(249 days)
Not Found
No
The summary describes image post-processing and quantitative analysis but does not mention AI, ML, or related terms like deep learning or neural networks. The analysis is based on "qualitative parametric maps" and "neuromelanin associated signal contrasts," which are standard image processing techniques.
No.
The device is a post-processing software that provides information as an adjunct to diagnosis, but it does not directly treat or manage a disease or condition. It is a diagnostic aid, not a therapeutic device.
Yes
The device "can provide information useful in determining neuromelanin association as an adjunct to diagnosis." It aids in diagnosis by providing information to a neuroradiologist.
Yes
The device description explicitly states "Terran NM-101 is a fully automated post-acquisition software as a medical device (SaMD)". The summary focuses entirely on the software's function of processing existing MR images and generating outputs, with no mention of accompanying hardware components.
Based on the provided information, Terran NM-101 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Terran NM-101's Function: Terran NM-101 is a software that processes and analyzes in vivo (within the body) imaging data acquired from an MRI scanner. It works directly with the MR images of the brain, not with biological specimens.
The description clearly states it's a "post-processing software medical device in visualization of the brain" and analyzes "input data acquired from Siemens 3T MR imaging systems." This is characteristic of medical imaging software, not an IVD.
N/A
Intended Use / Indications for Use
Terran NM-101 is a post-processing software medical device in visualization of the brain in older adults between the age of 51 to 83 years. Terran NM-101 analyzes input data acquired from Siemens 3T MR imaging systems, using a specified protocol (i.e., Turbo Spin Echo, TSE). Terran NM-101 can generate qualitative parametric maps from non-contrast T1-weighted image MR acquisition.
Terran NM-101 is also intended for automatic labeling, volumetric quantification and contrast quantification of segmentable brain tissues from a set of Siemens 37 acquired MR images. Brain tissue characterization and volumes of neuromelanin associated signal contrasts are determined based on analysis of qualitative parametric maps.
When interpreted by a neuroradiologist. Terran NM-101 images can provide information useful in determining neuromelanin association as an adjunct to diagnosis.
Terran NM-101 must always be used in combination with a T1-weighted image MR acquisition.
Product codes
LNH, LLZ
Device Description
Terran NM-101 is a fully automated post-acquisition software as a medical device (SaMD) that measures neuromelanin associated contrast to noise ratio (CNR) signal in the substantia nigra (SN) and locus coeruleus (LC) regions of non-contrast brain magnetic resonance imaging (MRI) images from Siemens 3 tesla (3T) MRI scanners. Terran NM-101 can generate qualitative parametric maps from non-contrast T1-weighted image MR acquisition.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
Brain
Indicated Patient Age Range
51 to 83 years
Intended User / Care Setting
Qualified Radiologist
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)
Non-clinical testing summary: The following design control, risk management and quality assurance methodologies were utilized to develop Terran NM-101: Risk Analysis, Requirements Review, Design Reviews, Testing on Unit Level (Verification), Integration Testing (System Verification), Performance Testing (V&V), Safety Testing (V&V), Simulated Use Testing (Validation). All predefined acceptance criteria for the engineering (preclinical) performance testing were met. The results from the preclinical testing performed on Terran NM-101 produced results consistently according to its intended use.
Clinical testing summary: The subject device of this premarket notification, Terran NM-101, did not require clinical studies to support substantial equivalence to the predicate devices. The results of the clinical performance reviews of the Terran NM-101 reports by neuroradiologists demonstrate that the Terran NM-101 clinical user needs and intended use requirements were fulfilled and all acceptance criteria were met.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
September 29, 2023
Terran Biosciences, Inc. % Kay Fuller Principal Regulatory & Clinical Research Consultant Medical Device Regulatory Solutions, LLC 230 Collingwood Dr., Suite 260 Ann Arbor, Michigan 48103
Re: K230187
Trade/Device Name: Terran NM-101 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LLZ Dated: August 26, 2023 Received: August 29, 2023
Dear Kay Fuller:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230187
Device Name Terran NM-101
Indications for Use (Describe)
Terran NM-101 is a post-processing software medical device in visualization of the brain in older adults between the age of 51 to 83 years. Terran NM-101 analyzes input data acquired from Siemens 3T MR imaging systems, using a specified protocol (i.e., Turbo Spin Echo, TSE). Terran NM-101 can generate qualitative parametric maps from non-contrast T1-weighted image MR acquisition.
Terran NM-101 is also intended for automatic labeling, volumetric quantification and contrast quantification of segmentable brain tissues from a set of Siemens 37 acquired MR images. Brain tissue characterization and volumes of neuromelanin associated signal contrasts are determined based on analysis of qualitative parametric maps.
When interpreted by a neuroradiologist. Terran NM-101 images can provide information useful in determining neuromelanin association as an adjunct to diagnosis.
Terran NM-101 must always be used in combination with a T1-weighted image MR acquisition.
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
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3
510(k) SUMMARY
Terran Biosciences, Inc. Terran NM-101
September 19, 2023
The following summary is provided pursuant to Section 513 (I) (3) (A) of the Federal Food Drug and Cosmetic Act:
1. GENERAL INFORMATION
| Submitter Information: | Terran Biosciences, Inc.
2457 Collins Ave., Suite 504
Miami Beach, FL 33140 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Kay Fuller, RAC
Principal Regulatory & Clinical Research Consultant
Medical Device Regulatory Solutions, LLC
734-846-7852 |
| 2. DEVICE INFORMATION | |
| Device Name: | Terran NM-101 |
| Proprietary Name: | Terran NM-101 |
| Common Name: | System, Nuclear Magnetic Resonance Imaging |
| Classification Name: | Magnetic Resonance Diagnostic Device |
| Classification Code: | LNH, LLZ |
| Regulation Number: | 21 CFR §892.1000 |
| 3. PREDICATE DEVICE(S) | The Terran NM-101 is similar to the primary predicate device
SyMRI cleared for US commercialization via K191036, on
6/13/2019 and predicate device NeuroQuant cleared for US
commercialization via K170981, on 9/7/2017. |
| 4. DEVICE DESCRIPTION | Terran NM-101 is a fully automated post-acquisition software as a
medical device (SaMD) that measures neuromelanin associated
contrast to noise ratio (CNR) signal in the substantia nigra (SN) and
locus coeruleus (LC) regions of non-contrast brain magnetic
resonance imaging (MRI) images from Siemens 3 tesla (3T) MRI
scanners. Terran NM-101 can generate qualitative parametric
maps from non-contrast T1-weighted image MR acquisition. |
4
- INDICATIONS FOR USE Terran NM-101 is a post-processing software medical device intended for use in visualization of the brain in older adults between the age of 51 to 83 years. Terran NM-101 analyzes input data acquired from Siemens 3T MR imaging systems, using a specified protocol (i.e., Turbo Spin Echo, TSE). Terran NM-101 can generate qualitative parametric maps from non-contrast T1-weighted image MR acquisition.
Terran NM-101 is also intended for automatic labeling, visualization, volumetric quantification and contrast quantification of seqmentable brain tissues from a set of Siemens 3T acquired MR images. Brain tissue characterization and volumes of neuromelanin associated signal contrasts are determined based on analysis of qualitative parametric maps. When interpreted by a neuroradiologist, Terran NM-101 images can provide information useful in determining neuromelanin association as an adjunct to diagnosis.
Terran NM-101 must always be used in combination with a T1weighted image MR acquisition.
The Terran NM-101 fundamental technological characteristics are similar to those of the predicate devices as described herein, and as described in the following table.
| Feature
Comparison
Criteria | Subject Device
Terran NM-101
K230187 | Primary Predicate Device A
K191036
SyMRI | Subject Device
SE to K191036? | Predicate Device B
K170981
NeuroQuant | Subject Device
SE to K173224? |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| 21 CFR Reg #,
Product Code &
Classification | 21 CFR §892.1000
21 CFR §892.2050
LNH / LLZ
Class II | 21 CFR §892.1000
LNH
Class II | Yes | 21 CFR §892.2050
LLLZ
Class II | Yes |
| Regulation Name | Magnetic resonance diagnostic device;
Picture archiving and communication system | Magnetic resonance diagnostic device | Yes | Picture archiving and
communications
system | Yes |
| Prescription Device
Rx Only | Yes | Yes | Yes | Yes | Yes |
| Indications for Use | Terran NM-101 is a post-processing software
medical device intended for use in visualization
of the brain in older adults between the age of
51 to 83 years. Terran NM-101 analyzes input
data acquired from Siemens 3T MR imaging
systems, using a specified protocol (i.e., Turbo
Spin Echo, TSE). Terran NM-101 can generate
qualitative parametric maps from non-contrast
T1-weighted image MR acquisition. Terran NM-
101 is also intended for automatic labeling,
visualization, volumetric quantification and
contrast quantification of segmentable brain
tissues from a set of Siemens 3T acquired MR
images. Brain tissue characterization and
volumes of neuromelanin associated signal
contrasts are determined based on analysis of
qualitative parametric maps. When interpreted
by a neuroradiologist, Terran NM-101 images
can provide information useful in determining
neuromelanin association as an adjunct to
diagnosis. Terran NM-101 must always be used
in combination with a T1-weighted image MR
acquisition. | SyMRI is a post-processing software medical
device intended for use in visualization of the
brain. SyMRI analyzes input data from MR
imaging systems. SyMRI utilizes data from a
multi-delay, multi-echo acquisition (MDME)
to generate parametric maps of R1, R2
relaxation rates, and proton density (PD).
SyMRI can generate multiple image
contrasts from the parametric maps.
SyMRI enables post-acquisition image
contrast adjustment. SyMRI is indicated for
head imaging. SyMRI is also intended for
automatic labeling, visualization and
volumetric quantification of segmentable
brain tissues from a set of MR images. Brain
tissue volumes are determined based on
modeling of parametric maps from MDME.
When interpreted by a trained physician,
SyMRI images can provide information useful
in determining diagnosis. SyMRI should
always be used in combination with at least
one other MR acquisition (e.g., T2-FLAIR). | Yes | NeuroQuant is intended
for automatic labeling,
visualization and
volumetric quantification
of segmentable brain
structures and lesions
from a set of MR
images. Volumetric
measurements may be
compared to reference
percentile data. | Yes |
| Intended Users | Qualified Radiologist | Qualified Radiologist | Yes | Qualified Radiologist | Yes |
| Feature | Subject Device | Primary Predicate Device A | Subject Device | Predicate Device B | Subject Device |
| Comparison
Criteria | Terran NM-101
K230187 | K191036
SyMRI | SE to
K191036? | K170981
NeuroQuant | SE to
K173224? |
| Type of Imaging Scans | MRI | MRI | Yes | MRI | Yes |
| Target Organ/System | MR Brain | MR Brain | Yes | MR Brain | Yes |
| Handle Multiple Studies | Yes | Yes | Yes | Yes | Yes |
| Field Strength | No : 1.5T
Yes : 3.0T | No: 1.5T
Yes: 3.0T | Yes | Yes: 1.5T
No: 3.0T | Yes |
| Mode | 3D | 3D | Yes | 3D | |
| Plane | Sagittal | Sagittal | Yes | Sagittal | Yes |
| Contrast Enhancement | T1 | T1 | Yes | T1 | Yes |
| Sequence | MPRAGE | MPRAGE | Yes | MPRAGE | Yes |
| Slice Thickness | 1.8 mm | Unknown | No | 1.2 mm | Yes |
| TR | 600 ms | 650 ms | Yes | 2300 ms | Yes |
| TE | 10 ms | 10 ms | Yes | Minimum | Yes |
| TI | ~ | ~ | Yes | 900 ms | Yes |
| Acquisition Time | 8 mins | 6 mins | Yes | 5-7 mins | Yes |
| Flip Angle | 120° | Unknown | No | 9° | Yes |
| Filter | Non | Non | Yes | Non | Yes |
| Data Source | Siemens 3T MRI scanner: T1 MRI
scans acquired with specified protocols
(i.e., TSE) | MRI scanner: 3D T1 MRI scans acquired
with specified protocols (i.e., MDME - GE
MAGiC, Philips SyntAc; Siemens 3 T
TSE_MDME) | Yes | MRI scanner: 3D T1 MRI scans
acquired with specified protocols | Yes |
| | | | | NeuroQuant Supports DICOM
format as input | |
| Operating System | Terran NM-101 Supports DICOM
format as input
Cloud-Based, Windows, Linux | SyMRI Supports DICOM format as input
Network Based Option, Windows, macOS | Yes | Cloud-Based, Windows, macOS,
Linux | Yes |
| Output | Supports DICOM format as output of
results that can be displayed on DICOM
workstations and PACS. | Supports DICOM format as output of results
that can be displayed on DICOM
workstations and PACS. | Yes | Supports DICOM format as output
of results that can be displayed on
DICOM workstations and PACS. | Yes |
| | Automatic labeling, visualization,
volumetric quantification and contrast
quantification of segmentable brain
tissues from a set of Siemens 3T
acquired MR images.
Brain tissue characterization and
volumes of neuromelanin associated
signal contrasts are determined based
on analysis of qualitative parametric | Automatic labeling, visualization and
volumetric quantification of segmentable
brain tissues from a set of MR images.
Brain tissue volumes are determined based
on modeling of parametric maps from
MDME.
Includes segmented color overlays and
parametric map reports. | | Automatic labeling, visualization
and volumetric quantification of
segmentable brain structures and
lesions from a set of MR images.
Provides volumetric measurements
of brain structures and lesions
Includes segmented color overlays
and morphometric reports. | |
| | maps.
Includes segmented color overlays and
parametric map reports.
When interpreted by a neuroradiologist,
Terran NM-101 images can provide
information useful in determining
neuromelanin association as an adjunct
to diagnosis. | When interpreted by a trained physician,
SyMRI images can provide information
useful in determining diagnosis. | | Automatically compares results to
reference percentile data and to
prior scans when available. | |
| Safety | Automated quality control functions:
- Complete input set check
- Scan protocol verification
- Brain alignment check
- NM associated CNR value check
- PHI check
- Cybersecurity threat assessment
(CTA) attestation
Results must be reviewed by a
neuroradiologist - adjunctive use
indication | Automated quality control functions:
None published
Results must be reviewed by a trained
physician | Yes | Automated quality control
functions:
-Tissue contrast check - Scan protocol verification
- Atlas alignment check
Results must be reviewed by a
trained physician | Yes |
| Sterility | N/A | N/A | N/A | N/A | N/A |
| Biocompatibility | N/A | N/A | N/A | N/A | N/A |
| Electrical Safety | N/A | N/A | N/A | N/A | N/A |
| Thermal Safety | N/A | N/A | N/A | N/A | N/A |
| Energy Used/Delivered | N/A | N/A | N/A | N/A | N/A |
| Chemical Safety | N/A | N/A | N/A | N/A | N/A |
| Radiation Safety | N/A | N/A | N/A | N/A | N/A |
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
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7. NON-CLINICA TESTING SUMMARY
The following design control, risk management and quality assurance methodologies were utilized to develop Terran NM-101:
- . Risk Analysis
- . Requirements Review
- Design Reviews .
- Testing on Unit Level (Verification)
- Integration Testing (System Verification) .
- . Performance Testing (V&V)
- Safety Testing (V&V)
- . Simulated Use Testing (Validation)
Software documentation for Moderate Level of Concern software per the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued on May 11, 2005, is also included in this premarket notification submission. Terran NM-101 was tested in accordance with the company's verification and validation procedures.
All predefined acceptance criteria for the engineering (preclinical) performance testing were met. The results from the preclinical testing performed on Terran NM-101 produced results consistently according to its intended use.
8. CLINICAL TESTING SUMMARY
The subject device of this premarket notification, Terran NM-101, did not require clinical studies to support substantial equivalence to the predicate devices.
The results of the clinical performance reviews of the Terran NM-101 reports by neuroradiologists demonstrate that the Terran NM-101 clinical user needs and intended use requirements were fulfilled and all acceptance criteria were met.
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9. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
The subject device and the primary predicate device are substantially equivalent, with respect to intended use, instructions for use. design features, technological characteristics, manufacturing methods, performance criteria, special controls, and safety and effectiveness. The subject device is substantially equivalent to the primary predicate device (K191036) noted herein.
10. CONCLUSION
The non-clinical and clinical reviews contained herein, demonstrates that Terran NM-101 performs according to its intended use. Terran Biosciences, Inc. considers the Terran NM-101 (subject device) to be substantially equivalent to the legally marketed primary predicate device noted herein, and is safe and effective for its labeled intended use.