(78 days)
No
The document describes a software upgrade for existing MRI systems and does not mention AI or ML capabilities. The performance studies focus on safety and effectiveness relative to the predicate devices, not on the performance of an AI/ML algorithm.
No.
The device is indicated for use as a diagnostic device that produces images to assist in diagnosis, not to provide therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices "are indicated for use as magnetic resonance diagnostic devices (MRDD's)" and that the images/spectra "may assist in diagnosis."
No
The device description explicitly states that Siemens Medical Solutions is adding an upgrade in software and hardware to the currently available MAGNETOM 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/or spectra of the internal structure and/or function of the head, body, or extremities. These images and spectra are then interpreted by a trained physician to assist in diagnosis.
- 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 details a software upgrade for MRI systems, which are imaging devices that work externally to the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific biomarkers, or performing any tests on specimens taken from the patient.
The device is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MAGNETOM Systems with the syngo MR 2002B are indicated for use as magnetic resonance diagnostic devices (MRDD's) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display 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.
Product codes
LNH, LNI
Device Description
The syngo MR 2002B (Numaris 4 VA21A) software upgrade will be available for the following MAGNETOM Family systems:
- . The MAGNETOM 1.0 Tesla Harmony system was described in premarket notification K970852 which received FDA clearance on June 5, 1997.
- . The MAGNETOM 1.5 Tesla Symphony system was described in premarket notification K971684 which received FDA clearance on August 4, 1997.
- The MAGNETOM 1.5 Tesla Sonata system was described in premarket notification . K993731 that received FDA clearance on December 23, 1999.
- The MAGNETOM 0.2 Tesla Concerto system was described in premarket notification ● K003192 which received FDA clearance on December 21, 2000.
- The MAGNETOM 3.0 Tesla Allegra system was described in premarket notification . K002179 which received FDA clearance on October 11, 2000.
- . The MAGNETOM 3.0 Tesla Trio system was described in premarket notification K013586 which received FDA clearance on December 28, 2001.
This includes Siemens upgrades of currently used MAGNETOM Impact/Expert, Vision, and Open (Viva) systems to systems described above.
Siemens Medical Solutions is adding an upgrade in software and hardware to the currently available MAGNETOM Systems. The MRI systems are exactly the same as what was described and cleared in the predicate premarket notifications. Variable safety and performance testing was completed; however the values are not significantly changed and, in the case of safety parameters remain below the level of concern.
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
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)
Laboratory testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K970852, K971684, K993731, K003192, K002179, K013586
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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JUN 1 3 2002
11 Appendix: 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
- I. General Information.
- Establishment:
- Address: Siemens Medical Solutions, Inc. 186 Wood Avenue South Iselin, N.J. 08830
Registration Number: 2240869
Contact Person: Mr. Jamie Yieh Technical Specialist, Regulatory Affairs Email: jamie.yieh@siemens.com Phone: (732) 321-4625 Fax: (732) 321-4841
- Date of Summary Preparation: March 26, 2002
Device Name:
•Trade Name: syngo MR 2002B
- Classification Name: Magnetic Resonance Diagnostic Device, CFR & 892.1000
·Classification: 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.
· Device Description:
· Intended Use
The MAGNETOM Systems with the syngo MR 2002B are indicated for use as magnetic resonance diagnostic devices (MRDD's) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display 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.
· Technological Characteristics
The syngo MR 2002B (Numaris 4 VA21A) software upgrade will be available for the following MAGNETOM Family systems:
- . The MAGNETOM 1.0 Tesla Harmony system was described in premarket notification K970852 which received FDA clearance on June 5, 1997.
- . The MAGNETOM 1.5 Tesla Symphony system was described in premarket notification K971684 which received FDA clearance on August 4, 1997.
- The MAGNETOM 1.5 Tesla Sonata system was described in premarket notification . K993731 that received FDA clearance on December 23, 1999.
- The MAGNETOM 0.2 Tesla Concerto system was described in premarket notification ● K003192 which received FDA clearance on December 21, 2000.
- The MAGNETOM 3.0 Tesla Allegra system was described in premarket notification . K002179 which received FDA clearance on October 11, 2000.
- . The MAGNETOM 3.0 Tesla Trio system was described in premarket notification K013586 which received FDA clearance on December 28, 2001.
This includes Siemens upgrades of currently used MAGNETOM Impact/Expert, Vision, and Open (Viva) systems to systems described above.
· General Safety and Effectiveness Concerns:
The introduction of the new syngo MR 2002B has no significant effect on the following MR safety and performance parameters:
[Safety]
- . Maximum Static Field
- Rate of Change of Magnetic Field
- . RF Power Deposition
- . Acoustic Noise Level
[Performance]
- Specification Volume ●
- . Signal to Noise
2
- Image Uniformity .
- Geometric Distortion .
- . Slice Profile, Thickness and Gap
- High Contrast Spatial Resolution .
Siemens Medical Solutions is adding an upgrade in software and hardware to the currently available MAGNETOM Systems. The MRI systems are exactly the same as what was described and cleared in the predicate premarket notifications. Variable safety and performance testing was completed; however the values are not significantly changed and, in the case of safety parameters remain below the level of concern.
· Substantial Equivalence:
Laboratory testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized image of an eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 2002
Mr. Jamie Yieh Re: K020991 Technical Specialist, Regulatory Affairs Siemens Medical Solutions, Inc. 186 Wood Avenue South ISELIN NI 08830
Trade/Device Name: MAGNETOM Systems with Syngo MR 2002B Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH and LNI Dated: March 26, 2002
Received: March 27, 2002
Dear Mr. Yieh:
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 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); 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
This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
3 Appendix: Indications for Use Statement
In accordance with FDA requirements (as of 1/1/96), the indications for use statement is attached on a separate page.
KO2 8 991 510(k) Number (if known) _
MAGNETOM systems with syngo MR 2002B Device Name:
Indications for Use:
The MAGNETOM Systems with the syngo MR 2002B are indicated for use as magnetic resonance diagnostic devices (MRDD's) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display 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.
(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
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K020991