K Number
K042718
Device Name
13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA
Date Cleared
2004-11-12

(43 days)

Product Code
Regulation Number
892.1000
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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.
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.
More Information

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

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): 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.

K962627, K020991, K983139

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 NameTrade 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
ManufacturerBruker BioSpin MRI GmbH
Rudolf-Plank-Straße 23
D-76275 Ettlingen, Germany
Registration Number9612385
Initial Importer/
DistributorSiemens Medical Solutions, Inc.
51 Valley Stream Parkway
Malvern, PA 19355
Registration Number2240869
Contact PersonNealie 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
StandardsNone 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 NamePremaket NotificationClearance Date
Siemens Medical Solutions
31P/1H heart/liver coil for Clinical Phosphorus
Spectroscopy Option MAGNETOM VisionK962627March 04, 1997
Siemens Medical Solutions
31P/1H heart/liver coil included in syngo MR 2002BK020991June 13, 2002
GE Medical Systems
Signa 1.5T Phosphorus Transmit/Receive Flex CoilK983139February 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.