(63 days)
Not Found
No
The description focuses on the hardware (coil) and its function in receiving MR signals, with no mention of AI/ML for image processing, analysis, or interpretation. The processing is described as being done by the MRT system.
No
The device is described as a diagnostic imaging device that provides images for trained physicians to interpret for the determination of a diagnosis, and it does not mention any therapeutic function.
Yes
The device is explicitly described as a "diagnostic imaging device" that provides images which, "When interpreted by a trained physician, ... provide information that can be useful in the determination of a diagnosis."
No
The device is described as a "local coil (receive only)" and a "16-channel coil (receive only)," which are physical hardware components used in MRI systems. It receives high-frequency signals and induces potential differences, indicating a hardware function.
Based on the provided information, the NHAC 16 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- NHAC 16 Function: The NHAC 16 is a receive-only coil used in conjunction with MRI systems. Its function is to receive high-frequency signals from hydrogen nuclei within the neonatal head and brain. These signals are then processed by the MRI system to create images.
- Direct Patient Interaction: The NHAC 16 interacts directly with the patient's body (the neonatal head) to acquire signals. It does not analyze specimens taken from the body.
- Imaging Modality: MRI is an imaging modality that visualizes internal structures of the body, not an analysis of biological samples.
The NHAC 16 is a component of an MRI system, which is a medical imaging device used for diagnostic purposes, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NHAC 16 is a local coil (receive only) and is intended to be used in conjunction with 1.5T or 3.0T magnetic resonance imaging (MRI) systems by Philips or Siemens and can be used in conjunction with the MR Diagnostics Incubator System nomag® IC. It provides MR images of the neonatal head, non-invasively and without the use of ionizing radiation.
Product codes
MOS
Device Description
The NHAC 16 is a 16-channel coil (receive only) and is intended to produce high resolution images of the neonate head and brain.
The NHAC 16 serves solely as a receiving coil for the reception of high frequency signals from the hydrogen nuclei. The hydrogen nuclei are induced into precession by the transmitting coil of the MRT device. The precessing magnetization induces potential differences in the NHAC 16 which are processed by the MRT system.
Used in an MR Scanner or used in the MR Diagnostics Incubator System nomag® IC and an MR Scanner, the NHAC 16 is indicated for use as a diagnostic imaging device to provide transversal, sagittal, coronal and oblique images of the internal structures of the head.
When interpreted by a trained physician, these images provide information that can be useful in the determination of a diagnosis. The excited nucleus is 1H (Hvdrogen).
The signal received by the coils is dependent upon the MRI parameters (T1 or spin-lattice relaxation time, T2 or spin-spin relaxation time, density of nuclei, flow velocity and chemical shift).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic resonance imaging (MRI)
Anatomical Site
neonatal head, brain
Indicated Patient Age Range
neonatal
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
General testing was performed to ensure that functional requirements were met and that the coil executes as expected. Performance testing was conducted using phantoms and accepted imaging quality metrics. Since neonates are a vulnerable patient population, for this particular device, the benefits of sample clinical images did not outweigh the risks associated with acquisition of those images. Therefore substantial equivalence was determined based solely on phantom images and sample clinical images of the neonatal head were not necessary to support the premarket submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 26, 2017
LMT Medical Systems GmbH % Mr. Thomas Plein Manager Q&RA Maria-Goeppert-Str. 5 Lubeck 23562 GERMANY
Re: K171515 Trade/Device Name: NHAC 16 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: July 7, 2017 Received: July 10, 2017
Dear Mr. Plein:
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.
1
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
For
Robert Ochs, Ph.D. 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 below. |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| | Indications for Use | |
| 510(k) Number (if known) | K171515 | |
| Device Name | NHAC 16 | |
| Indications for Use (Describe) | The NHAC 16 is a local coil (receive only) and is intended to be used in conjunction with 1.5T or 3.0T magnetic
resonance imaging (MRI) systems by Philips or Siemens and can be used in conjunction with the MR Diagnostics
Incubator System nomag® IC. It provides MR images of the neonatal head, non-invasively and without the use of
ionizing radiation. | |
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| | CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| | This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| | DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| | The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to: | |
| | Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov | |
| | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number." | |
| FORM FDA 3881 (8/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
レコートのり
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Special 510(k) Summary
l. SUBMITTER
LMT Medical Systems GmbH Maria-Goeppert-Str. 5 23562 Lübeck Germany Est.Reg.No.: 3009514037
Phone: +49-451-580980 Fax: +49-451-58098200
Contact Person: Thomas Plein Title: Manager Quality & Regulatory Affairs Email: regulatory@lmt-medicalsystems.com Date prepared: May 19, 2017
II. DEVICE
Trade name: Classification name: Product code: Regulation number: Device Class:
NHAC 16 Magnetic Resonance Diagnostic Device MOS 892.1000 ll
III. PREDICATE DEVICE
Manufacturer: LMT Medical Systems GmbH Device name: Neonate Array Coils 510(k) Number: K091047
IV. DEVICE DESCRIPTION AND INTENDED USE
Indications for Use:
The NHAC 16 is a local coil (receive only) and is intended to be used in conjunction with 1.5T or 3.0T magnetic resonance imaging (MRI) systems by Philips or Siemens and can be used in conjunction with the MR Diagnostics Incubator System nomag® IC. It provides MR images of the neonatal head, non-invasively and without the use of ionizing radiation.
4
Description:
The NHAC 16 is a 16-channel coil (receive only) and is intended to produce high resolution images of the neonate head and brain.
The NHAC 16 serves solely as a receiving coil for the reception of high frequency signals from the hydrogen nuclei. The hydrogen nuclei are induced into precession by the transmitting coil of the MRT device. The precessing magnetization induces potential differences in the NHAC 16 which are processed by the MRT system.
Used in an MR Scanner or used in the MR Diagnostics Incubator System nomag® IC and an MR Scanner, the NHAC 16 is indicated for use as a diagnostic imaging device to provide transversal, sagittal, coronal and oblique images of the internal structures of the head.
When interpreted by a trained physician, these images provide information that can be useful in the determination of a diagnosis. The excited nucleus is 1H (Hvdrogen).
The signal received by the coils is dependent upon the MRI parameters (T1 or spin-lattice relaxation time, T2 or spin-spin relaxation time, density of nuclei, flow velocity and chemical shift).
V. COMPARISON TO CLEARED DEVICE
The predicate device neonate array coils consists of:
- A 8-channel neonatal head array coil .
- A 12-channel neonatal body array coil .
The NHAC 16 is a 16-channel neonatal head array coil (NHAC) and a modification to the 8-channel neonatal head array coil. Therefore the following section will only compare the NHAC 16 to the 8-channel NHAC of the predicate device.
1. Electrical Design
The NHAC 16 has twice as much and smaller individual receive elements as the 8-channel NHAC which results in a higher SNR (signal-to-noiseratio) of the NHAC 16. The overall length of the receive elements in zdirection of the coil is longer which results in a larger field-of-view.
2. Principles of operation
The scientific principles of operation (receiving coils for magnetic resonance imaging) are identical between the predicate and the modified device.
3. Mechanical Design
Principal cylindrical geometry is the same while the NHAC 16 has 1" shorter width than the 8-channel NHAC. The NHAC 16 has a distinct shape at the upper side in feet-direction to improve the handling of patients with intubation. Depending on the MRI platform the NHAC 16 has two
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connection cables instead of one. The overall weight has increased from 2.5kg for the 8-channel NHAC to 2.8kg for the NHAC 16.
4. Materials
The same materials are used in the construction of the predicate and the modified device.
5. Power supply
Both devices are supplied by the MRI as the energy source.
VI. TEST/PERFORMANCE DATA
General testing was performed to ensure that functional requirements were met and that the coil executes as expected. Performance testing was conducted using phantoms and accepted imaging quality metrics. Since neonates are a vulnerable patient population, for this particular device, the benefits of sample clinical images did not outweigh the risks associated with acquisition of those images. Therefore substantial equivalence was determined based solely on phantom images and sample clinical images of the neonatal head were not necessary to support the premarket submission.
VII. CONCLUSIONS
As described in this summary, the modified device is substantially equivalent to the predicate device based on the analysis herein. The modified device raises no new concerns of safety or efficacy.