(42 days)
No
The summary describes a hardware component (a headcoil) for an MRI system and its intended use for diagnostic imaging and spectroscopy. There is no mention of software algorithms, image processing, or any terms related to AI or ML.
No
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a diagnostic imaging device to produce 1H images and 1H spectra of the internal structures of the head" and that the images and spectra "provide information that can be useful in determining diagnosis." It does not mention any therapeutic purpose.
Yes
The device is explicitly stated as "indicated for use as a diagnostic imaging device" and the information it provides can be "useful in determining diagnosis."
No
The device description explicitly states that the device "consists of the resonator and an electronic box," indicating it is a hardware component, not software only.
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 this device is a headcoil for an MRI system. It produces images and spectra of the internal structures of the head by utilizing magnetic resonance properties of protons and phosphorus.
- Method of Use: The device is used externally on the patient's head to acquire data directly from within the body, not from a sample taken from the body.
- Intended Use: The intended use is for diagnostic imaging and spectroscopy of the head, which is a form of in vivo (within the living body) diagnostic testing, not in vitro.
Therefore, this device falls under the category of medical imaging devices rather than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The 31P/1H headcoil for MAGNETOM Allegra is a transmit/receive birdcage type headcoil double resonant on phosphorus (31P) and proton (1H) frequencies.
Used in the Allegra system it is indicated for use as a diagnostic imaging device to produce 1H images and 1H spectra of the internal structures of the head. In addition, 31P spectra can be obtained within the same session without changing the coil.
The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules, in which the nucleus under investigation is contained, to be distinguished. The NMR properties that determine the image and spectra appearance are spin density, spin-lattice relaxation time (T1), spin-spin echo time (T2) and resonance frequency of the corresponding nucleus.
When interpreted by a trained physician, these images and spectra provide information that can be useful in determining diagnosis.
Product codes
MOS
Device Description
The 31P/1H headcoil for MAGNETOM Allegra is a transmit/receive birdcage type quadrature headcoil double resonant on phosphorus (31P) and proton (1H) frequencies. It is optimized for the main application: 31P spectroscopy potentially including also proton decoupling.
The coil consists of the resonator and an electronic box, which serves for switching transmit/receive, quadrature splitting, preamplifying and lowpass filtering in the receive pathway. The latter being essential for proton decoupling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Head
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)
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.
0
Section 1: 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
| I. General Information
| Device Name | Trade Name: | 31P/1H headcoil for MAGNETOM Allegra |
|---|---|---|
| Classification Name: | Magnetic Resonance Diagnostic Device | |
| CFR Section: | CFR § 892.1000 | |
| Classification: | Class II | |
| Product Code: | MOS - Magnetic Resonance Specialty Coil | |
| Manufacturer | Bruker BioSpin MRI GmbH | |
| Rudolf-Plank-Straße 23 | ||
| D-76275 Ettlingen, Germany | ||
| Registration Number | 9612385 | |
| Initial Importer/ | ||
| Distributor | Siemens Medical Systems, Inc. | |
| 51 Valley Stream Parkway | ||
| Malvern, PA 19355 | ||
| Registration Number | 2240869 | |
| Contact Person | Nealie Hartman | |
| Technical Specialist, Regulatory Affairs | ||
| Siemens Medical Solutions | ||
| 51 Valley Stream Parkway E-50 | ||
| Malvern, PA 19355 | ||
| Phone: (610) 448-1769 | ||
| Fax: (610) 448-1787 | ||
| Email: nealie.hartman@siemens.com | ||
| Performance | ||
| Standards | None established under Section 514 the Food, Drug, and Cosmetic Act. |
1
II. Safety and Effectiveness Supporting Substantial Equivalence
Device Description
The 31P/1H headcoil for MAGNETOM Allegra is a transmit/receive birdcage type quadrature headcoil double resonant on phosphorus (31P) and proton (1H) frequencies. It is optimized for the main application: 31P spectroscopy potentially including also proton decoupling.
The coil consists of the resonator and an electronic box, which serves for switching transmit/receive, quadrature splitting, preamplifying and lowpass filtering in the receive pathway. The latter being essential for proton decoupling.
Intended Use
The 31P/1H headcoil for MAGNETOM Allegra is a transmit/receive birdcage type headcoil double resonant on phosphorus (31P) and proton (1H) frequencies.
Used in the Allegra system it is indicated for use as a diagnostic imaging device to produce 1H images and 1H spectra of the internal structures of the head. In addition, 31P spectra can be obtained within the same session without changing the coil.
The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules, in which the nucleus under investigation is contained, to be distinguished. The NMR properties that determine the image and spectra appearance are spin density, spin-lattice relaxation time (T1), spin-spin echo time (T2) and resonance frequency of the corresponding nucleus.
When interpreted by a trained physician, these images and spectra provide information that can be useful in determining diagnosis.
Substantial Equivalence
Bruker and Siemens believe that, within the meaning of the Safe Medical Device Act of 1990, the 31P/1H headcoil for MAGNETOM Allegra is substantially equivalent to three coils:
| Coil Name | Premarket Notification | Clearance Date |
|---|---|---|
| Siemens Medical Solutions | ||
| 31P/1H heart/liver coil for Clinical Phosphorus | ||
| Spectroscopy Option MAGNETOM Vision | K962627 | March 04, 1997 |
| Siemens Medical Solutions | ||
| 31P/1H heart/liver coil included in syngo MR 2002B | K020991 | June 13, 2002 |
| GE Medical Systems | ||
| Signa 1.5T Phosphorus Transmit/Receive Flex Coil | K983139 | February 19, |
| 1999 |
Besides 1H imaging, these coils allow the non-invasive in vivo analysis of 31P-metabolites such as phosphocreatine (PCr), inorganic phosphate (Pi) or adenosine triphosphate (ATP) relevant in energy metabolism. The regions applied are heart, liver, muscle, and head.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 2004
Ms. Nealie Hartman · Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc., USA 51 Valley Stream Parkway MALVERN PA 19355
Re: K042617 Trade/Device Name: 31P/1H headcoil for MAGNETOM Allegra System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: September 23, 2004
Received: September 24, 2004
Dear Ms. Hartman:
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 tthe 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.
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.
3
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 number 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/cdrb/dsma/dsmamain.httml
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
4
Indications for Use
Ko42617 510(k) Number (if known) __
31P/1H headcoil for MAGNETOM Allegra System Device Name:
Indications for Use:
The 31P/1H headcoil for MAGNETOM Allegra is a transmit/receive birdcage type headcoil double resonant on phosphorus (31P) and proton (1H) frequencies.
Used in the Allegra system it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique 1H images and 1H spectra of the internal structures of the head. In addition, 31P spectra can be obtained within the same session without changing the coil.
The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules, in which the nucleus under investigation is contained, to be distinguished. The NMR properties that determine the image and spectra appearance are spin density, spin-lattice relaxation time (T1), spin-spin echo time (T2) of the corresponding nucleus.
When interpreted by a trained physician, these images and spectra 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 Prescription Use_ OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ h ! '){k} Numbe