(97 days)
The intended use of the 16 Ch Multipurpose Coil Variety 1.5T and 3T is, in conjunction with a Magnetic Resonance Scanner, body imaging for diagnostic with a MRI system.
It is indicated for use as a diagnostic imaging device transverse, sagittal, coronal and oblique images of the internal structures of special regions of the human body. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
The outcome of this is diagnostic images of toes, feet, ankle, knee, finger, hand, wrist, elbow, shoulder, carotid artery, inner ear and other parts of the body with similar structure can be taken.
The 16 Ch Multipurpose Coil Variety described in this document has been designed, depending upon model type, for use with a SIEMENS MRI system with field strength of 1.5 T or 3 T. The coil system serves only as a receiving coil for the reception of high frequency signals from the hydrogen -(1-H) nuclei. The hydrogen nuclei are induced into precession by the transmitting coil of the MRT device. The processing magnetization induces potential differences in the 16 Ch Multipurpose Coil Variety which are digitized and further processed in the MRT system
The provided text is a 510(k) summary for the NORAS 16 Ch Multipurpose Coil Variety, a Magnetic Resonance Diagnostic Device. This document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's technical characteristics and intended use. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies that would be typically found in a clinical study report for an AI/ML medical device.
Therefore, I cannot fulfill all aspects of your request based on the provided text.
Here is what can be inferred and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail metrics. The "acceptance criteria" here is substantial equivalence to predicate devices, meaning the device's performance is expected to be comparable to already cleared devices.
- Reported Device Performance: The document only states that the device is "safe and effective when used with the currently available Siemens MAGNETOM 1.5T/3T" based on conformity to NEMA and IEC standards for safety and performance. No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are provided or compared to a threshold.
| Criterion Type | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Safety & Efficacy | Conformity to NEMA Standards for performance and safety, and IEC 60601-2-33:2002 for safety issues with Magnetic Resonance Imaging Devices. | "Safe and effective when used with the currently available Siemens MAGNETOM 1.5T/3T" |
| Substantial Equivalence | The 16 Ch Multipurpose Coil Variety is substantially equivalent to the predicate devices: 8 Ch Multipurpose Coil (K083578) and 8-Channel Medium General Purpose Flex Coil (K111673) | Believed to be substantially equivalent based on intended use, technological characteristics, and safety/effectiveness concerns. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not mentioned. This document describes a new hardware device (an MRI coil), not an AI/ML algorithm that would typically undergo testing with a separate test set of data. The "testing" appears to be focused on engineering and safety standards compliance.
- Data Provenance: Not applicable in the context of clinical data for an AI/ML algorithm.
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. This relates to a hardware device (MRI coil), not an AI/ML algorithm requiring expert ground truth for image interpretation. The "ground truth" for the coil's performance would be physical measurements of signal-to-noise ratio, uniformity, safety parameters, etc.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used for establishing ground truth in clinical imaging studies for AI/ML algorithms.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Inferred Ground Truth: For a new MRI coil, the "ground truth" for its performance would likely be based on established engineering and physics principles, direct measurements of coil characteristics (e.g., signal-to-noise ratio, homogeneity, artifact levels), and compliance with international standards (NEMA, IEC 60601-2-33). It would not involve clinical image interpretation ground truth in the way an AI algorithm would.
8. The sample size for the training set
- Not applicable. This is a hardware device, not an AI/ML model that undergoes training on a dataset.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI/ML model is mentioned.
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Image /page/0/Picture/16 description: The image shows the logo for NORAS. The logo has the word "NORAS" in bold, black letters. To the right of the word is a line that resembles a heart rate monitor, and the words "MRI products" are written in small letters above and below the line.
P008 16 Ch Multipurpose Coil Variety_Summary_510(k)_revised.docx
510(k) Summary
MAY 0 8 2014
16 Ch Multipurpose Coil Variety
Date of Summary Preparation: March 25, 2014
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
- General Information 1.
Importer/Distributor Name and Address NORAS MRI products GmbH Leibnizstr.4 97204 Hoechberg / Germany
ERN: 3004929307 Owner/Operator Number: 9071737
Manufacturing Site Name and Address NORAS MRI products GmbH
Leibnizstr.4
97204 Hoechberg / Germany
ERN: 3004929307 Owner/Operator Number: 9071737
P008_16 Ch Multipurpose Coil Variety_Summary_510(k)_revised.docx
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Image /page/1/Picture/1 description: The image shows the logo for NORAS, a company that produces MRI products. The logo features the word "NORAS" in bold, black letters, with a horizontal line underneath. To the right of the word "NORAS" is a graphic that resembles a heartbeat line, with the letters "MRI product" written below it in a smaller font. The logo is partially contained within a white oval shape, with the left side of the oval being black.
Contact Person 2.
Zahed Sedighiani MSc. Medical Engineering Quality Assurance & International Licensing NORAS MRI products GmbH Leibnizstr.4 97204 Hoechberg Germany Tel: (+49) 931 / 29927-17 Fax: (+49) 931 / 29927-20 zahed.sedighiani@noras.de
Device Name and Classification నే.
| Trade Name: | 16 Ch Multipurpose Coil Variety |
|---|---|
| Common Name: | 16 Ch Multipurpose Coil Variety |
| Classification Name: | Magnetic Resonance Diagnostic Device |
| Classification Panel: | Radiology |
| CFR Number: | 21 CFR § 892.1000 |
| Device Class: | II |
| Product Code: | 90MOS |
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P008 16 Ch Multipurpose Coil Variety Summary_510(k)_revised.docx
Image /page/2/Picture/1 description: The image shows the logo for NORAS. The logo has the word "NORAS" in bold, sans-serif font. There is a line underneath the word "NORAS" that extends to the right and forms a heartbeat-like shape. To the right of the heartbeat shape, the words "MRI products" are written in a smaller font.
Device Description 4. 1
The 16 Ch Multipurpose Coil Variety described in this document has been de-signed, depending upon model type, for use with a SIEMENS MRI system with field strength of 1.5 T or 3 T. The coil system serves only as a receiving coil for the reception of high frequency signals from the hydrogen -(1-H) nuclei. The hydrogen nuclei are induced into precession by the transmitting coil of the MRT device. The processing magnetization induces potential differences in the 16 Ch Multipurpose Coil Variety which are digitized and further processed in the MRT system
Image /page/2/Picture/4 description: The image shows a collection of parts, possibly for a model or construction kit. There are several long, thin, rectangular pieces, a flat, square piece, and two sets of connected parts that appear to be axles or linkages with wheels or connectors at the ends. The parts are arranged on a white surface, and the image is in black and white. The arrangement suggests that these parts are intended to be assembled into a larger structure or mechanism.
The 16 Ch Multipurpose Coil Variety 1.5T (117235) 3T (117234) are suitable for use with the following MRI systems:
MAGNETOM Avanto 1.5T MAGNETOM Espree 1.5T MAGNETOM Aera 1.5T MAGNETOM Symphony a TIM 1.5T MAGNETOM Trio a TIM 3T MAGNETOM Skyra 3T MAGNETOM Verio 3T
Image /page/2/Picture/8 description: The image shows two white, mechanical arms against a dark background. Each arm has a complex, circular joint at the top, a segmented limb, and a small, rectangular foot at the bottom. The arms are positioned symmetrically, facing slightly inward, creating a balanced composition.
16 Ch Multipurpose Coil Variety
Image /page/2/Picture/10 description: The image shows a piece of equipment with two cylindrical objects on the left side. These cylinders are connected by a metal bar. The equipment also has a series of tubes and wires that are connected to a central hub.
8 Ch Multipurpose Coil CPC
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P008 16 Ch Multipurpose Coil Variety_Summary_510(k)_revised.docx
Image /page/3/Picture/1 description: The image shows the text "5. Intended Use / Indication for Use". The text is in a bold, sans-serif font. The number 5 is followed by a period.
NORAS
The intended use of the 16 Ch Multipurpose Coil Variety 1.5T and 3T is, in conjunction with a Magnetic Resonance Scanner, body imaging for diagnostic with a MRI system.
It is indicated for use as a diagnostic imaging device transverse, sagittal, coronal and oblique images of the internal structures of special regions of the human body. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
The outcome of this is diagnostic images of toes, feet, ankle, knee, finger, hand, wrist, elbow, shoulder, carotid artery, inner ear and other parts of the body with similar structure can be taken.
Substantial Equivalence 6.
NORAS MRI products GmbH believes that, within the meaning of the Safe Medical Devices Act of 1990, the 16 Ch Multipurpose Coil Variety is substantially equivalent to the following multipurpose coils:
| Predicate DeviceName andManufacturer | 510(k)Number | ClearanceDate | ProductCode | Comparable Properties |
|---|---|---|---|---|
| 8 Ch Multipurpose Coil(CPC) | K083578 | Jan 16 2009 | 90MOS | Intended Use / Indication for UseEnvironmentProton imagingHigh resolution of the body extremitiesCoil Design (Principle)Coil Design (Localization) |
| 8-Channel MediumGeneral Purpose FlexCoil | K111673 | Dec 23 2011 | 90MOS | Field of ViewMethod of Decoupling |
P008 16 Ch Multipurpose Coil Variety Summary_510(k)_revised.docx
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Page 5 of 5
Image /page/4/Picture/1 description: The image shows the logo for NORAS. The logo has the word "NORAS" in bold, black letters. To the right of the word is a line that looks like a heart rate monitor, and below that are the words "MRI products" in smaller letters.
P008_16 Ch Multipurpose Coil Variety_Summary_510(k)_revised.docx
7. Summary of Technological Characteristics of the Principal Device as Compared with the predicate Device
Summary of technological characteristics of the 16 Ch Multipurpose Coil Variety are the same as for the predicate devices 8 Ch Multipurpose Coil (CPC) or 8-Channel Medium General Purpose Flex Coil
The comarable technological characteristics are as follows:
- Coil Design (Principle) Phased Array Coil Design (Localization) Loop channels with preamplifier arranged oppositely in pairs · Method of Decoupling Active and Passive · Mode of Operation Receive only · Mode of tuning Tuned once in the factory
General Safety and Effectiveness Concerns 8.
The 16 Ch Multipurpose Coil Variety will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the IEC standards for safety issues with the Magnetic Resonance Imaging Devices. IEC 60601-2-33:2002. This will assure that the performance of this device can be considered safe and effective when used with the currently available Siemens MAGNETOM 1.5T/3T
The power tests which have been done by MRI manufacturer for the whole system can be found in Appendix C.
Conclusion as to Substantial Equivalence 9.
NORAS MRI products GmbH believes that, within the definition of the Safe Medical Devices Act of 1990, the 16 Ch Multipurpose Coil Variety is substantially equivalent to the predicate devices listed above.
Zahed Sedighiani
Quality and Regulatory Affairs Manager
March 25, 2014
P008_16 Ch Multipurpose Coil Variety_Summary_510(k)_revised.docx
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Image /page/5/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo consists of a symbol resembling an abstract caduceus or a stylized representation of human figures, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text and symbol are in black, and the background is white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8,2014
NORAS MRI products GmbH % Mr. Zahed Sedighiani Ouality and Regulatory Management Leibnizstr. 4 Hoechberg 97204 GERMANY
Re: K140252
Trade/Device Name: 16 Ch Multipurpose Coil Variety - 1.5T (117235) 3T (117234) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Il Product Code: MOS Dated: March 12, 2014 Received: March 14, 2014
Dear Mr. Sedighiani:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Mr. Sedighiani
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
Indications for Use
510(k) Number (if known) K140252
Device Name
16 Ch Multipurpose Coil Variety 1.5T / 3T
Indications for Use (Describe)
Intended Use / Indication for Use:
The intended use of the 16 Ch Multipurpose Coil Variety 1.5T and 3T is, in conjunction with a Magnetic Resonance Scanner, body imaging for diagnostic with a MRJ system.
It is indicated for use as a diagnostic in produce transverse, sagittal, coronal and oblique images of the internal structures of special regions of the human body. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
The outcome of this is diagnostic images of tocs, feet, ankle, knew, shoulder, caroid artery, inner ear and other parts of the body with similar structure can be taken.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Michael D. O'Hara
FORM FDA 3881 (1/14)
TSC Publishing Services (100) 444-1470 EI
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§ 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.