(48 days)
Not Found
No
The summary focuses on hardware modifications for patient transfer and workflow integration between existing MR and angiography systems. There is no mention of AI, ML, or advanced image processing features that would typically indicate the presence of such technology.
No.
The device is clearly indicated for diagnostic purposes, specifically for producing images and/or spectra to assist in diagnosis, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a magnetic resonance diagnostic device (MRDD)". It further clarifies that the images and parameters derived "when interpreted by a trained physician yield information that may assist in diagnosis."
No
The device description explicitly states that the sales bundle includes "new hardware for the MAGNETOM systems Aera and Skyra." This indicates the device is not software-only.
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 the MAGNETOM MR system is a "magnetic resonance diagnostic device (MRDD)" that produces images and/or spectra of the internal structure and/or function of the head, body, or extremities. This is an in vivo imaging technique, meaning it examines the body directly, not through samples.
- Intended Use: The intended use is to assist in diagnosis by providing images and derived physical parameters interpreted by a trained physician. This is consistent with an imaging device, not an IVD.
- Device Description: The description of the MAGNETOM Artis Combi Suite focuses on a workflow for transferring patients between an angiography system and an MR scanner. This further reinforces its role as an imaging system.
Therefore, the MAGNETOM MR system, as described, falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The 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.
Product codes (comma separated list FDA assigned to the subject device)
LNH, MOS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Head, Body, or Extremities
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.
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
SIEMENS
MAR 2 0 2014
Image /page/0/Picture/2 description: The image shows the text "K140253 Page 1 of 3" in a handwritten font. The text is black and is set against a white background. The text is likely part of a document or report, and the page number indicates that it is the first page of a three-page document. The year 2014 is also visible on the left side of the image.
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 Parkway
Mail Code D02
Malvern, PA 19355, USA
Registration Number: 2240869 |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Siemens AG
Henkestrasse 127
D-91052 Erlangen, Germany
Registration Number: 3002808157 |
| | SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.
Siemens MRI Center
Hi-Tech Industrial park (middle)
Gaoxin C. Ave., 2nd
Shenzhen 518057, P.R. CHINA
Registration Number: 3004754211 |
| Contact Person | Cordell L. Fields, Esq.
Regulatory Affairs Technical Specialist
Siemens Medical Solutions USA Inc.
51 Valley Stream Parkway
Mail Code D02
Malvern, PA 19355, USA
Phone: (610) 219-8518
Fax: (610) 427-3465
E-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
1
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 for | ||||
| MAGNETOM Aera, Skyra, Verio and Avanto | K121434, | |||
| cleared | ||||
| November 5, 2012 | Siemens AG | LNH | - MAGNETOM Aera and | |
| Skyra with syngo MR D13A |
- Tim Dockable Table |
| MAGNETOM Skyra with
TimTX TrueShape and
syngo MR D13C | K123510,
cleared May
17, 2013 | Siemens AG | LNH | - MAGNETOM Skyra with
syngo MR D13C - Tim Dockable Table |
| Table 1: | Predicate device(s) for MAGNETOM Artis Combi Suite for the
MAGNETOM 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
2
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.
3
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
4
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
5
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)
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FORM FDA 3881 (1/14)
PC Deblades bergues (301) . 14) 6:40