(76 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on hardware and software upgrades to existing MRI systems.
No
The device is described as a diagnostic tool that produces images to assist in diagnosis, not to treat a condition.
Yes
Explanation: 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 information they yield "may assist in diagnosis."
No
The device description explicitly states that Siemens Medical Systems is adding an upgrade in software and hardware to the currently available MAGNETOM Systems, indicating it is not software-only.
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's)" that produces images and/or spectra. These are interpreted by a trained physician to assist in diagnosis. This describes an in vivo diagnostic process, where the device interacts with the patient's body directly to obtain information.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro). This device does not operate on such samples.
- Device Description: The description details an MRI system, which is a type of medical imaging equipment used to visualize internal structures of the body. This aligns with an in vivo diagnostic device, not an IVD.
Therefore, the MAGNETOM Systems with the Numaris 4 VA15A are in vivo diagnostic devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The MAGNETOM Systems with the Numaris 4VA15A 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, based upon 'H and "P metabolites, 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
90 LNH
Device Description
Siemens Medical Systems 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.
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
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)
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)
K993731, K971684, K970852, K003192
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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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.
- General Information. I.
Establishment:
- Siemens Medical Systems, Inc. Address: 186 Wood Avenue South Iselin, N.J. 08830
Registration Number: 2240869
Contact Person: Mr. Jamie Yieh Technical Specialist, Regulatory Affairs Email: jamie.yieh@sms.siemens.com Phone: (732) 321-4625 Fax: (732) 321-4841.
July. 12th 2001 Date of Summary Preparation:
Device Name:
- •Trade Name: Numaris 4VA15A
- · 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 Numaris 4VA15A 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, based upon 'H and "P metabolites, 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 MAGNETOM systems with the new Numaris 4VA15A is substantially equivalent to the predicate MAGNETOM Systems with Numaris 4VA12A. The MAGNETOM Systems which will be affected will be:
- The MAGNETOM 1.5 Tesla Sonata system was described in premarket notification K993731 ● that received FDA clearance on December 23, 1999.
- The MAGNETOM 1.5 Tesla Symphony system was described in premarket notification ● K971684 which received FDA clearance on August 4, 1997.
- The MAGNETOM 1.0 Tesla Harmony system was described in premarket notification K970852 ● which received FDA clearance on June 5, 1997.
- The MAGNETOM 0.2 Tesla Concerto system was described in premarket notification K003192 . which received FDA clearance on 12/21/00.
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 Numaris 4VA15A 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
- Image Uniformity
- . Geometric Distortion
- . Slice Profile, Thickness and Gap
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High Contrast Spatial Resolution
Siemens Medical Systems 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. Therefore, the safety and performance testing was not completed since these values are exactly the same as described in the 510(k)s for these systems.
• 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 logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 7 2001
Re: K012202
Mr. Jamie Yieh Technical Specialist, Regulatory Affairs Siemens Medical Systems, Inc. 186 Wood Avenue South ISELIN NJ 08830
Trade/Device Name: Numeris 4.VA15A for Magnetom Systen MRI Accessory Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: 90 LNH Dated: July 12, 2001 Received: July 13, 2001
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.
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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
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510(k) Number (if known) _ KO / 2Z 02
MAGNETOM systems with Numaris 4VA15A Device Name:
Indications for Use:
The MAGNETOM Systems with the Numaris 4 VA15A 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, based upon 'H and "P metabolites, 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 in
OR
Over-The-Counter Use_
Nancy C. hogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012202
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