(48 days)
The MAGNETOM MR system [Acra/Skyra] is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.
Other physical parameters derived from the images and or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM MR system | Acra/Skyra] may also be used for imaging during interventional procedures with MR compatible devices such as in-room displays and MR Safe biopsy needles.
MAGNETOM Artis Combi Suite is the marketing name for the modification of MAGNETOM Aera and MAGNETOM Skyra to include a modified dockable table for use with a standalone Artis system in a clinical workflow. The market name, MAGNETOM Artis Combi Suite, refers to a sales bundle of single items that have been combined to build up a patient transfer workflow from one medical device to another.
MAGNETOM Artis Combi Suite enables the user to move a patient via a patient transfer board from the patient table of a angiography system of the Siemens Artis family to the MR scanner.
The intended use of the MAGNETOM Aera and MAGNETOM Skyra as well as Artis imaging systems remains unchanged.
The MAGNETOM Artis Combi Suite will only be available for MAGNETOM systems Aera and Skyra and will be available as an option to new manufactured scanners; existing scanners can be upgraded to this sales bundle. The sales bundles include new hardware for the MAGNETOM systems Aera and Skyra.
The provided text describes a 510(k) submission for the "MAGNETOM Artis Combi Suite for the MAGNETOM systems Aera and Skyra." This device is a sales bundle that enables the transfer of a patient on a patient transfer board from an angiography system to an MR scanner.
The submission focuses on establishing substantial equivalence to legally marketed predicate devices, not on proving a specific clinical performance metric with acceptance criteria. Therefore, the traditional concept of "acceptance criteria" and a "study to prove the device meets acceptance criteria" as typically applied to diagnostic algorithms or devices with measurable performance metrics (sensitivity, specificity, accuracy) does not directly apply here.
The "acceptance criteria" in this context are the requirements for demonstrating substantial equivalence to a predicate device, as outlined by the FDA. The "study" is the information provided in the 510(k) summary to support this claim of substantial equivalence.
Here's how to interpret the request based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (for Substantial Equivalence) | Reported Device Performance/Information in 510(k) |
|---|---|
| Intended Use: Device has the same intended use as legally marketed predicate devices. | "The intended use of the MAGNETOM Aera and MAGNETOM Skyra as well as Artis imaging systems remains unchanged." "MAGNETOM Aera and MAGNETOM Skyra and software syngo MR D13A with MAGNETOM Artis Combi Suite as well as MAGNETOM Skyra and software syngo MR D13C with MAGNETOM Artis Combi Suite has the same intended use... as the predicate devices with respect to the magnetic resonance features and functionalities." |
| Technological Characteristics: Device has substantially equivalent technological characteristics to predicate devices. | "The functionality of MAGNETOM Artis Combi Suite remains similar to that of the predicate devices, MAGNETOM Aera and MAGNETOM Skyra with software syngo MR D13A and syngo MR D13C for MAGNETOM Skyra." The document also lists specific predicates and mentions that the Artis Combi Suite includes "new hardware for the MAGNETOM systems Aera and Skyra." The primary difference is the "additional capabilities by allowing the user to move a patient transfer board from the patient table of a angiography system of the Siemens Artis family to the MR scanner." |
| Safety and Effectiveness: Differences in technological characteristics do not raise new questions of safety and effectiveness. | "There are no new issues of safety or effectiveness introduced with the MAGNETOM Artis Combi Suite." "Risk Management is ensured via a risk analysis in compliance with ISO 14971:2007." "Adhere to recognized and established industry standards, such as the IEC 60601-1 series." "Conform to the applicable FDA recognized and international IEC, ISO and NEMA standards." |
| Performance Data: Sufficient data to support the claims of substantial equivalence (e.g., non-clinical testing, compliance with standards). | The document implicitly relies on the existing clearances of the predicate devices and general compliance with industry standards. No specific new performance data (e.g., patient transfer speed, structural integrity testing) is detailed in this summary, but it states that "Risk Management is ensured" and the devices "conform to the applicable FDA recognized and international IEC, ISO and NEMA standards." |
2. Sample Size for the Test Set and Data Provenance
Not applicable in the traditional sense for this type of 510(k) submission. This is not a study assessing diagnostic performance on a patient dataset. The "test set" here refers to the technical evaluation and comparison to predicate devices, not a clinical trial with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth as in "expert consensus" for clinical findings is not relevant to this submission, which focuses on device modification and substantial equivalence. The "experts" involved would be the engineers and regulatory affairs specialists who conducted the risk analysis and ensured compliance with standards.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the context of clinical adjudication. The assessment is regulatory and technical against standards and predicate devices.
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. This device is not an AI-powered diagnostic tool, and no MRMC study or AI assistance is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not a standalone algorithm. It's a hardware modification and workflow integration.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this submission is established through compliance with regulatory standards (e.g., ISO 14971:2007 for risk management, IEC 60601-1 series for electrical and mechanical hazards) and demonstrated substantial equivalence to predicate devices, rather than clinical outcomes or pathology.
8. The sample size for the training set
Not applicable. This is not machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. This is not machine learning or AI.
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SIEMENS
MAR 2 0 2014
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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
Date Prepared: January 30, 2014
| Establishment | Siemens Medical Solutions USA, Inc.51 Valley Stream ParkwayMail Code D02Malvern, PA 19355, USARegistration Number: 2240869 |
|---|---|
| Manufacturer | Siemens AGHenkestrasse 127D-91052 Erlangen, GermanyRegistration Number: 3002808157 |
| SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.Siemens MRI CenterHi-Tech Industrial park (middle)Gaoxin C. Ave., 2ndShenzhen 518057, P.R. CHINARegistration Number: 3004754211 | |
| Contact Person | Cordell L. Fields, Esq.Regulatory Affairs Technical SpecialistSiemens Medical Solutions USA Inc.51 Valley Stream ParkwayMail Code D02Malvern, PA 19355, USAPhone: (610) 219-8518Fax: (610) 427-3465E-mail: Cordell.Fields@siemens.com |
Classification and Device Name
| Trade name: | MAGNETOM Artis Combi Suite for the MAGNETOM systems Aera and Skyra. |
|---|---|
| Classification Name: | Regulation Description:- Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| Regulation number: | 21 CFR § 892.1000 |
| Device Class: | II |
| Product Code: | Primary: LNH; Secondary: MOS |
MAGNETOM Artis Combi Suite for the MAGNETOM systems Aera/Skyra
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II Safety and Effectiveness Information Supporting Substantial Equivalence
Device Description
MAGNETOM Artis Combi Suite is the marketing name for the modification of MAGNETOM Aera and MAGNETOM Skyra to include a modified dockable table for use with a standalone Artis system in a clinical workflow. The market name, MAGNETOM Artis Combi Suite, refers to a sales bundle of single items that have been combined to build up a patient transfer workflow from one medical device to another.
MAGNETOM Artis Combi Suite enables the user to move a patient via a patient transfer board from the patient table of a angiography system of the Siemens Artis family to the MR scanner.
The intended use of the MAGNETOM Aera and MAGNETOM Skyra as well as Artis imaging systems remains unchanged.
The MAGNETOM Artis Combi Suite will only be available for MAGNETOM systems Aera and Skyra and will be available as an option to new manufactured scanners; existing scanners can be upgraded to this sales bundle. The sales bundles include new hardware for the MAGNETOM systems Aera and Skyra.
Substantial Equivalence
Sales bundle MAGNETOM Artis Combi Suite for the MAGNETOM systems Aera and Skyra is substantially equivalent to the following current legally marketed devices (please refer to Table 1):
| Predicate Device Name | FDA Clearance Number / Date | Manufacturer | Manufacturer, Product Code | Claim Substantial Equivalence to |
|---|---|---|---|---|
| syngo MR D 13A forMAGNETOM Aera, Skyra, Verio and Avanto | K121434,clearedNovember 5, 2012 | Siemens AG | LNH | - MAGNETOM Aera andSkyra with syngo MR D13A- Tim Dockable Table |
| MAGNETOM Skyra withTimTX TrueShape andsyngo MR D13C | K123510,cleared May17, 2013 | Siemens AG | LNH | - MAGNETOM Skyra withsyngo MR D13C- Tim Dockable Table |
| Table 1: | Predicate device(s) for MAGNETOM Artis Combi Suite for theMAGNETOM systems Aera and Skyra |
|---|---|
| ---------- | ----------------------------------------------------------------------------------------------- |
Safety and Effectiveness
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.
Risk Management is ensured via a risk analysis in compliance with ISO 14971:2007 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product. Siemens Medical Solutions
MAGNETOM Artis Combi Suite for the MAGNETOM systems Aera/Skyra
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SIEMENS
K140253
Page 3 of 3
USA. Inc. and Siemens AG adhere to recognized and established industry standards, such as the IEC 60601-1 series, to minimize electrical and mechanical hazards.
The MAGNETOM systems Aera and Skyra with sales bundle MAGNETOM Artis Combi Suite conform to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety as recommended by the respective MR FDA Guidance Document.
Indications for Use
Your MAGNETOM MR system [Aera / Skyra] 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. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Your MAGNETOM MR system [Aera / Skyra] may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
Conclusion as to Substantial Equivalence
MAGNETOM Aera and MAGNETOM Skyra and software syngo MR D13A with MAGNETOM Artis Combi Suite as well as MAGNETOM Skyra and software syngo MR D13C with MAGNETOM Artis Combi Suite has the same intended use and the same technical characteristics as the predicate devices with respect to the magnetic resonance features and functionalities. The differences between the subject device and the predicate devices, which include the aforementioned hardware, give the systems MAGNETOM Aera and MAGNETOM Skyra with SW syngo MR D13 and Artis family additional capabilities by allowing the user to move a patient transfer board from the patient table of a angiography system of the Siemens Artis family to the MR scanner. There are no new issues of safety or effectiveness introduced with the MAGNETOM Artis Combi Suite. The functionality of MAGNETOM Artis Combi Suite remains similar to that of the predicate devices, MAGNETOM Aera and MAGNETOM Skyra with software syngo MR D13A and syngo MR D13C for MAGNETOM Skyra.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 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 a stylized eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MID 20993-0002
March 20, 2014
Siemens Medical Solutions USA, Inc. % Cordell L. Fields, Esa. Regulatory Affairs Technical Specialist 51 Valley Stream Parkway, Mail Code D02 MALVERN PA 19355
Re: K140253
Trade/Device Name: MAGNETOM Artis Combi Suite for the MAGNETOM systems Aera and Skyra Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH Dated: January 30, 2014 Received: January 31, 2014
Dear Mr. Fields:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 (2 l CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2- Cordell L. Fields, Esq.
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htmfor the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
K140253
Device Name
"MAGNETOM Artis Combi Suite" for the MAGNETOM systems Acra and Skyra
Indications for Use (Describe)
The MAGNETOM MR system [Acra/Skyra] is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.
Other physical parameters derived from the images and or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM MR system | Acra/Skyra] may also be used for imaging during interventional procedures with MR compatible devices such as in-room displays and MR Safe biopsy needles.
Type of Use (Select one or both, as applicable)
[x] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
Smh. 7)
FORM FDA 3881 (1/14)
PC Deblades bergues (301) . 14) 6:40
§ 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.