(136 days)
Not Found
No
The document describes a standard MRI system and its intended use, focusing on hardware and basic image acquisition. There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the presence of such technology. The performance studies focus on equivalence to predicate devices, not on the performance of any AI/ML algorithms.
No
The device is described as a "magnetic resonance diagnostic device" and its purpose is to produce images and/or spectra to "assist in diagnosis," not to treat conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "magnetic resonance diagnostic device (MRDD)" and that the images and parameters "when interpreted by a trained physician yield information that may assist in diagnosis."
No
The device description clearly states it is a "magnetic resonance diagnostic device (MRDD)" and describes physical components like a "superconducting magnet design" and "open bore, whole body scanners," indicating it is a hardware system, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "magnetic resonance diagnostic device (MRDD)" that produces images and/or spectra of the internal structure and/or function of the body. It assists in diagnosis when interpreted by a trained physician.
- 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 Description: The device description confirms it's a whole-body scanner utilizing a superconducting magnet design, consistent with an MRI system, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the MAGNETOM Prisma and MAGNETOM Prismalit systems are imaging devices used for in vivo diagnosis, not in vitro diagnosis.
N/A
Intended Use / Indications for Use
The MAGNETOM Prisma and the MAGNETOM Prisma™ systems are 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 vield information that may assist in diagnosis.
The MAGNETOM Prisma and the MAGNETOM Prisma" MR systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-safe biopsy needles.
Product codes
LNH
Device Description
MAGNETOM Prisma (3 T) and MAGNETOM Prisma" (3 T) are similar to the previously cleared MAGNETOM Skyra (3 T) and MAGNETOM Trio a Tim System (TaTS) (3 T) systems utilizing a superconducting magnet design. The open bore, whole body scanners are designed for increased patient comfort. They focus on ergonomics and usability to reduce complexity of the MR workflow.
The MAGNETOM Prisma will be offered as ex-factory (new production) and the MAGNETOM Prismall will be offered as an upgrade to the currently installed MAGNETOM Trio a Tim System (TaTS) systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
head, body, or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician / Not Found
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)
Performance:
- · Specification Volume
- · Signal to Noise
- · Image Uniformity
- · Geometric Distortion
- · Slice Profile. Thickness and Gap
- High Contrast Spatial Resolution
Furthermore performance testing has been completed to show that the performance of the MAGNETOM Prisma and MAGNETOM Prisma™ with syngo® MR VD 13D Software is equivalent with respect to the predicate devices.
This assures that the performance of these devices can be considered as safe and effective with respect to the currently available MAGNETOM Skyra and MAGNETOM Trio a Tim System (TaTS) MR systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
NOV 22222013 SIEMENS
Section 5 510(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.
l. General Information
| Establishment | Siemens Medical Solutions USA. Inc.
51 Valley Stream Parkway
Mail Code D02
Malvern, PA 19355, USA |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number | 2240869 |
| Date Prepared | July 8, 2013 |
| Manufacturer | Siemens AG
Henkestrasse 127
D-91052 Erlangen, Germany |
| Registration Number | 3002808157 |
| Contact Person | Ms. Nadia Sookdeo
Regulatory Affairs Technical Specialist
Siemens Healthcare
Siemens Medical Solutions USA, Inc.
Customer Solutions Group
51 Valley Stream Parkway
Mail Code G01
Malvern, PA 19355, USA
Phone: (610) 448-4918
Fax: (610) 448-1787 |
| Device Name | Trade Names: MAGNETOM Prisma
MAGNETOM Prismafi |
| Classification Name:
CFR Code:
Classification: | Magnetic Resonance Diagnostic Device
21 CFR § 892.1000
Class II |
| Performance Standards | None established under Section 514 Subpart |
the Food, Drug and Cosmetic Act.
J of
1
SIEMENS
Image /page/1/Picture/1 description: The image shows a black and white abstract design. The design features a scattering of small, irregular black shapes against a white background. The shapes are concentrated towards the bottom left corner of the image, with a few isolated shapes dispersed towards the top.
II. Safety and Effectiveness Information Supporting Substantial Equivalence
Intended Use
The MAGNETOM Prisma and the MAGNETOM Prisma™ systems are 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 vield information that may assist in diagnosis.
The MAGNETOM Prisma and the MAGNETOM Prisma" MR systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-safe biopsy needles.
Device Description
MAGNETOM Prisma (3 T) and MAGNETOM Prisma" (3 T) are similar to the previously cleared MAGNETOM Skyra (3 T) and MAGNETOM Trio a Tim System (TaTS) (3 T) systems utilizing a superconducting magnet design. The open bore, whole body scanners are designed for increased patient comfort. They focus on ergonomics and usability to reduce complexity of the MR workflow.
The MAGNETOM Prisma will be offered as ex-factory (new production) and the MAGNETOM Prismall will be offered as an upgrade to the currently installed MAGNETOM Trio a Tim System (TaTS) systems.
Substantial Equivalence
It is Siemens opinion that the MAGNETOM Prisma systems and the upgraded MAGNETOM Prismad systems with syngo® MR VD13D software i are substantially equivalent to the following predicate devices:
| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| Siemens MAGNETOM Skyra (3 T) MR | ||
| system with syngo® MR D13D | K123510 | May 17, 2013 |
| Siemens MAGNETOM Trio a Tim System | ||
| (TaTS) (3 T) MR System with syngo® MR | ||
| B19 | K123938 | February 12, 2013 |
Safety and Effectiveness
2
SIEMENS
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.. These potential hazards are controlled by software means, user instructions, verification of requirements and validation of the clinical workflow to ensure that the product meets its intended uses. To minimize electrical, mechanical and radiation hazards. SIEMENS adheres to recognized and established industry practice and relevant international standards, such as the IEC 60601-1 series.
Operation of the MAGNETOM Prisma (3T) and the MAGNETOM Prisma" (3T) systems with syngo® MR VD13D software is substantially equivalent to the commercially available MAGNETOM Skyra (3T) Systems with syngo® MR VD13C SW (K123510) and MAGNETOM Trio a Tim System (TaTS) (3T) with syngo® MR B19 SW (K123938)
Additionally, as specified in the FDA quidance document "Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Devices" (released Nov. 1998) the following measurements of performance and safety data have been performed following NEMA or equivalent IEC and ISO standards:
Safety:
- · Maximum Static Field
- · Rate of Change of Magnetic Field
- · RF Power Deposition
- · Acoustic Noise Levels
Performance:
- · Specification Volume
- · Signal to Noise
- · Image Uniformity
- · Geometric Distortion
- · Slice Profile. Thickness and Gap
- High Contrast Spatial Resolution
The MAGNETOM Prisma and MAGNETOM Prisma™ syngo® MR VD13D software will conform to the measurements of safety parameters to the international IEC, ISO and NEMA standards for safety issues with Magnetic Resonance Imaging Diagnostic Devices.
Furthermore performance testing has been completed to show that the performance of the MAGNETOM Prisma and MAGNETOM Prisma™ with syngo® MR VD 13D Software is equivalent with respect to the predicate devices.
This assures that the performance of these devices can be considered as safe and effective with respect to the currently available MAGNETOM Skyra and MAGNETOM Trio a Tim System (TaTS) MR systems.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird with outstretched wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 22, 2013
Siemens Medical Solutions USA, Inc. % Ms. Nadia Sookdeo Regulatory Affairs Technical Specialist 51 Valley Stream Parkway, D02 MALVERN PA 19355
Re: K132119
Trade/Device Name: MAGNETOM Prisma, MAGNETOM Prisma 11 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 5, 2013 Received: November 8, 2013
Dear Ms. Sookdeo:
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. Ilsting 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 (21 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 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.
4
Page 2-Ms. Sookdeo
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2)CFR 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/ReportaProblem/default.htm for 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/Resourcesfor You/Industrv/default.htm.
Sincerely yours.
Michael D. O'Hara
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: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K132119
Device Name
. –
MAGNETOM Prisma and MAGNETOM Prisma fit
Indications for Use (Describe)
The MAGNETOM Prisms and MAGNETOM Prismalit systems are indicated for use as a magnetic resomance diagnostic device (MRDD) that produces transverse, sagital, 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 Prisma and MAGNETOM Prismalit systems may also be imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR Safe biopsy needles.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpant 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) (Signature) | Michael D. O'Hara |
|---|---|
| ------------------------------------------------------------------------------ | ------------------- |
FORM FDA 3881 (9/13)
PSC Publicition Services ( VII ) 441-4740 EF