(77 days)
Not Found
No
The summary describes a software update for an existing MR system that includes new sequences and image processing functions, but it does not mention AI, ML, or any related terms like deep learning or neural networks. The focus is on standard image processing techniques within the context of MR imaging.
No.
The device is described as a "magnetic resonance diagnostic device" used to produce images and spectra that assist in diagnosis, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a magnetic resonance diagnostic device (MRDD)".
No
The device description explicitly states it is a "software update" for "MAGNETOM Systems," which are magnetic resonance diagnostic devices (hardware). The software provides additional and improved applications for these existing hardware systems.
Based on the provided information, 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 spectra of the internal structure and/or function of the body. This is a description of an in vivo diagnostic device, meaning it is used to diagnose conditions within a living organism.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform tests on such samples.
- Device Description: The device description focuses on software updates for a magnetic resonance system, which is an imaging modality used directly on the patient.
- Input Imaging Modality: The input is "Magnetic Resonance," which is an in vivo imaging technique.
Therefore, the MAGNETOM systems described are in vivo diagnostic devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The MAGNETOM systems described above 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 yield information that may assist in diagnosis.
The MAGNETOM systems described above 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 (comma separated list FDA assigned to the subject device)
LNH
Device Description
The software update syngo MR B17 offers additional and improved applications for MAGNETOM Systems. It includes sequences and image processing functions for oncology, neurology, orthopaedics and cardio-vascular imaging.
Mentions image processing
Yes
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
5 510(k) Summary NOV - 7 2008
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 Parkway
Malvern. PA 19355 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number | 2240869 |
| Manufacturer | Siemens AG.
Henkestrasse 127
D-91052 Erlangen. Germany |
| Registration Number | 8010024 |
| Contact Person | Elizabeth Lazaro
Regulatory Technical Specialist.
51 Valley Stream Parkway
Malvern, PA 19355
Phone: (610) 448-3393
Fax: (610) 448-1787 |
| Device Name | |
| Trade name | MAGNETOM Systems with software syngo MR B1 |
| Classification Name | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| Regulation number: | 21 CFR § 892.1000 |
| Device Class: | II |
| Product Code: | LNH |
Summary Device Description
The software update syngo MR B17 offers additional and improved applications for MAGNETOM Systems. It includes sequences and image processing functions for oncology, neurology, orthopaedics and cardio-vascular imaging.
1
II. Safety and Effectiveness Information Supporting Substantial Equivalence.
MAGNETOM Systems:
MAGNETOM Avanto MAGNETOM Espree MAGNETOM Symphony a Tim System MAGNETOM Trio a Tim System MAGNETOM Verio
with software syngo MR B17
Intended Use
The MAGNETOM systems described above 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 yield information that may assist in diagnosis.
The MAGNETOM systems described above 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
Performance Standards
None established under Section 514 the Food. Drug. and Cosmetic Act.
2
Substantial Equivalence
Siemens believes that the MAGNETOM systems with software syngo MR B17 are substantially equivalent to the following cleared medical devices:
| Predicate
Device Name | Predicate
Software Name | FDA Clearance
Number | FDA Clearance
Date |
|-------------------------------------------------|----------------------------|-------------------------|-----------------------|
| MAGNETOM
Verio | software syngo MR
B15V | K072237 | Oct 10, 2007 |
| MAGNETOM
Systems - I and
T-class releases | software syngo MR
B15 | K062454 | Nov 3, 2006 |
General Safety and Effectiveness Concerns:
The introduction of the MAGNETOM systems with software syngo MR B17 has no significant concerns of safety and efficacy.
Siemens is adding a software upgrade to the currently available MAGNETOM Systems. 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 Risk Analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing.
The MAGNETOM Systems with software syngo MR B17 will conform to the measurement of safety and performance parameters to the international IEC and ISO standards, where applicable.
3
Image /page/3/Picture/0 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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight, representing the department's mission to protect and promote the health and well-being of Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elizabeth Lazaro Regulatory Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway MALVERN PA 19533
Re: K082427
Trade/Device Name: Magnetom Systems: Magnetom Avanto, Magnetom Espree, Magnetom Symphony a Tim System, Magnetom Trio a Tim System and Magnetom Verio with software Syngo MR B17
Regulation Number: 21 CFR 892,1000
Regulation Name: Magnetic resonance diagnostic device
· Regulatory Class: II
Product Code: LNH
Dated: August 22, 2008
Received: August 22, 2008
Dear Ms. Lazaro:
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 such 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.
NOV - 7 200
4
Page 2
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
hope M. Zhang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K082427
Magnetom Systems:
MAGNETOM Avanto MAGNETOM Espree MAGNETOM Symphony a Tim System MAGNETOM Trio a Tim System MAGNETOM Verio with software syngo MR B17
Indications for Use:
The MAGNETOM systems described above 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 yield information that may assist in diagnosis.
The MAGNETOM systems described above 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.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helu Remu
(Division Sign-Off)
Division of Reproductive, Abdominal Radiological Devices 510(k) Number
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