TBS INSIGHT

{0}------------------------------------------------ 510K Summary Page 1 of 4 medimaps group This summary of the 510(k) Premarket Notification for the medimaps group 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 : _K121716 OCT 5 2012 | Company: | medimaps group<br>Chemin des aulx, 18<br>1294 Plan les Ouates<br>Switzerland | |-------------------------|--------------------------------------------------------------------------------| | Telephone: | + (41) 22 884 86 44 | | Fax: | + (41) 22 884 83 00 | | Contact Person: | Christophe Lelong<br>Chief Operations Officer<br>e-mail: clelong@med-imaps.com | | Date Prepared: | June, 4, 2012 | | Device Names: | | | Trade/Proprietary Name: | TBS iNsight | | Common or Usual Name: | Bone microarchitecture assessment from medical imaging | | Device Class | Class II | | Classification Name: | 21 CFR 892.1170 - Bone Densitometer | #### DEVICE DESCRIPTION Product Code: TBS iNsight is a software package that provides an estimate of the trabecular bone quality based on analysis of data derived from DEXA examination. The program utilizes a quantitative bone structural algorithm that analyzes the texture of AP spine projection scans from which the Trabecular Bone Score (TBS) is mathematically derived. The results (TBS) can be used for comparison to a reference database of age-matched controls. #### INTENDED USE / INDICATIONS FOR USE KGI The Med-Imaps TBS iNsight is a software provided for use as a complement to a DEXA analysis. It computes the antero-posterior spine DEXA 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 DEXA image and has been shown to be related to bone microarchitecture and fracture risk. This data provides information independent of BMD value; it is used as a complement to the data obtained from the DEXA analysis and the clinical examination (questioning by the clinician about patient history, bioassay of bone resorption markers ... ). The TBS score can assist the health care professional in assessment of fracture risk and 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. {1}------------------------------------------------ ## PREDICATE DEVICE : ' _ The TBS iNsight software is considered substantially equivalent to FDA cleared predicate The TDO INSIGN of the both indications for use and technological characteristics. de not with regare to to treviously acquired x-ray images to provide an estimate of the bone strength and a comparison to a normative data cohort for interpretation. This predicate device is Imaging Therapeutics OsDx Hip BMD System, cleared under K082402. #### SUBSTANTIAL EQUIVALENCE The following table provides a more detailed substantial equivalence discussion : | | Predicate Device | Subject Device | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Name | OsDx Hip BMD System<br>(K082402) | TBS iNsight | | Classification | Class II | Identical | | Product Code | KGI | Identical | | Classification<br>Name | Bone Densitometer | Identical | | Classification Rule | 21 CFR 992.1170 | Identical | | Device Description | The OsDx Hip BMD System is a<br>software package that provides<br>an estimate of BMD based on<br>analysis of data derived from<br>scanned hip X-rays. The program<br>utilizes a quantitative bone<br>structural algorithm that<br>measures a composite of<br>weighted cortical and trabecular<br>parameters in proximal femur<br>projection radiographs from which<br>total hip bone mineral density<br>(BMD) is mathematically derived.<br>Image analysis can take place<br>remotely or at the point of care.<br>The results, expressed as<br>gm/cm², can be used for<br>comparison to a reference data<br>base of young normals (T-score)<br>or age-matched controls (Z-<br>Score). | TBS iNsight is a software package<br>that provides an estimate of the<br>trabecular bone quality based on<br>analysis of data derived from DEXA<br>examination data (dual-energy<br>images, Regions of interest, patients<br>data). The program utilizes a<br>quantitative bone structural algorithm<br>that analyzes the texture of AP spine<br>projection scans from which the<br>Trabecular Bone Score (TBS) is<br>mathematically derived.<br>The results (TBS) can be used for<br>comparison to a reference database<br>of age-matched controls. | | Data source | Importation of external data<br>source | Identical | | Imaging technology | X-Ray absorption | Identical | | Data analysis method | Data image processing Algorithm | Identical | | | Quantitative bone structural<br>algorithm that measures a<br>composite of weighted cortical<br>and trabecular parameters in<br>proximal femur projection<br>radiographs from which BMD is<br>mathematically derived | Quantitative bone micro-structural<br>algorithm that analyzes the porosity<br>of the trabecular bone in DEXA<br>projection images, using the<br>experimental variogram approach<br>from which the TBS is<br>mathematically derived | {2}------------------------------------------------ | | Predicate Device | Subject Device | |----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------| | Product Name · | OsDx Hip BMD System<br>(K082402) | TBS iNsight | | Data Output | Estimate of Bone Mineral Density<br>(BMD) on selected ROI<br>Combines measurements of<br>projected trabecular bone pattern,<br>with cortical bone and geometric<br>dimensions to estimate the total<br>hip BMD | TBS calculated on selected ROI<br>Analyses projected trabecular bone<br>pattern to estimate the trabecular<br>bone score (TBS) | # CONFORMITY TO RECOGNISED STANDARDS TBS iNsight has been developed in accordance with the following product standards & FDA Guidance : - IEC 62304:2006, Medical Device Software: Software Life Cycle Processes 1. - 150 14971:2007, Medical Devices: Application of Risk Management to Medical 11. Devices - General Principles of Software Validation; Final Guidance for Industry and FDA Staff 111. (2002) - Guidance for Off-the-Shelf Software Use in Medical Devices (1999) IV. - Guidance for Industry Cybersecurity for Networked Medical Devices Containing Off-V. the Shelf (OTS) Software (2005) ## PERFORMANCE BENCH TESTING | Bench Test Performance was demonstrated via the following : - Correlations between microarchitecture and TBS computed on simulated projections from µCT datasets This study was to demonstate the level of correlation between the microarchitecture parameters of the 3-dimensional (3D) bone volume using a µCT (GE-Locus) and the TBS values computed on the 2D projected image of the bone volume, using thirty human cadaveric vertebrae. Significant correlations were observed between TBS and 3D microarchitecture parameters, regardless of the projection resolution. - Correlations between microarchitecture and TBS on DEXA scans . This study was to demonstrate the correlations between the 3D microarchitecture parameters of human anteroposterior vertebrae and the TBS values computed on DEXA (Dual X-ray Absorptiometry) acquisitions, using thirty human cadaveric vertebrae. Significant correlations were detected between TBS and 3D parameters of bone microarchitecture. The study indicates that TBS adds value and power of differentiation between samples with similar BMDs but different bone microarchitectures. It strengthens our assumption that it is possible to estimate bone microarchitecture status from DEXA imaging using TBS. TBS reproducibility ex-vivo This study is to evaluate the ex-vivo reproducibility of TBS without repositioning. {3}------------------------------------------------ The study shows that the TBS ex-vivo precision error is lower than 0.02, the The Stady Shower than 1.5 %, and the least significant change is lower than 4.2 96. These results show that TBS is reproducible and, considering measurement rules rricss Toullie onow the be used to monitor microarchitecture changes across time. ## CLINICAL TESTING | The performance of TBS iNsight was evaluated via clinical studies covering the following : - Clinical Aspects diagnostic value . - Olinical Aspecte alagro alagraminate a fractured patient from a control patient (nonfractured), independently and in conjunction with BMD, has been evaluated through five cross-sectional studies. In all studies TBS was significantly lower in women with fractures versus without. - Clinical Aspects prognostic value . Gillical Aspecto - progressions that will fracture from those who will not, independently and in conjunction with BMD, has been evaluated through three longitudinal studies. In all studies spine TBS and BMD predicted fractures equally well and independently. - Clinical Aspects . - Monitoring changes across time | ୦ In the two in-vivo reproducibility studies that were conducted, the mean TBS reproducibility value (CV%) at L1-L4 achieved 1.8%, showing that TBS is reproducible as the BMD and considering rules edited by the ISCD. - Treatment follow-up | o rreatment follow up BMD and TBS values in patients treated either with zoledronic acid (vs placebo), teriparatide (vs ibandronate) or bisphosphonates (vs placebo), Strontium Ranelate (vs Alendronate), Tamoxifen & Exemestane (vs placebo) and Denosumab (vs placebo). For all six studies, the results were consistent with published literature. with published morations. monitor change across time, particularly for treated patients. - Clinical Aspects Age-related US reference data . Olinical Aspedo - Aige Iding Non-Hispanic white US women aged 30 to 90 years has A & Gainludi Cid y in Civilian obtained for all lumbar vertebral combinations (L1, L2, L3, L4) decreased significantly with age. These decreases seen in lumbar spine TBS reflect age-related microarchitecture changes at spine. # CONCLUSION medimaps group has demonstrated through the performance testing that the safety and nfounleps group noo Neight is not compromised and that they met all acceptance criteria, demonstrating that it can be considered substantially equivalent to the predicate device. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to represent the department's mission of protecting the health of all Americans and providing essential human services. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 5 2012 OCT MEDIMAPS Group SA C/O Christophe Lelong Chief Operations Officer 18 Chemin des Aulx PLAN LES OUATES 1228 SWITZERLAND Re: K121716 Trade/Device Name: Med- Imaps TBS iNsight Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: Class II Product Code: KGI Dated: August 24, 2012 Received: August 30, 2012 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. If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of {5}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mahal D. Oken. for Janine M. Morris Director Division of Radiological Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # INDICATIONS FOR USE The Med-Imaps TBS iNsight is a software provided for use as a complement to a DEXA analysis. It computes the antero-posterior spine DEXA examination file and calculates a andrylis. It oompated the anters ps) that is compared to those of the age-matched controls. Soore (Trasecure Bono one texture of the DEXA image and has been shown to be related to The TOO is defired from the frexture risk. This data provides information independent of BMD bone intoroundstare annolement to the data obtained from the DEXA analysis and the value, it is been not on the clinician about patient history, bioassay of bone resorption markers ... ). resorption maners... }} The TBS score can assist the health care professional in assessment of fracture risk and in monitoring the effect of treatments on patients across time. T monitoring the oneot on many additional factors that should be considered before making diagnostic or therapeutic recommendations. The software does not diagnose making are recommend treatment regimens. Only the health care professional can make these judgments. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) (Division Sign-Off) Office of in Vitro 510K K121716 Page 1 / 1