(31 days)
The MAGNETOM Trio a Tim System is intended for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. These images and/or spectra, when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Trio a Tim System may also be used for imaging during interventional procedures performed with MR compatible devices such as in room display and MR safe biopsy needles.
The MAGNETOM Trio a Tim System is a 3.0 T closed superconducting magnet whole body designed scanner. It consists of the same types of hardware that are currently available with the MAGNETOM Trio and Avanto systems.
This 510(k) summary does not contain information on specific acceptance criteria or a study designed to prove the device meets those criteria in the way a clinical study for an AI/ML device would. Instead, this submission focuses on demonstrating substantial equivalence to previously cleared predicate devices.
Here's a breakdown of the information that is available and what is missing based on your requested categories:
1. A table of acceptance criteria and the reported device performance
- Missing from the provided text. The document states "Performance Standards: None established under Section 514 the Food. Drug. and Cosmetic Act." This indicates that the device is not subject to specific quantitative performance standards set by the FDA for its category at the time of submission. The submission relies on "substantial equivalence" to predicate devices.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Missing from the provided text. Since no specific performance study is detailed (beyond demonstrating conformity to NEMA and IEC standards for hardware safety and performance), there is no mention of a test set, its sample size, or its data provenance.
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)
- Missing from the provided text. No information provided as there is no specific performance study involving ground truth assessment detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Missing from the provided text. No information provided as there is no specific performance study detailed.
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
- Not applicable / Missing from the provided text. This device is a Magnetic Resonance Diagnostic Device (MRDD), primarily a hardware system for acquiring images, not an AI/ML-based diagnostic assistant. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this type of device and is not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable / Missing from the provided text. This is a hardware system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Missing from the provided text. Not applicable as no specific performance study requiring ground truth is detailed.
8. The sample size for the training set
- Missing from the provided text. Not applicable, as this is a hardware device, not an AI/ML system requiring a training set in the conventional sense.
9. How the ground truth for the training set was established
- Missing from the provided text. Not applicable.
Summary of Device Acceptance and Study as Performed (Based on provided text):
The acceptance of the MAGNETOM Trio a Tim System for 510(k) clearance was primarily based on demonstrating substantial equivalence to existing, legally marketed predicate devices:
- Siemens MAGNETOM 1.5 T Avanto (K032428, October 16, 2003)
- Siemens MAGNETOM 3.0 T Trio (K013586, December 28, 2001)
The study supporting this claim of substantial equivalence involved demonstrating that the MAGNETOM Trio a Tim System's operation is substantially equivalent to the predicate devices and that it conforms to recognized industry standards:
- NEMA Standards: For the measurement of performance and safety parameters.
- IEC Standard: For safety issues with Magnetic Resonance Imaging Devices.
The submission argues that adherence to these standards and the similarity in hardware types ("consists of the same types of hardware that are currently available with the MAGNETOM Trio and Avanto systems") ensures the device's performance is safe and effective in comparison to the predicates.
Essentially, for this 510(k) clearance, the "acceptance criteria" were met by establishing that the new device operates similarly to and adheres to the same safety and performance benchmarks as its already-cleared predecessors, rather than by conducting a de novo clinical performance study with specific quantitative performance metrics.
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12 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.
I. General Information
| Establishment | Siemens Medical Solutions. Inc.51 Valley Stream ParkwayMalvern. PA 19355 |
|---|---|
| Registration Number | 2240869 |
| Manufacturer | Siemens AG. Bereich MedHenkestrasse 127D-91052 Erlangen. Germany |
| Registration Number | 8010024 |
| Contact Person | Ms. Ana LadinoTechnical Specialist. Regulatory Submissions51 Valley Stream ParkwayMalvern. PA 19355Phone: (610)448-1785Fax: (610) 448-1787 |
| Device Name | Trade Name: MAGNETOM Trio a Tim SystemClassification Name: Magnetic Resonance Diagnostic DeviceCFR Code: 21 CFR § 892.1000Classification: Class II |
Performance Standards
None established under Section 514 the Food. Drug. and Cosmetic Act.
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II. Safety and Effectiveness Information Supporting Substantial Equivalence.
Indications for Use
The MAGNETOM Trio a Tim System is intended for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. These images and/or spectra, when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Trio a Tim System may also be used for imaging during interventional procedures performed with MR compatible devices such as in room display and MR safe biopsy needles.
Device Description
The MAGNETOM Trio a Tim System is a 3.0 T closed superconducting magnet whole body designed scanner. It consists of the same types of hardware that are currently available with the MAGNETOM Trio and Avanto systems.
Substantial Equivalence
The system is substantially equivalent to the following cleared medical devices:
| Predicate Device Name | FDA ClearanceNumber | FDA Clearance Date |
|---|---|---|
| Siemens MAGNETOM 1.5 T Avanto | K032428 | October 16, 2003 |
| Siemens MAGNETOM 3.0 T Trio | K013586 | December 28, 2001 |
General Safety and Effectiveness Concerns:
Operation of the MAGNETOM Trio a Tim System is substantially equivalent to the commercially available MAGNETOM 3.0 T Trio System and 1.5 T Avanto System.
The MAGNETOM Trio a Tim System will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. This will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM Trio and Avanto systems.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.
FEB 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ana Ladino Technical Specialist Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway MALVERN PA 19355
Re: K050200
Trade/Device Name: MAGNETOM Trio a Tim System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: January 25, 2005 Received: January 28, 2005
Dear Ms. Ladino:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leviewed your becalled by equivalent (for the indications for use stated in above and nave deceminearketed predicate devices marketed in interstate commerce prior to the enclosure) to tegally manelou produced Device Amendments, or to devices that have been May 20, 1770, the onlinement active and of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accondation warmarket approval application (PMA). You may, therefore, market the do not require approval of a promance of the Act. The general controls provisions of the Act device, subject to the general version, 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 If your device is other the (see and additional controls. Existing major regulations affecting your Apploval), It inay of our 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 I Tcase be advised that 1991 to issual your device complies with other requirements of the Act or any FTA has made a decemmation mad your were rederal agencies. You must comply with all the r cacral statues and regulation 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) (21 CFR Part 8017, good manakelif applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k)
The same of the supplied of a line of a latestial againsteals This letter will allow you to begin market as walness of your device of your device to a legally
premarket notification. The FDA finding of substantial equise of your device premarket notification. The FDA Inding of substantial equiratelie of your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleased
on the regulation of the fillers for af Hearing numbers, based on the r If you desire specific advice for your device on but facemig regarities. (even 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 Also, please note the regulation entitled, "Misoraniality of your responsibilities under the Act from the 807.97). You may obtain other general informations on your responsibility of the number (800)
Division of Small Manufacturers, International and Consumer Assistance at its t DAVIsion of Sman Man-6597 or at its Internet address 056-2011-01-11-01-12-2017-01-11 11:11:11 11-01-2017
Sincerely yours,
Nanay C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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3 Indications for Use Statement
510(k) Number (if known) _Ko So2 00
Device Name: MAGNETOM Trio a Tim System
Indications for Use:
The MAGNETOM Trio a Tim System is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. These images and/or spectra, when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Trio a Tim System may also be used for imaging during interventional procedures performed with MR compatible devices such as, in room display and MR safe biopsy needles.
(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 | |
|---|---|---|---|---|
| David A. Legmann (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices | ||||
| 510(k) Number | K050200 |
Siemens 510(k) Premarket Notification MAGNETOM Trio a Tim System
January 25, 2005
CONFIDENTIAL
§ 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.