(43 days)
Not Found
No
The document describes a magnetic resonance imaging coil and its intended use for diagnostic imaging and spectroscopy, with no mention of AI or ML technologies for image processing, analysis, or interpretation.
No
The 'Intended Use / Indications for Use' section states that the device is "indicated for use as a diagnostic imaging device". It is used to produce images and spectra that "provide information that can be useful in determining diagnosis," rather than directly treating a condition.
Yes
This device is explicitly stated to be "indicated for use as a diagnostic imaging device" and provides "images and spectra [that] provide information that can be useful in determining diagnosis."
No
The device description explicitly states it is a "transmit/receive surface coil type headcoil" and includes a "resonator and an electronic box," indicating it is a hardware component.
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 is used to obtain images and spectra directly from within the head of a patient.
- Intended Use: The intended use is for diagnostic imaging of internal structures of the head and obtaining spectra from within the head. This is an in vivo (within the living body) application, not in vitro (outside the living body).
The device is a component of a medical imaging system used for diagnostic purposes, but it does not perform tests on samples taken from the body.
N/A
Intended Use / Indications for Use
The 13C/IH occipital headcoil for MAGNETOM Allegra is a transmit/receive surface coil type headcoil double resonant on carbon (13C) and proton (1H) frequencies.
Used in the Allegra system it is indicated for use as a diagnostic imaging device 1H Osed in the Anegra system it is in internal structures of the head. In addition, 13C spectra can be obtained within the same session without changing the coil.
The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. The mages produced for ophich the nucleus under investigation is contained to be Specula "anow" the "moreoarer that determine the image and spectra appearance are spin density, spin-latice relaxation time (TI), 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 (comma separated list FDA assigned to the subject device)
MOS
Device Description
The 13C/1H occipital headcoil for MAGNETOM Allegra is a transmit/receive surface coil type 1H-The 13C/IT occipian headcoil double resonant on carbon (13C) and proton (1H) frequencies. It is quadrature) . C mical neader dodore rsoctanscopy potentially including proton decoupling.
The coil consists of the resonator and an electronic box which serves for switching transmit/receive, I he consists of the resoliation and an envolvening in the receive pathway. The latter being essential for proton decoupling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance
Anatomical Site
head
Indicated Patient Age Range
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Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
0
Section 1: 510(k) Summary
42718
This summary of 510(k) safety and effectiveness information is being submitted in accordance with
er and of the first for 1900 - - LA GED & 907 03 I his summary of 510(x) sa.65) sa.65 - 1.990 and 21 CFR § 807.92.
I. General Information | ||
---|---|---|
Device Name | Trade Name: | 13C/1H occipital 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 Solutions, 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
Device Description
The 13C/1H occipital headcoil for MAGNETOM Allegra is a transmit/receive surface coil type 1H-The 13C/IT occipian headcoil double resonant on carbon (13C) and proton (1H) frequencies. It is quadrature) . C mical neader dodore rsoctanscopy potentially including proton decoupling.
The coil consists of the resonator and an electronic box which serves for switching transmit/receive, I he consists of the resoliation and an envolvening in the receive pathway. The latter being essential for proton decoupling.
Intended Use
The 13C/IH occipital headcoil for MAGNETOM Allegra is a transmit/receive surface coil type headcoil double resonant on carbon (13C) and proton (1H) frequencies.
Used in the Allegra system it is indicated for use as a diagnostic imaging device 1H Osed in the Anegra system it is in internal structures of the head. In addition, 13C spectra can be obtained within the same session without changing the coil.
The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. The mages produced for ophich the nucleus under investigation is contained to be Specula "anow" the "moreoarer that determine the image and spectra appearance are spin density, spin-latice relaxation time (TI), 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
Bulbstantial Equivalence 13C/IH occipital headcoil for MAGNETOM Allegra is substantially equivalent to three coils:
Coil Name | Premaket 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 |
Although these coils are designed for non-invasive in vivo detection of phosphorus-31-metabolites instead of the carbon-13-metabolites detectable with the coil described in this submission, we believe that they are substantially equivalent Magnetic Resonance Specialty Coils for spectroscopy of nuclei other than protons (1H), the latter being used for magnetic resonance imaging (MRI).
There are numerous publications by researchers worldwide to support the usefulness of 13C spectroscopy. No risks different to standard MRI occur for the patient during these investigations.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2 2004
Ms. Nealie Hartman Technical Specialist, Regulatory Affairs Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E50 MALVERN PA 19355
Re: K042718
Trade/Device Name: 13C/1H occipital 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 29, 2004 Received: September 30, 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 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); 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.