Terran NM-101

K230187 · Terran Biosciences, Inc. · LNH · Sep 29, 2023 · Radiology

Device Facts

• Record ID: K230187
• Device Name: Terran NM-101
• Applicant: Terran Biosciences, Inc.
• Product Code: LNH · Radiology
• Decision Date: Sep 29, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Terran NM-101 is a fully automated post-processing SaMD; analyzes non-contrast T1-weighted MRI data from Siemens 3T scanners (TSE protocol). Device generates qualitative parametric maps; performs automatic labeling, volumetric quantification, and contrast quantification of segmentable brain tissues. Specifically measures neuromelanin-associated contrast-to-noise ratio (CNR) in substantia nigra (SN) and locus coeruleus (LC) regions. Used by neuroradiologists in clinical settings; output provided as DICOM images/reports for display on PACS/workstations. Neuroradiologist interprets output to assist in clinical diagnosis. Benefits include standardized, automated quantification of neuromelanin-associated signals to support diagnostic decision-making.

Clinical Evidence

No clinical studies were required. Evidence consists of non-clinical design verification, system integration testing, performance testing (V&V), and simulated use testing. Clinical performance reviews by neuroradiologists confirmed that user needs and intended use requirements were fulfilled and all acceptance criteria were met.

Technological Characteristics

Post-processing SaMD; operates on cloud-based, Windows, or Linux platforms. Inputs: Siemens 3T MRI (TSE protocol). Outputs: DICOM parametric maps, volumetric/contrast quantification reports. Features automated quality control (input check, protocol verification, brain alignment, NM-associated CNR check, PHI check, and cybersecurity threat assessment).

Indications for Use

Indicated for visualization of the brain in adults aged 51-83 years. Used as an adjunct to diagnosis for determining neuromelanin association when interpreted by a neuroradiologist. Requires use with T1-weighted MR acquisition.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• SyMRI (K191036)
• NeuroQuant (K170981)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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

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# 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*)

| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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## 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.<br>2457 Collins Ave., Suite 504<br>Miami Beach, FL 33140 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Kay Fuller, RAC<br>Principal Regulatory & Clinical Research Consultant<br>Medical Device Regulatory Solutions, LLC<br>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<br>SyMRI cleared for US commercialization via K191036, on<br>6/13/2019 and predicate device NeuroQuant cleared for US<br>commercialization via K170981, on 9/7/2017. |
| 4. DEVICE DESCRIPTION | Terran NM-101 is a fully automated post-acquisition software as a<br>medical device (SaMD) that measures neuromelanin associated<br>contrast to noise ratio (CNR) signal in the substantia nigra (SN) and<br>locus coeruleus (LC) regions of non-contrast brain magnetic<br>resonance imaging (MRI) images from Siemens 3 tesla (3T) MRI<br>scanners. Terran NM-101 can generate qualitative parametric<br>maps from non-contrast T1-weighted image MR acquisition. |

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5. 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<br>Comparison<br>Criteria | Subject Device<br>Terran NM-101<br>K230187 | Primary Predicate Device A<br>K191036<br>SyMRI | Subject Device<br>SE to K191036? | Predicate Device B<br>K170981<br>NeuroQuant | Subject Device<br>SE to K173224? |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| 21 CFR Reg #,<br>Product Code &<br>Classification | 21 CFR §892.1000<br>21 CFR §892.2050<br>LNH / LLZ<br>Class II | 21 CFR §892.1000<br>LNH<br>Class II | Yes | 21 CFR §892.2050<br>LLLZ<br>Class II | Yes |
| Regulation Name | Magnetic resonance diagnostic device;<br>Picture archiving and communication system | Magnetic resonance diagnostic device | Yes | Picture archiving and<br>communications<br>system | Yes |
| Prescription Device<br>Rx Only | Yes | Yes | Yes | Yes | Yes |
| Indications for Use | Terran NM-101 is a post-processing software<br>medical device intended for use in visualization<br>of the brain in older adults between the age of<br>51 to 83 years. Terran NM-101 analyzes input<br>data acquired from Siemens 3T MR imaging<br>systems, using a specified protocol (i.e., Turbo<br>Spin Echo, TSE). Terran NM-101 can generate<br>qualitative parametric maps from non-contrast<br>T1-weighted image MR acquisition. Terran NM-<br>101 is also intended for automatic labeling,<br>visualization, volumetric quantification and<br>contrast quantification of segmentable brain<br>tissues from a set of Siemens 3T acquired MR<br>images. Brain tissue characterization and<br>volumes of neuromelanin associated signal<br>contrasts are determined based on analysis of<br>qualitative parametric maps. When interpreted<br>by a neuroradiologist, Terran NM-101 images<br>can provide information useful in determining<br>neuromelanin association as an adjunct to<br>diagnosis. Terran NM-101 must always be used<br>in combination with a T1-weighted image MR<br>acquisition. | SyMRI is a post-processing software medical<br>device intended for use in visualization of the<br>brain. SyMRI analyzes input data from MR<br>imaging systems. SyMRI utilizes data from a<br>multi-delay, multi-echo acquisition (MDME)<br>to generate parametric maps of R1, R2<br>relaxation rates, and proton density (PD).<br>SyMRI can generate multiple image<br>contrasts from the parametric maps.<br>SyMRI enables post-acquisition image<br>contrast adjustment. SyMRI is indicated for<br>head imaging. SyMRI is also intended for<br>automatic labeling, visualization and<br>volumetric quantification of segmentable<br>brain tissues from a set of MR images. Brain<br>tissue volumes are determined based on<br>modeling of parametric maps from MDME.<br>When interpreted by a trained physician,<br>SyMRI images can provide information useful<br>in determining diagnosis. SyMRI should<br>always be used in combination with at least<br>one other MR acquisition (e.g., T2-FLAIR). | Yes | NeuroQuant is intended<br>for automatic labeling,<br>visualization and<br>volumetric quantification<br>of segmentable brain<br>structures and lesions<br>from a set of MR<br>images. Volumetric<br>measurements may be<br>compared to reference<br>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<br>Criteria | Terran NM-101<br>K230187 | K191036<br>SyMRI | SE to<br>K191036? | K170981<br>NeuroQuant | SE to<br>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<br>Yes : 3.0T | No: 1.5T<br>Yes: 3.0T | Yes | Yes: 1.5T<br>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<br>scans acquired with specified protocols<br>(i.e., TSE) | MRI scanner: 3D T1 MRI scans acquired<br>with specified protocols (i.e., MDME - GE<br>MAGiC, Philips SyntAc; Siemens 3 T<br>TSE_MDME) | Yes | MRI scanner: 3D T1 MRI scans<br>acquired with specified protocols | Yes |
| | | | | NeuroQuant Supports DICOM<br>format as input | |
| Operating System | Terran NM-101 Supports DICOM<br>format as input<br>Cloud-Based, Windows, Linux…