(43 days)
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.
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.
The provided text describes a 510(k) summary for a medical device: a 13C/1H occipital headcoil for the MAGNETOM Allegra system. This document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance metrics for a new, standalone diagnostic algorithm.
Therefore, much of the requested information regarding acceptance criteria, performance metrics, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not available in the provided text. The document is primarily concerned with regulatory clearance based on substantial equivalence, and not the performance evaluation of a novel algorithm for diagnostic interpretation.
Here's what can be extracted based on the provided text, and what remains unknown:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of diagnostic performance (e.g., sensitivity, specificity). The acceptance criterion implicitly met is "substantial equivalence" to predicate devices for its intended use as a diagnostic imaging device for 1H and for obtaining 13C spectra, with the understanding that the images and spectra provide information "useful in determining diagnosis" when interpreted by a trained physician.
- Reported Device Performance: No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, AUC) are reported for the device itself because it is a hardware component (a coil) used in an existing MRI system, not a diagnostic algorithm.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The submission is for a new hardware component (headcoil) being cleared through substantial equivalence, not a machine learning algorithm requiring a test set for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. No test set or ground truth establishment by experts for a diagnostic algorithm's performance is described. The document states that images and spectra, when interpreted by a trained physician, provide useful diagnostic information.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set requiring expert adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, not done. This is a hardware submission, not a study evaluating an AI algorithm for improving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, not applicable. This device is a hardware component for an MRI system; it is not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not Provided. For the use of the device in diagnosis, the "ground truth" would ultimately be established clinically by "trained physicians" interpreting the images and spectra, but this is not part of a performance study for the coil itself.
8. The sample size for the training set
- Not applicable / Not provided. No training set is mentioned as this is a hardware device based on principles of physics, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable / Not provided. No training set or ground truth for it is mentioned.
Summary of available information:
The document is a 510(k) summary for a medical device, a specific type of headcoil for an MRI system. The submission aims to establish substantial equivalence to existing, legally marketed predicate devices, rather than demonstrating the diagnostic performance of a novel algorithm against specific acceptance criteria. The equivalence argument is based on the device's technological characteristics, intended use, and the fact that it performs similar functions (imaging with 1H, spectroscopy with 13C) to predicate devices that perform imaging with 1H and spectroscopy with 31P. The document explicitly states that the images and spectra produced by the device, when interpreted by a trained physician, can be useful for diagnosis. There are no details provided about performance studies, sample sizes, expert ground truth, or adjudication methods because the regulatory pathway chosen (510(k) substantial equivalence for a hardware component) does not typically require this level of detail for diagnostic performance beyond demonstrating safety and functional equivalence to predicates.
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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 forMAGNETOM 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 GmbHRudolf-Plank-Straße 23D-76275 Ettlingen, Germany | |
| Registration Number | 9612385 | |
| Initial Importer/Distributor | Siemens Medical Solutions, Inc.51 Valley Stream ParkwayMalvern, PA 19355 | |
| Registration Number | 2240869 | |
| Contact Person | Nealie HartmanTechnical Specialist, Regulatory AffairsSiemens Medical Solutions51 Valley Stream Parkway E-50Malvern, PA 19355Phone: (610) 448-1769Fax: (610) 448-1787Email: nealie.hartman@siemens.com | |
| PerformanceStandards | None established under Section 514 the Food, Drug, and Cosmetic Act. |
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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 Solutions31P/1H heart/liver coil for Clinical PhosphorusSpectroscopy Option MAGNETOM Vision | K962627 | March 04, 1997 |
| Siemens Medical Solutions31P/1H heart/liver coil included in syngo MR 2002B | K020991 | June 13, 2002 |
| GE Medical SystemsSigna 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.
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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.
§ 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.