(33 days)
The MAGNETOM Essenza is 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. Depending on the region of interest, contrast agents may be used. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Essenza may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR-safe biops y needles.
The MAGNETOM Essenza System is a 1.5 T closed superconducting magnet designed scanner. It consists of the same types of hardware (with a modified gradient coil, RF body resonator and magnet) that are currently available with the MAGNETOM Avanto Systems, including Matrix Coils and Total Imaging Matrix (Tim) Technolgy.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Siemens MAGNETOM Essenza:
Based on the provided 510(k) summary for the Siemens MAGNETOM Essenza (K071925), the device is a Magnetic Resonance Diagnostic Device (MRDD). The submission emphasizes substantial equivalence to previously cleared predicate devices (Siemens MAGNETOM 1.5 T Avanto, Software syngo MR VB15, and Siemens MAGNETOM 1.5 T Symphony).
Crucially, this submission does not describe a study to prove the device meets specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy) using a test set against ground truth. Instead, the acceptance criteria are focused on conformance to established safety and performance standards for MRDDs to demonstrate substantial equivalence to predicate devices.
Let's break down the information based on your requested categories:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Statement |
|---|---|---|
| Safety and Effectiveness | Conformance to FDA recognized NEMA Standards for the measurement of performance and safety parameters. | "The MAGNETOM Essenza will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters..." |
| Safety and Effectiveness | Conformance to the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. | "...and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices." |
| Substantial Equivalence | The device's hardware (modified gradient coil, RF body resonator, magnet) is of the same type as currently available in MAGNETOM Avanto Systems, including Matrix Coils and Total Imaging Matrix (Tim) Technology. | "It consists of the same types of hardware (with a modified gradient coil, RF body resonator and magnet) that are currently available with the MAGNETOM Avanto Systems, including Matrix Coils and Total Imaging Matrix (Tim) Technolgy." |
| Overall Equivalence | Performance considered safe and effective similar to the currently available MAGNETOM Avanto and MAGNETOM Symphony 1.5 T systems. | "This will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM Avanto and MAGNETOM Symphony 1.5 T systems." |
Note: The "reported device performance" here is a statement of intent and design comparability, rather than numerical performance metrics from a clinical study.
2. 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 clinical study data is mentioned for the evaluation of diagnostic performance. The submission relies on technical comparisons and adherence to standards rather than a new clinical performance study.
3. 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 clinical test set requiring expert ground truth establishment is described in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication is described.
5. 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 device is a magnetic resonance diagnostic device (MRI scanner), not an AI-powered diagnostic tool. The submission is for the core imaging hardware and associated technology, not for an AI algorithm assistance to human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a hardware device (MRI scanner), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical diagnostic performance study requiring ground truth is described in this 510(k) summary. The "ground truth" for this submission are the established safety and performance standards for MRDDs and the characteristics of the predicate devices.
8. The sample size for the training set
- Not applicable. This submission does not describe an AI/machine learning model that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set or AI model is described.
Summary of Approach:
The 510(k) for the MAGNETOM Essenza focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than proving de novo clinical performance through efficacy studies. The "acceptance criteria" are therefore primarily regulatory and technical: conforming to recognized safety and performance standards (NEMA, IEC) and showcasing hardware and technological similarities to cleared devices. There is no mention of clinical studies involving patient data to establish diagnostic performance metrics like sensitivity or specificity.
{0}------------------------------------------------
K07/925
Section 5: 510(k) Summary
5 510(k) Summary
AUG 1 4 2007
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 ParkwayMalvern. PA 19355 |
|---|---|
| Registration Number | 2240869 |
| Manufacturer | Siemens Mindit Magnetic Resonance Ltd.Siemens MRI Center,Gaoxin C. Ave. 2ndHi-Tech Industrial Park,ShenZhen 518057, PR. China |
| Registration Number | 3004754211 |
| Contact Person | Ms. Judy CampbellTechnical Specialist. Regulatory Submissions51 Valley Stream ParkwayMalvern. PA 19355Phone: (610)448-4918Fax: (610) 448-1787 |
| Device Name | Trade Name: MAGNETOM EssenzaClassification Name: Magnetic Resonance Diagnostic DeviceCFR Code:21 CFR § 892.1000Classification:Class II |
Performance Standards
None established under Section 514 the Food, Drug, and Cosmetic Act.
{1}------------------------------------------------
Section 5: 510(k) Summary
II. Safety and Effectiveness Information Supporting Substantial Equivalence.
Intended Use
The MAGNETOM Essenza is indicated for use as magnetic resonance diagnostic devices (MRDD) that produces 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. Depending on the region of interest, contrast agents may be used. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.
The MAGNETOM Essenza 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.
Device Description
The MAGNETOM Essenza System is a 1.5 T closed superconducting magnet designed scanner. It consists of the same types of hardware (with a modified gradient coil, RF body resonator and magnet) that are currently available with the MAGNETOM Avanto Systems, including Matrix Coils and Total Imaging Matrix (Tim) Technolgy.
Substantial Equivalence
The system is substantially equivalent to the following cleared medical devices:
| Predicate Device Name | FDA ClearanceNumber | FDA ClearanceDate |
|---|---|---|
| Siemens MAGNETOM 1.5 T Avanto | K032428 | Oct 16, 2003 |
| Software syngo MR VB15 | K062454 | Nov 3, 2006 |
| Siemens MAGNETOM 1.5 TSymphony (MAGNETOM Project 047) | K971684 | Aug 5, 1997 |
General Safety and Effectiveness Concerns:
The MAGNETOM Essenza will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. This will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM Avanto and MAGNETOM Symphony 1.5 T systems.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Blvd., Rockville MD 20850. The text is in a simple, sans-serif font and is easy to read. The image is likely a scan or photograph of a document.
AUG 1 4 2007
Ms. Judith Campbell Regulatory Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway MALVERN PA 19355
Re: K071925
Trade/Device Name: MAGNETOM Essenza Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: July 11, 2007 Received: July 12, 2007
Dear Ms. Campbell: :
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/9 description: The image is a circular seal with the text "1906-2006" at the top. The letters "FDA" are in the center of the seal in a bold, sans-serif font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial". The seal appears to be a commemorative emblem for the centennial anniversary of the FDA.
wing and Oremoting O's
{3}------------------------------------------------
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). 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy Chogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
4 Indications for Use Statement
510(k) Number (if known)_ Kひフ/ 9 2 5
Device Name: MAGNETOM Essenza
Indications for Use:
The MAGNETOM Essenza is 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. Depending on the region of interest, contrast agents may be used. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Essenza may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR-safe biops y needles.
(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
J.L. Hanz
(Division Sign-Off)
OR
of Reproductive. Ab
§ 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.