TBS iNsight (V4)

K243218 · Medimaps Group SA · KGI · Jan 17, 2025 · Radiology

Device Facts

• Record ID: K243218
• Device Name: TBS iNsight (V4)
• Applicant: Medimaps Group SA
• Product Code: KGI · Radiology
• Decision Date: Jan 17, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

TBS iNsight is indicated as an adjunct to BMD and other clinical factors, for the assessment of bone health and the management of primary and secondary osteoporosis. Primary osteoporosis can occur in both sexes with aging, and in females due to the menopause and associated estrogen deficiency. Secondary osteoporosis occurs as a result of an underlying disease or condition, which alters bone metabolism leading to a net loss of bone and degradation of bone quality, for example, diabetes, hyperparathyroidism, chronic kidney disease and rheumatological conditions.

Device Story

TBS iNsight (V4) is a software application that processes raw DXA images of the AP lumbar spine to calculate Trabecular Bone Score (TBS), a metric reflecting bone microarchitecture. It functions as a complement to standard DXA BMD analysis and clinical risk factors. The device uses an Adapted Experimental Variogram (modified fractal-like approach) to measure spatial variation in image texture. Unlike its predecessor, V4 directly measures tissue thickness from DXA data rather than estimating it via BMI. The system architecture consists of a client-side 'TBS Agent' on DXA scanners and a centralized server for result management and DICOM/PACS communication. Used in hospitals and radiology clinics by physicians, radiologists, and DXA technicians, the output provides TBS scores, T-scores, Z-scores, and FRAX-adjusted fracture risk probabilities. These outputs assist clinicians in diagnosing osteoporosis, assessing fracture risk, and monitoring treatment efficacy. The software does not provide automated diagnoses or treatment recommendations; final clinical decisions remain the responsibility of the healthcare professional.

Clinical Evidence

Evidence includes ex vivo and in vivo studies. Ex vivo validation using 30 human cadaver vertebrae showed strong correlations between TBS V4 and microCT bone microarchitecture parameters. Agreement studies (15 cadaver vertebrae) showed excellent agreement with the predicate (r > 0.99). Reproducibility was confirmed in 132 participants across four DXA systems, meeting ISCD precision standards. Fracture risk assessment performance was validated using data from >17,000 individuals across 14 international cohorts, demonstrating statistical equivalence to the predicate in TBS-adjusted FRAX and BMD T-score outputs.

Technological Characteristics

Software-based bone densitometry analysis. Inputs: raw DXA images. Processing: Adapted Experimental Variogram (modified fractal-like approach) for texture analysis. Direct tissue thickness measurement (7-30 cm range). Connectivity: Client-server architecture (TBS Agent on DXA, centralized server), DICOM/PACS integration. Cybersecurity: Data encryption (at rest/transit), role-based access control. Compatible with GE and Hologic DXA systems.

Indications for Use

Indicated for men and women for bone health assessment and fracture risk management. TBS iNsight computes Trabecular Bone Score (TBS) from AP lumbar spine DXA images as a complement to DXA analysis and clinical examination. Optional 10-year fracture risk assessment (hip and major osteoporotic) via FRAX, validated for Caucasian and Asian men and post-menopausal women aged 40-90. Not validated for individuals under 20 years old.

Regulatory Classification

Identification

A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• TBS iNsight (K152299)

Submission Summary (Full Text)

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January 17, 2025

Medimaps Group SA % Giorgio Zoia Quality and Regulatory VP, Medimaps SA Group Chemin du Champ-des-Filles 36 Plan-les-Ouates, 1228 SWITZERLAND

Re: K243218

Trade/Device Name: TBS iNsight (V4) Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: Class II Product Code: KGI Dated: December 20, 2024 Received: December 20, 2024

# Dear Giorgio Zoia:

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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 mediation-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-regulatory

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assistance/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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products 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) K243218

Device Name TBS iNsight (v4)

#### Indications for Use (Describe)

TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture.

TBS iNsight provides as an option an assessment of 10-year fracture risk. It provides an estimate of 10-year probability of hip fracture and 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate is based on the WHO's FRAX® Fracture Risk Assessment Tool, after adjustment for the TBS. The tool has been validated for Caucasian and Asian men and post-menopausal women between 40 and 90 years old.

TBS provides information independent of BMD value: it is used as a complement to the data obtained from the DXA analysis and the clinical examination (questioning by the clinician about patient history, bioassay of bone resorption markers...).

The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk.

The TBS score can assist the health care professional in monitoring the effect of treatments on patients across time. Overall fracture risk will depend on many additional factors that should be considered before making diagnostic or therapeutic recommendations. The software does not disease or recommend treatment regimens. Only the health care professional can make these judgments.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <div>区</div> |
|----------------------------------------------|--------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | |

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# 510(K) SUMMARY

| Date: | January 16, 2025 |
|-------|------------------|
|-------|------------------|

510(k) Number: K243218

## 1) Applicant Information

| 510(k) Owner: | Medimaps Group SA |
|-----------------|---------------------------------------------------|
| | Chemin du Champ-des-Filles 36 Plan-les-<br>Ouates |
| | 1228 Switzerland |
| Contact Person: | Giorgio Zoia, PhD |
| | Quality and Regulatory VP |
| | Phone [phone] |
| | Email [e-mail] |

- 2) Device Identification

| Trade Name: | TBS iNsight (V4) |
|---------------------|-------------------|
| Common Name: | Bone densitometer |
| Regulation Number : | 892.1170 |
| Regulation Name: | Bone densitometer |
| Regulatory Class: | II |

KGI

## 3) Predicate Device

Product Code:

| Trade Name: | TBS iNsight |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510 (k) Number: | K152299 |
| Common Name: | Bone densitometer |
| Regulation Number : | 892.1170 |
| Regulation Name: | Bone densitometer |
| Regulatory Class: | ============================================================================================================================================================================== |
| Product Code: | KGI |

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## Device Description Summary

TBS iNsight is a software application provided for use as a complement to bone mineral density (BMD) acquired from dual energy X-ray absorptiometry (DXA) and other clinical risk factors for osteoporosis and fragility fracture. It calculates a score (Trabecular Bone Score - TBS) derived from the texture of the DXA image of the anterior-posterior (AP) lumbar spine and has been shown to be related to bone microarchitecture. The method analyzes X-ray based images acquired by DXA imaging systems and produces the TBS based on the computation of an Adapted Experimental Variogram (modified fractallike approach). This variogram is used to measure the degree of spatial variation between pairs of data points in a spatial dimension of a region of a digital image.

The absolute TBS values for the same equivalent tissue thickness vary slightly between GE and Hologic systems. Additionally, within each system, variability in TBS values can be observed across different scan modes. To address these differences, corrections are applied that are both device-specific and mode-specific. For instance, TBS is corrected differently for GE and Hologic systems to account for inherent differences in tissue thickness assessment. Furthermore, corrections are also tailored separately for each scan mode within the same system, ensuring that TBS measurements remain consistent and reliable regardless of the scan mode used. These device-specific and mode-specific corrections are necessitated by differences in the dynamic range of tissue thickness measurements between GE and Hologic devices. The variations arise due to differences in the methodologies used to assess tissue thickness. To harmonize these discrepancies and ensure measurement accuracy, correction fits derived from ex-vivo data are applied individually to each device and scan mode. This approach ensures the accuracy and consistency of TBS measurements across all configurations.

The device is intended to be used for bone health assessment in medical facilities employing one or more DXA system(s) to which the subject device is connected. These facilities are usually hospitals, clinics, healthcare centers, radiology practices and medical imaging centers. The software is designed to be used by qualified clinical professionals (including physicians, radiologists and DXA technicians) and the physicians are solely responsible for making all final patient management decisions.

## Intended Use

TBS iNsight is indicated as an adjunct to BMD and other clinical factors, for the assessment of bone health and the management of primary and secondary osteoporosis. Primary osteoporosis can occur in both sexes with aging, and in females due to the menopause and associated estrogen deficiency. Secondary osteoporosis occurs as a result of an underlying disease or condition, which alters bone metabolism leading to a net loss of bone and degradation of bone quality, for example, diabetes, hyperparathyroidism, chronic kidney disease and rheumatological conditions.

## Indication for Use

TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture.

TBS iNsight provides as an option an assessment of 10-year fracture risk. It provides an estimate of 10year probability of hip fracture and 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate is based on the WHO's FRAX® Fracture Risk

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Assessment Tool, after adjustment for the TBS. The tool has been validated for Caucasian and Asian men and post-menopausal women between 40 and 90 years old.

TBS provides information independent of BMD value; it is used as a complement to the data obtained from the DXA analysis and the clinical examination (questioning by the clinician about patient history, bioassay of bone resorption markers...).

The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk.

The TBS score can assist the health care professional in monitoring the effect of treatments on patients across time.

Overall fracture risk will depend on many additional factors that should be considered before making diagnostic or therapeutic recommendations. The software does not diagnose disease or recommend treatment regimens. Only the health care professional can make these judgments.

## Technological Comparison

The subject device, TBS iNsight V4, has been designed to maintain identical core functionalities as its predicate, specifically in the computation of Trabecular Bone Score (TBS) from DXA (Dual-energy X-ray Absorptiometry) image texture and the provision of complementary DXA analysis. TBS iNsight V4 and the predicate compute TBS from DXA image textures and provide complementary DXA analysis, ensuring continuity in the primary operational utility of the technology.

Differences:

- Algorithm for Tissue Thickness: Unlike the predicate device which uses BMI to estimate tissue thickness in its TBS computation algorithm, the subject device directly measures tissue thickness (TT) using the DXA system. This direct measurement potentially increases the accuracy of TBS calculations.

- System Architecture: The system architecture of the subject device represents an evolution from the standalone software model used in the predicate. The subject device includes a two-component system comprising a TBS Agent (client) installed on each DXA device and a centralized server that manages results and facilitates DICOM communication with PACS. This advancement supports enhanced scalability and integration within clinical settings.

- Data Security: TBS iNsight V4 introduces robust encryption protocols by incorporating encryption or role-based access control, aligning the new device with current best practices in data security.

Table 1. Substantial equivalence of TBS iNsight v4 to predicate device

| Elements of<br>Comparison | Subject device | Predicate Device | Comparison<br>to predicate<br>device |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Device Name | TBS iNsight | TBS iNsight | Unchanged |
| Software Version | 4 | 3 | Updated |
| Manufacturer | Medimaps | Medimaps | Unchanged |
| 510(k) # | K243218 | K152299 | N/A |
| Class | Class II | Class II | Unchanged |
| Elements of<br>Comparison | Subject device | Predicate Device | Comparison<br>to predicate<br>device |
| Classification Rule /<br>Name | 21 CFR 892.1170 Bone Densitometer | 21 CFR 892.1170 Bone Densitometer | Unchanged |
| Product Code | KGI | KGI | Unchanged |
| Level of Concern | Basic Documentation | Moderate | Unchanged |
| Intended Use | TBS is indicated as an aid, in conjunction with other<br>clinical factors, for the diagnosis of primary and<br>secondary osteoporosis. Primary osteoporosis can occur<br>in both sexes with ageing, and in women due to the<br>menopause and associated estrogen deficiency.<br>Secondary osteoporosis occurs as a result of an<br>underlying disease or condition, which alters bone<br>metabolism leading to a net loss of bone and degradation<br>of bone quality, for example, diabetes,<br>hyperparathyroidism, chronic kidney disease and<br>rheumatological conditions. | TBS is indicated as an aid, in conjunction with other<br>clinical factors, for the diagnosis of primary and<br>secondary osteoporosis. Primary osteoporosis can occur<br>in both sexes with ageing, and in women due to the<br>menopause and associated estrogen deficiency.<br>Secondary osteoporosis occurs as a result of an<br>underlying disease or condition, which alters bone<br>metabolism leading to a net loss of bone and degradation<br>of bone quality, for example, diabetes,<br>hyperparathyroidism, chronic kidney disease and<br>rheumatological conditions. | Unchanged |
| Indications for Use | TBS iNsight is a software provided for use as a<br>complement to both DXA analysis and clinical<br>examination. It computes the antero-posterior spine DXA<br>examination file and calculates a score (Trabecular Bone<br>Score - TBS) that is compared to those of the age<br>matched controls. The TBS is derived from the texture of<br>the DXA image and has been shown to be related to bone<br>microarchitecture.<br>TBS iNsight provides as an option an assessment of 10-<br>year fracture risk. It provides an estimate of 10-year<br>probability of hip fracture and 10-year probability of a<br>major osteoporotic fracture (clinical spine, forearm, hip<br>or shoulder fracture). This estimate is based on the<br>WHO'S FRAX® Fracture Risk Assessment Tool, after<br>adjustment for the TBS. The tool has been validated for<br>Caucasian and Asian men and post-menopausal women<br>between 40 and 90 years old.<br>TBS provides information independent of BMD value; it is<br>used as a complement to the data obtained from the DXA<br>analysis and the clinical examination (questioning by the<br>clinician about patient history, bioassay of bone<br>resorption markers...).<br>The results can be used by a physician in conjunction with<br>other clinical risk factors as an aid in the diagnosis of<br>osteoporosis and other medical conditions leading to<br>altered trabecular bone microarchitecture, and ultimately<br>in the assessment of fracture risk.<br>The TBS score can assist the health care professional in<br>monitoring the effect of treatments on patients across<br>time.<br>Overall fracture risk will depend on many additional<br>factors that should be considered before making<br>diagnostic or therapeutic recommendations. The<br>software does not diagnose disease or recommend<br>treatment regimens. Only the health care professional<br>can make these judgments. | TBS iNsight is a software provided for use as a<br>complement to both DXA analysis and clinical<br>examination. It computes the antero-posterior spine DXA<br>examination file and calculates a score (Trabecular Bone<br>Score - TBS) that is compared to those of the age<br>matched controls. The TBS is derived from the texture of<br>the DXA image and has been shown to be related to bone<br>microarchitecture.<br>TBS iNsight provides as an option an assessment of 10-<br>year fracture risk. It provides an estimate of 10-year<br>probability of hip fracture and 10-year probability of a<br>major osteoporotic fracture (clinical spine, forearm, hip<br>or shoulder fracture). This estimate is based on the<br>WHO'S FRAX® Fracture Risk Assessment Tool, after<br>adjustment for the TBS. The tool has been validated for<br>Caucasian and Asian men and post-menopausal women<br>between 40 and 90 years old.<br>TBS provides information independent of BMD value; it is<br>used as a complement to the data obtained from the DXA<br>analysis and the clinical examination (questioning by the<br>clinician about patient history, bioassay of bone<br>resorption markers...).<br>The results can be used by a physician in conjunction with<br>other clinical risk factors as an aid in the diagnosis of<br>osteoporosis and other medical conditions leading to<br>altered trabecular bone microarchitecture, and ultimately<br>in the assessment of fracture risk.<br>The TBS score can assist the health care professional in<br>monitoring the effect of treatments on patients across<br>time.<br>Overall fracture risk will depend on many additional<br>factors that should be considered before making<br>diagnostic or therapeutic recommendations. The<br>software does not diagnose disease or recommend<br>treatment regimens. Only the health care professional<br>can make these judgements. | Unchanged |
| Technological Characteristics | | | |
| Mode of operation | Dual Energy X-ray Absorptiometry | Dual Energy X-ray Absorptiometry | Unchanged |
| Input data | Raw DXA images and patient data | Raw DXA images and patient data | Unchanged |
| Measurements<br>pro…