The MAGNETOM OPEN viva with the Permanent magnet is an open, whole body scanner. The MAGNETOM Open Viva with the Permanent magnet is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the MAGNETOM OPEN with the permanent magnet reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Device Description

The MAGNETOM OPEN viva with the Permanent magnet is an open, whole body scanner.

AI/ML Overview

This 510(k) submission describes a Magnetic Resonance Imaging (MRI) device, the Magnetom Open Viva with Permanent Magnet, and does not involve AI or algorithms. Therefore, many of the requested criteria, such as those related to AI algorithm performance, training sets, and expert adjudication, are not applicable.

Here's the relevant information based on the provided text:

Acceptance Criteria and Device Performance

The device is a medical imaging device (MRI) and its "performance" is assessed against established safety and technical specifications for MRI systems. The submission states that the modifications to this new model (a new permanent magnet) do not affect these critical safety and performance parameters.

Acceptance Criteria (Safety Parameter with Action Levels & Performance Levels)	Reported Device Performance (Unaffected by Modifications)
Maximum Static Field	Unaffected
Rate of Change of Magnetic Field	Unaffected
RF Power Deposition	Unaffected
Acoustic Noise Levels	Unaffected
Specification Volume	Unaffected
Signal to Noise	Unaffected
Image Uniformity	Unaffected
Geometric Distortion	Unaffected
Slice Profile, Thickness and Gap	Unaffected
High Contrast Spatial Resolution	Unaffected

Study Description for Substantial Equivalence

The study conducted was a laboratory testing to demonstrate "substantial equivalence" to a predicate device, the currently available MAGNETOM OPEN viva System. The purpose was to show that the technological differences (the new permanent magnet) do not raise any new questions pertaining to safety and effectiveness.

1. Sample sized used for the test set and the data provenance:

Sample Size: Not specified in the provided text. The testing was laboratory-based, implying physical device measurements rather than patient data.
Data Provenance: Not specified, but given it's laboratory testing of a device, it would be internal to the manufacturer's testing facilities. It's prospective testing of the manufactured device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable. This is not a study involving human interpretation of images for diagnosis or ground truth establishment. It's about direct measurement of the device's physical and imaging characteristics.
Qualifications of Experts: Not applicable.

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

Not applicable. No human interpretation or adjudication of diagnostic findings was involved in this assessment for substantial equivalence.

4. 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:

No. This study is for a standalone MRI device, not an AI-assisted interpretation tool. Therefore, MRMC studies and effect sizes related to AI assistance are not applicable.

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

No. This is not an algorithm. It's a medical imaging device. The "standalone" performance here refers to the device's physical and imaging capabilities.

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

Ground Truth: The "ground truth" for this type of device evaluation is adherence to pre-defined engineering specifications, safety standards (e.g., those from the FDA guidance document for MR Diagnostic Devices), and performance metrics (e.g., Signal to Noise, Image Uniformity). These are objective, measurable parameters of the device itself.

7. The sample size for the training set:

Not applicable. This is not an AI algorithm requiring a training set.

8. How the ground truth for the training set was established:

Not applicable.

Summary

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K99 4316

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 Systems, Inc. 186 Wood Avenue South Iselin, N.J. 08830
Registration Number: 2240869
Contact Person: Mr. Jamie Yieh Technical Specialist, Regulatory Submissions Phone: (732) 321-4625 Fax: (732) 321-4841

Date of Summary Preparation: 12/21/99

Device Name:

Trade Name: Magnetom Open Viva with Permanent Magnet
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

· Technological Characteristics

The MAGNETOM OPEN viva with the new Permanent Magnet is substantially equivalent to the currently available MAGNETOM OPEN viva System.

· General Safety and Effectiveness Concerns:

Operation of the MAGNETOM OPEN viva with the new Permanent Magnet is substantially equivalent to standard operation of the MAGNETOM OPEN viva System. The following are the safety parameter with action levels:

Maximum Static Field ●
. Rate of Change of Magnetic Field
RF Power Deposition .
. Acoustic Noise Levels

and performance levels

. Specification Volume
. Signal to Noise
Image Uniformity .
. Geometric Distortion
. Slice Profile, Thickness and Gap
. High Contrast Spatial Resolution

specified by the FDA guidance document for MR Diagnostic Devices are unaffected by the modifications described within this notification.

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• 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 stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The text is in all caps and is in a sans-serif font. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2000

Jamie Yieh Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830

Re:

K994316 Magnetom Open Viva with Permanent Magnet Dated: December 21, 1999 Received: December 22, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Mr. Yieh:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, 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 vour device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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".

Sinceraty yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) _ 1943 ملا

Device Name: Magnetom Open viva

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

Over-The-Counter Use

David A. Segner

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Devic 510(k) Number

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.