(9 days)
The intended use of the Flex Loop Coil Set 3 T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body.
Used in the MAGNETOM 3 T Trio, a Tim System, the Flex Loop Coils are indicated for use as a diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the body. The images produced by the MAGNETOM 3 T Trio, a Tim System with the Flex Loop Coils reflect the spatial distribution of protons (hydogen nuclei) exhibiting magnetic resonance.
When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
The intended use of the MAGNETOM 3 T Trio, a Tim System is not affected in any way by the use of the new Flex Loop Coil Set 3 T.
The Flex Loop Coil Set 3 T consists of five receive-only coils and one interface, which contains the preamplifiers, cable traps and a combiner network. The coils are two 4-channel flexible coils (Flex Coil Large and Flex Coil Small) and three linear polarized (LP) flexible coils (Loop Coil 4 cm, 7 cm and 11 cm).
Here's a breakdown of the acceptance criteria and study information for the Flex Loop Coil Set 3 T, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Parameter | Acceptance Criteria (Stated or Implied by Equivalence Claim) | Reported Device Performance (Summary) |
|---|---|---|---|
| Safety | Maximum Static Field | Unaffected by modification | Meets safety standards (implied by "unaffected" claim) |
| Rate of Change of Magnetic Field | Unaffected by modification | Meets safety standards (implied by "unaffected" claim) | |
| RF Power Deposition | Unaffected by modification | Meets safety standards (implied by "unaffected" claim) | |
| Acoustic Noise Level | Unaffected by modification | Meets safety standards (implied by "unaffected" claim) | |
| Biocompatibility | No new materials, therefore no new biocompatibility issues | Biocompatibility equivalent to predicate devices | |
| Performance | Geometric Distortion | Unaffected by modification | Performance equivalent to predicate devices |
| Slice Profile, Thickness & Gap | Unaffected by modification | Performance equivalent to predicate devices | |
| High Contrast Spatial Resolution | Unaffected by modification | Performance equivalent to predicate devices | |
| Signal to Noise Ratio (SNR) | Equivalent to predicate devices (per NEMA MS-6 standard) | Equivalent to predicate devices (per NEMA MS-6 standard) | |
| Image Uniformity | Equivalent to predicate devices (per NEMA MS-6 standard) | Equivalent to predicate devices (per NEMA MS-6 standard) |
Important Note: The document consistently states that the new device's safety and performance parameters are unaffected by the modifications described or that they are equivalent to predicate devices. Specific numerical acceptance thresholds are not explicitly provided in this 510(k) summary, as the nature of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device rather than to establish new performance benchmarks. The "acceptance criteria" here are essentially the demonstration of equivalence to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify a distinct "test set" in the context of clinical images or patient data. The testing mentioned appears to be primarily laboratory and physical performance testing of the coils themselves.
- Sample Size: Not applicable in terms of patient numbers. The testing was on the device itself.
- Data Provenance: The testing was "Laboratory and clinical testing," which typically means internal studies conducted by the manufacturer, Siemens AG, in Germany. It does not specify whether this involved human subjects, but the nature of the tests (SNR, image uniformity, etc.) suggests physical measurements on a scanner. It is prospective in the sense that these tests were performed on the new device to support its 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for the performance parameters (SNR, image uniformity, geometric distortion, etc.) is established by technical measurements and adherence to standards (e.g., NEMA MS-6), not by human expert interpretation of a clinical test set.
4. Adjudication Method for the Test Set
Not applicable, as the evaluation was based on objective technical measurements and comparison to standards/predicate device performance, not on human interpretation requiring adjudication.
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, an MRMC comparative effectiveness study was not done. The device is a hardware component (MRI coils), not an AI-powered diagnostic tool. Therefore, the concept of human reader improvement with/without AI assistance is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a hardware device (MRI coil), not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for the performance parameters was objective technical measurements and established engineering/physics standards (e.g., SNR and image uniformity tested according to the NEMA MS-6 standard). For safety, the ground truth refers to established safety limits and regulations for MRI devices.
8. The Sample Size for the Training Set
No training set is mentioned or applicable, as this is a new hardware device rather than a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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Kabb313
Section 8 510(k) Summary
8 510(k) Summary
NJV 1 7 2006
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
General Information I.
Date of summary preparation: September 18, 2006
Manufacturer
Siemens AG, Medical Solutions Henkestrasse 127 D-91052 Erlangen, Germany
Headquarters: Siemens AG Wittelsbacherplatz 2 D-80333 Munich, Germany
Registration Number 8010024
Importer/Distributor
Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Registration Number 2240869
Contact Person
Ms. Ruth Schneiss Regulatory Affairs Manager Henkestrasse 127 D-91052 Erlangen, Germany Phone: +49 (9131) 84-7445 Fax: +49 (9131) 84-2200 e-mail: ruth.schneiss@siemens.com
Image /page/0/Picture/16 description: The image is blurry and difficult to make out. It appears to show some text, but the text is illegible due to the poor image quality. It is not possible to provide a more detailed description without a clearer image.
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Classification and Device Name
| Classification Panel: | Radiology |
|---|---|
| Classification Name: | Magnetic Resonance Diagnostic DeviceAccessory |
| Device Class: | Class II [21 CFR § 892.1000] |
| Product Code: | LNH |
| Common Name: | Special Purpose Coil |
| Trade Name: | Flex Loop Coil Set 3 T |
Safety and Effectiveness Information Supporting Substantial II. Equivalence
Intended Use
The intended use of the Flex Loop Coil Set 3 T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body. Maghed in the MAGNETOM 3 T Trio, A Tim System, the Flex Loop Coils are intended to produce transversal, sagittal, coronal and oblique images of the internal structures of the body.
Device Description
The Flex Loop Coil Set 3 T consists of five receive-only coils and one interface, which contains the preamplifiers, cable traps and a combiner network. The coils are two 4-channel flexible coils (Flex Coil Large and Flex Coil Small) and three linear polarized (LP) flexible coils (Loop Coil 4 cm, 7 cm and 11 cm).
Image /page/1/Picture/8 description: The image shows a grainy, black and white photograph. There are two distinct objects visible in the image. The first object, labeled with a pointer and the number (1), appears to be a light-colored, elongated shape. The second object is a darker, circular shape located towards the right side of the image.
(1) Coll socket
(2) Plug for coil socket on the patient table
Figure 10: Flex loop interface
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Image /page/2/Figure/1 description: The image shows three identical diagrams with labels. Each diagram shows a component labeled as '(1)' and another component labeled as '(2)'. According to the text below the diagrams, '(1)' refers to the 'Coil loop' and '(2)' refers to the 'Coil plug'.
Figure 11: Loop coils 4 cm, 7 cm, 11 cm
Image /page/2/Figure/3 description: The image contains two identical diagrams of an electronic component, each labeled with numbers corresponding to different parts. Label (1) indicates the center markings, (2) points to the electronic boxes, and (3) identifies the coil plug. The diagrams appear to be technical illustrations, possibly from a manual or guide, providing a visual reference for identifying the component's features.
Figure 12: Flex Coil large and small
Equivalency Information
Siemens believes that the Flex Loop Coil Set 3 T for MAGNETOM Trio, a Tim System is substantially equivalent to the Flex Loop Coil Set for MAGNETOM 1.5 T systems described in the following submissions.
| Predicate Device Name | FDA ClearanceNumber | FDA ClearanceDate |
|---|---|---|
| Siemens MAGNETOM 1.5 TSymphony | K971684 | Aug. 05 1997 |
| Siemens MAGNETOM 1.5 TAvanto | K032428 | Oct. 16 2003 |
| Siemens MAGNETOM 3 T Trio,a Tim System | K050200 | Feb. 28 2005 |
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Summary of Technological Characteristics of the Principal Device as Compared with the Predicate Device
Although the new Flex Loop Coils are designed for a field strength of 3 T, we believe that they are substantially equivalent to the predicate Flex Loop Coils for 1.5 T MAGNETOM Systems.
General Safety and Effectiveness Concerns
The following safety and performance parameters:
[Safety]
- Maximum Static Field
- Rate of Change of Magnetic Field
- RF Power Deposition
- Acoustic Noise Level
[Performance]
- 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.
The following parameters were considered for the new Flex Loop Coil Set 3 T
{Safety| - Biocompatibility
[Performance] - Signal to Noise Ratio
- Image Uniformity
No new materials were used for the new Flex Loop Coil Set 3 T compared to their predicate devices. Therefore no biocompatibility tests were performed. Signal to Noise Ratio (SNR) and image uniformity tests acc. to NEMA MS-6 standard were performed for the new Flex Loop Coil Set 3 T and the results presented in this submission show that they are equivalent with the predicate devices.
Conclusion as to Substantial Equivalence
Laboratory and clinical testing was 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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Cover Letter FDA
Image /page/4/Picture/1 description: The image shows the TÜV SÜD America logo. The logo consists of a black octagon with the text "TÜV" over "SÜD" inside a white rectangle. Below the octagon, the word "America" is written. The logo is a certification mark indicating that a product or service has been tested and certified by TÜV SÜD.
Date: 18.October 2006
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, MD 20850
Premarket Notification RE:
To Whom It May Concern:
Enclosed in duplicate is the following information:
Purpose of Submission: Special 510(k) A.
- B. Name and Address of the Third Party:
TÜV Product Service 1775 Old Highway 8 New Brighton, MN 55112-1891
Name and Address of the Manufacturer: ்.
Siemens Medical Solutions Henkestrasse 127 91052 Erlangen, Germany
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Siemens Medical Solutions % Mr. Stefan Preiss Responsible Third Party Official TÜV Product Service 1775 Old Hwy 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891
NOV 17 2006
Re: K063373
Trade/Device Name: Flex Loop Coil Set 3 T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 20, 2006 Received: November 8, 2006
Dear Mr. Preiss:
We have reviewed your Section 510(k) premarket notification of intent to market the device n & re reviewed your overmined 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 I spice 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/5/Picture/8 description: The image is a circular seal with the text "1906-2006" at the top. The letters "PA" 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 below the word "Centennial". The text around the edge of the seal is difficult to read due to the image quality.
Protecting and Promoting Public Health
{6}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri- 1 issualited of a complies with other requirements of the Act that FDA has made a delemmation than Judinistered by other Federal agencies. You must of any Federal Statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements, and 801); good manufacturing practice requirements as set CFK Part 607), labeling (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (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 S10(k) This letter will anow you to begin manages ,
premarket notification. The FDA finding of substantial equivalence of your device to a legally prematication. The PDF inneling sification 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 If you desire specific advice for your de 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" Also, picase note the regulation other general information on your responsibilities under (21CFN Fall 607.97). Tod may obtain offecturers, 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 C. Hogdon
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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2 Indications for Use Statement
510(k) Number (if known)
Device Name: Flex Loop Coil Set 3 T
Indications for Use:
The intended use of the Flex Loop Coil Set 3 T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body.
Used in the MAGNETOM 3 T Trio, a Tim System, the Flex Loop Coils are indicated for use as a diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the body. The images produced by the MAGNETOM 3 T Trio, a Tim System with the Flex Loop Coils reflect the spatial distribution of protons (hydogen nuclei) exhibiting magnetic resonance.
When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
The intended use of the MAGNETOM 3 T Trio, a Tim System is not affected in any way by the use of the new Flex Loop Coil Set 3 T.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy L Broadon
(Division Sign-Off)
Division of Reproductive, Abdominal
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063373
Siemens 510(k) Premarket Notification September 18, 2006 Flex Loop Coil Set for MAGNETOM 3 T System
Page 2-1
§ 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.