TBS iNsight

K152299 · Medimaps Group SA · KGI · Apr 29, 2016 · Radiology

Device Facts

• Record ID: K152299
• Device Name: TBS iNsight
• Applicant: Medimaps Group SA
• Product Code: KGI · Radiology
• Decision Date: Apr 29, 2016
• 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 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 diagnose disease, or recommend treatment regimens. Only the health care professional can make these judgments.

Device Story

TBS iNsight is software used by clinicians to analyze raw DXA images of the lumbar spine. It calculates a Trabecular Bone Score (TBS) based on image texture, which serves as a proxy for bone microarchitecture. The software integrates this TBS with the WHO FRAX tool to provide an adjusted 10-year fracture risk probability. It operates as a complement to standard DXA analysis and clinical history. Physicians use the output—TBS scores, T-scores, Z-scores, and fracture risk percentages—alongside other clinical risk factors to aid in diagnosing osteoporosis and monitoring treatment efficacy. The device does not diagnose disease or recommend specific treatments; it provides data to support clinical decision-making.

Clinical Evidence

Clinical evidence includes three published studies and a report from the Frax group validating the use of TBS as an independent clinical risk factor to adjust WHO FRAX probabilities. Additional evidence includes a cohort study of 29,000 Canadian women to establish fracture risk categories, with subsequent studies confirming applicability to the US population. Normative data was derived from the NHANES IV database, covering a diverse US population (Non-Hispanic white, Non-Hispanic black, and Mexican men and women, aged 20-85) to establish age-related TBS trends.

Technological Characteristics

Software-based analysis of DXA images. Utilizes Dual Energy X-ray Absorptiometry (DXA) input. Provides Lumbar Spine TBS, TBS T-scores/Z-scores, and FRAX-adjusted fracture risk. Developed in accordance with IEC 62304 (software life cycle), ISO 14971 (risk management), and FDA guidance for off-the-shelf software and cybersecurity.

Indications for Use

Indicated for Caucasian and Asian men and post-menopausal women aged 40-90 years as a complement to DXA analysis and clinical examination to assess bone microarchitecture and 10-year fracture risk (hip and major osteoporotic).

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

• Med-Imaps TBS iNsight (K121716)
• GE Lunar FRAX™ 10-year Fracture Risk software option (K082317)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 29, 2016

Medimaps Group SA % Mr. Christophe Lelong Chief Technical Officer 18, Chemin des Aulx CH-1228 Plan les Ouates SWITZERLAND

Re: K152299

Trade/Device Name: TBS iNsight Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: II Product Code: KGI Dated: March 22, 2016 Received: March 25, 2016

Dear Mr. Lelong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K152299

Device Name TBS iNsight

#### 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)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(K) SUMMARY

This summary of the 510(k) Premarket Notification for the TBS iNsight software is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### The assigned 510(k) number is : K152299

| Owner: | Medimaps group<br>Chemin des aulx, 18<br>1294 Plan les Ouates<br>Switzerland |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Telephone:<br>Fax: | + (41) 22 884 86 44<br>+ (41) 22 794 66 65 |
| Contact Person: | Christophe Lelong<br>Chief Technology Officer<br>e-mail: [e-mail] |
| Date Prepared: | April 25, 2016 |
| Device Names: | |
| Trade/Proprietary Name: | TBS iNsight |
| Common or Usual Name: | TBS iNisght® software, and its calibration phantom, for analysis<br>of bone microarchitecture and osteoporosis management. |
| Device Class | Class II |
| Classification Name:<br>Product Code: | 21 CFR 892.1170 - Bone Densitometer<br>KGI |

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Image /page/4/Picture/0 description: The image contains the logo for Medimaps. The logo consists of the word "medimaps" in a sans-serif font, with the "m" in lowercase. To the right of the word is a graphic element composed of nine small squares arranged in a 3x3 grid. The squares are in two colors: teal and black, with the teal squares forming a diagonal line from the upper left to the lower right of the grid.

## DEVICE DESCRIPTION

TBS iNsight is a software provided for use as a complement to to both DXA analysis and clinical examination. It computes the AP spine DXA examination file and calculates the 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.

It provides as an option an assessment of 10-year fracture risk, based on the WHO's FRAX® Tool, after adjustment for the TBS.

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.

## INTENDED USE / INDICATIONS 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 agematched 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 vears 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.

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Image /page/5/Picture/0 description: The image shows the logo for Medimaps. The logo consists of the word "medimaps" in a sans-serif font, with the "m" in lowercase and the rest of the letters in lowercase. To the right of the word is a small graphic consisting of nine squares arranged in a 3x3 grid. The squares are colored in a teal and black pattern.

## PREDICATE DEVICES

The TBS iNsight software is considered substantially equivalent to FDA cleared predicate devices with regards to both indications for use and technological characteristics. In that both TBS iNsight and its predicate devices provide an assessment of the risk for fracture of patients based on DXA scans.

This predicate devices are Med-Imaps TBS iNsight, cleared under K121716, and GE Lunar FRAX™ 10-year Fracture Risk software option, cleared under K082317.

# SUBSTANTIAL EQUIVALENCE

The following table provides a more detailed substantial equivalence discussion :

| | Subject Device | Predicate Device 1 | Predicate Device 2 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | TBS iNsight | TBS iNsight | GE Lunar FRAX™ 10-year Fracture<br>Risk software option |
| Classification | Class II | Identical | Identical |
| Product Code | KGI | Identical | Identical |
| Classification<br>Name | Bone Densitometer | Identical | Identical |
| Classification Rule | 21 CFR 892.1170 | Identical | Identical |
| 510(k) | K152299 | K121716 | K082317 |
| Intended use | TBS iNsight is a software provided for<br>use as a complement to both DXA<br>analysis and clinical examination. It<br>computes the antero-posterior spine<br>DXA examination file and calculates a<br>score (Trabecular Bone Score - TBS)<br>that is compared to those of the age-<br>matched controls. The TBS is derived<br>from the texture of the DXA image and<br>has been shown to be related to bone<br>microarchitecture.<br><br>TBS iNsight provides as an option an<br>assessment of 10-year fracture risk. It<br>provides an estimate of 10-year<br>probability of hip fracture and 10-year<br>probability of a major osteoporotic<br>fracture (clinical spine, forearm, hip or<br>shoulder fracture). This estimate is<br>based on the WHO's FRAX® Fracture<br>Risk Assessment Tool, after adjustment<br>for the TBS. The tool has been<br>validated for Caucasian and Asian men<br>and post-menopausal women between<br>40 and 90 years old.<br><br>TBS provides information independent<br>of BMD value; it is used as a<br>complement to the data obtained from<br>the DXA analysis and the clinical<br>examination (questioning by the<br>clinician about patient history, bioassay<br>of bone resorption markers...).<br><br>The results can be used by a physician<br>in conjunction with other clinical risk<br>factors as an aid in the diagnosis of | The Med-Imaps TBS iNsight is a<br>software provided for use as a<br>complement to a DXA analysis. It<br>computes the antero-posterior spine<br>DXA examination file and calculates a<br>score (Trabecular Bone Score - TBS)<br>that is compared to those of the age-<br>matched controls. The TBS is derived<br>from the texture of the DXA image and<br>has been shown to be related to bone<br>microarchitecture and fracture risk.<br><br>This data provides information<br>independent of BMD value; it is used as<br>a complement to the data obtained<br>from the DXA analysis and the clinical<br>examination (questioning by the<br>clinician about patient history, bioassay<br>of bone resorption markers...).<br><br>The results can be used by a physician<br>in conjunction with other clinical risk<br>factors as an aid in the diagnosis of | The FRAX™ 10-Year Fracture Risk<br>software option is an accessory to<br>currently marketed GE Lunar bone<br>densitometer devices, which are<br>intended to estimate the bone mineral<br>density and body composition (lean and<br>fat tissue mass) of patients when<br>medically indicated by their physicians.<br><br>This software option is intended to<br>provide an assessment of 10-year<br>fracture risk. The option provides an<br>estimate of 10-year probability of hip<br>fracture and 10-year probability of a<br>major osteoporotic fracture (clinical<br>spine, forearm, hip or shoulder<br>fracture). This estimate is based on the<br>patient's age, sex, country, ethnicity,<br>height, weight, femur neck BMD T-<br>score, and the presence or absence of<br>several risk factors and is computed<br>using the FRAX™ Fracture Risk<br>Assessment Tool endorsed by the<br>World Health Organization (WHO). The<br>tool has been validated for men and<br>post-menopausal women between 40<br>and 90 years old. The output is<br>provided in a separate screen display<br>and report that can be viewed or<br>printed or exported to an optional<br>physician report generator tool.<br><br>The results can be used by a physician<br>in conjunction with other clinical risk<br>factors as an aid in the diagnosis of |
| | Subject Device | Predicate Device 1 | Predicate Device 2 |
| Product Name | TBS iNsight | TBS iNsight | GE Lunar FRAX™ 10-year Fracture<br>Risk software option |
| | osteoporosis and other medical<br>conditions leading to altered trabecular<br>bone microarchitecture, and ultimately<br>in the assessment of fracture risk. | | osteoporosis and medical conditions<br>leading to reduced bone density, and<br>ultimately in the assessment of fracture<br>risk. |
| | The TBS score can assist the health<br>care professional in monitoring the<br>effect of treatments on patients across<br>time. | The TBS score can assist the health<br>care professional in assessment of<br>fracture risk and in monitoring the effect<br>of treatments on patients across time. | |
| | Overall fracture risk will depend on<br>many additional factors that should be<br>considered before making diagnostic or<br>therapeutic recommendations. The<br>software does not diagnose disease, or<br>recommend treatment regimens. Only<br>the health care professional can make<br>these judgments. | Overall fracture risk will depend on<br>many additional factors that should be<br>considered before making diagnostic or<br>therapeutic recommendations. The<br>software does not diagnose disease, or<br>recommend treatment regimens. Only<br>the health care professional can make<br>these judgments. | |
| Software Level of<br>concern | Moderate | Identical | Identical |
| Technique | Dual Energy X-ray Absorptiometry<br>(DXA) | Identical | Identical |
| Input Data | Raw DXA images and patients data | Identical | Identical |
| Measurements<br>provided | •Lumbar Spine TBS<br><br>•TBS T-score and Z-score<br><br>•TBS Category of fracture risk: high,<br>medium, or low<br><br>•FRAX® Adjusted for TBS Estimate<br>of 10-Year Fracture Risk based on<br>clinical risk factors, BMD and TBS:<br>Indication of % probability of a hip<br>fracture in the next 10 years or %<br>probability of a major osteoporotic<br>fracture (clinical spine, forearm, hip<br>or shoulder fracture) in the next 10<br>years | •Lumbar Spine TBS<br><br>•Indication of fracture risk based on<br>the patient's TBS | •Lumbar Spine BMD<br><br>•Femur BMD<br><br>•BMD T-score and Z-score<br><br>•WHO Category of bone loss:<br>normal, osteopenia (low bone<br>mass), or osteoporotic<br><br>•WHO FRAX™ Estimate of 10-Year<br>Fracture Risk based on BMD and<br>clinical risk factors: Indication of %<br>probability of a hip fracture in the<br>next 10 years or % probability of a<br>major osteoporotic fracture (clinical<br>spine, forearm, hip or shoulder<br>fracture) in the next 10 years. |

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Based on the comparison given above and the discussion of the intended use, technological characteristics, input data and measurements provided by the subject and predicate devices, the subject device is substantially equivalent to the cited predicate devices.

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Image /page/7/Picture/0 description: The image contains the logo for Medimaps. The logo features the word "medimaps" in a sans-serif font, with "medimaps" in lowercase letters. To the right of the wordmark is a stylized graphic composed of small squares arranged in a grid-like pattern. The squares are in two colors: teal and black.

## CONFORMITY TO RECOGNISED STANDARDS

TBS iNsight has been developed in accordance with the following product standards & FDA Guidance :

- 1. IEC 62304:2006, Medical Device Software: Software Life Cycle Processes
- II. ISO 14971:2007, Medical Devices: Application of Risk Management to Medical Devices
- III. General Principles of Software Validation: Final Guidance for Industry and FDA Staff (2002)
- Guidance for Off-the-Shelf Software Use in Medical Devices (1999) IV.
- V. Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software (2005)

#### PERFORMANCE BENCH TESTING

No new bench testing since K121716.

## CLINICAL TESTING

The performance of TBS iNsight was evaluated via clinical studies covering the following :

- Clinical Aspects FRAX adjusted for TBS ● TBS is an independent clinical risk factor for fracture and can be used in association with WHO's FRAX® to adjust and improve the FRAX® probability of hip fracture and of major osteoporotic fracture in postmenopausal women and in men. This was demonstrated using 3 published studies and a report provided by the Frax group to Medimaps.
- Clinical Aspects TBS iNstats ●

TBS iNsight provides a breakdown of the patients DXA exams based on their BMD and TBS values. The fracture risk is each cell has been evaluated based on a cohort of 29,000 Canadian women. Two studies have been used to demonstrate that the TBS categories of fracture risk computed from the Canadian study are applicable to the US population and another study to demonstrate that the TBS values of the population included in the Canadian study are similar to the normal TBS values of the US population.

- Normative data ●
A US clinical study including Non-Hispanic white US women and men. Non-Hispanic black US women and men and Mexican women and men, aged 20 to 85 years has been conducted. The data provided from the Nhanes IV database, which is the reference database for the US. TBS values obtained for all lumbar vertebral combinations (L1, L2, L3, L4) decreased significantly with age. These decreases seen in lumbar spine TBS reflect the age-related microarchitecture changes at spine.

Based on this clinical studies, no new questions arise regarding the safety and effectiveness of this device, which can be considered substantially equivalent to the predicate devices.

#### CONCLUSION

Medimaps group has demonstrated through the testings that the safety and effectiveness of TBS iNsight is not compromised and that they met all acceptance criteria, demonstrating that it can be considered substantially equivalent to the predicate devices.