(492 days)
If the "Reference Device(s)" section contains "Not Found", please provide "Not Found" as the answer. Otherwise, list the K/DEN numbers.
Not Found
No
The summary describes a passive receive-only MRI coil and does not mention any software or algorithms that would incorporate AI/ML for image processing or interpretation.
No.
The device is indicated for use as a diagnostic imaging device to provide information useful in the determination of a diagnosis, not for therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a diagnostic imaging device" and that the images it provides "can be useful in the determination of a diagnosis."
No
The device description explicitly states it is a "phased array coil with rectangle loop design and integrated RF preamp per channel," which are hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this device is an MRI coil used to acquire images directly from the patient's body (head, spine, torso of neonates).
- IVDs are used to provide information about a physiological or pathological state. While the images produced by this device are used by a trained physician to aid in diagnosis, the device itself is acquiring physical signals from the body, not analyzing biological samples.
- The device description focuses on the physical characteristics of the coil and its use in an MRI scanner. There is no mention of reagents, assays, or the analysis of biological specimens, which are hallmarks of IVDs.
The device is a diagnostic imaging device used in conjunction with an MRI scanner.
N/A
Intended Use / Indications for Use
The Neonate Array Coils are local coils (receive only) and are 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 LMT nomage IC MR-compatible. They provide MR images of the neonatal head or body, noninvasively without the use of ionizing radiation. 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 (Proton).
Used in a MR Scanner or used in the LMT nomag IC incubator and a MR Scanner, the Neonate Array Colls (receive only) are indicated for use as a diagnostic imaging device to provide transversal, sagittal, coronal, and axial images of the structures of the:
- head (Neonate Head Array Coil)
- spine, torso (Neonate Body Array Coil).
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 (Proton). 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). The Neonate Array coils are compatible to Siemens and Philips MRIs with 1.5T or 3.0T.
Product codes
MOS
Device Description
The Neonate Array Coils (in the following NAC) is a phased array coil with rectangle loop design and integrated RF preamp per channel. It is a receive-only coil with rectangle for horizontal B-field scanners with field strengths of 1.5T or 3.0T.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
neonatal head or body, head, spine, torso
Indicated Patient Age Range
Neonate
Intended User / Care Setting
trained physician
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)
Not Found
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/0 description: The image shows the text "LMT Medical Systems GmbH - Osterweide 8 - 23562 Luebeck - Germany". The text appears to be an address for LMT Medical Systems GmbH. The address includes the street name, house number, postal code, city, and country.
510(k) Summary
Preparation Date: Applicant
June, 8th 2010 LMT Medical Systems GmbH Osterweide 8 23562 Luebeck Germany
Establ. Registration No. Contact Person:
Thomas Bohnen Tel: +49-451-58098-14 Fax. +49-451-58098-15 Email: bohnen@lammersmedical.com
Proprietary Name
Common Name Device Panel: Product Code Class
Neonate Head Array Coil (NHAC) Neonate Body Array Coil (NBAC) Coil, Magnetic Resonance, Specialty Radiology MOS (21 CFR 892.1000) 2
Applicable standards
IEC 60601-2-33 NEMA MS-1 NEMA MS-3 NEMA MS-6 NEMA MS-9
Legally marketed devices
RF Coils, Advanced Imaging Research, Inc. (K023929)
Reason for 510(k):
New device (Traditional)
AUG 1 8 2010
4091047
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K091047
p. 2/2
...LMT
Intended Use
The Neonate Array Coils are local coils (receive only) and are 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 LMT nomage IC MR-compatible
They provide MR images of the neonatal head or body, noninvasively without the use of ionizing radiation. 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 (Proton).
Description of the Device
The Neonate Array Coils (in the following NAC) is a phased array coil with rectangle loop design and integrated RF preamp per channel. It is a receive-only coil with rectangle
for horizontal B-field scanners with field stars of for horizontal B-field scanners with field strengths of 1.5T of 3.0T.
Design and Specifications
The safety and performance parameters specified by the FDA guidance for MR Diagnostic Devices are met by the NAC.
Performance - Imaging
Safety
-
Imaging
-
Static Field Strength
-
Acoustic Noise
-
dB/dt
-
RF Heating
-
Biocompatibility
Comparison summary
LMT Medical Systems believes that the following technology characteristics of NAC (LMT) and the above mentioned predicate devices (Advanced Imaging Research, Inc. (K023929)) are substantially equivalent concerning w
- Environmental specifications .
- Ergonomics of the patient-user interface
- Performance specifications .
FI
Thomas Bohnen, QM and Regulatory Affairs
LMT Medical Systems GmbH, Germany
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health & Human Services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Kristina Luetje Regulatory Affairs Manager LMT Medical Systems GmbH Osterweide 8, Lubeck 23562 GERMANY
AUG 1 8 2010
Re: K091047
Trade/Device Name: Neonate Array Coils Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: June 16, 2010 Received: June 21, 2010
Dear Ms. Luetie:
' 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 5 00%). This ket 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 day ince to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
LMT Medical Systems GmbH – NHAC and NBAC 510(k) submission
Indications for Use
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: Neonate Array Coils
Used in a MR Scanner or used in the LMT nomag IC incubator and a MR Scanner, the Neonate Array Colls (receive only) are indicated for use as a diagnostic and a MR Scanner,
device to provide transversal, sacittel, connel, and chical device to provide (rocolve only) are indicated for use as a diagnostic imaging
structures of the structures of the -
- head (Neonate Head Array Coil) .
- spine, torso (Neonate Body Array Coil). .
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 (Proton). The signal received by the coils is dependent upon the MRI parameters (T1 (Proton).
Intice relaxation time. T2 as an and is dependent upon the MRI parameters (T1 or spinlattice relaxation time, T2 or spin-spin relaxation time, density of nuclei, flow velocity and chemical shift). The Neonate Array coils are compatible to Siemens and Philips
MRTs with 1 ET or 3 oT MRTs with 1.5T or 3.0T.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
D.D.L.
sion of Radiologics
Health and Safety
510K. K091047