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.

Device Description

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, The MAGNETOM 1.5 Tesla Symphony system, The MAGNETOM 1.0 Tesla Harmony system, The MAGNETOM 0.2 Tesla Concerto system. This includes Siemens upgrades of currently used MAGNETOM Impact/Expert, Vision, and Open (Viva) systems to systems described above. 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Numaris 4VA15A:

This document is a 510(k) summary for a software and hardware upgrade to existing Magnetic Resonance Diagnostic Devices (MRDDs) manufactured by Siemens. The core premise of the submission is that the upgrade, Numaris 4VA15A, does not significantly alter the safety or performance of the existing predicate devices. Therefore, the provided text does not contain a study specifically designed to establish new acceptance criteria or prove device performance through a clinical trial or a detailed bench test against new, specific metrics for the Numaris 4VA15A itself.

Instead, the submission argues for substantial equivalence by stating that the safety and performance parameters remain unchanged from the already cleared predicate devices.

Let's break down the information based on your requested points:

A table of acceptance criteria and the reported device performance

There are no new acceptance criteria or reported device performance metrics specifically for the Numaris 4VA15A upgrade. The submission states that the safety and performance parameters are exactly the same as those described and cleared in the 510(k)s for the predicate devices.

The document lists the following parameters as having no significant effect due to the Numaris 4VA15A upgrade:

Category	Parameter	Reported Performance (for Numaris 4VA15A)	Acceptance Criteria (for Numaris 4VA15A)	Note
Safety	Maximum Static Field	(Implicitly unchanged from predicate)	(Implicitly unchanged from predicate)	These values are stated to be "exactly the same as described in the 510(k)s for these systems."
	Rate of Change of Magnetic Field	(Implicitly unchanged from predicate)	(Implicitly unchanged from predicate)
	RF Power Deposition	(Implicitly unchanged from predicate)	(Implicitly unchanged from predicate)
	Acoustic Noise Level	(Implicitly unchanged from predicate)	(Implicitly unchanged from predicate)
Performance	Specification Volume	(Implicitly unchanged from predicate)	(Implicitly unchanged from predicate)
	Signal to Noise	(Implicitly unchanged from predicate)	(Implicitly unchanged from predicate)
	Image Uniformity	(Implicitly unchanged from predicate)	(Implicitly unchanged from predicate)
	Geometric Distortion	(Implicitly unchanged from predicate)	(Implicitly unchanged from predicate)
	Slice Profile, Thickness and Gap	(Implicitly unchanged from predicate)	(Implicitly unchanged from predicate)
	High Contrast Spatial Resolution	(Implicitly unchanged from predicate)	(Implicitly unchanged from predicate)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No specific test set or data provenance is detailed for the Numaris 4VA15A as a new device requiring performance validation. The submission relies on the existing clearance of predicate devices, stating that "the MRI systems are exactly the same as what was described and cleared in the predicate premarket notifications." "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," but no details on these lab tests (sample size, data provenance) are provided.

Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No new ground truth establishment for a test set is described for the Numaris 4VA15A.

Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No new test set is described.

If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device, and no MRMC study is mentioned.

If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an MRI system upgrade, not a standalone algorithm.

The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for new ground truth establishment by this submission. The devices, when interpreted by a "trained physician," yield information that may assist in diagnosis, implying that clinical diagnosis (likely based on various inputs, including expert interpretation, potentially pathology, and patient outcomes) would form the ultimate ground truth for the predicate devices' diagnostic capabilities.

The sample size for the training set

Not applicable. This document describes an upgrade to existing hardware/software, not a new algorithm that requires a training set.

How the ground truth for the training set was established

Not applicable. No training set is mentioned.

Summary

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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:

(please do not write below this line- continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation

Prescription Use in

Over-The-Counter Use_

Nancy C. hogdon

(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012202

Regulation Number and Section

§ 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.