA Tests were done on Software platform syngo MR2004A. 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 the Symphony are applicable to all MAGNETOM 1.5T systems.
Traditional 510(k) Noras Rontgen- Und Medizintechnik GmbH OR Head Coil 1.5T March 16, 2006
CONFIDENTIAL
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Image /page/3/Picture/0 description: The image shows the logo for NORAS Röntgen- und Medizintechnik. The word "NORAS" is in large, bold, black letters. To the right of "NORAS" is a black line that forms a V shape, and to the right of that is the text "RÖNTGEN- UND MEDIZINTECHNIK" in smaller, bold, black letters. A black line underlines the text.
Conclusion as to Substantial Equivalence 9.
Noras and Siemens believe that, within the definition of the Safe Medical Devices Act of 1990, the Noras 8-channel phased array OR head coil 1.5T is substantially equivalent to the predicate device listed above.
Auebert Wares
Hubert Noras President
March 16, 2006
Traditional 510(k) Noras Rontgen- Und Medizintechnik GmbH OR Head Coil 1.5T March 16, 2006
CONFIDENTIAL
000 07
7
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY - 5 2006
Ms. Judith Campbell Regulatory Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway, E-50 MALVERN PA 19355
Re: K060758
Trade/Device Name: Noras OR Head Coil 1.5 T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: March 16, 2006 Received: March 21, 2006
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 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.
5
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 (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.
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 prumber 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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known):
Device Name:
Noras OR Head Coil 1.5 T
Indications for Use:
The intended use of the Noras OR head coil 1.5 T 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 1.5T 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-CONT NUE ON ANOTHER PAGE OF 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 | K060258 |
|---|---|
| Page | of |
Traditional 510(k)
Noras Rontgen- Und Medizintechnik GmbH
CONFIDENTIAL
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March 16, 200€
CONFIDENTIAL