(249 days)
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.
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.
Acceptance Criteria and Study for Terran NM-101
Based on the provided FDA 510(k) summary for Terran NM-101, the following information can be extracted regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing specific quantitative acceptance criteria for the device's performance metrics (e.g., accuracy, precision of volumetric quantification). It states that "All predefined acceptance criteria for the engineering (preclinical) performance testing were met." and "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."
Without further details on the specific "predefined acceptance criteria," a detailed quantitative table cannot be constructed. However, based on the device's intended use and the comparison to predicate devices, general performance categories implicitly covered would include:
| Performance Category | Implied Acceptance Criteria (Qualitative) | Reported Device Performance |
|---|---|---|
| Automatic Labeling Accuracy | Accurate and consistent labeling of brain tissues, SN, and LC. | "Automatic labeling... of segmentable brain tissues from a set of Siemens 3T acquired MR images." "Brain tissue characterization... are determined based on analysis of qualitative parametric maps." Implied accuracy demonstrated by meeting user needs and clinical requirements. |
| Volumetric Quantification Accuracy | Accurate and reproducible volumetric measurements of identified brain tissues. | "Volumetric quantification... of segmentable brain tissues from a set of Siemens 3T acquired MR images." "Brain tissue volumes... are determined based on analysis of qualitative parametric maps." Implied accuracy demonstrated by meeting user needs and clinical requirements. |
| Contrast Quantification Accuracy | Accurate and reproducible quantification of neuromelanin associated signal contrasts in SN and LC. | "Contrast quantification of segmentable brain tissues from a set of Siemens 3T acquired MR images." "neuromelanin associated signal contrasts are determined based on analysis of qualitative parametric maps." Implied accuracy and reliability demonstrated by meeting user needs and clinical requirements. |
| Qualitative Parametric Map Generation | Generation of clear and interpretable qualitative parametric maps from non-contrast T1-weighted MR images. | "Terran NM-101 can generate qualitative parametric maps from non-contrast T1-weighted image MR acquisition." Implied quality demonstrated by meeting user needs and clinical requirements. |
| Interoperability | Ability to accept input from specified MRI systems and output results in DICOM format. | "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 Supports DICOM format as input." "Supports DICOM format as output of results that can be displayed on DICOM workstations and PACS." This function was explicitly stated as met. |
| Safety Features | Automated quality control functions to ensure data integrity and proper processing. | "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." These were stated as implemented and confirmed. |
| Adjunctive Use Utility | Provides information useful to neuroradiologists in determining neuromelanin association as an adjunct to diagnosis. | "When interpreted by a neuroradiologist, Terran NM-101 images can provide information useful in determining neuromelanin association as an adjunct to diagnosis." This clinical utility was evaluated and found to meet requirements based on neuroradiologist review. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size of the test set used for performance evaluation. However, it does mention that:
- Data Provenance: The input data is acquired from "Siemens 3T MR imaging systems, using a specified protocol (i.e., Turbo Spin Echo, TSE)." No specific country of origin is mentioned for the data, nor is it explicitly stated whether it was retrospective or prospective. Given the nature of a 510(k) submission and the focus on "preclinical" and "clinical performance reviews," it is highly likely that this involved retrospective data from existing MR scans.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states: "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."
- Number of Experts: The exact number of neuroradiologists is not specified. It uses the plural, "neuroradiologists," implying more than one.
- Qualifications of Experts: The experts are identified as "neuroradiologists." This indicates they are medical doctors specializing in radiology with subspecialty training and expertise in interpreting neuroimaging (brain, spine, head, and neck). No specific years of experience are provided, but their subspecialty qualification is stated.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). It states "clinical performance reviews... by neuroradiologists," which implies expert assessment. However, without further detail, it's not possible to determine if a formal adjudication process was used to resolve discrepancies among multiple expert readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a formal Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI vs. without AI assistance is not mentioned as part of the evidence provided in this 510(k) summary. The document states: "The subject device of this premarket notification, Terran NM-101, did not require clinical studies to support substantial equivalence to the predicate devices." This suggests that the clinical evaluation was primarily a "performance review" by neuroradiologists to confirm the output's utility, rather than a comparative effectiveness study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
While the device's core functionality (automatic labeling, quantification, and parametric map generation) is an algorithm-only function, the 510(k) summary emphasizes its "adjunctive use" and states: "Results must be reviewed by a neuroradiologist - adjunctive use indication." This strongly implies that the primary performance validation for regulatory clearance was in the context of human-in-the-loop use, where the neuroradiologist interprets the AI-generated images. The "preclinical" and "engineering" testing likely covered the standalone accuracy of the algorithm's outputs, but the "clinical performance reviews" integrated the human expert.
7. The Type of Ground Truth Used
The ground truth for the test set appears to be expert consensus/review by neuroradiologists. While the device performs "automatic labeling, volumetric quantification and contrast quantification," the ultimate assessment of its performance and clinical utility was based on the "clinical performance reviews of the Terran NM-101 reports by neuroradiologists." This suggests that the neuroradiologists' interpretations and judgments served as the reference standard for evaluating the device's output. There is no mention of pathology or outcomes data being used as ground truth for this submission.
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size of the training set used for developing the Terran NM-101 algorithm. The focus of the 510(k) summary is on substantiating equivalence and demonstrating performance for the submission (test) dataset, not on the specifics of the training data.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for the training set was established. This detail would typically be part of the technical documentation for the device's development but is not required for a 510(k) summary focused on demonstrating substantial equivalence to predicate devices and performance of the final product.
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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 (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
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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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
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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.2457 Collins Ave., Suite 504Miami Beach, FL 33140 |
|---|---|
| Contact Information: | Kay Fuller, RACPrincipal Regulatory & Clinical Research ConsultantMedical Device Regulatory Solutions, LLC734-846-7852 |
| 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 deviceSyMRI cleared for US commercialization via K191036, on6/13/2019 and predicate device NeuroQuant cleared for UScommercialization via K170981, on 9/7/2017. |
| 4. DEVICE DESCRIPTION | Terran NM-101 is a fully automated post-acquisition software as amedical device (SaMD) that measures neuromelanin associatedcontrast to noise ratio (CNR) signal in the substantia nigra (SN) andlocus coeruleus (LC) regions of non-contrast brain magneticresonance imaging (MRI) images from Siemens 3 tesla (3T) MRIscanners. Terran NM-101 can generate qualitative parametricmaps from non-contrast T1-weighted image MR acquisition. |
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- 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.
| FeatureComparisonCriteria | Subject DeviceTerran NM-101K230187 | Primary Predicate Device AK191036SyMRI | Subject DeviceSE to K191036? | Predicate Device BK170981NeuroQuant | Subject DeviceSE to K173224? |
|---|---|---|---|---|---|
| 21 CFR Reg #,Product Code &Classification | 21 CFR §892.100021 CFR §892.2050LNH / LLZClass II | 21 CFR §892.1000LNHClass II | Yes | 21 CFR §892.2050LLLZClass II | Yes |
| Regulation Name | Magnetic resonance diagnostic device;Picture archiving and communication system | Magnetic resonance diagnostic device | Yes | Picture archiving andcommunicationssystem | Yes |
| Prescription DeviceRx Only | Yes | Yes | Yes | Yes | Yes |
| Indications for Use | Terran NM-101 is a post-processing softwaremedical device intended for use in visualizationof the brain in older adults between the age of51 to 83 years. Terran NM-101 analyzes inputdata acquired from Siemens 3T MR imagingsystems, using a specified protocol (i.e., TurboSpin Echo, TSE). Terran NM-101 can generatequalitative parametric maps from non-contrastT1-weighted image MR acquisition. Terran NM-101 is also intended for automatic labeling,visualization, volumetric quantification andcontrast quantification of segmentable braintissues from a set of Siemens 3T acquired MRimages. Brain tissue characterization andvolumes of neuromelanin associated signalcontrasts are determined based on analysis ofqualitative parametric maps. When interpretedby a neuroradiologist, Terran NM-101 imagescan provide information useful in determiningneuromelanin association as an adjunct todiagnosis. Terran NM-101 must always be usedin combination with a T1-weighted image MRacquisition. | SyMRI is a post-processing software medicaldevice intended for use in visualization of thebrain. SyMRI analyzes input data from MRimaging systems. SyMRI utilizes data from amulti-delay, multi-echo acquisition (MDME)to generate parametric maps of R1, R2relaxation rates, and proton density (PD).SyMRI can generate multiple imagecontrasts from the parametric maps.SyMRI enables post-acquisition imagecontrast adjustment. SyMRI is indicated forhead imaging. SyMRI is also intended forautomatic labeling, visualization andvolumetric quantification of segmentablebrain tissues from a set of MR images. Braintissue volumes are determined based onmodeling of parametric maps from MDME.When interpreted by a trained physician,SyMRI images can provide information usefulin determining diagnosis. SyMRI shouldalways be used in combination with at leastone other MR acquisition (e.g., T2-FLAIR). | Yes | NeuroQuant is intendedfor automatic labeling,visualization andvolumetric quantificationof segmentable brainstructures and lesionsfrom a set of MRimages. Volumetricmeasurements may becompared to referencepercentile 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 |
| ComparisonCriteria | Terran NM-101K230187 | K191036SyMRI | SE toK191036? | K170981NeuroQuant | SE toK173224? |
| 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 : 1.5TYes : 3.0T | No: 1.5TYes: 3.0T | Yes | Yes: 1.5TNo: 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 MRIscans acquired with specified protocols(i.e., TSE) | MRI scanner: 3D T1 MRI scans acquiredwith specified protocols (i.e., MDME - GEMAGiC, Philips SyntAc; Siemens 3 TTSE_MDME) | Yes | MRI scanner: 3D T1 MRI scansacquired with specified protocols | Yes |
| NeuroQuant Supports DICOMformat as input | |||||
| Operating System | Terran NM-101 Supports DICOMformat as inputCloud-Based, Windows, Linux | SyMRI Supports DICOM format as inputNetwork Based Option, Windows, macOS | Yes | Cloud-Based, Windows, macOS,Linux | Yes |
| Output | Supports DICOM format as output ofresults that can be displayed on DICOMworkstations and PACS. | Supports DICOM format as output of resultsthat can be displayed on DICOMworkstations and PACS. | Yes | Supports DICOM format as outputof results that can be displayed onDICOM workstations and PACS. | Yes |
| Automatic labeling, visualization,volumetric quantification and contrastquantification of segmentable braintissues from a set of Siemens 3Tacquired MR images.Brain tissue characterization andvolumes of neuromelanin associatedsignal contrasts are determined basedon analysis of qualitative parametric | Automatic labeling, visualization andvolumetric quantification of segmentablebrain tissues from a set of MR images.Brain tissue volumes are determined basedon modeling of parametric maps fromMDME.Includes segmented color overlays andparametric map reports. | Automatic labeling, visualizationand volumetric quantification ofsegmentable brain structures andlesions from a set of MR images.Provides volumetric measurementsof brain structures and lesionsIncludes segmented color overlaysand morphometric reports. | |||
| maps.Includes segmented color overlays andparametric map reports.When interpreted by a neuroradiologist,Terran NM-101 images can provideinformation useful in determiningneuromelanin association as an adjunctto diagnosis. | When interpreted by a trained physician,SyMRI images can provide informationuseful in determining diagnosis. | Automatically compares results toreference percentile data and toprior 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) attestationResults must be reviewed by aneuroradiologist - adjunctive useindication | Automated quality control functions:None publishedResults must be reviewed by a trainedphysician | Yes | Automated quality controlfunctions:-Tissue contrast check- Scan protocol verification- Atlas alignment checkResults must be reviewed by atrained 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.
§ 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.